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

Background Mobile health (mHealth) is increasingly advocated for diabetes management. It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with type 2 diabetes (T2DM). A new mobile applicati...

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Published in:Current controlled trials in cardiovascular medicine 2022-06, Vol.23 (1), p.504-504, Article 504
Main Authors: Suleiman, Noor, Alkasem, Meis, Al Amer, Zaina, Salameh, Obada, Al-Thani, Noora, Hamad, Mohammad Khair, Baagar, Khaled, Abdalhakam, Ibrahem, Othman, Manal, Dughmosh, Ragae, Al-Mohanadi, Dabia, Al Sanousi, Ali, Bashir, Mohammed, Chagoury, Odette, Taheri, Shahrad, Abou-Samra, Abdul-Badi
Format: Article
Language:English
Subjects:
Blood pressure
Care and treatment
Cellular telephones
Chronic illnesses
Clinical trial
Clinical trials
Consent
Diabetes
Diabetes therapy
Dietitians
Education
Glucose
Health aspects
Health care
Heart attacks
Hypoglycemia
Insulin
Intervention
Lifestyle change
Medical personnel
Medicine
Metabolism
Mobile applications
Mobile communications networks
Mobile health
Patient satisfaction
Patients
Self-management
Smartphones
Study Protocol
Technology application
Telemedicine
Testing
Type 2 diabetes
Type 2 diabetes mellitus
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Summary:Background Mobile health (mHealth) is increasingly advocated for diabetes management. It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with type 2 diabetes (T2DM). A new mobile application was specifically built for people with T2DM with the help of the local expertise. The objective of the study was to evaluate the effectiveness of the mobile app. Methods The planned study is an ongoing open-label randomised controlled trial in which adults living with T2DM treated with insulin will be randomised 1:1 to the use of this diabetes application versus current standard care. The primary outcome will be the difference in mean HbA1c from baseline to 6 months. Other outcome measures include anthropometric measures, hypoglycaemic events, medication adjustments, number of clinical interactions and missed appointments and patient perceptions of their disease and diabetes self-management. The study will randomise 180 subjects for assessment of the primary outcome. Discussion We hypothesise that the diabetes-specific mobile application will improve glycaemic control, increase patient empowerment for self-management of diabetes and improve interaction between patients and healthcare providers. If the Qatar Diabetes Mobile Application Trial (QDMAT) demonstrates this, it will inform clinical services for the future self-management of T2DM. Trial registration ClinicalTrials.gov Identifier: NCT03998267. Registered on 26 June 2019 Keywords: Type 2 diabetes mellitus, Self-management, Mobile health, Lifestyle change, Clinical trial
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-022-06334-5