Qatar Diabetes Mobile Application Trial

NCT03998267 | Unknown

• 1 other identifier: 17292
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes Mellitus

Keywords

mobile health; m-health

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• Subject perceptions of diabetes self management

  6 months

• Change in subjects attitudes towards disease

  6 months

• Changes in insulin doses

  6 months

• Changes in reported hypoglycemia

  6 months

• Time to achieve normoglycemia

  6 months

Other Outcomes (3)

• Exploratory outcome

  6 months

• Exploratory outcome

  6 months

• Exploratory outcome

  6 months

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

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

Device: Droobi; Other: Standard of care

Standard of care arm

PLACEBO COMPARATOR

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

Other: Standard of care

Interventions

Droobi DEVICE

A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise.

Intervention arm

Standard of care OTHER

Standard of care including physicians, dietetics and diabetes educators support

Intervention arm; Standard of care arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Qatar Computing Research Institute (QCRI): collaborator
• Droobi Health: collaborator

Study Sites (1)

Hamad General Hospital

Doha, Qatar

RECRUITING

Related Publications (11)

• 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.

  PMID: 28293606 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.

  PMID: 27861583 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.

  PMID: 19964700 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.

  PMID: 28249025 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.

  PMID: 19364893 BACKGROUND

• Ristau R, Yang J, White J. Evaluation and Evolution of Diabetes Mobile Applications: Key Factors for Health Care Professionals Seeking to Guide Patients.

  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.

  PMID: 28249834 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.

  PMID: 27332269 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.

  PMID: 15735199 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.

  PMID: 23937988 BACKGROUND

• 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.

  PMID: 35710428 DERIVED

Related Links

• Droobi Health application website

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Noor N Suleiman, MD

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noor N Suleiman, MD

CONTACT

+97455816515; nsuleiman@hamad.qa

Dabia H Al Mohanadi

CONTACT

+97455524801; DAlMohanadi@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 26, 2019
• Study Start: August 22, 2019
• Primary Completion: August 17, 2020
• Study Completion: December 31, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)