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Type2 Diabetes MellitusQDMATNCT03998267

Qatar Diabetes Mobile Application Trial

A study testing Droobi in people with Type2 Diabetes Mellitus, run by Hamad Medical Corporation at 1 site in Qatar.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Type2 Diabetes Mellitus
What is being tested?
Droobi
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteQatar
Study dates
22 Aug 2019to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • • 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 locations and contacts

1 site in 1 country.

Noor N Suleiman, MD contact

+97455816515

nsuleiman@hamad.qa

Dabia H Al Mohanadi contact

+97455524801

DAlMohanadi@hamad.qa

Qatar1 site, 1 recruiting

  • Hamad General Hospital

    Doha

    Noor Suleiman, MD, nsuleiman@hamad.qa

    Recruiting

Other trials in Qatar

About this study

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.

Being tested
Droobi, Standard of care
Keywords
mobile health, m-health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DroobiDevice

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

  • Standard of careOther

    Standard of care including physicians, dietetics and diabetes educators support

Study groups in NCT03998267
Study groupRoleWhat they receive
Intervention armActive comparatorFor 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
Receives: Device: Droobi; Other: Standard of care
Standard of care armPlacebo comparatorFor 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
Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in mean HbA1c

    Difference in mean HbA1C between the intervention arm and the standard care

    Measured: 6 months

  2. Difference in mean HbA1c

    Difference in mean HbA1C between the intervention arm and the standard care

    Measured: 3 months

Secondary outcomes (10)

  1. Subject perceptions of diabetes self management

    Within subject changes in perceptions of diabetes self-management as assessed by diabetes self-management questionnaire (DSMQ) scores subsection glucose management and overall rating. DSM-Q is a 16 item questionnaire to assess self-care activities associated with glycemic control. Four subscales, 'Glucose Management' (GM), 'Dietary Control' (DC), 'Physical Activity' (PA), and 'Health-Care Use' (HU), as well as a 'Sum Scale' (SS) as a global measure of self-care. Scale scores are calculated as sums of item scores and then transformed to a scale ranging from 0 to 10 (raw score / theoretical maximum score * 10. A transformed score of ten thus represents the highest self-rating of the assessed behavior

    Measured: 6 months

  2. Change in subjects attitudes towards disease

    Within subject changes in attitudes towards disease assessed the proportion of subjects with diabetes distress scales (DDS) scores consistent with moderate or high distress.The DDS yields a total distress score plus 4 subscale (emotional burden,physical distress, regimen distress and interpersonal distress) scores each addressing a different kind of distress. A mean item score 2.0-2.9 is considered moderate distress and a mean score of more than or equal to 3 is considered high stress.

    Measured: 6 months

  3. Changes in insulin doses

    Difference in number of recommended insulin dose adjustments per subject between intervention and usual care arm

    Measured: 6 months

  4. Changes in reported hypoglycemia

    Difference in the number of reported hypoglycemic events per subject between the intervention and usual care arm.

    Measured: 6 months

  5. Time to achieve normoglycemia

    Reduction in the time required to reach normoglycemia (in-range blood glucose readings) between the intervention and control groups.

    Measured: 6 months

  6. Number of clinical interactions

    • Differences in the number of clinical interactions per subjects with healthcare providers through the mobile app and through usual means in the standard care

    Measured: 6 months

  7. Missed clinical appointments

    Percent of missed clinical appointments in each arm.

    Measured: 6 months

  8. Weight

    Changes in weight from baseline at 6 months

    Measured: 6 months

  9. Blood Pressure

    Changes in blood pressure from baseline at 6 months

    Measured: 6 months

  10. Lipids

    Changes in lipids from baseline at 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2019
  2. Study start22 Aug 2019
  3. Primary completion17 Aug 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03998267
Sponsor's protocol ID
17292
Acronym
QDMAT
Status last verified
Feb 2020
First submitted
11 Jun 2019
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28293606

  • 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.

    PubMed 27861583

  • 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.

    PubMed 19964700

  • 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.

    PubMed 28249025

  • 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.

    PubMed 19364893

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

  • 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.

    PubMed 28249834

  • 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.

    PubMed 27332269

  • 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.

    PubMed 15735199

  • 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.

    PubMed 23937988

  • 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.

    PubMed 35710428

Questions about this trial

What is this clinical trial studying?

A study testing Droobi in people with Type2 Diabetes Mellitus, run by Hamad Medical Corporation at 1 site in Qatar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Noor N Suleiman, MD (+97455816515, nsuleiman@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in mean HbA1c (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03998267, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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