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    HP:0100651: Type I diabetes mellitus

    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 (23)


    Name (Synonyms) Correlation
    drug2391 Peer Mentor Delivery Wiki 0.35
    drug3497 Use of Facetime with child and parents during induction Wiki 0.35
    drug3457 Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 Wiki 0.35
    Name (Synonyms) Correlation
    drug3447 Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Wiki 0.35
    drug1351 Glycaemic levels Wiki 0.35
    drug3507 V-SARS Wiki 0.35
    drug3459 Two doses of placebo at the emergency vaccination schedule Wiki 0.35
    drug1007 DiaBetter Together Wiki 0.35
    drug3446 Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki 0.35
    drug3458 Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly Wiki 0.35
    drug3453 Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Wiki 0.35
    drug3445 Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 Wiki 0.35
    drug3460 Two doses of placebo at the routine vaccination schedule Wiki 0.35
    drug3277 Tele-interventions related to diabetes management and mental well-being Wiki 0.35
    drug3550 Video-Based intervention Wiki 0.35
    drug3559 Virtual Care at Home Wiki 0.35
    drug3452 Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki 0.35
    drug3521 VXA-CoV2-1 Wiki 0.35
    drug3465 Two doses of placebo at the schedule of day 0,28 Wiki 0.25
    drug3454 Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki 0.25
    drug3451 Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki 0.25
    drug2276 Online Survey Wiki 0.16
    drug2284 Online survey Wiki 0.16

    Correlated MeSH Terms (3)


    Name (Synonyms) Correlation
    D003922 Diabetes Mellitus, Type 1 NIH 0.94
    D003920 Diabetes Mellitus, NIH 0.49
    D003924 Diabetes Mellitus, Type 2 NIH 0.20

    Correlated HPO Terms (2)


    Name (Synonyms) Correlation
    HP:0000819 Diabetes mellitus HPO 0.49
    HP:0005978 Type II diabetes mellitus HPO 0.20

    Clinical Trials

    Navigate: Correlations   HPO

    There are 8 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 12 months, HbA1c will be collected by at least one of the following methods: study visit at Texas Children's Hospital or Baylor College of Medicine to collect point of care HbA1c 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) If unable to attend study visit, a home Hemoglobin A1c kit (A1cNow SELFCHECK, PTS Diagnostics, NGSP-Certified) will be mailed to the participant to complete and return to the study team. Collected for young adult participants in both arms, not Peer Mentors.

    Measure: Glycemic Control (HbA1c)

    Time: Baseline through 12-Months 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 subscales scores are calculated from 1-100 (higher = better quality of life). Collected for young adult participants in both arms (baseline, 6 mo, 12 mo) and Peer Mentors (pre- and post-involvement in study).

    Measure: Health-Related Quality of Life (Type 1 Diabetes and Life)

    Time: Baseline, 6-Month Post-Randomization, & 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 2-Way Social Support Scale (2SSS) is a 20-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 (Receiving scales only, 10 items: baseline, 6 mo, 12 mo) and Peer Mentors (Receiving and Giving scales, 20 items: pre- and post-involvement in study).

    Measure: Social Support (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 4a assesses participants' feelings of being isolated from other people. There is no time frame for responding to this measure. Participants respond to 4 items on a scale from 1(Never) to 5 (Always) and are calculated into a total score (higher = more perceived isolation). Collected for young adult participants in both arms, not Peer Mentors.

    Measure: Social Isolation (PROMIS Short Form Social Isolation 4a)

    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 the Knowledge (12 items - baseline and 12 mos only), Navigation (13 items, baseline, 6 and 12 mos), Health Behaviors (9 items, baseline and 12 mos only) scales 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, 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, not Peer Mentors.

    Measure: General Quality of Life (Satisfaction with Life Scale)

    Time: Baseline, 6-Month Post-Randomization, & 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 Physical Activity, Quality of Life and Depression of 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

    HPO Nodes


    Reports

    Data processed on December 13, 2020.

    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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