Pilot-Testing Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Healthmine app.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Hyperglycemia, Physical Inactivity, Lifestyle (Sedentary Behavior and Physical Activity). Basic parameters: 16 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes: Pilot Study
Overview
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.
Interventions
- Other Healthmine app
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.
Primary outcome measures
- Usability of Healthmine app [Time frame: 15 days and 30 days after starting study-provided CGM and Healthmine app use]
Secondary outcome measures (12)
- Days with CGM data [Time frame: 30-day CGM wear period]
- Days with Fitbit data [Time frame: 30-day Fitbit wear period]
- Mean CGM glucose [Time frame: 30-day CGM wear period]
- Step count [Time frame: 30-day Fitbit wear period]
- Diabetes Self-Management [Time frame: Baseline and 30 days (change from baseline to 30 days)]
- Treatment Self-Regulation [Time frame: Baseline and 30 days (change from baseline to 30 days)]
- Self-Reported Physical Activity [Time frame: Baseline and 30 days (change from baseline to 30 days)]
- Diet Quality [Time frame: Baseline and 30 days (change from baseline to 30 days)]
- Glucose monitoring satisfaction [Time frame: 30 days (following CGM wear period)]
- Glucose coefficient of variation [Time frame: 30-day CGM wear period]
- Glucose time below range [Time frame: 30-day CGM wear period]
- Glucose time in range [Time frame: 30-day CGM wear period]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Cognitive impairment or severe psychiatric conditions that could interfere with participation in behavioral intervention for diabetes self-management
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Children's Hospital of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT07270016 · STUDY25100193 · 1R01DK137803-01A1