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D003922: Diabetes Mellitus, Type 1

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (19)


Name (Synonyms) Correlation
drug3493 Tuberculin test Wiki 0.33
drug3595 VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) Wiki 0.33
drug1030 DiaBetter Together Wiki 0.33
Name (Synonyms) Correlation
drug3332 Tele-interventions related to diabetes management and mental well-being Wiki 0.33
drug3581 Vaginal fluid Covid-19 PCR test Wiki 0.33
drug3552 Use of Facetime with child and parents during induction Wiki 0.33
drug3484 Treatment for COVID-19 Wiki 0.33
drug1383 Glycaemic levels Wiki 0.33
drug3852 glucose control and sensor usage Wiki 0.33
drug3503 Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki 0.33
drug2433 Peer Mentor Delivery Wiki 0.33
drug3486 Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days : Wiki 0.33
drug3603 Video based aerobic exercise Wiki 0.33
drug3523 UB-612 Wiki 0.24
drug3509 Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki 0.24
drug3506 Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki 0.24
drug3520 Two doses of placebo at the schedule of day 0,28 Wiki 0.24
drug2325 Online survey Wiki 0.15
drug2317 Online Survey Wiki 0.15

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D003920 Diabetes Mellitus, NIH 0.52
D003924 Diabetes Mellitus, Type 2 NIH 0.19

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0100651 Type I diabetes mellitus HPO 0.94
HP:0000819 Diabetes mellitus HPO 0.47
HP:0005978 Type II diabetes mellitus HPO 0.19

Clinical Trials

Navigate: Correlations   HPO

There are 9 clinical trials


1 DiaBetter Together: A Strengths-based, Peer Mentor Transition RCT for Young Adults With Type 1 Diabetes

DiaBetter 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.

NCT04247620
Conditions
  1. Type 1 Diabetes
Interventions
  1. Behavioral: DiaBetter Together
  2. Behavioral: Peer Mentor Delivery
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

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-Randomization

Secondary Outcomes

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization

Description: 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-Randomization
2 Impact of Tele-Interventions During the COVID-19 Pandemic on Glycemic Control and Attitude Toward the Disease in Patients With Diabetes Mellitus - A Randomized Clinical Trial

INTRODUCTION 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 Clínicas 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.

NCT04344210
Conditions
  1. COVID
  2. Diabetes Mellitus, Type 2
  3. Diabetes Mellitus, Type 1
Interventions
  1. Behavioral: Tele-interventions related to diabetes management and mental well-being
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus Type II diabetes mellitus

Primary Outcomes

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)

Secondary Outcomes

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)
3 Patient Living With Type 1 Diabetes' Experience During the COVID-19 Pandemic in Quebec

Given the current situation with COVID-19 declared pandemic on March 11, 2020 and the requirement for physical distancing and to limit social interactions, and for some, to quarantine, the investigators will survey patients living with type 1 diabetes (and their families, if they are <18 years) about their current experience with their diabetes management to understand their needs. The primary objective is to describe the exposition and the impact of COVID-19 pandemic on type 1 diabetes. The investigators will recruit people with type 1 diabetes from all ages living in Quebec to answer a short online survey.

NCT04384471
Conditions
  1. Type1diabetes
  2. Covid19
Interventions
  1. Other: Online survey
MeSH:Diabetes Mellitus, Type 1
HPO:Type I diabetes mellitus

Primary Outcomes

Description: Severe hypoglycemia and diabetic ketoacidosis

Measure: Self-reported acute diabetes complication

Time: Since March 11, 2020

Secondary Outcomes

Description: In the last week, how many episodes of hypoglycemia did you have? Answer based on the following definition of hypoglycemia: measured blood sugar levels lower than 4.0 mmol/L and/or common symptoms [shaking, sweating, anxiety, confusion, difficulty concentrating, nausea, or other symptoms] and/or disappearance of symptoms with carbohydrate intake.

Measure: Self-reported hypoglycemia

Time: Last 7 days

Description: Since the start of the COVID-19 pandemic (March 11), have you had difficulty getting a hold of any of the following diabetes supplies Scale: 1- no difficulties at all to 7- I could not get any supplies i) Blood glucose meter ii) Blood glucose meter strips iii) Insulin iv) Glucagon v) Ketone strips vi) Continuous glucose monitor sensors or related supplies vii) Insulin pump supplies viii) Alcohol wipes

Measure: Ability to get diabetes supplies and to access diabetes care

Time: Since March 11, 2020

Description: Since the start of the COVID-19 pandemic (March 11), are you worried about access to any of the following diabetes supplies? Scale: 1- not at all worried to 7- I am very worried i) Blood glucose meter ii) Blood glucose meter strips iii) Insulin iv) Glucagon v) Ketone strips vi) Continuous glucose monitor sensors or related supplies vii) Insulin pump supplies viii) Alcohol wipes

Measure: Concern about not having access to diabetes supplies and to access diabetes care

Time: Since March 11, 2020

Description: Two questions on food security One question on physical activity

Measure: Impact of the pandemic situation on daily life activities

Time: Since March 11, 2020

Description: PHQ-9 scale for depression screening and the GAD7 scale for generalized anxiety among adult participants.

Measure: Impact on stress, anxiety and depression for adults participants

Time: Last 2 weeks

Description: Short Mood and Feelings Questionnaire (SMFQ) for children and adolescent.

Measure: Impact on stress, anxiety and depression for children and adolescents

Time: Last 2 weeks
4 Glycaemia and Cardiac Function in Patients With COVID-19

The 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.

NCT04410718
Conditions
  1. Diabetes Mellitus
  2. Diabetes Mellitus, Type 2
  3. Diabetes Mellitus, Type 1
  4. COVID
Interventions
  1. Other: Glycaemic levels
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus Type II diabetes mellitus

Primary Outcomes

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).

Secondary Outcomes

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 admission

Description: 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 admission

Description: 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)
5 Glycemic Control Among Children and Adolescents With Type 1 Diabetes During COVID-19 Pandemic in Egypt: A Pilot Study

During 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.

NCT04531111
Conditions
  1. Type 1 Diabetes
  2. Covid19
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

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 weeks

Secondary Outcomes

Description: 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 weeks
6 Clinical Characteristics and Outcome of Hospitalized Children and Adolescent Patients With Type 1 Diabetes During the COVID-19 Pandemic: Data From a Single Center Surveillance Study in Egypt

Although 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.

NCT04536285
Conditions
  1. Type 1 Diabetes
  2. Covid19
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

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 months

Description: Acute phase reactants

Measure: Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.

Time: 4 months

Description: Intensive care admission

Measure: Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.

Time: 4 month

Secondary Outcomes

Description: 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 months

Description: 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 month
7 Evaluation of Quality of Life, Physical Activity and Depression in Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic

During 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.

NCT04558645
Conditions
  1. Type 1 Diabetes Mellitus
  2. Covid19
Interventions
  1. Other: Online Survey
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

Description: Physical activity level using International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be evaluated.

Measure: Physical activity level

Time: Five minutes

Description: Quality of life using Short Form Health Survey (SF-36) will be evaluated.

Measure: General Quality of life

Time: Ten minutes

Secondary Outcomes

Description: Depression using Hospital Anxiety and Depression Scale will be evaluated.

Measure: Depression

Time: Three minutes

Description: Anxiety using Hospital Anxiety and Depression Scale will be evaluated.

Measure: Anxiety

Time: Three minutes

Description: 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 day

Description: Loneliness using UCLA Loneliness Scale Short Form (ULS-8) will be evaluated.

Measure: Loneliness

Time: Three minutes

Description: Hypoglisemia fear using Hypoglisemia Fear Survey (HFS) will be evaluated.

Measure: Hypoglisemia fear

Time: Five minutes

Description: Dyspnea during daily life activites using Modified Medical Research Dyspnea Scale will be evaluated.

Measure: Dyspnea

Time: Two minutes
8 Covid-19 and Type 1 Diabetes - a Multicenter Study

Although 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.

NCT04623697
Conditions
  1. Covid19
  2. type1diabetes
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

Description: C-peptide AUC of the MMTT at baseline and one year follow-up

Measure: Stimulated insulin secretion

Time: One years

Secondary Outcomes

Description: HbA1c measure at one year

Measure: HbA1c

Time: One years

Description: Fasting blood glucose

Measure: Fasting blood glucose

Time: One years
9 Observational Study of Glycemic Control and Self-management of Young People (Aged 13 to 25 Years ) With Type 1 Diabetes During COVID-19 Lockdown.

Lockdown 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.

NCT04669912
Conditions
  1. Type 1 Diabetes
Interventions
  1. Other: glucose control and sensor usage
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

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 lockdown

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 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)

Secondary Outcomes

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).

HPO Nodes


Reports

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.

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