Individual Study / Agarwal et al.; JMIR Mhealth Uhealth. 2019

Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial

Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial

Initiatives -
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
  • Individuals

Number of participants

Number of participants
223
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

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
18
Newborns
Twins
Countries
  • Canada
Ethnic Origin
Health Status
  • 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
  • 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
2019
End Date
2019
Data sources
  • Mobile data collection
    • Smartphone apps