Qatar Diabetes Mobile Application Trial

Type2 Diabetes Mellitus Clinical Trial

— QDMAT  

Official title:

Qatar Diabetes Mobile Application Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03998267
• Other study ID #: 17292
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Hamad Medical Corporation
• Contact: Noor N Suleiman, MD
• Phone: +97455816515
• Email: nsuleiman[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2020
• Est. primary completion date: August 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Qatar	Hamad General Hospital	Doha

Sponsors (3)

Lead Sponsor	Collaborator
Hamad Medical Corporation	Droobi Health, Qatar Computing Research Institute (QCRI)

Country where clinical trial is conducted

Qatar, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Seto E, Istepanian RS, Cafazzo JA, Logan A, Sungoor A. UK and Canadian perspectives of the effectiveness of mobile diabetes management systems. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:6584-7. doi: 10.1109/IEMBS.2009.5333998. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	6 months
Other	Exploratory outcome	Increased mobile application acceptance by documentation of patients experiences with the mobile application	6 months
Other	Exploratory outcome	Reduction in hospital admissions	6 months
Primary	Difference in mean HbA1c	Difference in mean HbA1C between the intervention arm and the standard care	6 months
Primary	Difference in mean HbA1c	Difference in mean HbA1C between the intervention arm and the standard care	3 months
Secondary	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
Secondary	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
Secondary	Changes in insulin doses	Difference in number of recommended insulin dose adjustments per subject between intervention and usual care arm	6 months
Secondary	Changes in reported hypoglycemia	Difference in the number of reported hypoglycemic events per subject between the intervention and usual care arm.	6 months
Secondary	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
Secondary	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
Secondary	Missed clinical appointments	Percent of missed clinical appointments in each arm.	6 months
Secondary	Weight	Changes in weight from baseline at 6 months	6 months
Secondary	Blood Pressure	Changes in blood pressure from baseline at 6 months	6 months
Secondary	Lipids	Changes in lipids from baseline at 6 months	6 months

External Links

•   Droobi Health application website