Back to resultsQatar Diabetes Mobile Application Trial (QDMAT)
Primary Purpose
Type2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Droobi
Standard of care
Sponsored by
About this trial
This is an interventional supportive care trial for Type2 Diabetes Mellitus focused on measuring mobile health, m-health
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.
Sites / Locations
- Hamad General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention arm
Standard of care arm
Arm 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
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
Outcomes
Primary Outcome Measures
Difference in mean HbA1c
Difference in mean HbA1C between the intervention arm and the standard care
Difference in mean HbA1c
Difference in mean HbA1C between the intervention arm and the standard care
Secondary Outcome Measures
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
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.
Changes in insulin doses
Difference in number of recommended insulin dose adjustments per subject between intervention and usual care arm
Changes in reported hypoglycemia
Difference in the number of reported hypoglycemic events per subject between the intervention and usual care arm.
Time to achieve normoglycemia
Reduction in the time required to reach normoglycemia (in-range blood glucose readings) between the intervention and control groups.
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
Missed clinical appointments
Percent of missed clinical appointments in each arm.
Weight
Changes in weight from baseline at 6 months
Blood Pressure
Changes in blood pressure from baseline at 6 months
Lipids
Changes in lipids from baseline at 6 months
Full Information
NCT ID
NCT03998267
First Posted
June 11, 2019
Last Updated
February 12, 2020
Sponsor
Hamad Medical Corporation
Collaborators
Qatar Computing Research Institute (QCRI), Droobi Health
1. Study Identification
Unique Protocol Identification Number
NCT03998267
Brief Title
Qatar Diabetes Mobile Application Trial
Acronym
QDMAT
Official Title
Qatar Diabetes Mobile Application Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
August 17, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation
Collaborators
Qatar Computing Research Institute (QCRI), Droobi Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus
Keywords
mobile health, m-health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Active Comparator
Arm 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
Arm Title
Standard of care arm
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Droobi
Intervention Description
A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care including physicians, dietetics and diabetes educators support
Primary Outcome Measure Information:
Title
Difference in mean HbA1c
Description
Difference in mean HbA1C between the intervention arm and the standard care
Time Frame
6 months
Title
Difference in mean HbA1c
Description
Difference in mean HbA1C between the intervention arm and the standard care
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Subject perceptions of diabetes self management
Description
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
Time Frame
6 months
Title
Change in subjects attitudes towards disease
Description
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.
Time Frame
6 months
Title
Changes in insulin doses
Description
Difference in number of recommended insulin dose adjustments per subject between intervention and usual care arm
Time Frame
6 months
Title
Changes in reported hypoglycemia
Description
Difference in the number of reported hypoglycemic events per subject between the intervention and usual care arm.
Time Frame
6 months
Title
Time to achieve normoglycemia
Description
Reduction in the time required to reach normoglycemia (in-range blood glucose readings) between the intervention and control groups.
Time Frame
6 months
Title
Number of clinical interactions
Description
• Differences in the number of clinical interactions per subjects with healthcare providers through the mobile app and through usual means in the standard care
Time Frame
6 months
Title
Missed clinical appointments
Description
Percent of missed clinical appointments in each arm.
Time Frame
6 months
Title
Weight
Description
Changes in weight from baseline at 6 months
Time Frame
6 months
Title
Blood Pressure
Description
Changes in blood pressure from baseline at 6 months
Time Frame
6 months
Title
Lipids
Description
Changes in lipids from baseline at 6 months
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Exploratory outcome
Description
Increased mobile application usability by the system usability scale (SUS) at 6 months. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. An SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret the results involves "normalizing" the scores to produce a percentile ranking
Time Frame
6 months
Title
Exploratory outcome
Description
Increased mobile application acceptance by documentation of patients experiences with the mobile application
Time Frame
6 months
Title
Exploratory outcome
Description
Reduction in hospital admissions
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noor N Suleiman, MD
Phone
+97455816515
Email
nsuleiman@hamad.qa
First Name & Middle Initial & Last Name or Official Title & Degree
Dabia H Al Mohanadi
Phone
+97455524801
Email
DAlMohanadi@hamad.qa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noor N Suleiman, MD
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad General Hospital
City
Doha
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noor Suleiman, MD
Email
nsuleiman@hamad.qa
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28293606
Citation
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.
Results Reference
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PubMed Identifier
27861583
Citation
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.
Results Reference
background
PubMed Identifier
19964700
Citation
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.
Results Reference
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PubMed Identifier
28249025
Citation
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.
Results Reference
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PubMed Identifier
19364893
Citation
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.
Results Reference
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Citation
Ristau R, Yang J, White J. Evaluation and Evolution of Diabetes Mobile Applications: Key Factors for Health Care Professionals Seeking to Guide Patients.
Results Reference
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PubMed Identifier
28249834
Citation
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.
Results Reference
background
PubMed Identifier
27332269
Citation
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.
Results Reference
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PubMed Identifier
15735199
Citation
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.
Results Reference
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PubMed Identifier
23937988
Citation
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.
Results Reference
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PubMed Identifier
35710428
Citation
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.
Results Reference
derived
Links:
URL
https://www.droobihealth.com/
Description
Droobi Health application website
Learn more about this trial
Qatar Diabetes Mobile Application Trial
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