Qatar Diabetes Mobile Application Trial

Study Overview
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Brief Summary
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Diabetes mobile technology is an emerging and rapidly expanding field that seeks to combine cutting edge behavioral insights with best practice in diabetes self management education to improve patient empowerment and deliver better patient outcomes.The question that arises is whether or not, diabetes mobile applications are effective in improving glycemic control, clinical outcomes, quality of life and overall patient satisfaction, in diabetic patients in Qatar. To answer this, we plan to enroll 90 diabetic patients into a custom-made diabetes app for Qatar (Droobi) (as intervention group) in comparison with 90 diabetic patients followed in the current standard care, matched in characteristics (as control group). We have the hypothesis that with utilization of the mobile application, patients will have improved glycemic control, improved self management and patient empowerment; together with improved patient-educator/doctor interaction.

Official Title
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Qatar Diabetes Mobile Application Trial

Conditions
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Type2 Diabetes Mellitus

Intervention / Treatment
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* Device: Droobi
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Adults with T2DM (more than 18 yrs of age and younger than 60) who are able to provide consent Arabic speaking and non-arabic speaking T2DM patients, who can communicate in Arabic and or English language. Uncontrolled diabetes with HbA1c more than or equal to 8.5% T2DM on insulin with or without any other oral medication Subject must have a smart phone (must be an iOS (Apple) phone user) and must be interested in using a smart phone app. Subject must have no visual impairment. Minimal level of literacy (able to read and write in english or arabic). To be able to communicate via chat with the mobile app team through the app as evidenced by at least weekly use of any of the social media such as WhatsApp, Viber, Facebook Messenger etc Subject must be willing to utilize a mobile application for diabetes control Exclusion Criteria: • Recent history (3 months) of stroke or Myocardial infarction. Patients with proliferating retinopathy Patients with an acute illness during the past 2 weeks. Patients who plan to be away for more than 3 months. Patients with CKD requiring dialysis. Hypoglycemia unawareness. More than one episode of severe hypoglycemia in the previous 6 months. Female patients who are planning for pregnancy in the coming 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects with T2DM will be randomised into an intervention arm and standard care arm. Subjects in the intervention arm receive usual diabetes care in addition to the mobile app while subjects in the standard care will receive usual diabetes care only.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention arm<br>For the subjects using the app (intervention group): The mobile app team shall do the following: Educate/train patients on app usage Patients will be subscribed to the app and their profile on the app will be created Subjects will log in their blood sugar readings and communicate with the mobile app team (educators and physician) via the app Additionally patients will be placed on a diet and lifestyle plan as agreed upon by the patient and health care provider team, best suited towards the patient's needs Throughout the study, patient will receive notifications and advice on how to follow diet and lifestyle changes Throughout the study; patient interaction and app usage will be tracked Patients will additionally be interviewed by the research team together with Droobi to capture app experience at 3 months and 6 months | Device: Droobi<br>* A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise.<br>Other: Standard of care<br>* Standard of care including physicians, dietetics and diabetes educators support<br>|
| Placebo Comparator: Standard of care arm<br>For the subjects not using the app (the standard of care group): At time 0, will be seen by the dietician and diabetes educators at HGH endocrine clinics as part of standards of care The educators contact number and diabetes hotline number will be provided to the patients o The diabetes hotline number #16099 is a new service provided to diabetes patients at the national diabetes center to help communicate with the diabetes educators with questions relating to their diabetes management, medication adjustment such as dose titrations etc. Appointments thereafter with the educator and/or dietician will be decided and scheduled according to the individual patient needs, with a minimum visit every 3 months during the study period | Other: Standard of care<br>* Standard of care including physicians, dietetics and diabetes educators support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean HbA1c | Difference in mean HbA1C between the intervention arm and the standard care | 6 months | 
| Difference in mean HbA1c | Difference in mean HbA1C between the intervention arm and the standard care | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject perceptions of diabetes self management | Within subject changes in perceptions of diabetes self-management as assessed by diabetes self-management questionnaire (DSMQ) scores subsection glucose management and overall rating. DSM-Q is a 16 item questionnaire to assess self-care activities associated with glycemic control. Four subscales, 'Glucose Management' (GM), 'Dietary Control' (DC), 'Physical Activity' (PA), and 'Health-Care Use' (HU), as well as a 'Sum Scale' (SS) as a global measure of self-care. Scale scores are calculated as sums of item scores and then transformed to a scale ranging from 0 to 10 (raw score / theoretical maximum score * 10. A transformed score of ten thus represents the highest self-rating of the assessed behavior | 6 months | 
| Change in subjects attitudes towards disease | Within subject changes in attitudes towards disease assessed the proportion of subjects with diabetes distress scales (DDS) scores consistent with moderate or high distress.The DDS yields a total distress score plus 4 subscale (emotional burden,physical distress, regimen distress and interpersonal distress) scores each addressing a different kind of distress. A mean item score 2.0-2.9 is considered moderate distress and a mean score of more than or equal to 3 is considered high stress. | 6 months | 
| Changes in insulin doses | Difference in number of recommended insulin dose adjustments per subject between intervention and usual care arm | 6 months | 
| Changes in reported hypoglycemia | Difference in the number of reported hypoglycemic events per subject between the intervention and usual care arm. | 6 months | 
| Time to achieve normoglycemia | Reduction in the time required to reach normoglycemia (in-range blood glucose readings) between the intervention and control groups. | 6 months | 
| Number of clinical interactions | • Differences in the number of clinical interactions per subjects with healthcare providers through the mobile app and through usual means in the standard care | 6 months | 
| Missed clinical appointments | Percent of missed clinical appointments in each arm. | 6 months | 
| Weight | Changes in weight from baseline at 6 months | 6 months | 
| Blood Pressure | Changes in blood pressure from baseline at 6 months | 6 months | 
| Lipids | Changes in lipids from baseline at 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile health, m-health