Pilot-Testing Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-24
SponsorUniversity of Pittsburgh

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Healthmine app

    Other intervention

    Participants 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

30 Participants
are divided into 1 treatment group
Group A: Single-arm pilot studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
15 days and 30 days after starting study-provided CGM and Healthmine app use

Secondary outcomes

1

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.

Time frame
30-day CGM wear period
2

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.

Time frame
30-day Fitbit wear period
3

Mean CGM glucose

Mean glucose obtained from study-provided CGM

Time frame
30-day CGM wear period
4

Step count

Step count data will be obtained via study-provided Fitbit.

Time frame
30-day Fitbit wear period

Other outcomes

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