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| Name | Class |
|---|---|
| Qatar Computing Research Institute (QCRI) | UNKNOWN |
| Droobi Health | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Active Comparator | For the subjects using the app (intervention group): The mobile app team shall do the following:
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| Standard of care arm | Placebo Comparator | For the subjects not using the app (the standard of care group):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Droobi | Device | A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise. |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcome | 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 |
Inclusion Criteria:
• Adults with T2DM (more than 18 yrs of age and younger than 60) who are able to provide consent
Exclusion Criteria:
• Recent history (3 months) of stroke or Myocardial infarction.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noor N Suleiman, MD | Contact | +97455816515 | nsuleiman@hamad.qa | |
| Dabia H Al Mohanadi | Contact | +97455524801 | DAlMohanadi@hamad.qa |
| Name | Affiliation | Role |
|---|---|---|
| Noor N Suleiman, MD | Hamad Medical Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad General Hospital | Recruiting | Doha | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28293606 | Background | 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. | |
| 27861583 | Background | 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. |
| Label | URL |
|---|---|
| Droobi Health application website | View source |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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.
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| Standard of care | Other | Standard of care including physicians, dietetics and diabetes educators support |
|
| 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 |
| 6 months |
| Exploratory outcome | Increased mobile application acceptance by documentation of patients experiences with the mobile application | 6 months |
| Exploratory outcome | Reduction in hospital admissions | 6 months |
| 19964700 | Background | 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. |
| 28249025 | Background | Kitsiou S, Pare 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. |
| 19364893 | Background | 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. |
| Background | Ristau R, Yang J, White J. Evaluation and Evolution of Diabetes Mobile Applications: Key Factors for Health Care Professionals Seeking to Guide Patients. |
| 28249834 | Background | Bonoto BC, de Araujo VE, Godoi 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. |
| 27332269 | Background | 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. |
| 15735199 | Background | 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. doi: 10.2337/diacare.28.3.626. |
| 23937988 | Background | 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. |
| 35710428 | Derived | Suleiman N, Alkasem M, Al Amer Z, Salameh O, Al-Thani N, Hamad MK, Baagar K, Abdalhakam I, Othman M, Dughmosh R, Al-Mohanadi D, Al Sanousi A, Bashir M, Chagoury O, Taheri S, Abou-Samra AB. Qatar Diabetes Mobile Application Trial (QDMAT): an open-label randomised controlled trial to examine the impact of using a mobile application to improve diabetes care in type 2 diabetes mellitus-a study protocol. Trials. 2022 Jun 16;23(1):504. doi: 10.1186/s13063-022-06334-5. |