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Name (Synonyms) | Correlation | |
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drug3509 | Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki | 0.28 |
drug3506 | Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki | 0.28 |
drug3520 | Two doses of placebo at the schedule of day 0,28 Wiki | 0.28 |
Name (Synonyms) | Correlation | |
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drug3587 | Vascular occlusion test Wiki | 0.20 |
drug2485 | Pioglitazone 30 mg Wiki | 0.20 |
drug3500 | Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 Wiki | 0.20 |
drug3515 | Two doses of placebo at the routine vaccination schedule Wiki | 0.20 |
drug3490 | Trier Social Stress Test Wiki | 0.20 |
drug3513 | Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly Wiki | 0.20 |
drug3493 | Tuberculin test Wiki | 0.20 |
drug3595 | VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) Wiki | 0.20 |
drug3501 | Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki | 0.20 |
drug3512 | Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 Wiki | 0.20 |
drug1030 | DiaBetter Together Wiki | 0.20 |
drug2218 | No intervention - quality of life measure Wiki | 0.20 |
drug3739 | antidiabetic treatment Wiki | 0.20 |
drug3572 | VITROS Anti-SARS-CoV-2 IgG test Wiki | 0.20 |
drug3332 | Tele-interventions related to diabetes management and mental well-being Wiki | 0.20 |
drug3581 | Vaginal fluid Covid-19 PCR test Wiki | 0.20 |
drug3514 | Two doses of placebo at the emergency vaccination schedule Wiki | 0.20 |
drug1488 | Hospital: DD-CA Wiki | 0.20 |
drug3552 | Use of Facetime with child and parents during induction Wiki | 0.20 |
drug3484 | Treatment for COVID-19 Wiki | 0.20 |
drug1383 | Glycaemic levels Wiki | 0.20 |
drug3593 | Venous blood was collected for biochemistry testing Wiki | 0.20 |
drug1028 | Dexcom G6 Wiki | 0.20 |
drug3580 | Vaccine coverage assessment Wiki | 0.20 |
drug3562 | V-SARS Wiki | 0.20 |
drug1863 | Losmapimod oral tablet Wiki | 0.20 |
drug3863 | hospitalisation, necessity of ICU, mortality rate, lung involvement Wiki | 0.20 |
drug1829 | Linagliptin 5 MG Wiki | 0.20 |
drug3507 | Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki | 0.20 |
drug3664 | Weight Counseling Wiki | 0.20 |
drug3640 | Viusid and Asbrip Wiki | 0.20 |
drug3852 | glucose control and sensor usage Wiki | 0.20 |
drug3961 | no interventional study Wiki | 0.20 |
drug3479 | Travelan OTC Wiki | 0.20 |
drug3503 | Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki | 0.20 |
drug3576 | VXA-CoV2-1 Wiki | 0.20 |
drug2433 | Peer Mentor Delivery Wiki | 0.20 |
drug1911 | MANAGEMENT OF COVID-19 Wiki | 0.20 |
drug1700 | Intervention for TECC Model Wiki | 0.20 |
drug3555 | Use of the pinpointIQ solution (physIQ, Inc.) Wiki | 0.20 |
drug3486 | Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days : Wiki | 0.20 |
drug3508 | Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Wiki | 0.20 |
drug1489 | Hospital: Usual Care (UC) Wiki | 0.20 |
drug3502 | Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Wiki | 0.20 |
drug3461 | Tranexamic acid Wiki | 0.14 |
drug3546 | Unfractionated heparin Wiki | 0.14 |
drug3523 | UB-612 Wiki | 0.14 |
drug689 | Canakinumab Wiki | 0.14 |
drug2780 | Radiation therapy Wiki | 0.14 |
drug3958 | no intervention Wiki | 0.12 |
drug4087 | standard of care Wiki | 0.11 |
drug2763 | REGN10933+REGN10987 combination therapy Wiki | 0.10 |
drug3340 | Telemedicine Wiki | 0.10 |
drug2317 | Online Survey Wiki | 0.09 |
drug2557 | Placebo oral tablet Wiki | 0.03 |
drug2490 | Placebo Wiki | 0.03 |
drug1507 | Hydroxychloroquine Wiki | 0.02 |
Name (Synonyms) | Correlation | |
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D003922 | Diabetes Mellitus, Type 1 NIH | 0.52 |
D003924 | Diabetes Mellitus, Type 2 NIH | 0.40 |
D044882 | Glucose Metabolism Disorders NIH | 0.28 |
Name (Synonyms) | Correlation | |
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HP:0000819 | Diabetes mellitus HPO | 0.98 |
HP:0100651 | Type I diabetes mellitus HPO | 0.49 |
HP:0005978 | Type II diabetes mellitus HPO | 0.40 |
Name (Synonyms) | Correlation | |
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HP:0000818 | Abnormality of the endocrine system HPO | 0.14 |
HP:0001392 | Abnormality of the liver HPO | 0.07 |
Navigate: Correlations HPO
There are 26 clinical trials
The overarching goal of this proposal is to understand the comparative effectiveness of obesity counseling as covered by CMS in improving weight loss for adults either with or at high risk of type 2 diabetes. CMS and most insurers now include obesity screening and counseling benefits, with no cost sharing to patients. Since overweight patients are at highest risk for diabetes, improved weight management services could prevent diabetes and its negative health outcomes. Beneficiaries with obesity are eligible for up to 20 face-to-face visits for weight counseling in the primary care setting. The investigators propose comparing weight and diabetes outcomes in three states using EHR and claims data before and after this policy was implemented by leveraging the novel infrastructure of the Patient-Centered Outcomes Research Institute-funded PaTH Clinical Data Research Network. Following developments during the COVID-19 pandemic, the investigators further plan to leverage our study infrastructure across five health systems to understand the comparative effectiveness of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes and how these approaches impact the subgroup of patients with COVID-19.
Description: Weight change during counseling and/or % of weight change during program and maintained over remaining time period will be assessed in both the diabetes and pre-diabetes cohorts.
Measure: Weight change Time: 10 yearsDescription: In the pre-diabetes cohort, diabetes incidence will be determined as the % of patients who develop diabetes following weight counseling. In the diabetes cohort, uncontrolled diabetes will be measured.
Measure: Diabetes Incidence Time: 10 yearsDescription: Incidence of hospitalization will be assessed for COVID-19 positive patients
Measure: Hospitalization Time: 1 yearDescription: Incidence of intubation will be assessed for COVID-19 positive patients
Measure: Intubation Time: 1 yearDescription: Incidence of death will be assessed for COVID-19 positive patients
Measure: Death Time: 1 yearDiaBetter Together is a strengths-based peer support intervention delivered to young adults (age 17-25) by trained Peer Mentors (age 20-35) during the transition between pediatric and adult diabetes care. The aims of this proposed randomized controlled trial are to evaluate the impact of the intervention on glycemic control (primary), time to first adult care visit, adherence, and psychosocial outcomes (secondary) in young adults with T1D after 12 months.
Description: HbA1c is the average blood glucose over 3-4 months. The American Diabetes Association recommends an HbA1c target of <7.0%. HbA1c is collected via fingerstick/blood assay at routine diabetes visits and will be extracted from the medical record at each clinic visit during the study period. At Baseline and 12 months, HbA1c will be collected using the following methods: Collection of most recent HbA1c from review of electronic medical chart (Texas Children's or Baylor College of Medicine) or medical records from outside provider (obtained with written permission from participant). A dried blood spot at-home Hemoglobin A1c kit (Whatman 903 card, BD Microtainer HI-Flow Contact-Activated Lancet) will be mailed to the participant to complete and return to the study team for analysis on the Vitros 4600 HbA1c assay (correlated with the DCA 2000). Collected for young adult participants in both arms, not Peer Mentors.
Measure: Glycemic Control (HbA1c) Time: Baseline through 12-Month Post-RandomizationDescription: Time will start on the date of the last pediatric care visit (may differ from date of enrollment in study). The event of interest is the date of the first adult care visit. Participants who do not follow-up with an adult care provider within 12 months of the last pediatric visit will be censored for the event at the 12-month time point. Collected for young adult participants in both arms, not Peer Mentors.
Measure: Time to First Adult Care Visit Time: 12-Month Post-RandomizationDescription: The Self-Care Inventory-Revised, Short Form (SCI-RSF) is a 9-item measure that asks respondents the frequency with which they completed diabetes self-management tasks in the past 1-2 months. Item responses range from (1) Never to (5) Always, higher scores = higher adherence. Collected for young adult participants in both arms (baseline, 6 mo, 12 mo) and Peer Mentors (pre- and post-involvement in study).
Measure: Diabetes Self-Management/Adherence (Self-Care Inventory-Revised, Short Form) Time: Baseline, 6-Month Post-Randomization, & 12-Month Post-RandomizationDescription: The Type 1 Diabetes and Life (T1DAL) measure assesses diabetes-specific health-related quality of life. Participants will complete the T1DAL version for their age (Adolescent: 12-17, 23 items; Young Adult: 18-25, 27 items; Adult-1: 26-45, 27 items), which asks respondents to rate the degree to which each item is true about their everyday quality of life with diabetes. Items responses range from 1 (not at all true) to 5 (very true) and total and sub-scales scores are calculated from 1-100 (higher = better quality of life). Collected for young adult participants in both arms (baseline and 12 mo) and Peer Mentors (pre- and post-involvement in study).
Measure: Health-Related Quality of Life (Type 1 Diabetes and Life) Time: Baseline and 12-Month Post-RandomizationDescription: The Diabetes Strengths and Resilience (DSTAR) measure assesses participants' self-perceptions about what they do well with diabetes (known as diabetes strengths). Participants will complete the Young Adult version of the DSTAR, which asks respondents to rate how often the items represent their experiences/perspectives about their diabetes strengths. Items responses range from 0 (never) to 4 (almost always) and are calculated for total and subscale scores (higher = more strengths). Collected for young adult participants in both arms, not Peer Mentors.
Measure: Diabetes Strengths (Diabetes Strengths and Resilience measure) Time: Baseline, 6-Month Post-Randomization, & 12-Month Post-RandomizationDescription: The Brief 2-Way Social Support Scale (Brief-2SSS) is a 12-item measure that assesses participants' experiences of giving and receiving social support. There are four scales: giving emotional support, giving instrumental support, receiving emotional support, and receiving instrumental support. Items responses range from 0 (not at all) to 5 (always) and are calculated for total and subscale scores (higher = more perceived support). Collected for young adult participants in both arms (baseline, 6, & 12 mos) and Peer Mentors (pre- and post-involvement in study).
Measure: Social Support (Brief 2-Way Social Support Scale) Time: Baseline, 6-Month Post-Randomization, & 12-Month Post-RandomizationDescription: The Diabetes Distress Scale for Adults with T1D (DDS-T1D) is a 28-item self-report scale that measures participants' experiences with distress related to living with diabetes. It assesses seven dimensions of distress: powerlessness, management distress, hypoglycemia distress, negative social perceptions, eating distress, physician distress, and friends/family distress. Items responses range from 1 (not a problem) to 6 (a very serious problem) and are calculated for total and subscale scores (higher = more distress). Collected for young adult participants in both arms (baseline, 6 mo, 12 mo) and Peer Mentors (pre- and post-involvement in study).
Measure: Diabetes Distress (Diabetes Distress Scale for Adults with T1D) Time: Baseline, 6-Month Post-Randomization, & 12-Month Post-RandomizationDescription: The PROMIS Short Form Depression 4a consists of 4 items that are pulled from the PROMIS Depression Item Bank v1.0. These items assess how often the individual has been bothered by depression-related symptoms, including negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), and decreased positive affect and engagement (loss of interest, meaning, and purpose), over the last 7 days. Items responses range from 1 (never) to 6 (always) and are calculated into a total score (higher = more depressive symptoms). Collected for young adult participants in both arms, not Peer Mentors.
Measure: Depressive Symptoms (PROMIS Short Form Depression 4a) Time: Baseline, 6-Month Post-Randomization, & 12-Month Post-RandomizationDescription: The PROMIS Short Form Emotional Support 4a assesses perceived feelings of being cared for and valued as a person and having supportive relationships. Participants respond to 4 items on a scale from 1(Never) to 5 (Always) and are calculated into a total score (higher = more perceived support). Collected for young adult participants in both arms, not Peer Mentors.
Measure: Emotional Support (PROMIS Short Form Emotional Support 4a) Time: Baseline, 6-Month Post-Randomization, & 12-Month Post-RandomizationDescription: The PROMIS Short Form Informational Support 4a assesses perceptions about the information or resources others provide to them (adequacy, availability, helpfulness). Participants respond to 4 items on a scale from 1(Never) to 5 (Always) and are calculated into a total score (higher = more perceived support). Collected for young adult participants in both arms, not Peer Mentors.
Measure: Informational Support (PROMIS Short Form Informational Support 4a) Time: Baseline, 6-Month Post-Randomization, & 12-Month Post-RandomizationDescription: The PROMIS Short Form Social Isolation item is a single-item measure from the PROMIS item bank that assesses participants' feelings of being isolated from other people. There is no time frame for responding to this measure. Participants respond to 1 item on a scale from 1 (Never) to 5 (Always), which is calculated into a total score (higher = more perceived isolation). Collected for young adult participants in both arms (baseline, 6, & 12 mos), not Peer Mentors.
Measure: Social Isolation (PROMIS Short Form Social Isolation item) Time: Baseline, 6-Month Post-Randomization, & 12-Month Post-RandomizationDescription: The Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth (READDY) is a 46-item self-report scale that measures participants' preparation for the transition to adult diabetes care, including: knowledge of diabetes, navigation of diabetes care, management skills and behaviors, and insulin pump skills if applicable. Only 18 items from the 3 subscales [Knowledge (4 items - baseline and 12 mos only), Navigation (13 items, baseline, 6 and 12 mos), Health Behaviors (1 item, baseline and 12 mo only)] will be administered for this study. Items responses range from 0 (haven't thought about it) to 5 (yes, I can do this) and are calculated for a total score (higher = more ready). Collected for young adult participants in both arms (baseline, 6, & 12 mos), not Peer Mentors.
Measure: Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) Time: Baseline, 6-Month Post-Randomization, & 12-Month Post-RandomizationDescription: The Satisfaction with Life Scale (SWLS) is a 5-item self-report scale that measures participants' perceptions about their life overall. Items responses range from 1 (strongly disagree) to 7 (strongly agree) and are calculated for a total score (higher = better quality of life). Collected for young adult participants in both arms (baseline and 12 mo), not Peer Mentors.
Measure: General Quality of Life (Satisfaction with Life Scale) Time: Baseline and 12-Month Post-RandomizationDescription: The Pittsburgh Sleep Quality Index (PSQI) - Revised is a 9-item, self-report scale that measures several aspects of participants' sleep, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, and diabetes-related sleep disturbance (new items - not in original measure). This revised version excludes the following components from the original measure: daytime dysfunction and use of sleep-promoting medication. Participants complete 4 open-ended items on sleep latency, efficiency, and duration, 4 scaled-response items on sleep disturbance and diabetes-related sleep disturbance ranging from 0 (Not during past month) to 3 (Three or more times a week), and 1 scaled-response item on subjective sleep quality ranging from 0 (Very good) to 3 (Very bad). A global score is not calculated; subscales are calculated independently (higher = worse sleep quality). Collected for young adult participants in both arms (baseline and 12 mo), not Peer Mentors.
Measure: Subjective Sleep Experiences (Pittsburgh Sleep Quality Index - Revised) Time: Baseline and 12-Month Post-RandomizationDescription: The Oelsner MESA COVID-19 - Revised is a 10-item self-report scale that measures participants' social distancing and hygiene behaviors during the COVID-19 pandemic. Participants rate how often they engaged in specific precautionary behaviors at the peak of the pandemic (Spring/Summer 2020) and over the past month. Item responses range from 0 (Never) to 4 (Always) and are calculated for a total score (higher = engaged in precautionary behaviors more frequently). Collected for young adult participants in both arms (baseline and 12 mo) and Peer Mentors (pre-involvement in study).
Measure: COVID-19 Protective Behaviors (Oelsner MESA COVID-19 - Revised) Time: Baseline and 12-Month Post-RandomizationDescription: The COVID-19 Experiences Questionnaire for Young Adults with T1D (CEQ-YAD) is a 33-item, self-report questionnaire assessing how the COVID-19 pandemic impacted young adults with type 1 diabetes, including items about: (1) overall impact of the COVID-19 pandemic, (2) changes in life circumstances due to the pandemic, (3) self and family exposure to COVID-19, (4) changes in diabetes management due to the pandemic, and (5) changes in everyday activities and mood due to the pandemic. It uses mixed-methods, including scaled, Yes/No, and open-ended items asking about participants' experiences during the peak of the pandemic (Spring/Summer 2020) and over the past 12 months. A total score is calculated by summing response values from scaled and Yes/No items (higher = most negative/worst impact from COVID-19 pandemic). Collected for young adult participants in both arms (baseline and 12 mo) and Peer Mentors (pre-involvement in study).
Measure: COVID-19 Experiences (COVID-19 Experiences Questionnaire for Young Adults with T1D) Time: Baseline and 12-Month Post-RandomizationDescription: The Stressful Event Questionnaire assess the number and types of stressful life events experienced during the past year. Participants are asked to select any stressful life events from a list (for example: financial stressors, legal troubles, change in employment, etc.) and to include any stressful events experienced that are not already listed. A total score is calculated by summing the number of events selected or included by the participant (higher = more stressful live events experienced). Collected for young adult participants in both arms (baseline and 12 mo), not Peer Mentors.
Measure: Stressful Events (Stressful Event Questionnaire) Time: Baseline and 12-Month Post-RandomizationCOVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death. Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study. The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies. This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.
Description: Prevalence of severe forms among all COVID-19 patients with diabetes
Measure: Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19 Time: 1 monthDescription: Use the body weight, type of diabetes, tglycemic control (HbA1C at admission), the comorbidities and complications associated with diabetes and finally the usual therapies.
Measure: describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19 Time: 1 monthDescription: death at 7 days after admission, hospital death and date of death, total length of hospitalization and discharge procedures, serious form requiring the use of artificial ventilation with tracheal intubation and date of use of this treatment, decision to limit
Measure: describe the prognosis of hospitalized subjects with diabetes and COVID-19 Time: 1 monthDescription: care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7
Measure: describe the care management of hospitalized subjects with diabetes and COVID-19 Time: 1 monthINTRODUCTION In critical situations, such as the current COVID 19 pandemic, themes of fear, uncertainty and stigmatization are common and constitute barriers to appropriate medical and mental health interventions. These challenges, when faced by those who live with a chronic disease, such as diabetes mellitus (DM), can negatively influence quality of life and adherence to treatment, compromising the control of the disease. OBJECTIVES The present study aims to investigate the effectiveness of a tele-intervention during the COVID-19 pandemic in improving glycemic control, lipid profile, blood pressure levels and parameters of medication adherence, mental well-being and sleep quality in patients with type 1 DM and type 2 DM. METHODS A randomized clinical trial will be carried out with patients with a previous diagnosis of type 1 DM and type 2 DM, who are registered at the Hospital de ClÃnicas de Porto Alegre (HCPA). Inclusion criteria will be age greater than or equal to 18 years, collection of HbA1c in the HCPA laboratory in January, February or March 2020 and availability to receive weekly phone calls. Patients will be randomized, stratified by type of diabetes, in two groups: G1: participants will receive a tele-intervention by a case manager weekly to discuss topics related to diabetes management and mental well-being during the social distancing period ; G2: participants will receive the usual care. The primary outcome assessed will be the variation in HbA1c levels comparatively between groups, with or without a tele-guided strategy, after four months of social distancing (or as long as the recommendation of social distancing measures remains). Secondary outcomes will include experiencing confirmation of COVID-19 infection, variation in lipid profile, blood pressure levels and variation in parameters of emotional distress related to diabetes, eating disorders, medication adherence, symptoms minor psychiatric disorders and altered sleep patterns, which will be evaluated with specific and validated scales. According to the sample calculation, 150 patients will be included in the study (92 with type 2 DM and 58 with type 1 DM). Analysis by intention to treat will be performed separately for patients with type 1 DM and with type 2 DM. SCHEDULE The proposed experiment will start immediately after approval of this project by the research ethics committee. The duration of the proposed intervention is 4 months (or as long as the recommendation of social distancing measures remains. This means that the study may be completed before or after that period, based on national recommendations for social distancing in Brazil), with a data analysis plan and publication of the results until September 2020.
Description: Variation in HbA1c levels comparatively between groups after the period of social distancing measures.
Measure: Variation in HbA1c levels Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Confirmation of coronavirus infection by rapid test
Measure: COVID-19 infection Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Comparison of the lipid profile of the last year with the lipid profile after the intervention between the groups.
Measure: Variation in lipid profile Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Comparison of the blood pressure level of the last consultation with the pressure after the intervention between the groups.
Measure: Variation in blood pressure levels Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of emotional distress associated with the routine of living with diabetes - B-PAID (Brazilian Problem Areas In Diabetes Scale)
Measure: Comparison of emotional distress associated with the routine of living with diabetes after intervention between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of eating disorders - EAT - 26 SCALE (Teste de Atitudes Alimentares)
Measure: Comparison of eating disorders between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of adherence to the proposed clinical treatment - SCI R (Self-Care Inventory - revised)
Measure: Comparison of adherence to the proposed clinical treatment between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of minor psychiatric disorders - SRQ 20 (Self Report Questionnaire)
Measure: Comparison of minor psychiatric disorders between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of sleep pattern changes - MSQ (Mini Sleep Questionnaire)
Measure: Comparison of sleep pattern changes between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)The coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.
Description: Clinical change is defined as 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19: 0 - No clinical or virological evidence of infection; 1 - No limitation of activities; 2 - Limitation of activities; 3 - Hospitalized, no oxygen therapy; 4 - Oxygen by mask or nasal prongs; 5 - Non-invasive ventilation or high-flow oxygen; 6 - Intubation and mechanical ventilation; 7 - Ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation; 8 - Death.
Measure: Time to clinical change Time: 28 daysDescription: Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19.
Measure: Percent of patients with clinical improvement. Time: 28 daysThis is a two-arm, open-label, randomized, phase 2, controlled center study to assess the safety and efficacy of Viusid and Asbrip in patients with mild to moderate symptoms of respiratory disease caused by 2019 coronavirus infection. Patients will be randomized to receive daily doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours or standard care. Viusid and Asbrip will be administered orally. A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip plus standard of care and 20 control patients with standard of care. Treatment duration: 21 days.
Description: The number of days required to achieve a score of 0 for each symptom category. Resolution of symptoms: fever (time frame: 21 days) Fever based on a 0-3 scale: 0 = ≤98.6, 1 => 98.6- 100.6, 2 => 100.6 - 102.6, 3 => 102.6 Resolution of symptoms: cough (time frame: 21 days) Cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe Resolution of symptoms: shortness of breath (time frame: 21 days) Shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = walking on a flat surface 3 = shortness of breath when dressing or doing daily activities Resolution of symptoms: fatigue (period: 21 days) Fatigue based on a 0-3 scale: 1 = mild fatigue, 2 = moderate fatigue, 3 = severe fatigue. Composite score that includes all symptoms: (time frame: 21 days) Total composite score of symptoms on days 5, 10, 15, and 21 of study supplementation.
Measure: Symptom resolution Time: 21 daysDescription: Disease severity will be measured using a disease severity clinical event scale (assessed until day 21) Change from baseline in the patient's health status on an ordinal scale of 7 categories (time frame: days 3, 7, 14, 21) death Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, with non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, which does not require supplemental oxygen Not hospitalized, limitation of activities. Not hospitalized, without limitations in activities. Note: lower scores mean a worse result.
Measure: Cumulative incidence of disease severity Time: 21 daysDescription: Differences in the number of patients who received complementary medications for diagnosis between the study arms.
Measure: Complementary drugs required Time: 21 daysDescription: Differences in the number of patients in the study groups experiencing side effects of the supplements.
Measure: Side effects of supplementation Time: 21 daysDescription: PCR analysis at day 0, 7th, 14th and 21th to measure and compare viral load
Measure: Duration of SARS-CoV-2 PCR positivity Time: 21 daysDescription: Blood biochemical analysis at day 0, 3rd, 7th, 14th and 21th
Measure: Concentration of reactive protein c in peripheral blood Time: 21 daysDescription: Number of Incidence of hospitalization
Measure: Incidence of hospitalization Time: 21 daysDescription: Number of days of hospitalization
Measure: Duration (days) of hospitalization Time: 21 daysDescription: Number of Incidences of mechanical ventilation supply per patient
Measure: Incidence of mechanical ventilation supply Time: 21 daysDescription: Number of days with mechanical ventilation supply
Measure: Duration (days) of mechanical ventilation supply Time: 21 daysDescription: Number of incidences of oxygen use
Measure: Incidence of oxygen use Time: 21 daysDescription: Number of days of oxygen use per patient
Measure: Duration (days) of oxygen use Time: 21 daysDescription: Number of death per group
Measure: Mortality rate Time: 21 daysDescription: Number of days patient need to recover from disease
Measure: Time to return to normal activity Time: 21 daysDescription: Change from baseline in serum cytokine IL-1 level by blood biochemical analysis at day 0, 3, 7, 14 and 21
Measure: Change from baseline in serum cytokine levels Time: 21 daysDescription: Change from baseline in serum cytokine IL-6 level by blood biochemical analysis at day 0, 3, 7, 14 and 21
Measure: Change from baseline in serum cytokine levels Time: 21 daysDescription: Change from baseline in serum cytokine TNF-α level by blood biochemical analysis at day 0, 3, 7, 14 and 21
Measure: Change from baseline in serum cytokine levels Time: 21 daysDescription: Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages by blood biochemical analysis at day 0, 3, 7, 14 and 21
Measure: Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages Time: 21 daysDescription: Change from baseline in CD3 +, CD4 + and CD8 + T cell counts by blood biochemical analysis at day 0, 3, 7, 14 and 21.
Measure: Change from baseline in CD3 +, CD4 + and CD8 + T cell counts Time: 21 daysDescription: Change in liver function test (AST, ALT and TBIL) by blood biochemical analysis at day 0, 4, 7, 14 and 21.
Measure: Change in liver function test Time: 21 daysDescription: Change in kidney function with eGFR rate by blood and urinary biochemical analysis at day 0, 4, 7, 14 and 21.
Measure: Change in kidney function test Time: 21 daysDescription: Change in kidney function with creatine clearance rate by blood and urinary biochemical analysis at day 0, 4, 7, 14 and 21.
Measure: Change in kidney function test Time: 21 daysDescription: Change in routine blood test red blood cells concentration by blood biochemical analysis at day 0, 4, 7, 14 and 21.
Measure: Change in routine blood test Time: 21 daysDescription: Change in routine blood test white blood cell concentration by blood biochemical analysis at day 0, 4, 7, 14 and 21.
Measure: Change in routine blood test Time: 21 daysDescription: Change in routine blood test D-dimer level by blood biochemical analysis at day 0, 4, 7, 14 and 21.
Measure: Change in routine blood test Time: 21 daysDescription: Change in routine blood test fibrinogen level by blood biochemical analysis at day 0, 4, 7, 14 and 21.
Measure: Change in routine blood test Time: 21 daysDescription: Change in myocardial enzyme CPK-MB by blood biochemical analysis at daty 0, 4, 7, 14 and 21
Measure: Change in myocardial enzymes Time: 21 daysDescription: Change in myocardial enzymes troponins by blood biochemical analysis at daty 0, 4, 7, 14 and 21
Measure: Change in myocardial enzymes Time: 21 daysThe study design is observational, exploratory study consisting of two cohorts of COVID-19 patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing on the effect of plasma glucose levels on cardiac function will be evaluated by repeated assessment of cardiac function by echocardiography and measurement of plasma glucose. Furthermore, blood coagulability will be evaluated to determine the importance of diabetes status and plasma glucose changes for whole blood coagulability at time of admission to the ICU and progression in coagulability abnormalities. In the medical ward cohort, two assessments will be performed separated by no more than 12 hours. In the ICU cohort, three assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of patients admitted to medical ward (hospitalisation cohort). The primary hypothesis is that levels of plasma glucose have clinically significant impact on left ventricular systolic function in patients with COVID-19 admitted to the ICU. The secondary hypothesis is that the impact of plasma glucose on left ventricular systolic function is associated with glycaemic control prior to admission as measured by HbA1c.
Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measure: Plasma glucose levels and left ventricular ejection fraction Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measure: Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measure: Plasma glucose levels and strain analysis Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measure: Plasma glucose levels and mitral annular systolic velocity Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measure: Plasma glucose levels and left ventricular ejection fraction (sub-group analysis) Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measure: Plasma glucose levels and strain analysis (sub-group analysis) Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measure: Plasma glucose levels and mitral annular systolic velocity (sub-group analysis) Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measure: HbA1c, Plasma glucose levels and strain analysis Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measure: HbA1c, Plasma glucose levels and mitral annular systolic velocity Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes at time of admission to the ICU (ICU cohort only)
Measure: Diabetes status and whole blood coagulability and fibrinolysis Time: At time of admission to the ICU (max. 24 hours after admission to the ICU)Description: Difference in change in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes treated at the ICU (ICU cohort only)
Measure: Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay Time: From first until last assessment during ICU stay (max. 24 hours).Description: The prognostic value of cardiac function and TEG on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death
Measure: Prognostic value of TEG analysis Time: From time of admission and until four weeks after admissionDescription: The prognostic value of cardiac function on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death
Measure: Prognostic value of cardiac function Time: From time of admission and until four weeks after admissionDescription: Difference in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)
Measure: Diabetes status and high-sensitivity troponins Time: At the time of admission to the ICU (max. 24 hours after admission to the ICU)Description: Difference in change in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)
Measure: Diabetes status and change high-sensitivity troponins Time: From first until last assessment during ICU stay (max. 24 hours)By Jan 7, 2020, Chinese scientists had isolated a novel coronavirus, from patients with virus-infected pneumonia. The WHO designated later this virus as COVID-19 (coronavirus disease 2019). This exponential pandemic coronavirus infection is responsible for severe forms in 15 to 20%, for critical ill requiring ventilation in 5% and for mortality in 2%. Algeria was part of the 13 top priority countries identified by WHO based on their direct links and volume of travel to the infected provinces in China. It is known that some predisposing conditions lead to a worse outcome with coronavirus. In China, the overall case-fatality rate was 2.3%, but was higher in patients with diabetes (7.3%). In Italy, the most common comorbidities associated with death from COVID-19 were hypertension (73.8%) and diabetes (33.9%). The US Centers for Disease Control and Prevention suggests diabetes is the most common comorbidity in COVID-19 cases. In the largest cohort NHS England study, death from COVID-19 was strongly associated with uncontrolled diabetes (after full adjustment, HR 2.36). The West Algerian CORODIAB-13 study aims is (1) to assess the prevalence of diabetes among hospitalized patients with Covid-19, (2) to describe the phenotypic characteristics of patients with diabetes, and (3) to identify the parameters specific to the diabetic which are associated with severe forms. In the future, this study will provide answers for two main questions 1. Why diabetics are more at risk of developing Covid-19 infection? 2. Why diabetics are at high risk of developing severe forms?
Description: Assess the prevalence of diabetes among hospitalized patients with Covid-19 in Area of Tlemcen
Measure: Prevalence of diabetes among all hospitalized COVID-19 Time: 3 monthsDescription: Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19
Measure: Diabetes-related factors risk Time: 3 monthsThis is a randomized controlled trial of isolated patients with diabetes admitted to Nordsjællands Hospital with or without COVID-19-pneumonia. A continuous glucose monitoring (CGM) based system with transmission of glucose data to a central system is used for remote monitoring of glucose levels and compared to standard finger-prick glucose. Blinded (to patients) CGM is mounted in the finger-prick group.
Description: TIR is presented in percent of time in which the participants' glucose values are in different glucose ranges.
Measure: Time In Range (TIR) for blood glucose Time: 1-2 weeksDescription: Saved patient-personnel contacts related to blood glucose measurements, incl. time healthcare providers spent on diabetes related tasks and PPE related tasks, during the patients' hospitalization.
Measure: Saved patient-personnel contacts related to blood glucose measurements. Time: 1-2 weeksDescription: Additional glucose outcomes based on data from Dexcom G6 are for example Time Above Range (TAR), Time Below Range (TBR), average glucose, variance in glucose (CV), etc.
Measure: Glucose variations during hospitalization Time: 1-2 weeksDescription: That is: Tablet-based and insulin-based regimens and number of times that sliding scale insulin (including dose of insulin) has been administered for each patient.
Measure: Blood glucose lowering interventions Time: 1-2 weeksDescription: Number of techincal errors during the sensors lifetime.
Measure: CGM sensor performance Time: 1-2 weeksDescription: Hospital death (yes/no), length of stay at hospital, need for respiratory support (yes/no) and intensive care (yes/no), recovered vs. fatal (death within 60 days from admission).
Measure: Course of hospital stay. Time: 1-2 weeksThe outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes. The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care. This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.
Description: HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.
Measure: Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic. Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdownDescription: Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records
Measure: Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy Time: 6 weeks period following the end of the lockdownDescription: Use BMI, lipid profile, renal and hepatic function from medical records
Measure: Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown. Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdownDescription: Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization
Measure: Describe the proportion of patients who presented with one or more significant clinical event during the lockdown. Time: 6 weeks period following the end of the lockdownDescription: Proportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation
Measure: Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown. Time: 6 weeks period following the end of the lockdownDescription: Porportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco
Measure: Describe the proportion of patients who changed their lifestyle's habits during the lockdown. Time: 6 weeks period following the end of the lockdownDescription: Proportion of patients who consulted their GP, a specialist physician, pharmacist, biologist, nurse, paramedic, other healthcare professional; type of visit (regular face to face, telemedecine); method for prescription renewal; reason for delay in care; hospitalization (excluding for COVID-19)
Measure: Describe healthcare consumption of patients with diabetes during the lockdown. Time: 6 weeks period following the end of the lockdownDescription: Proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.
Measure: Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19. Time: 6 weeks period following the end of the lockdownThe strict rules applied in Italy during the recent COVID-19 pandemic, with the prohibition to attend any regular outdoor activity, are likely to influence the degree of metabolic control of patients with type 2 diabetes. The aim of this observational, prospective, single centre study was to evaluate the immediate impact of the lockdown rules on the metabolic profile of a cohort of patients with type 2 diabetes.
Description: Blood glucose was expressed in mg/dl and was determined by standard techniques.
Measure: Glucose Time: One week after the end of the lockdown periodDescription: HbA1c was expressed as percentage or mmol/l and was determined by standard techniques.
Measure: HbA1c Time: One week after the end of the lockdown periodDescription: Complete lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, Triglcerydes) were expressed in mg/dl or mmol/l and were determined by standard techniques.
Measure: Lipid profile Time: One week after the end of the lockdown periodThe purpose of this study is to evaluate whether Canakinumab has beneficial effects on patients with Type 2 diabetes mellitus and coronavirus disease 19 (COVID19).
Description: Treatment and placebo will be compared on the basis of the unmatched win-ratio approach of Pocock. When comparing two patients, the winner will be determined by the first component in which the two patients differ (4 weeks after randomization): longer survival time longer ventilation-free time longer ICU-free time shorter hospitalization time If there is no difference between treatment and Placebo: the win ratio is 1. If there is a difference between treatment and Placebo: the win ratio is not 1.
Measure: unmatched win ratio after treatment with canakinumab compared to Placebo (composite endpoint) Time: within 4 weeks after treatment with canakinumab or placeboDescription: Time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever comes first. "The seven-category ordinal scale consists of the following categories: not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and death"
Measure: Time to clinical improvement Time: From randomization up to 4 weeksDescription: Death rate during the 4-week period after study treatment
Measure: Death rate Time: 4 weeksDescription: Admission to the intensive care unit from the medical ward during the 4-week period after study treatment
Measure: Admission to intensive care unit (ICU) Time: 4 weeksDescription: Secondary worsening of disease (i.e., development of Acute respiratory distress Syndrome (ARDS), increase of oxygen demand after 72h of treatment)
Measure: Secondary worsening of disease Time: 4 weeksDescription: Prolonged hospital stay > 3 weeks
Measure: Prolonged hospital stay Time: >3 weeksDescription: Ratio to baseline in the glycated hemoglobin
Measure: Change in ratio to baseline in the glycated hemoglobin Time: Baseline, Day 29 and Day 90Description: Ratio to baseline in the fasting glucose
Measure: Change in ratio to baseline in the fasting glucose Time: Baseline, Day 29Description: Ratio to baseline in the fasting insulin
Measure: Change in ratio to baseline in the fasting insulin Time: Baseline, Day 29Description: Ratio to baseline in the fasting c-peptide
Measure: Change in ratio to baseline in the fasting c-peptide Time: Baseline, Day 29Description: Ratio to baseline in the C-reactive protein (CRP)
Measure: Ratio to baseline in the C-reactive protein (CRP) Time: Baseline, Day 29 and Day 90Description: Ratio to baseline in the D-dimer
Measure: Change in ratio to baseline in the D-dimer Time: Baseline, Day 29Description: Ratio to baseline in the Natriuretic peptide (NTproBNP)
Measure: Change in ratio to baseline in the Natriuretic peptide (NTproBNP) Time: Baseline, Day 29 and Day 90Description: Ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)
Measure: Change in ratio to baseline in the Glomerular Filtration Rate Renal (eGFR) Time: Baseline, Day 29 and Day 90Description: Type of antidiabetic treatment at Day 29
Measure: Type of antidiabetic treatment at Day 29 Time: Day 29Description: Number of antidiabetic treatment at Day 29
Measure: Number of antidiabetic treatment at Day 29 Time: Day 29Description: Type of antidiabetic treatment at three months
Measure: Type of antidiabetic treatment at three months Time: Month 3Description: Number of antidiabetic treatment at three months
Measure: Number of antidiabetic treatment at three months Time: Month 3During the current unusual situation with COVID-19 pandemic and the lockdown applied in most of the countries, school students were kept at home and offered e-learning modules and all activities were suspended. Lockdown entails significant modifications of life style, involving changes in physical activities, dietary habits and nutrition, which are likely to impact glycemic control. So the aim of the current study is to evaluate the impact of COVID-19 pandemic on glycemic control among children and adolescents with type 1 diabetes.
Description: Change in HbA1c from baseline to 3 month after the lockdown
Measure: Impact of COVID-19 pandemic and lockdown on glycemic control among a sample of Egyptian children and adolescents with type 1 diabetes Time: 12 weeksDescription: Change in total insulin dosage from baseline to 3 month after the lockdown
Measure: Impact of COVID-19 pandemic and lockdown on insulin dosage among a sample of Egyptian children and adolescents with type 1 diabetes Time: 12 weeksThe treatment with pioglitazone added to the standard treatment of patients with DM2 hospitalized for COVID-19 may produce a decrease in the number of patients who progress to a second phase of severe systemic inflammation.
Description: Number of patients receive pioglitazone treatment during their hospital stay who receive support with mechanical ventilation, enter the ICU and / or die.
Measure: Patients treated with pioglitazone, together with conventional treatment for COVID-19 infection, who during their admission evolve towards the need to receive support with mechanical ventilation, enter the ICU and / or die. Time: Through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Proportion of patients who develop heart failure or adverse reaction associated with treatment.
Measure: Incidence of pioglitazone treatment-Emergent Adverse Events in patients with DM2 and symptomatic SARS-CoV-2 infection. Time: Everyday through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Changes in this inflammation parameter: C-reactive protein (in mg/dl)
Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment. Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Changes in this inflammation parameter: D-dimer (in μg/mL)
Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment. Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Changes in this inflammation parameter: ferritin (in ng/mL)
Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment. Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Changes in this inflammation parameter: creatine kinase (CK) (in mg/dL)
Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment. Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Changes in this inflammation parameter: number of lymphocytes (in μL)
Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment. Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital dischargeAlthough reports showed that children with well controlled diabetes do not appear to have increased risk of infection with SARS-CoV-2, however data are scarce regarding the extent to which clinical and demographic data of patient could modify the outcome and severity of the disease. Additionally, the link between covid-19 and diabetes remains controversial.
Description: complications and comorbidities associated with diabetes
Measure: Clinical characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. Time: 4 monthsDescription: Acute phase reactants
Measure: Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. Time: 4 monthsDescription: Intensive care admission
Measure: Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. Time: 4 monthDescription: Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents
Measure: Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents Time: 4 monthsDescription: Impact of Covid-19 pandemic on presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes
Measure: Presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes during COVID-19 Pandemic in Egypt Time: 4 monthPatients with diabetes have been listed as people at higher risk for severe illness from COVID-19. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This observational study aims to to evaluate the risk of disease severity and mortality in association with diabetes in COVID-19 inpatients and identify the clinical and biological features associated with worse outcomes.
Description: to assess risk of intensive care unit admission and/or death among COVID-19 inpatients
Measure: prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients Time: february 23 to march 31, 2020Description: to compare risk of death among inpatients in presence or absence of diabetes
Measure: prevalence of death among COVID-19 inpatients with and without diabetes Time: february 23 to march 31, 2020Description: to compare intensive care unit admission among inpatients in presence or absence of diabetes
Measure: prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes Time: february 23 to march 31, 2020Description: to identify socio-demographic as predictors of severe prognosis (death or intensive care unit admission) during hospitalization
Measure: demographic and clinical characteristics (age,gender, comorbidity status) and death and/or intensive care unit admission during hospitalization Time: february 23 to march 31, 2020Description: to identify laboratory variables as predictors of severe prognosis (death or intensive care unit admission) during hospitalization
Measure: laboratory parameters (glycated hemoglobin, glucose at admission, renal and liver function markers, blood count, inflammatory markers, hemostasis) and death and/or intensive care unit admission during hospitalization Time: february 23 to march 31, 2020Description: to identify pharmacological therapies as predictors of severe prognosis (death or intensive care unit admission) during hospitalization
Measure: pharmacological therapies and death and/or intensive care unit admission during hospitalization Time: february 23 to march 31, 2020Description: to compare total length of hospitalization in patients with or without diabetes
Measure: number of days of hospitalization in patients with and without diabetes Time: february 23 to march 31, 2020During the COVID-19 pandemic, the time spent at the home of patients has increased because of national quarantine policies and patients' fear of getting sick. For this reason, in this ongoing process, patients have been unable to go to work regularly due to their chronic diseases (being on administrative leave) and their fear of going out. These reasons have prevented being physically active. The aim of the study is to evaluate the physical activity level, quality of life, glucose control, anxiety, depression, fear of hypoglycemia and loneliness perceptions of patients with type 1 diabetes mellitus during the COVID-19 pandemic period and compared with healthy controls.
Description: Physical activity level using International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be evaluated.
Measure: Physical activity level Time: Five minutesDescription: Quality of life using Short Form Health Survey (SF-36) will be evaluated.
Measure: General Quality of life Time: Ten minutesDescription: Depression using Hospital Anxiety and Depression Scale will be evaluated.
Measure: Depression Time: Three minutesDescription: Anxiety using Hospital Anxiety and Depression Scale will be evaluated.
Measure: Anxiety Time: Three minutesDescription: It will be questioned how many times patients have had hypoglycemic attacks (<4 mmol/L and common symptoms) in the last 7 days.
Measure: Self-reported hypoglycemia Time: Last seven dayDescription: Loneliness using UCLA Loneliness Scale Short Form (ULS-8) will be evaluated.
Measure: Loneliness Time: Three minutesDescription: Hypoglisemia fear using Hypoglisemia Fear Survey (HFS) will be evaluated.
Measure: Hypoglisemia fear Time: Five minutesDescription: Dyspnea during daily life activites using Modified Medical Research Dyspnea Scale will be evaluated.
Measure: Dyspnea Time: Two minutesDiabetes management and follow-up has become a challenge during the COVID-19 pandemic. Nation-wide lockdowns and social distancing measures adopted in an attempt to break the chain of COVID-19 transmission have significantly disrupted routine care and follow-up of diabetes. In the health sector, especially in low-income countries such as Pakistan, there has been a shift of resources and staff reassignment from stable chronic illnesses to support COVID-19 pandemic. Disruption of routine outpatient health services and travel restrictions increase the risk of worsening diabetes control and diabetes-related health outcomes. Additionally, social isolation amidst an atmosphere of fear and uncertainty contributes to stress further affecting glycaemic control.
Description: Death due to diabetes-related complications or otherwise
Measure: All-cause mortality Time: during 3months of lockdownDescription: %age of participants with one or more symptoms of fever, sore throat, cough, dyspnoea
Measure: COVID-19 illness Time: During 3months of lockdownThe COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to non-Hispanic populations. The supplemental Dulce Digital-COVID Aware (DD-CA) intervention addresses specific barriers in diverse underserved Hispanic and Latino communities to improve glucose control and lower transmission of COVID-19 during a highly vulnerable period post hospitalization discharge, to reduce hospital readmission rates. This supplement will integrate COVID educational messaging with glucose management messaging within a low-cost, easily adoptable digital texting platform and offer critical information in a culturally and linguistically relevant manner to address specific barriers in diverse underserved communities.
Description: The Electronic Medical Record (EMR) will be used to identify readmissions during each patient's unique follow up period. Unadjusted between group differences will first be analyzed by comparing proportion of patients with any hospital readmissions within the 30-day period by a Fisher's exact test. Followup analyses will be conducted using multiple logistic regression models to account for gender, ethnicity, race, comorbid conditions including COVID-19, medication use, and baseline glycemic control, in addition to study arm, as fixed effects in predicting the primary outcome, rate of readmissions within 30-days. We do not anticipate missing data for covariates included in regression models since demographic data will be captured directly from the EMR, and baseline glycemic control (i.e. HbA1c at hospital admission) and COVID-19 diagnosis will be determined during the admission of study enrollment.
Measure: Readmission rate (30-days) Time: 30-daysDescription: Additional metrics of glycemic control will be captured for each study participant from the EMR including HbA1c at 90-days post-discharge. Unadjusted group mean differences in HbA1c will be assessed with a students t-test, followed by multiple linear regression analysis controlling for baseline HbA1c (at time of initial admission), as well as covariates including gender, ethnicity, race, comorbid conditions including COVID-19, and medication/steriod use, in addition to study arm, as fixed effects in predicting HbA1c at 90 days.
Measure: Glycosylated Hemoglobin (HbA1c) Time: Baseline, 90-daysDescription: Diabetes distress will be measured using the Diabetes Distress Scale (DDS); range 1-6, with higher scores indicating worse outcomes/greater diabetes-related emotional stress. The survey will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
Measure: Diabetes Distress Scale Time: Baseline, 90-daysDescription: Research assistants will deliver the COVID-19 Patient Survey (PhenixToolkit) to each participant at their 90-day follow up to obtain their COVID-19 diagnosis status to determine whether any new infections occurred in the 90-day post-discharge time frame. Additional questions in the survey will be used for descriptive analyses to characterize infections. Differences in proportions of patients experiencing new infections per group (i.e. patients who were negative at discharge but had a self-reported positive test within 90 days) will be compared by Fisher's exact tests.
Measure: COVID-19 Patient Survey Time: 90-daysDescription: Summary of Diabetes Self-Care Activities (SDSCA; range 0-7, with higher scores indicating better outcomes/greater adherence to diabetes self-management behaviors) will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
Measure: Summary of Diabetes Self-Care Activities Survey Time: Baseline, 90-daysDescription: Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 (range 0-100, with higher scores reflecting better outcomes/higher quality of life) will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
Measure: PROMIS Quality of Life Scale Time: Baseline, 90-daysDescription: Knowledge, Attitudes and Practices Toward COVID-19 Survey (range 0-12, with higher scores reflecting better knowledge of COVID-19) will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
Measure: Knowledge, Attitudes and Practice Toward COVID-19 Survey Time: Baseline, 90-daysDescription: Socio-Economic Status (SES), nativity, duration of US residence, Marital status, depressive symptoms and healthcare utilization will be measured immediately post enrollment, prior to randomizing.
Measure: Demographics Questionnaire Time: BaselineDescription: Exploratory analyses will be conducted similarly to our Primary Outcome. The EMR will be used to identify readmissions during each patient's unique follow up period. Unadjusted between group differences will first be analyzed by comparing proportion of patients with any hospital readmissions within the 90-day period by a Fisher's exact t-test. Followup analyses will be conducted using multiple logistic regression models to account for gender, ethnicity, race, comorbid conditions including COVID-19, medication use, and baseline glycemic control, in addition to study arm, as fixed effects in predicting the exploratory outcome, rate of readmissions within 90-days.
Measure: Readmission Rate (90-days) Time: 90-daysAll hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study. The patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.
Description: The time between admission to hospital and discharge
Measure: Duration of Hospitalisation Time: 1 yearDescription: The admission of hospitalized patients to the intensive care unit.
Measure: The need for ICU Time: 1 yearDescription: Mortality rates of patients
Measure: Mortality Time: 1 yearDescription: The presence of lung involvement on thorax CT
Measure: Lung involvement Time: 1 yearThe study aimed to evaluate the effect of SARS-COV-2 infection on metabolic status in patients with diabetes mellitus. Patients' HbA1c levels before and after SARS-COV-2 infection will be evaluated.
Description: the change in A1c levels
Measure: A1c Time: 6 months (3 months before and after COVID-19The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for type 2 diabetes designed to support patients with diabetes and mental health concerns during COVID-19.
Description: The primary outcome in this study is feasibility, specifically process outcomes. This includes assessing recruitment number
Measure: Feasibility - Recruitment Numbers Time: Through the study completion, an average of 4 monthsDescription: The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics
Measure: Feasibility - Participant characteristics Time: up to 8-weeksDescription: The primary outcome in this study is feasibility, specifically process outcomes. This includes participant retention rate (e.g., defined by time between first and last visit)
Measure: Feasibility - Participant Engagement (retention rate) Time: up to 8-weeksDescription: The primary outcome in this study is feasibility, specifically process outcomes. This includes intensity (e.g., number of session participants attend)
Measure: Feasibility - Participant Engagement (intensity) Time: up to 8-weeksDescription: The primary outcome in this study is feasibility, specifically process outcomes. This includes drop out (consented/enrolled but did not attend first one-on-one)
Measure: Feasibility - Participant Engagement (drop out) Time: up to 8-weeksDescription: The primary outcome in this study is feasibility, specifically process outcomes. This includes the amount of time a coach spends per interaction
Measure: Feasibility - Delivery of Intervention (Time with coach) Time: up to 8-weeksDescription: The primary outcome in this study is feasibility, specifically process outcomes. This includes the mode of the interaction (i.e., virtual, telephone or both)
Measure: Feasibility - Delivery of Intervention (Mode of interaction) Time: up to 12-weeksDescription: The primary outcome in this study is feasibility, specifically process outcomes. This includes what strategies are used by the coach (i.e., educational, psychosocial support, behaviour modifications, or case management/monitoring)
Measure: Feasibility - Delivery of Intervention (Coach strategies) Time: up to 12-weeksDescription: The secondary outcome consists of study participant experience/satisfaction.
Measure: Study Participant experience and satisfaction via semi-structured interview Time: up to 8-weeksDescription: The secondary outcome consists of Care Coordinator experience and satisfaction.
Measure: Care Coordinator experience and satisfaction via semi-structured interview Time: up to 8-weeksDescription: The secondary outcome consists of Virtual Care Team experience and satisfaction.
Measure: Virtual Care Team experience and satisfaction via semi-structured interview Time: up to 8-weeksDescription: The exploratory outcomes will include Health Behaviour metrics via International Physical Activity Questionnaire). Individual scores per question, the higher the score means the higher the level of physical activity.
Measure: Exploratory Outcome - Health Behaviour metrics (physical activity) Time: up to 4-weeksDescription: The exploratory outcomes will include Health Behaviour metrics (via Mediterranean Diet Adherence Screener Modified (MEDAS modified)
Measure: Exploratory Outcome - Health Behaviour metrics (diet) Time: up to 4-weeksDescription: The exploratory outcomes will include Health Behaviour metrics (via readiness to change ruler (smoking, alcohol, nutrition, physical activity). Minimum score: 0; maximum score: 10; higher score represented a better outcome.
Measure: Exploratory Outcome - Health Behaviour metrics (confidence/importance to change behaviour) Time: up to 12-weeksDescription: The exploratory outcomes will include substance use (via GAINS-SS (Global Appraisal of Individual Needs- Short Screener). Minimum score: 0; maximum score: 20; higher score represented a worse outcome.
Measure: Exploratory Outcome - Substance Use (GAINS-SS) Time: up to 12-weeksDescription: The exploratory outcomes will include substance use (Alcohol Use Disorders Identification Test (AUDIT); Minimum score: 0; maximum score: 40; higher score represented a worse outcome.
Measure: Exploratory Outcome - Substance Use (alcohol) Time: up to 12-weeksDescription: The exploratory outcomes will include substance use (via heaviness of smoking index - 2 items out of Fagerstrom test for nicotine dependence (FTND)); Minimum score: 0; maximum score: 6; higher score represented a worse outcome.
Measure: Exploratory Outcome - Substance Use Time: up to 12-weeksDescription: The exploratory outcomes will include Mental Health measures (via Patient Health Questionnaire (PHQ-9)). Minimum score: 0; maximum score: 27; higher score represented a worse outcome.
Measure: Exploratory Outcome - Mental Health (depression) Time: up to 12-weeksDescription: The exploratory outcomes will include Mental Health measures via Generalized Anxiety Disorder-7 (GAD-7). Minimum score: 0; maximum score: 21; higher score represented a worse outcome.
Measure: Exploratory Outcome - Mental Health (Anxiety) Time: up to 12-weeksDescription: The exploratory outcomes will include Mental Health measures via Diabetes awareness and insight scale. Minimum score: 0; maximum score: 10; higher score represented a better outcome.
Measure: Exploratory Outcome - Mental Health (Diabetes awareness/insight) Time: up to 12-weeksDescription: The exploratory outcomes will include Mental Health measures via Diabetes Distress Scale. Minimum score: 0; maximum score: 6; higher score represented a worse outcome.
Measure: Exploratory Outcome - Mental Health (Diabetes Distress) Time: up to 12-weeksDescription: The exploratory outcomes will include Mental Health measures via perceived stress scale (PSS). Minimum score: 0; maximum score: 40; higher score represented a worse outcome (i.e., higher perceived stress).
Measure: Exploratory Outcome - Mental Health (Stress) Time: up to 12-weeksDescription: The exploratory outcomes will include quality of life (via European Quality of Life - 5 Dimensions scale - EQ5D). Minimum score: 0; maximum score: 100; higher score represented a better outcome.
Measure: Exploratory Outcome - Quality of Life Time: up to 12-weeksDescription: The exploratory outcomes will include quality of life (via Verona satisfaction scale). Minimum score: 0; higher score represented a better outcome.
Measure: Exploratory Outcome - Quality of Life Time: up to 12-weeksDescription: self-report
Measure: Exploratory Outcome - Waist circumference Time: up to 12-weeksDescription: self-report
Measure: Exploratory Outcome - BMI (height/weight) Time: up to 12-weeksDescription: self-report
Measure: Exploratory Outcome - Blood pressure Time: up to 12-weeksDescription: list
Measure: Exploratory Outcome - Current medication Time: up to 12-weeksDescription: Hemoglobin A1C levels
Measure: Exploratory Outcome - Blood work Time: up to 12-weeksDescription: Brief Pain Inventory-sf. Minimum score: 0; maximum score: 10; higher score represented a worse outcome (i.e., more pain).
Measure: Exploratory Outcome - Pain Time: up to 12-weeksDescription: months
Measure: Exploratory Outcome - Diabetes duration Time: up to 12-weeksDescription: Diabetes Self-Management and Technology Questionnaire (DSMT-Q); Minimum score: 0; maximum score: 48; higher score represented a worse outcome.
Measure: Exploratory Outcome - Diabetes self-management Time: up to 12-weeksAlthough recognized as an autoimmune disease the etiology of type 1 diabetes remains unknown. Virus infections has been suggested as a possible agent triggering the autoimmune reaction finally resulting in beta-cell destruction and fate of insulin secretion. SARS Cov-2 virus enters the infected cells by binding to the ACE-2 receptor, which is abundant in many tissues including the pancreas. Accordingly, SARS Covid-19 infection may trigger the development of type 1 diabetes either by an activation of the immune system or directly via beta-cell infection and destruction. Our aim is to study the impact of the Covid-19 epidemic on the development of type 1 diabetes. This will be done in two ways: a clinical study and an epidemiological follow up. During the next two years, adult patients with newly diagnosed type 1 diabetes will be asked to participate. Type 1 diabetes will be diagnosed by usual means and a mixed meal tolerance test will be performed at time of diagnosis and after one year to evaluate beta-cell function. People with type 1 diabetes and serologically documented previous SARS Covid-19 will be compared with people with no previous infection regarding beta-cell function and fate of insulin secretion. In addition, we will estimate the number of new diagnosed type 1 diabetes patients compared to previous years.
Description: C-peptide AUC of the MMTT at baseline and one year follow-up
Measure: Stimulated insulin secretion Time: One yearsDescription: HbA1c measure at one year
Measure: HbA1c Time: One yearsDescription: Fasting blood glucose
Measure: Fasting blood glucose Time: One yearsThere were 83,85,440 confirmed cases of COVID-19 worldwide with a mortality rate of 5.4% according to the situation report of the World Health Organisation on June 19, 2020. In India there were 3,95,048 confirmed cases of COVID-19 with a mortality rate of 3.3%. In Tamil Nadu there were 54,449 confirmed cases of COVID-19 with a mortality rate of 1.2% according to the report of Ministry of Health and Family Welfare, Government of India on June 19, 2020. COVID-19 infection is a double challenge for people with diabetes. India has a large number of persons with diabetes (more than 77 million). Recent studies have reported rising prevalence both in the urban and rural populations. The incidence of type 2 diabetes (T2D) also shows an increasing trend in the last few decades. Mortality seems to be threefold higher in people with diabetes when COVD-19 coexists when compared with mortality due to COVID-19 without comorbidities. Yang et al noted that among 52 intensive care patients who had COVID 19 infection, 22% had diabetes among the non-survivors. In a study of 173 patients with severe disease, 16.2% had diabetes, and in another study of 140 hospitalized patients, 12% had diabetes. Li et al compared intensive care and non-intensive care patients who had COVID-19. They showed a twofold increase in the incidence of diabetes in intensive care patients. In addition to diabetes; the other common co-morbidities present in COVID 19 patients were hypertension (20%), cardiovascular disease (16%), and lung disease (6%). In this context, patients with diabetes have been listed as people with higher severity for COVID-19 by several health authorities. However, precise data regarding patients with and without diabetes having COVID-19 infection are still lacking. Moreover, the relationship between diabetes and the severity of COVID-19 remains unknown. In this study, we intend to identify the disease severity and mortality in people with and without diabetes admitted for COVID-19 in southern India.
Description: To identify the disease severity and outcome among people with and without diabetes hospitalized for COVID 19 virus infection
Measure: Severity of COVID 19 among people with and without diabetes Time: Up to 1 monthDescription: Number of patients who were in ICU
Measure: Number of patients who were in ICU Time: Up to 1 monthDescription: Number of patients who had tracheal intubation
Measure: Number of patients who had tracheal intubation Time: Up to 1 monthDescription: Number of patients who had respiratory complication
Measure: Number of patients who had respiratory complication Time: Up to 1 monthDescription: Number of death
Measure: Number of death Time: Up to 1 monthDescription: Correlation of BMI with complications, tracheal intubation and mortality
Measure: Correlation of BMI with complications, tracheal intubation and mortality Time: Up to 1 monthDescription: Length of hospital stay
Measure: Length of hospital stay Time: Up to 1 monthThe study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020. Retrospective records were examined by examining the electronic data files of the patients. Polymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed. Patients over 18 years of age with and without a medical history of DM in their history were identified and compared in 2 groups.
Description: Mortality rates of patients
Measure: Mortality Time: 3 monthsDescription: The time between admission to intensive care unit and discharge
Measure: length of stay in intensive care Time: 3 monthsLockdown resulting from the COVID-19 pandemic was an unpreceded model of the impact of lifestyle on chronic diseases, especially for adolescents and young adults with type 1 diabetes (T1D) whose lifestyle is known to strongly impact disease management. The investigators aimed to assess changes in self-monitoring and glycemic control in this population before, during, and after the two-month French lockdown. Te investigators hypothesized an improvement in glucose control and glucose sensor usage. The protocol will include all patients with T1D from 13 to 25 years old using a flash glucose monitoring related to the LibreView cloud platform. The primary outcome, evolution of percentage of glucose time in range 70-180 mg/dL (TIR), and secondary outcomes (glucose management indicator GMI, time spent below range TBR, and sensor usage) will be analyzed with a linear mixed-effects regression model.
Description: Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure: Changes in percentage of time spent in range 70-180 mg/dL after lockdown compared to before lockdown Time: Measure repeated 2 times : month before lockdown (28 days), after lockdownDescription: Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure: Changes in percentage of time spent in range 70-180 mg/dL during first month of lockdown compared to before lockdown Time: Measure repeated 2 times : month before lockdown (28 days), first month of lockdown (28 days)Description: Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure: Changes in percentage of time spent in range 70-180 mg/dL during second month of lockdown compared to before lockdown Time: Measure repeated 2 times : month before lockdown (28 days), second month of lockdown (28 days)Description: Glucose Management Indicator (GMI) approximates the laboratory A1C level expected based on average glucose measured using continuous glucose monitoring data collected on Libreview.
Measure: Evolution of glucose management indicator (GMI) compared to before lockdown. Time: Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).Description: Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure: Evolution of glucose time spent below range <54 mg/dL Time: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).Description: Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure: Evolution of glucose time spent below range 54 - 70 mg/dL Time: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).Description: Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure: Evolution of glucose time spent below range 180-250 mg/dL Time: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).Description: Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure: Evolution of glucose time spent below range > 250 mg/dL Time: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).Description: Average glucose level in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure: Evolution of average glucose in mg/dL compared to before lockdown. Time: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).Description: Number of hypoglycaemia events (glycemia under 70 mg/dL during at least 15 minutes) in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure: Evolution of hypoglycaemia frequency compared to before lockdown. Time: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).Description: The level of glucose data collected related to the glucose monitoring frequency and the number of scans with continuous glucose monitoring data collected on Libreview.
Measure: Evolution of glucose sensor use compared to before lockdown. Time: Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports