Clinical trial NCT03998267: Qatar Diabetes Mobile Application Trial
Official title: Qatar Diabetes Mobile Application Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes Mellitus
Keywords: mobile health
m-health
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Qatar Computing Research Institute (QCRI)
name: Droobi Health
First posted: 2019-06-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Difference in mean HbA1c
timeFrame: 6 months
measure: Difference in mean HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: Subject perceptions of diabetes self management
timeFrame: 6 months
measure: Change in subjects attitudes towards disease
timeFrame: 6 months
measure: Changes in insulin doses
timeFrame: 6 months
measure: Changes in reported hypoglycemia
timeFrame: 6 months
measure: Time to achieve normoglycemia
timeFrame: 6 months
measure: Number of clinical interactions
timeFrame: 6 months
measure: Missed clinical appointments
timeFrame: 6 months
measure: Weight
timeFrame: 6 months
measure: Blood Pressure
timeFrame: 6 months
measure: Lipids
timeFrame: 6 months
Other outcomes:
measure: Exploratory outcome
timeFrame: 6 months
measure: Exploratory outcome
timeFrame: 6 months
measure: Exploratory outcome
timeFrame: 6 months
Locations:
city: Doha
country: Qatar
facility: Hamad General Hospital
Study officials:
affiliation: Hamad Medical Corporation
name: Noor N Suleiman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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