Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial
Initiatives
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The primary objective of this study was to conduct a pragmatic randomized controlled trial of the BlueStar mobile app to determine if app usage leads to improved HbA1c levels among diverse participants in real-life clinical contexts. It was hypothesized that this mobile app would improve self-management and HbA1c levels compared with controls.
Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
- Start Year
- 2019
Design
- Study design
- Clinical trial cohort
Marker Paper
Agarwal P, Mukerji G, Desveaux L, et al. Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019;7(1):e10321. Published 2019 Jan 10. doi:10.2196/10321
PUBMED 30632972
Recruitment
- Sources of Recruitment
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- Individuals
Number of participants
- Number of participants
- 223
- Number of participants with biosamples
Access
Availability of data and biosamples
| Data | |
| Biosamples | |
| Other |
Timeline
Participants with an HbA1c
The study consisted of a multicenter pragmatic randomized controlled trial. Overall, 110 participants randomized to the immediate treatment group (ITG) received the intervention for 6 months, and 113 participants randomized to the wait-list control (WLC) group received usual care for the first 3 months and then received the intervention for 3 months.
Selection Criteria
- Minimum age
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18
- Newborns
- Twins
- Countries
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- Canada
- Ethnic Origin
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- Health Status
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- diabetes type 2
- Other criteria
- Participants were eligible for inclusion in the study if they met the following criteria: (1) adults aged older than 18 years; (2) obtaining care for T2DM at a participating DEP; (3) HbA1c ≥8.0% on most recent laboratory report within the last 3 months; (4) currently using an active email address or able and willing to obtain one; and (5) able to read the English language (self-reported). Patients were excluded if they have type 1 diabetes, were on continuous glucose monitoring, had an insulin pump, were on dialysis, pregnant, or are unable to use a computer or mobile phone because of severe mental or physical impairment.
Recruitment
- Sources of recruitment
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- General population
Number of participants
- Number of participants
- 223
- Number of participants with biosamples
Data Collection Event
The intervention was the BlueStar mobile app, designed to act as a virtual coach for patients with T2DM. The app was preloaded onto a cellular network–connected Samsung smartphone (with all other features disabled). The phone was connected to a cellular data plan for internet connectivity and was able to connect to local Wi-Fi networks. If participants used the app without an internet connection, the information was saved and uploaded to the secure server when the phone regained an internet
- Start Date
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2019
- End Date
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2019
- Data sources
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Mobile data collection
- Smartphone apps
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Mobile data collection