Qatar Diabetes Mobile Application Trial (QDMAT)

Hamad Medical Corporation (HMC)

Status: Unknown

Conditions: Type2 Diabetes Mellitus

Treatments: Device: Droobi; Other: Standard of care

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03998267

17292

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups, including a placebo group

Intervention arm

Active Comparator group

Description:

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

Treatment:

Device: Droobi

Other: Standard of care

Standard of care arm

Placebo Comparator group

Description:

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

Treatment:

Other: Standard of care