QDMAT: Qatar Diabetes Mobile Application Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention arm 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
A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise.
Other: Standard of care
Standard of care including physicians, dietetics and diabetes educators support
|
| Placebo Comparator: Standard of care arm 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
Standard of care including physicians, dietetics and diabetes educators support
|
Outcome Measures
Primary Outcome Measures
- Difference in mean HbA1c [6 months]
Difference in mean HbA1C between the intervention arm and the standard care
- Difference in mean HbA1c [3 months]
Difference in mean HbA1C between the intervention arm and the standard care
Secondary Outcome Measures
- Subject perceptions of diabetes self management [6 months]
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
- Change in subjects attitudes towards disease [6 months]
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.
- Changes in insulin doses [6 months]
Difference in number of recommended insulin dose adjustments per subject between intervention and usual care arm
- Changes in reported hypoglycemia [6 months]
Difference in the number of reported hypoglycemic events per subject between the intervention and usual care arm.
- Time to achieve normoglycemia [6 months]
Reduction in the time required to reach normoglycemia (in-range blood glucose readings) between the intervention and control groups.
- Number of clinical interactions [6 months]
• Differences in the number of clinical interactions per subjects with healthcare providers through the mobile app and through usual means in the standard care
- Missed clinical appointments [6 months]
Percent of missed clinical appointments in each arm.
- Weight [6 months]
Changes in weight from baseline at 6 months
- Blood Pressure [6 months]
Changes in blood pressure from baseline at 6 months
- Lipids [6 months]
Changes in lipids from baseline at 6 months
Other Outcome Measures
- Exploratory outcome [6 months]
Increased mobile application usability by the system usability scale (SUS) at 6 months. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. An SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret the results involves "normalizing" the scores to produce a percentile ranking
- Exploratory outcome [6 months]
Increased mobile application acceptance by documentation of patients experiences with the mobile application
- Exploratory outcome [6 months]
Reduction in hospital admissions
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hamad General Hospital | Doha | Qatar |
Sponsors and Collaborators
- Hamad Medical Corporation
- Qatar Computing Research Institute (QCRI)
- Droobi Health
Investigators
- Principal Investigator: Noor N Suleiman, MD, Hamad Medical Corporation
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Alhuwail D. Diabetes Applications for Arabic Speakers: A Critical Review of Available Apps for Android and iOS Operated Smartphones. Stud Health Technol Inform. 2016;225:587-91.
- Alotaibi MM, Istepanian R, Philip N. A mobile diabetes management and educational system for type-2 diabetics in Saudi Arabia (SAED). Mhealth. 2016 Aug 24;2:33. doi: 10.21037/mhealth.2016.08.01. eCollection 2016.
- Bonoto BC, de Araújo VE, Godói IP, de Lemos LL, Godman B, Bennie M, Diniz LM, Junior AA. Efficacy of Mobile Apps to Support the Care of Patients With Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. JMIR Mhealth Uhealth. 2017 Mar 1;5(3):e4. doi: 10.2196/mhealth.6309.
- Cui M, Wu X, Mao J, Wang X, Nie M. T2DM Self-Management via Smartphone Applications: A Systematic Review and Meta-Analysis. PLoS One. 2016 Nov 18;11(11):e0166718. doi: 10.1371/journal.pone.0166718. eCollection 2016. Review.
- Istepanian RS, Zitouni K, Harry D, Moutosammy N, Sungoor A, Tang B, Earle KA. Evaluation of a mobile phone telemonitoring system for glycaemic control in patients with diabetes. J Telemed Telecare. 2009;15(3):125-8. doi: 10.1258/jtt.2009.003006.
- Kitsiou S, Paré G, Jaana M, Gerber B. Effectiveness of mHealth interventions for patients with diabetes: An overview of systematic reviews. PLoS One. 2017 Mar 1;12(3):e0173160. doi: 10.1371/journal.pone.0173160. eCollection 2017.
- Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31.
- Ristau R, Yang J, White J. Evaluation and Evolution of Diabetes Mobile Applications: Key Factors for Health Care Professionals Seeking to Guide Patients.
- Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013 Aug 13;11:138. doi: 10.1186/1477-7525-11-138.
- Seto E, Istepanian RS, Cafazzo JA, Logan A, Sungoor A. UK and Canadian perspectives of the effectiveness of mobile diabetes management systems. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6584-7. doi: 10.1109/IEMBS.2009.5333998.
- 17292