About this trial
The goal of this study is to pilot test features of a new smartphone app and to gather feedback related to wearing a continuous glucose monitor (CGM) and a Fitbit device, as well as to obtain input on health behavior-focused messages delivered through the app. The study will enroll English-speaking participants aged 16-24 years who were diagnosed with type 2 diabetes before age 18. Participants will be asked to fill out surveys about diabetes, physical activity, and diet before and after wearing a CGM for 30 days. At the end of wearing the CGM, participants will complete an interview about their experience.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 16-24 years, any sex or gender
Diagnosis of type 2 diabetes in childhood (younger than 18 years of age)
English-speaking (app in English)
Possession of personal smartphone that is compatible with FreeStyle Libre app
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Healthmine app
Other interventionParticipants will wear study-provided continuous glucose monitoring device and Fitbit physical activity tracker for 30 consecutive days. During the same period, they will use an investigator-developed smartphone app (Healthmine), which is being developed to pair CGM and Fitbit data. Participants will receive up to one message about health behavior change (e.g., physical activity, nutrition) daily and will be able to use Healthmine to log exercise and dietary intake.
Treatment groups
Trial outcomes
Primary outcomes
Usability of Healthmine app
Assessed via the System Usability Scale (SUS), a 10-item questionnaire measuring perceived usability of a system or technology. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The total SUS score is calculated by summing the score contributions from each item (for odd-numbered items, subtract 1 from the user response; for even-numbered items, subtract the user response from 5), multiplying the sum by 2.5, resulting in a score ranging from 0 to 100. Higher scores indicate better perceived usability, with scores above 68 considered above average usability.
Secondary outcomes
Days with CGM data
The number of days with continuous glucose monitoring data available will be divided by the total number of requested days of wear (30) to obtain percentage of days with data.
Days with Fitbit data
The number of days with Fitbit data available will be divided by the total number of requested days of wear (30) to obtain percentage of days with data.
Mean CGM glucose
Mean glucose obtained from study-provided CGM
Step count
Step count data will be obtained via study-provided Fitbit.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
San Diego State University
Collaborator
Emory University
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Michigan
Collaborator
Dartmouth College
Collaborator