CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D003920: Diabetes Mellitus NIH

(Synonyms: Diabetes M, Diabetes Me, Diabetes Mel, Diabetes Mell, Diabetes Melli, Diabetes Mellit, Diabetes Mellitu, Diabetes Mellitus, Diabetes Mellitus,, Diabetes Mellitus,)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (19)


Name (Synonyms) Correlation
drug752 Dexcom G6 Wiki 0.32
drug2379 Supported Adopted Intervention 2 Wiki 0.32
drug2380 Supported Adopted Intervention 3 Wiki 0.32
drug1001 Glycaemic levels Wiki 0.32
drug1342 Lifestyle App Wiki 0.32
drug1346 Linagliptin 5 MG Wiki 0.32
drug242 Attention Control Intervention 4 Wiki 0.32
drug2642 Video based aerobic exercise Wiki 0.32
drug2917 no interventional study Wiki 0.32
drug2082 Respiratory physiotherapy Wiki 0.32
drug2667 Viusid and Asbrip Wiki 0.32
drug2117 Ruxolitinib 5 MG Wiki 0.32
drug2449 Tele-interventions related to diabetes management and mental well-being Wiki 0.32
drug2378 Supported Adopted Intervention 1 Wiki 0.32
drug2208 Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX] Wiki 0.32
drug1403 MANAGEMENT OF COVID-19 Wiki 0.32
drug3012 standard therapy Wiki 0.18
drug601 Colchicine Wiki 0.11
drug1613 No intervention Wiki 0.08

Correlated MeSH Terms (11)


Name (Synonyms) Correlation
D003924 Diabetes Mellitus, Type 2 NIH 0.52
D008659 Metabolic Diseases NIH 0.32
D003922 Diabetes Mellitus, Type 1 NIH 0.32
D004700 Endocrine System Diseases NIH 0.32
D044882 Glucose Metabolism Disorders NIH 0.32
D001835 Body Weight NIH 0.22
D000073496 Frailty NIH 0.14
D008107 Liver Diseases NIH 0.11
D012140 Respiratory Tract Diseases NIH 0.07
D018352 Coronavirus Infections NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.03

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0000819 Diabetes mellitus HPO 1.00
HP:0005978 Type II diabetes mellitus HPO 0.52
HP:0100651 Type I diabetes mellitus HPO 0.32
HP:0000818 Abnormality of the endocrine system HPO 0.32
HP:0001392 Abnormality of the liver HPO 0.11

There are 10 clinical trials

Clinical Trials


1 Improving Diabetes Care Through Effective Personalized Patient Portal Interactions

Patient-facing eHealth technologies are those that connect patients and the healthcare system, and include online patient portals. Although many organizations are adopting patient portals, there is limited understanding of how the different portal features help improve health outcomes. This study is designed to develop and test an intervention to improve adoption and use of patient portal features for diabetes management.

NCT02953262 Diabetes Mellitus Behavioral: Supported Adopted Intervention 1 Behavioral: Supported Adopted Intervention 2 Behavioral: Supported Adopted Intervention 3 Behavioral: Attention Control Intervention 4
MeSH:Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: The investigators will examine the changes in use of MHV from baseline to 6 month follow-up, including use of secure messaging, Blue Button, and prescription refills.

Measure: Changes in My HealtheVet patient portal use

Time: Baseline & 6 month follow up

2 Prolonged Sedentary Behavior in Older Women With and Without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk

Sedentary behavior has been linked to cardiovascular morbidity and mortality, and is particularly common in older adults with type 2 diabetes. The purpose of this observational, mixed-methods study is to better understand the relationship between prolonged sedentary behavior and cardiovascular and metabolic health in older women.

NCT04262128 Diabetes Mellitus, Type 2 Healthy
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Measure: time sedentary measured via triaxial accelerometer

Time: 7 days

Measure: average sedentary bout length measured via triaxial accelerometer

Time: 7 days

Description: peak volume of oxygen consumption (VO2 peak) in ml/kg/min measured via graded exercise test

Measure: cardiorespiratory fitness

Time: 8-12 minutes

Description: glucose infusion rate in mg/kg/min as measured via hyperinsulinemic-euglycemic clamp

Measure: insulin sensitivity

Time: 3 hours

Measure: change in skeletal muscle deoxygenated hemoglobin concentration during single leg calf exercise measured via near-infrared spectroscopy

Time: 30 minutes

3 "Coronavirus SARS-CoV2 and Diabetes Outcomes" : CORONADO

COVID-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.

NCT04324736 Coronavirus Diabetes Other: no interventional study
MeSH:Coronavirus Coronavirus Infections Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

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 month

Secondary Outcomes

Description: 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 month

Description: 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 month

Description: 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 month

4 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 COVID Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 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)

5 Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19

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.

NCT04371978 COVID 19 Coronavirus Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases Dipeptidyl-Peptidase IV Inhibitors Linagliptin Severe Acute Respiratory Syndrome Coronavirus 2 Sars-CoV2 Hypoglycemic Agents Respiratory Tract Diseases Inc Incretins Hormones Drug: Linagliptin 5 MG
MeSH:Coronaviru Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus Diabetes Mellitus, Type 2 Metabolic Diseases Glucose Metabolism Disorders Respiratory Tract Diseases Endocrine System Diseases
HPO:Abnormality of the endocrine system Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

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 days

Secondary Outcomes

Measure: Percent of serious adverse events and premature discontinuation of treatment.

Time: 28 days

Description: 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 days

Measure: Length of hospitalization.

Time: 28 days

Measure: All-cause mortality.

Time: 28 days

Measure: Percent of supplemental oxygen use.

Time: 28 days

Measure: Supplemental oxygen-free days.

Time: 28 days

Measure: Percent of mechanical ventilation use.

Time: 28 days

Measure: Ventilator-free days.

Time: 28 days

Measure: Percent of ICU admissions.

Time: 28 days

Measure: ICU-free days.

Time: 28 days

Measure: Percent of 50% decrease in C-reactive protein (CRP) levels

Time: Up to 28 days

Measure: Time to virologic response, defined as no detection of SARS-CoV-2 in a PCR test.

Time: 28 days

6 Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients in Teodoro Maldonado Carbo Specialty's Hospital Infected and Diagnosed by SARS-Cov-2 With COVID-19

This 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.

NCT04407182 Covid-19 Sars-CoV2 Diabete Mellitus Cardiopathy Pulmonary Disease Renal Disease Liver Diseases Dietary Supplement: Viusid and Asbrip
MeSH:Liver Diseases Diabetes Mellitus
HPO:Abnormality of the liver Decreased liver function Diabetes mellitus Elevated hepatic transaminase

Primary Outcomes

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 days

Secondary Outcomes

Description: 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 days

Description: Differences in the number of patients who received complementary medications for diagnosis between the study arms.

Measure: Complementary drugs required

Time: 21 days

Description: Differences in the number of patients in the study groups experiencing side effects of the supplements.

Measure: Side effects of supplementation

Time: 21 days

Description: 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 days

Description: Blood biochemical analysis at day 0, 3rd, 7th, 14th and 21th

Measure: Concentration of reactive protein c in peripheral blood

Time: 21 days

Description: Number of Incidence of hospitalization

Measure: Incidence of hospitalization

Time: 21 days

Description: Number of days of hospitalization

Measure: Duration (days) of hospitalization

Time: 21 days

Description: Number of Incidences of mechanical ventilation supply per patient

Measure: Incidence of mechanical ventilation supply

Time: 21 days

Description: Number of days with mechanical ventilation supply

Measure: Duration (days) of mechanical ventilation supply

Time: 21 days

Description: Number of incidences of oxygen use

Measure: Incidence of oxygen use

Time: 21 days

Description: Number of days of oxygen use per patient

Measure: Duration (days) of oxygen use

Time: 21 days

Description: Number of death per group

Measure: Mortality rate

Time: 21 days

Description: Number of days patient need to recover from disease

Measure: Time to return to normal activity

Time: 21 days

Other Outcomes

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: Change in myocardial enzymes troponins by blood biochemical analysis at daty 0, 4, 7, 14 and 21

Measure: Change in myocardial enzymes

Time: 21 days

7 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 Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 COVID 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)

8 Prevalence of Diabetes Among Hospitalized Patients With Covid-19 in West of Algeria. Identification of Diabetes-related Associated Factors Severe Forms

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?

NCT04412746 Coronavirus Infections Diabetes Mellitus Prevalence Risk Factors Patient Outcome Assessment Severe Acute Respiratory Syndrome Drug: MANAGEMENT OF COVID-19
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

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 months

Description: Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19

Measure: Diabetes-related factors risk

Time: 3 months

9 Remote Glucose Monitoring of Patients With Diabetes Quarantined During the COVID-19 Pandemic - a Hospital-Based Randomized Controlled Trial of the Effect of Remote Continuous Glucose Monitoring Compared to Usual Glucose Monitoring

This 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.

NCT04430608 Diabetes Covid-19 Infection Device: Dexcom G6
MeSH:Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

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 weeks

Secondary Outcomes

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: Number of techincal errors during the sensors lifetime.

Measure: CGM sensor performance

Time: 1-2 weeks

Description: 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 weeks

10 Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study

The study team want to see if changes in lifestyle and behaviors and self-monitoring of diet and physical activity in older adults who have type 2 Diabetes (T2D) may help to prevent or reduce frailty. Frailty occurs in older adults and leads people to have falls, become disabled, require nursing home placement, and have increased risk of death. T2D is one of the major risk factors for frailty. T2D is a significant problem in older adults and is known to increase the risk of future frailty.

NCT04440449 Frailty Weight, Body Type 2 Diabetes Behavioral: Lifestyle App
MeSH:Diabetes Mellitus Frailty Body Weight
HPO:Diabetes mellitus

Primary Outcomes

Description: Change in frailty measured on a scale using a frailty score (0, 1, 2, 3, 4,or 5), with higher scores out of 5 representing greater frailty. Assessments used for scoring include 1) self reported weight loss, 2) self-reported exhaustion 3) low physical activity based on the Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ) 4) Handgrip strength 5) 10 foot walk pace

Measure: Frailty Scale

Time: Baseline to 6 months

Secondary Outcomes

Description: Change in HbA1c measured over the study period

Measure: Glycated hemoglobin (HbA1c)

Time: Baseline to 6 months

Description: For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

Measure: Patient-Reported Outcomes Measurement Information System (PROMIS)

Time: Baseline to 6 months

Description: The study team will administer the Short Physical Performance Battery (SPPB)69 to assess three lower extremity tasks; 1) standing balance (ability to stand with the feet together in side-by-side, semi-and full-tandem positions for 10 seconds each); 2) a 4-meter walk to assess usual gait speed; 3) time to complete 5 repeated chair stand. Each of the 3 performance measures is assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create a score ranging from 0 to 12 (best). The SPPB is sensitive to change over time

Measure: Short Physical Performance Battery (SPPB)

Time: Baseline to 6 months


HPO Nodes


HP:0000819: Diabetes mellitus
Genes 528
PLIN1 ABCC8 CASR PRSS1 ELMO2 LIMK1 SOX3 PDX1 SLC2A2 PDX1 PDX1 HNF1A HYMAI SPINK1 GNAS COX1 REEP6 PRPF6 STAT3 ND2 SPINK1 KLF11 KIAA1549 WRN KCNJ11 LIG4 ARL6 EDA2R ELN KCNJ11 FOXH1 WFS1 PWAR1 HMGA1 RRM2B GPR35 LIPE PRSS2 WRAP53 STAT3 HAMP TRNC PPP1R3A ATM PAX4 MMP14 RDH12 CP ZNF408 BRAF TRNK TRNL1 ND4 TTC7A NDUFS3 NDUFV2 AEBP1 SPINK1 PSTPIP1 HMGA2 LRP6 LIPE PALLD TCF4 TRNQ CDKN2A TRNK TTPA INS NDUFB11 GJA1 PAX4 CEL PTCH1 PRSS2 XRCC4 BSCL2 SLC7A14 LMNB2 BBS2 PALB2 INSR TIMMDC1 NDUFAF8 NDUFB10 SIX3 AGBL5 WRN GAS1 COX3 PLAGL1 TREX1 PDX1 SMAD4 SLC19A2 LMNA CORIN PDE8B IL6 BEST1 CRX PRKAR1A WFS1 TGIF1 MST1 NDN GCK NDUFS6 CFTR RETN FOXRED1 RBP3 CNGB1 LIPC ZNF513 GPD2 UBR1 NDUFAF4 WFS1 FOS ABCC8 CISD2 TRNQ IFT140 HFE HYMAI IRS1 HNF4A RNASEH2B FGF8 ARMC5 APOA5 LEMD3 DCAF17 PPARG EDA TP53 DCAF17 AGPAT2 GLRX5 OFD1 TINF2 TRNS1 MAGEL2 APPL1 MAPK8IP1 ARL6 GTF2IRD1 PPARG TRNH NDUFS8 NDUFAF3 TDGF1 CDHR1 SNORD115-1 ZFYVE26 TMEM126B CP IGF2BP2 PTPN22 CAV1 CNGA1 DHDDS RFC2 KIZ MEN1 HBB XRCC4 TRNW PRPF8 FOXP1 ABCC8 LMNA NEK2 SNRPN LMNA MAK FGFR1 MMP2 CLIP2 GCK BBS2 HESX1 KCNJ11 ZFP57 PRKACA GLIS3 HNF1A VANGL1 NDUFS2 NEUROD1 NDUFV1 ABCA4 C8ORF37 TRNS2 DMPK LEP BRCA1 ADAR IFIH1 GCK CERKL NRL COX1 CTRC INS GJB4 WFS1 AIP RAC1 GJB3 SBDS ND5 PTF1A LMNA ITCH PROM1 PRSS1 PIK3R1 NEUROD1 HBB GCK CISD2 ND6 IMPDH1 TERT LEPR ALMS1 BRCA2 PRCD BMP2 CAT ELN KCNJ11 TRNL1 PNPLA6 PAX4 NDUFAF2 FOXP3 GATA6 PRPF4 PLAGL1 NODAL HNF1A CA4 TUB CAV1 RNASEH2C TTC8 POLR3A PIK3R1 NR2E3 HNF4A NDUFB3 POLA1 PWRN1 PRKACA PCARE AR INSR COX2 STOX1 IL2RA PDE4D BSCL2 HGSNAT CTNS DNAJC3 IGF1R KLF11 IPW GJA1 GCK DLL1 PEX10 HNF1B CTC1 DNM1L ND6 ARHGEF18 RP1 SLC25A4 NSMCE2 TRNL1 CLRN1 AHR STAT1 NDUFS7 ND1 OPA1 DNAJC3 NDUFAF5 ABCC8 AMACR NOP10 EIF2AK3 MKKS ABCC8 PPARG TRNF ALMS1 GUCA1B PDE6G CTNNB1 CCDC28B ND3 INSR LHX1 CDON APOE HNF4A CPA1 SLC29A3 DMXL2 TOPORS IDH3B NEUROG3 HFE SCAPER ND1 ARL2BP PDE6B BLK TRNE HNF1B HNF1B SAMHD1 PEX6 NEUROD1 NPAP1 COX3 GPR101 CNOT1 EIF2S3 PRPF3 IL2RA HLA-DRB1 ZIC2 NDUFS1 SPATA7 TRMT10A BLM CYP19A1 FUZ PRKAR1A CYTB PTRH2 LMNA TRNV FBN1 MLXIPL ZFP57 AIP KCNJ11 KCNJ11 KRAS FLT1 FXN PLIN1 INS WFS1 TWNK RPGR HNF4A DISP1 BLK PNPLA2 POLG MC4R POLG2 BAZ1B NSMCE2 RTEL1 TRNS2 PROKR2 ND1 PPARG NDP AHI1 SOX2 SAG SLC29A3 HERC2 UBR1 IER3IP1 KCTD1 ABCC8 CFTR CNBP CAVIN1 SLC12A3 MKRN3-AS1 FOXP3 SLC16A2 TWNK PROK2 PCNT EYS COX2 TRNF RGR GTF2I STAT1 PAX4 DHX38 IDH3A ZMPSTE24 PPP1R15B XRCC4 PTPN1 CLCNKB HJV ERGIC1 LEPR RHO SHH NPM1 ZBTB20 ATM NDUFA6 INS AIRE RP9 PTF1A TCF7L2 KLHL7 DNAJC21 AKT2 RLBP1 AKT2 TP53 PLCD1 NKX2-5 CDH23 NDUFS4 FOXC2 HNF1A LMNA LMNA MTNR1B HNF1A TRNW MKRN3 SRP54 GLI2 NDUFA1 IRS2 NDUFA11 TERC USH2A CTRC POC1A RP2 ITPR3 MOG PDX1 IFT172 APPL1 ARNT2 ATP6 ND5 SNORD116-1 CIDEC BBS1 NDUFAF1 PDE11A FAM161A RPE65 PDE4D PARN INS PRPH2 ROM1 TBL2 OTX2 POLD1 MAFA HNF4A KDSR CEP19 GCK SEMA4A ARL3 CEL LRAT HNF1A GATA6 TULP1 SNRNP200 IFT88 AGPAT2 TRNE FSCN2 TRNS1 NDUFB9 GATA3 STUB1 ENPP1 MERTK RNASEH2A KCNJ11 HLA-DQB1 NHP2 FXN IMPG2 SUFU POMGNT1 EIF2AK3 SARS2 HYMAI GCK TKT USB1 ZMPSTE24 PRPF31 HNF1B PDX1 SLC30A8 PNPLA2 SLC19A2 DKC1 PDE6A USP8 EFL1 FGFR1 CRB1 PEX1 NUBPL