Qatar Diabetes Mobile Application Trial

NCT ID: NCT03998267

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm

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

Group Type ACTIVE_COMPARATOR

Droobi

Intervention Type DEVICE

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

Standard of care

Intervention Type OTHER

Standard of care including physicians, dietetics and diabetes educators support

Standard of care arm

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

Group Type PLACEBO_COMPARATOR

Standard of care

Intervention Type OTHER

Standard of care including physicians, dietetics and diabetes educators support

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Droobi

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

Intervention Type DEVICE

Standard of care

Standard of care including physicians, dietetics and diabetes educators support

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qatar Computing Research Institute (QCRI)

UNKNOWN

Sponsor Role collaborator

Droobi Health

UNKNOWN

Sponsor Role collaborator

Hamad Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Noor N Suleiman, MD

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hamad General Hospital

Doha, , Qatar

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Qatar

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Noor N Suleiman, MD

Role: CONTACT

+97455816515

Dabia H Al Mohanadi

Role: CONTACT

+97455524801

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Noor Suleiman, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28293606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27861583 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19964700 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28249025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19364893 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 28249834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27332269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15735199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23937988 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35710428 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.droobihealth.com/

Droobi Health application website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17292

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mobile Diabetes Management
NCT01107015 COMPLETED NA
Diabetes Go Mobile! Pilot Study
NCT02858648 COMPLETED NA