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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 (18)


    Name (Synonyms) Correlation
    drug1791 Glycaemic levels Wiki 0.28
    drug4304 Tele-interventions related to diabetes management and mental well-being Wiki 0.28
    drug5279 treated with hyperimmune plasma Wiki 0.28
    Name (Synonyms) Correlation
    drug327 Anti-Human Thymocyte Immunoglobulin, Rabbit Wiki 0.28
    drug2016 Hypocaloric, moderate low fat diet Wiki 0.28
    drug2015 Hypocaloric, low carbohydrate diet Wiki 0.28
    drug5285 vaccine Wiki 0.28
    drug2555 Mediterranean diet, no caloric restriction Wiki 0.28
    drug5251 suspected of COVID-19 infection Wiki 0.28
    drug3661 Resilient, Empowered, Active Living-Telehealth (REAL-T) Wiki 0.28
    drug1024 CoYoT1 Care Wiki 0.28
    drug753 CFZ533 Wiki 0.28
    drug5293 visual analogue scale Wiki 0.28
    drug5267 this study is non- interventional Wiki 0.28
    drug2956 Online Survey Wiki 0.12
    drug2969 Online survey Wiki 0.12
    drug4070 Standard Care Wiki 0.11
    drug3195 Placebo Wiki 0.01

    Correlated MeSH Terms (5)


    Name (Synonyms) Correlation
    D003922 Diabetes Mellitus, Type 1 NIH 1.00
    D003920 Diabetes Mellitus, NIH 0.49
    D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH 0.14
    Name (Synonyms) Correlation
    D003924 Diabetes Mellitus, Type 2 NIH 0.12
    D050177 Overweight NIH 0.08

    Correlated HPO Terms (2)


    Name (Synonyms) Correlation
    HP:0000819 Diabetes mellitus HPO 0.49
    HP:0005978 Type II diabetes mellitus HPO 0.12

    Clinical Trials

    Navigate: Correlations   HPO

    There are 13 clinical trials


    1 Accelerating Solutions to Optimize Glycemic Control and Weight Management In Young Adults With Type 1 Diabetes

    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.

    NCT03651622
    Conditions
    1. Diabetes Mellitus, Type 1
    2. Overweight and Obesity
    Interventions
    1. Behavioral: Hypocaloric, low carbohydrate diet
    2. Behavioral: Hypocaloric, moderate low fat diet
    3. Behavioral: Mediterranean diet, no caloric restriction
    MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1 Overweight
    HPO:Diabetes mellitus Type I diabetes mellitus

    Primary Outcomes

    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) 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 2

    Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) 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 3

    Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

    Description: 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) Visit

    Description: 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) Visit

    Description: 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) Visit

    Description: 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) Visit

    Description: 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) Visit

    Description: 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) Visit

    Secondary Outcomes

    Description: 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) Visit

    Description: 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) Visit

    Description: 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) Visit

    Description: 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) Visit

    Description: 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) Visit

    Description: 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) Visit
    2 CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes

    CoYoT1 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.

    NCT03793673
    Conditions
    1. Type 1 Diabetes Mellitus
    Interventions
    1. Behavioral: CoYoT1 Care
    2. Other: Standard Care
    MeSH:Diabetes Mellitus, Type 1
    HPO:Type I diabetes mellitus

    Primary Outcomes

    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 months

    Description: 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 months

    Description: 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 months

    Description: : 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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)

    Secondary Outcomes

    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 months

    Description: 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 months

    Description: Diabetes visit expenses questions - polar questions, multiple choice, and open-ended

    Measure: Costs to Patients

    Time: 12 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %

    Measure: Glycemic Control at Baseline

    Time: HbA1c for the last 12 months

    Description: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %

    Measure: Glycemic Control Progression

    Time: For each visit (until the end of study) - 12 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Other Outcomes

    Description: 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]
    3 Evaluation of a Complex Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study

    This study will evaluate (1) the efficacy of REAL-T, a lifestyle-based telehealth intervention, in improving glycemic control (HbA1c) and psychosocial outcomes, (2) which effects are retained over a 6-month follow-up period, and (3) the mediating mechanisms responsible for the intervention's effects. Half of participants will receive REAL-T, while the other half will receive their usual care.

    NCT04023487
    Conditions
    1. Diabetes Mellitus, Type 1
    Interventions
    1. Behavioral: Resilient, Empowered, Active Living-Telehealth (REAL-T)
    MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
    HPO:Diabetes mellitus Type I diabetes mellitus

    Primary Outcomes

    Description: HbA1C is a measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C will be measured using a finger-prick test and DCA Vantage Analyzer point-of-care system.

    Measure: Change in glycemic control, using Glycated Hemoglobin (HbA1C)

    Time: Baseline, 3 months, 6 months, 9 months, and 12 months

    Secondary Outcomes

    Description: 15-item questionnaire assessing diabetes-related quality of life (qol). Each item contains two parts. Part A is: "If I did not have diabetes, [the question topic] would be", followed by 5 options ranging from "very much better" (or similar; scored as -3) to "worse" (or similar; scored as 1). The fourth option is always "the same" and scored as 0. Part B is: "[the question topic] is" followed by 4 options ranging from "very important" (scored as 3) to "not at all important" (scored as 0). For each question, scores on parts A and B are multiplied, and the 15 products are summed for a total score. Questions 2, 4, 6, 8, 9, & 11 have preliminary yes/no questions, and when a "no" response is given, parts A and B are skipped and the score for that question is 0. The minimum score on each question is -9 and the maximum is 3, with total scores ranging from -135 to 45. Positive scores reflect perceived positive impact of diabetes on qol; negative scores reflect perceived negative impact on qol.

    Measure: Change in diabetes-related quality of life, using the "Audit of Diabetes-Dependent Quality of Life-15" (ADD-QoL-15)

    Time: Baseline, 6 months, and 12 months

    Description: 17-item questionnaire assessing diabetes-related emotional distress. Total scores (mean score on all 17 items) range from 1 to 6. Sub-scale scores (emotional burden, physician-related distress, regimen-related distress, and interpersonal distress) each range from 1 to 6. A total or sub-scale score 2.0 - 2.9 should be considered 'moderate distress,' and a total or sub-scale score > 3.0 should be considered 'high distress.'

    Measure: Change in diabetes-related emotional distress, using the "Diabetes Distress Scale" (DDS)

    Time: Baseline, 6 months, and 12 months

    Description: Short Form 12-item Health Survey Ver. 2 (SF-12v2) is a 12-item questionnaire assessing functional health & well-being over the last 4 weeks in 8 health domains (physical functioning, role participation with physical health problems, bodily pain, general health, vitality, social functioning, role participation with emotional health problems, mental health), all from the patient's point of view. These 8 domains can be summarized into a physical component summary (PCS) and a mental component summary (MCS). Higher scores indicate a better health state. MCS and PCS scores range from 0-100. Scores are calibrated using general population-derived normative data so that 50 is the avg score or norm. Results can be further summarized into a single preference-based health utility number ranging from 1 (equivalent to perfect health) to 0 (equivalent to being dead), using a complex scoring algorithm (SF-6D) derived from surveying a general U.S. population's preferences for specific health states.

    Measure: Change in functional health and well-being, using the "SF-12v2® Health Survey"

    Time: Baseline, 6 months, and 12 months

    Description: 27-item questionnaire assessing self-care activities associated with glycemic control. Higher values indicate more effective self-management. Transformed scores = Actual sum of items / maximum possible sum of items x 10. Total transformed scores range from 0 to 10. Transformed scores on six sub-scales (Dietary control, Glucose management, Glucose monitoring, Medication adherence, Physical activity, and Physician contact) also range from 0 to 10.

    Measure: Change in global diabetes self-management, using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R).

    Time: Baseline, 3 months, 6 months, 9 months, and 12 months

    Description: 3-item questionnaire (Wilson,Lee, Fowler, & Rogers, 2016) assessing adherence to diabetes medication regimen. Item responses for the three adherence items are linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 the best. A total summary score is calculated as the mean of the three individual items, with a range of 0 to 100.

    Measure: Change in medication adherence, using the "3-item adherence self-report scale" questionnaire

    Time: Baseline, 3 months, 6 months, 9 months, and 12 months

    Description: 4-item questionnaire assessing habit strength for testing blood sugar, using 7-point likert scales. Scores range from 4 to 28. A higher score indicates greater automaticity.

    Measure: Change in automaticity of behavior (testing blood sugar), using the "Self-Report Behavioural Automaticity Index" (SRBAI)

    Time: Baseline, 3 months, 6 months, 9 months, and 12 months

    Description: 8-item questionnaire assessing self-efficacy for performing diabetes self-management, using 5-point likert scales. The scale is scored by averaging the scores of all completed items. Scores range from 8 to 40, with higher scores indicating higher self-efficacy.

    Measure: Change in self-efficacy for performing diabetes self-management, using the "Diabetes Empowerment Scale - Short Form" (DES-SF)

    Time: Baseline, 3 months, 6 months, 9 months, and 12 months

    Description: 19-item questionnaire, adapted for type 1 diabetes, assessing the degree to which a person's motivation for a particular behavior or a set of behaviors is relatively autonomous or self-determined. Each item can receive a value ranging from 1 - 7 as selected by the participant. The scale has 2 sub-scales: the autonomous regulatory style and the controlled regulatory style. Calculating the scores for the sub-scales consists of averaging the items on that sub-scale. A Relative Autonomous Motivation Index can be formed by subtracting the average for the controlled reasons from the average for the autonomous reasons. Scores range from 1 to 7, with 7 indicating a strong identification with the given autonomy style. The autonomous regulatory style represents the most self-determined form of motivation.

    Measure: Change in autonomy of taking insulin and/or checking blood sugar, using the "Treatment Self-Regulation Questionnaire" (TSRQ)

    Time: Baseline, 3 months, 6 months, 9 months, and 12 months

    Description: 9 diabetes-related expense questions designed by the study (polar questions, multiple choice, and open-ended). Questions assess loss of income or other productivity due to diabetes (3 items), and impact of cost and health insurance on access to and use of insulin and test strips (6 items).

    Measure: Change in cost to patients

    Time: Baseline, 3 months, 6 months, 9 months, and 12 months

    Description: The number of blood glucose checks over the 14 days prior to each assessment session will be recorded through download of participants' meter data or, if incompatible, through manual review of blood glucose checks recorded on the participant's meter.

    Measure: Change in self management of blood glucose, using the # of blood glucose checks

    Time: Baseline, 3 months, 6 months, 9 months, and 12 months

    Description: The proportion of time when blood glucose was between 70 and 180 mg/dl, as measured by an Abbott FreeStyle Libre Pro continuous glucose monitor worn on the arm for 14 days.

    Measure: Change in glycemic control, using Percent Time-in-Range

    Time: Baseline, 6 months, and 12 months

    Description: The proportion of time when blood glucose was above 180 mg/dl, as measured by an Abbott FreeStyle Libre Pro continuous glucose monitor worn on the arm for 14 days.

    Measure: Change in glycemic control, using Percent Time in Hyperglycemia

    Time: Baseline, 6 months, and 12 months

    Description: The proportion of time when blood glucose was below 70 mg/dl, as measured by an Abbott FreeStyle Libre Pro continuous glucose monitor worn on the arm for 14 days.

    Measure: Change in glycemic control, using Percent Time in Hypoglycemia

    Time: Baseline, 6 months, and 12 months

    Description: 18-item questionnaire assessing intervention participants' satisfaction with the study's telehealth procedures. Scores on items 4-14 (likert-scaled items) range from 1 to 5, with 5 indicating higher satisfaction. Total score is calculated by averaging items 4-14. The remaining 7 items are Yes/No, Yes/No/Maybe, and open-ended items used to characterize the population descriptively and indicate willingness to use/recommend telehealth in the future. These additional 7 items are not used in any scoring calculations.

    Measure: Telehealth Satisfaction

    Time: 6 months

    Description: 8-item healthcare utilization questionnaire designed by the study. Polar; Yes/No questions about health service usage in the last month: (e.g., "have you had to be admitted to the hospital?"). Open-ended questions about number of time health services were used, (e.g., "how many times were you admitted to the hospital for reasons related to diabetes?").

    Measure: Change in cost to payor

    Time: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months

    Other Outcomes

    Description: 19-item questionnaire, designed by the study, gathering background data on demographic characteristics and baseline healthcare utilization (for prior 3 months). No total score will be calculated. Scores on individual items will be used as covariates in various analyses.

    Measure: Background Information

    Time: Baseline
    4 Investigator- and Subject-blinded, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy Trial of CFZ533 in Pediatric and Young Adult Subjects With New Onset Type 1 Diabetes (T1DM)

    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.

    NCT04129528
    Conditions
    1. Type 1 Diabetes Mellitus
    Interventions
    1. Drug: CFZ533
    2. Other: Placebo
    MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
    HPO:Diabetes mellitus Type I diabetes mellitus

    Primary Outcomes

    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 months

    Description: 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 months

    Secondary Outcomes

    Description: To evaluate the pharmacokinetics (PK) of CFZ533.

    Measure: Free CFZ533 plasma concentration.

    Time: at day 1

    Description: To evaluate the pharmacokinetics (PK) of CFZ533.

    Measure: Free CFZ533 plasma concentration.

    Time: at 1 week

    Description: To evaluate the pharmacokinetics (PK) of CFZ533.

    Measure: Free CFZ533 plasma concentration.

    Time: at 12 months

    Description: To evaluate the treatment effect of CFZ533 on full or partial remission.

    Measure: Proportion of subjects with full or partial remission.

    Time: at 12 months

    Description: To evaluate durability of effects of CFZ533 on pancreatic beta cell function.

    Measure: Stimulated C-peptide AUC by MMTT.

    Time: at 3 years
    5 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)
    6 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
    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
    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)
    8 MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D)

    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

    NCT04509791
    Conditions
    1. Diabetes Mellitus, Type 1
    Interventions
    1. Drug: Anti-Human Thymocyte Immunoglobulin, Rabbit
    MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
    HPO:Diabetes mellitus Type I diabetes mellitus

    Primary Outcomes

    Measure: the area under the stimulated C-peptide response curve

    Time: over the first 2 hours of a MMTT [ mixed meal tolerance test] at 12 months post treatment

    Secondary Outcomes

    Measure: the area under the stimulated C-peptide response curve

    Time: over teh first 2 hours of a MMTT at baseline, 3, 6 and 12 months

    Measure: DBS [dry blood spot] C-peptide measurements

    Time: at all observation times

    Measure: CD4 positive T cells and CD8 positive T cells

    Time: over 12 months

    Measure: HBA1c

    Time: over 12 months

    Measure: insulin require months

    Time: over 12 months

    Measure: T1D-associated autoantibodies ( GADA [glutamic acid decarboxylase antibodies], IAA [insulin auto-antibodies], IA-2A [IA-2 antibodies] and ZnT8A

    Time: over 12 months

    Measure: CGM [continuous glucose monitoring] measurements ( time in range, time above time below)

    Time: over 12 months
    9 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
    10 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
    11 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
    12 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
    13 Hb A1C Pre and Post Confinement in Latin American Children With Type 1 Diabetes: Dulce Study Group

    A multicenter retrospective observational study among children with type 1 diabetes will be performed. The Objective of this study will be to determine a) the association between the increase in Hba1c in children with type 1 diabetes and confinement due to the COVID 19 pandemic. b) the association between the frequency of patient care during social confinement and the Hba1c values. Different centers from Latin America including Argentina, Peru, Panama, Chile, and Ecuador will participate in this study. Children younger than 17 years with a diagnosis of type 1 diabetes prior to 2018 will be included. Data from the medical records of the participating centers will be collected on the Hb A1c value before and after confinement (6 months completed). The initial (base) value will be taken as a value of HbA1c registered in the patient's Clinical History for the year 2018, 2019, and 2020 pre and post quarantine (Sep-Oct-Nov) 2020, considering compliance with six months of quarantine. Hb A1c should have been performed in the same institution or with the same methods in order to avoid bias.

    NCT04640064
    Conditions
    1. Type1diabetes
    2. Childhood ALL
    MeSH:Precursor Cell Lymphoblastic Leukemi Precursor Cell Lymphoblastic Leukemia-Lymphoma Diabetes Mellitus Diabetes Mellitus, Type 1
    HPO:Diabetes mellitus Type I diabetes mellitus

    Primary Outcomes

    Description: The increase in Hba1c in children with type 1 diabetes and confinement due to the COVID 19 pandemic

    Measure: Hb A1C pre and post Confinement in Latin American children with Type 1 Diabetes

    Time: six months

    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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