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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug950 | CoYoT1 Care Wiki | 0.32 |
| drug1642 | Glycaemic levels Wiki | 0.32 |
| drug3917 | Tele-interventions related to diabetes management and mental well-being Wiki | 0.32 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2319 | Mediterranean diet, no caloric restriction Wiki | 0.32 |
| drug304 | Anti-Human Thymocyte Immunoglobulin, Rabbit Wiki | 0.32 |
| drug1840 | Hypocaloric, moderate low fat diet Wiki | 0.32 |
| drug1839 | Hypocaloric, low carbohydrate diet Wiki | 0.32 |
| drug697 | CFZ533 Wiki | 0.32 |
| drug2706 | Online survey Wiki | 0.16 |
| drug3701 | Standard Care Wiki | 0.16 |
| drug2696 | Online Survey Wiki | 0.14 |
| drug2916 | Placebo Wiki | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003920 | Diabetes Mellitus, NIH | 0.44 |
| D003924 | Diabetes Mellitus, Type 2 NIH | 0.15 |
| D050177 | Overweight NIH | 0.11 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100651 | Type I diabetes mellitus HPO | 1.00 |
| HP:0000819 | Diabetes mellitus HPO | 0.44 |
| HP:0005978 | Type II diabetes mellitus HPO | 0.15 |
Navigate: Correlations HPO
There are 10 clinical trials
An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches. COVID-19 PROVISIONS: Due to restrictions in place on in-person visits due to COVID-19 precautions, some subjects may remain in the study longer than 10.5 months. As of June 2020, the study transitioned to a completely virtual format. Those who were due for a measurement visit during the time that research activities were halted, prior to the approval of the virtual procedures, remained on the diet they were currently assigned to, supported by bi-weekly Registered Dietitian (RD) counseling, until they were able to be scheduled for a virtual visit.
Description: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in weight - Randomization 1 Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) VisitDescription: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in weight - Randomization 2 Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) VisitDescription: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in weight - Randomization 3 Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) VisitDescription: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in HbA1C - Randomization 1 Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) VisitDescription: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in HbA1C - Randomization 2 Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) VisitDescription: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in HbA1C - Randomization 3 Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) VisitDescription: Change in the percent of time spent in hypoglycemia during Continuous Glucose Monitor (CGM) wear time will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from the insertion of the CGM at Measurement Visit 2.
Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 1 Time: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) VisitDescription: Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.
Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 2 Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) VisitDescription: Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.
Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 3 Time: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) VisitDescription: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.
Measure: Change in percent body fat - Randomization 1 Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) VisitDescription: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.
Measure: Change in percent body fat - Randomization 2 Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) VisitDescription: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.
Measure: Change in percent body fat - Randomization 3 Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) VisitDescription: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from CGM insertion at Measurement Visit 2.
Measure: Difference in time spent within target blood glucose range - Randomization 1 Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) VisitDescription: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.
Measure: Difference in time spent within target blood glucose range - Randomization 2 Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) VisitDescription: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.
Measure: Difference in time spent within target blood glucose range - Randomization 3 Time: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) VisitCoYoT1 to California (CTC) was initiated to develop a patient-centered, home telehealth care model for young adults (YA) ages 16-25 with T1D. It is a 2x2 factorial design, 15-month intervention. Eighty participants will be randomized to Standard Care or CoYoT1 Care, which is delivered by telehealth or in-person. CoYoT1 Care is a patient-centered care model that consists of three major components: shared decision making (patient and provider agree upon priorities for the medical visit), autonomy and supportive care (provider training in communication strategies such as motivational interviewing), and goal setting and action planning (provider training to coach YA in setting SMART goals, developing action plans, and designing follow up plans). Additionally, didactic expert-led sessions (Standard Care) or peer-led, YA-driven group sessions (CoYoT1 Care) are included. At the end of the study, a focus group will be completed to assist in determining which features YA felt were critical to their success from the telehealth intervention, group components, and provider behaviors. ***COVID-19 Update: Due to current hospital and clinical policy adaptation for COVID-19, all participants who were randomized into in-person appointments will now receive care via Telehealth. Telehealth has been implemented hospital-wide and will be the temporary delivery of care method during this pandemic. Participants have been notified of this change and given instruction on how to participate in a Telehealth appointment.
Description: Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
Measure: Number of participants with completed appointments in telemedicine cohort Time: 12 monthsDescription: Patient online attendance as assessed using an online patient experience questionnaire - Polar Questions; Yes or no response questions related to patient's online appointment (i.e., did you have an online appointment? Did you attend your appointment?)
Measure: Number of participants with completed appointments in telemedicine cohort Time: 12 monthsDescription: In-person patient appointment attendance assessed using an online patient experience questionnaire. Polar questions; Yes or No response questions related to patient's in-person appointment (i.e., did you have an in-person appointment? Did you attend your in-person appointment?
Measure: Number of participants with completed medical appointments in standard care cohort Time: 12 monthsDescription: : Likert scale "Very dissatisfied" is 1, "Dissatisfied" is 2, "Neutral" is 3, "Satisfied" is 4, and "Very Satisfied" is 5. Higher scores indicate more satisfaction, lower scores indicate low satisfaction
Measure: Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire Time: 12 monthsDescription: Cultural Competence Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10, low range indicates low trust and high values indicate trust.
Measure: Provider Experience as assessed using the CAHPS survey Time: 12 monthsDescription: Likert scale; "Strongly disagree" is 1, "Somewhat disagree" is 2, "Neutral" is 3, "Somewhat Agree" is 4, and "Strongly Agree" is 5. Scores are summed and the average is taken; higher scores is more self-efficacy
Measure: Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire Time: [Time Frame: For each visit (until the end of study) - 12 months]Description: Telehealth Utilization satisfaction as assessed using a telehealth satisfaction questionnaire. Likert scale; range 1-5, low values indicate low satisfaction and higher values indicate high satisfaction. Polar: Yes or No response questions, "Would you use telehealth again?" Open ended; patient comments about experience.
Measure: Provider Satisfaction as assessed using the Satisfaction Provider survey Time: 12 monthsDescription: Patient Experience Measures Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10; lower range represents low rating, higher ranges indicate higher rating
Measure: Patient Experience Time: 12 monthsDescription: Social determinants of health as assessed using a social and environmental factors questionnaire. Polar; Yes or No questions about food insecurity and transportation, "did you worry that your food would run out before you got money to buy more?" "have you or your family ever been unable to go to the doctor because of distance or transportation?"
Measure: Social Determinants of Health Tool Time: At 0 (baseline)Description: Transportation cost to patient as assessed using a Transportation Questionnaire. Multiple choice questions about mode of transportation used to get to appointment, "driving own vehicle," "riding public transit," "ride with family member or friend." Open ended to assess cost of parking, bus fare.
Measure: Costs to Patients Time: 12 monthsDescription: Number of patients with need for a technology device (cellphone) as assessed using a Device Assessment questionnaire. Polar; Yes or No question about access to personal device patient has for online appointment, "do you have a personal device to access the internet?." Multiple choice questions about device; "Mobile phone," "Laptop," "Tablet," "Ethernet," "Wi-Fi."
Measure: Costs to Patients Time: 12 monthsDescription: Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
Measure: Costs to Patients Time: 12 monthsDescription: Cost to Institution as assessed by Patient Health Utilization questionnaire. Polar; Yes or No questions about health service usage in the last three months, "have you had to be admitted to the hospital?" Open-ended question about number of time health services were used, "how many times were you admitted to the hospital for reasons related to diabetes?"
Measure: Cost to Instituition Time: 12 monthsDescription: Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to online appointment. "Did you attend your online appointment?" "What types of providers did you see?" Open-ended questions asking about time, "how long did it take?"
Measure: Cost to Instituition Time: 12 monthsDescription: Cost to Institution as assessed using the In-Person Appointment questionnaire. Polar; Yes or No questionnaire about appointment attendance; "did you attend an in-person appointment?" "How long was your in-person appointment?" Open-ended questions about time, "how long did it take?"
Measure: Cost to Instituition Time: 12 monthsDescription: Cost to Institution as assessed using the Clinic Cost, Preparation, and Delivery for Providers and Staff questionnaire. Multiple choice questions about person (Doctor, Nurse and Social Worker) and appointment type provided to patient
Measure: Cost to Instituition Time: 12 monthsDescription: Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained, "Doctor," "Nurse Practitioner," "Social Worker." Polar; Yes or No questions about provider and staff training for telehealth appointment; training on, "camera and mic," "loading Webex platform."
Measure: Cost to Instituition Time: 12 monthsDescription: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Measure: Glycemic Control at Baseline Time: HbA1c for the last 12 monthsDescription: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Measure: Glycemic Control Progression Time: For each visit (until the end of study) - 12 monthsDescription: Cost to Payor as assessed using Health Care Utilization Online questionnaire. Polar; Yes and No questions about patient use of health services, "In the last 3 months, has 911 been called because of your diabetes?" Open-ended questions about rate of health service use, "how many times was 911 called?"
Measure: Cost to Payor Time: 12 months (monthly)Description: Cost to payor as assessed using Clinic Cost, Preparation, and Delivery questionnaire for Providers or Staff. Open ended questions about length of training and technology used, along with any comments about appointment delivery.
Measure: Cost to Payor Time: 12 monthsDescription: Cost to payor as assessed using the Team Costs of Provider or Staff questionnaire. Open ended question asking about length of training and training required on "billing process," "data collection process," "camera and mic."
Measure: Cost to Payor Time: 12 monthsDescription: Multiple Choice and fill-in. Questions about time spent training young adults and training required on "Agenda setting", "Camera and Mic", "Loading Webex platform".
Measure: Cost to Payor as as assessed using the Team Costs- YA Time: 12 monthsDescription: Likert scale; used to measure respondents' endorsement of particular statements. Descriptive system top answer is 1 and last answer is 5. Missing items will be coded as 9. Online software used to score.
Measure: Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire. Time: At 0 (baseline) and 12 months (after visit 4)Description: "Rarely or none of the time (less than 1 day)" is 0, "Some or a little of the time (1-2 days)" is 1, "Occasionally or a moderate amount of time" is 2, "Most or all of the time (5-7 days)" is 3. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Measure: Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D) Time: At 0 (baseline) and 12 months (after visit 4)Description: Likert scale; "Excellent" is 1, "Very good" is 2, "Good" is 3, "Fair" is 4, and "Poor" is 5. An algorithm is used to generate the physical and mental health composite scores for comparison (a confirmatory factor analyses).Items are scored so that a higher score indicates a better health state.
Measure: Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure Time: At 0 (baseline) and 12 months (after visit 4)Description: Likert scale; "Not a problem" is 1, "A slight problem" is 2, "A moderate problem" is 3, "Somewhat serious problem" is 4, "A Serious Problem" is 5, and "A very serious problem" is 6. There are 4 subscales that address the dimensions of distress and to score, the appropriate item(s) are summed and divided by appropriate number. A mean item score of 3 or higher is considered moderate distress. burden, regimen distress, interpersonal distress and physician distress; likert scale
Measure: Dimensions of distress (e.g., emotional burden, regimen distress, interpersonal distress and physician distress) as assessed using the Diabetes Distress Scale (DDS) Time: At 0 (baseline) and 12 months (after visit 4)Description: Diabetes-related psychosocial self-efficacy as assessed using the Diabetes Empowerment Scale Short Form (DES-SF); Likert scale; "Strongly disagree" is 1, "Somewhat disagree" is 2, "Neutral" is 3, "Somewhat Agree" is 4, and "Strongly Agree" is 5. Scores are summed and the average is taken; higher scores is more self-efficacy
Measure: Assessment of Diabetes-Related Psychosocial Self-Efficacy Time: At 0 (baseline) and 12 months (after visit 4)Description: Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?"
Measure: Self Care - Realted to Diabetes as assessed by Self-Care questionnaire Time: [At 0 (baseline) and each visit (until the end of study) - 12 months]Description: Record keeping for tools to give to patients in transition to non-study visits (ie: Shared Decision Making tool and Tidepool)
Measure: CoYoT1 Care - Tools Questions Time: [At 12 months or Visit 4]Description: Record keeping for tools to give to patients in transition to non-study visits (ie:Tidepool)
Measure: Standard Care - Tools Questions Time: [At 12 months or Visit 4]The study is a Phase 2, multicounty, multicenter, non-confirmatory, investigator- and subject masked, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CFZ533 on preservation of residual pancreatic β-cell function in new onset T1DM in pediatric and young adult subjects.
Description: To evaluate safety and tolerability of CFZ533 in new onset T1DM.
Measure: Proportion of subjects with adverse events (AE)/serious adverse events (SAE) in treatment groups. Time: at 16 monthsDescription: To evaluate the treatment effect of CFZ533 on pancreatic beta cell function.
Measure: Stimulated C-peptide AUC by mixed meal tolerance test (MMTT). Time: at 12 monthsDescription: To evaluate the pharmacokinetics (PK) of CFZ533.
Measure: Free CFZ533 plasma concentration. Time: at day 1Description: To evaluate the pharmacokinetics (PK) of CFZ533.
Measure: Free CFZ533 plasma concentration. Time: at 1 weekDescription: To evaluate the pharmacokinetics (PK) of CFZ533.
Measure: Free CFZ533 plasma concentration. Time: at 12 monthsDescription: To evaluate the treatment effect of CFZ533 on full or partial remission.
Measure: Proportion of subjects with full or partial remission. Time: at 12 monthsDescription: To evaluate durability of effects of CFZ533 on pancreatic beta cell function.
Measure: Stimulated C-peptide AUC by MMTT. Time: at 3 yearsINTRODUCTION 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.
Description: Variation in HbA1c levels comparatively between groups after the period of social distancing measures.
Measure: Variation in HbA1c levels Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Confirmation of coronavirus infection by rapid test
Measure: COVID-19 infection Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Comparison of the lipid profile of the last year with the lipid profile after the intervention between the groups.
Measure: Variation in lipid profile Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Comparison of the blood pressure level of the last consultation with the pressure after the intervention between the groups.
Measure: Variation in blood pressure levels Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of emotional distress associated with the routine of living with diabetes - B-PAID (Brazilian Problem Areas In Diabetes Scale)
Measure: Comparison of emotional distress associated with the routine of living with diabetes after intervention between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of eating disorders - EAT - 26 SCALE (Teste de Atitudes Alimentares)
Measure: Comparison of eating disorders between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of adherence to the proposed clinical treatment - SCI R (Self-Care Inventory - revised)
Measure: Comparison of adherence to the proposed clinical treatment between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of minor psychiatric disorders - SRQ 20 (Self Report Questionnaire)
Measure: Comparison of minor psychiatric disorders between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of sleep pattern changes - MSQ (Mini Sleep Questionnaire)
Measure: Comparison of sleep pattern changes between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)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.
Description: Severe hypoglycemia and diabetic ketoacidosis
Measure: Self-reported acute diabetes complication Time: Since March 11, 2020Description: 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 daysDescription: 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, 2020Description: 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, 2020Description: Two questions on food security One question on physical activity
Measure: Impact of the pandemic situation on daily life activities Time: Since March 11, 2020Description: 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 weeksDescription: Short Mood and Feelings Questionnaire (SMFQ) for children and adolescent.
Measure: Impact on stress, anxiety and depression for children and adolescents Time: Last 2 weeksThe study design is observational, exploratory study consisting of two cohorts of COVID-19 patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing on the effect of plasma glucose levels on cardiac function will be evaluated by repeated assessment of cardiac function by echocardiography and measurement of plasma glucose. Furthermore, blood coagulability will be evaluated to determine the importance of diabetes status and plasma glucose changes for whole blood coagulability at time of admission to the ICU and progression in coagulability abnormalities. In the medical ward cohort, two assessments will be performed separated by no more than 12 hours. In the ICU cohort, three assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of patients admitted to medical ward (hospitalisation cohort). The primary hypothesis is that levels of plasma glucose have clinically significant impact on left ventricular systolic function in patients with COVID-19 admitted to the ICU. The secondary hypothesis is that the impact of plasma glucose on left ventricular systolic function is associated with glycaemic control prior to admission as measured by HbA1c.
Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measure: Plasma glucose levels and left ventricular ejection fraction Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measure: Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measure: Plasma glucose levels and strain analysis Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measure: Plasma glucose levels and mitral annular systolic velocity Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measure: Plasma glucose levels and left ventricular ejection fraction (sub-group analysis) Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measure: Plasma glucose levels and strain analysis (sub-group analysis) Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measure: Plasma glucose levels and mitral annular systolic velocity (sub-group analysis) Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measure: HbA1c, Plasma glucose levels and strain analysis Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measure: HbA1c, Plasma glucose levels and mitral annular systolic velocity Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes at time of admission to the ICU (ICU cohort only)
Measure: Diabetes status and whole blood coagulability and fibrinolysis Time: At time of admission to the ICU (max. 24 hours after admission to the ICU)Description: Difference in change in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes treated at the ICU (ICU cohort only)
Measure: Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay Time: From first until last assessment during ICU stay (max. 24 hours).Description: The prognostic value of cardiac function and TEG on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death
Measure: Prognostic value of TEG analysis Time: From time of admission and until four weeks after admissionDescription: The prognostic value of cardiac function on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death
Measure: Prognostic value of cardiac function Time: From time of admission and until four weeks after admissionDescription: Difference in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)
Measure: Diabetes status and high-sensitivity troponins Time: At the time of admission to the ICU (max. 24 hours after admission to the ICU)Description: Difference in change in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)
Measure: Diabetes status and change high-sensitivity troponins Time: From first until last assessment during ICU stay (max. 24 hours)A phase II, Multi-centre, randomised, double-blind, placebo-controlled, Multi-arm parallel cohort trial. - to investigate the effect of 2.5 mg/kg og ATG on the preservation of stimulated C-peptide at 12 months compared to placebo - to identify the minimally effective dose of ATG that shows an effect on C-peptide when compared to placebo at 12 months
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.
Description: Change in HbA1c from baseline to 3 month after the lockdown
Measure: Impact of COVID-19 pandemic and lockdown on glycemic control among a sample of Egyptian children and adolescents with type 1 diabetes Time: 12 weeksDescription: Change in total insulin dosage from baseline to 3 month after the lockdown
Measure: Impact of COVID-19 pandemic and lockdown on insulin dosage among a sample of Egyptian children and adolescents with type 1 diabetes Time: 12 weeksAlthough reports showed that children with well controlled diabetes do not appear to have increased risk of infection with SARS-CoV-2, however data are scarce regarding the extent to which clinical and demographic data of patient could modify the outcome and severity of the disease. Additionally, the link between covid-19 and diabetes remains controversial.
Description: complications and comorbidities associated with diabetes
Measure: Clinical characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. Time: 4 monthsDescription: Acute phase reactants
Measure: Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. Time: 4 monthsDescription: Intensive care admission
Measure: Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. Time: 4 monthDescription: Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents
Measure: Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents Time: 4 monthsDescription: Impact of Covid-19 pandemic on presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes
Measure: Presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes during COVID-19 Pandemic in Egypt Time: 4 monthDuring the COVID-19 pandemic, the time spent at the home of patients has increased because of national quarantine policies and patients' fear of getting sick. For this reason, in this ongoing process, patients have been unable to go to work regularly due to their chronic diseases (being on administrative leave) and their fear of going out. These reasons have prevented being physically active. The aim of the study is to evaluate the physical activity level, quality of life, glucose control, anxiety, depression, fear of hypoglycemia and loneliness perceptions of patients with type 1 diabetes mellitus during the COVID-19 pandemic period and compared with healthy controls.
Description: Physical activity level using International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be evaluated.
Measure: Physical activity level Time: Five minutesDescription: Quality of life using Short Form Health Survey (SF-36) will be evaluated.
Measure: General Quality of life Time: Ten minutesDescription: Depression using Hospital Anxiety and Depression Scale will be evaluated.
Measure: Depression Time: Three minutesDescription: Anxiety using Hospital Anxiety and Depression Scale will be evaluated.
Measure: Anxiety Time: Three minutesDescription: It will be questioned how many times patients have had hypoglycemic attacks (<4 mmol/L and common symptoms) in the last 7 days.
Measure: Self-reported hypoglycemia Time: Last seven dayDescription: Loneliness using UCLA Loneliness Scale Short Form (ULS-8) will be evaluated.
Measure: Loneliness Time: Three minutesDescription: Hypoglisemia fear using Hypoglisemia Fear Survey (HFS) will be evaluated.
Measure: Hypoglisemia fear Time: Five minutesDescription: Dyspnea during daily life activites using Modified Medical Research Dyspnea Scale will be evaluated.
Measure: Dyspnea Time: Two minutesAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 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.
Drug Reports MeSH Reports HPO Reports