Recruiting

Smartphone App

Sponsor:

University of Pittsburgh

Code:

NCT06375460

Conditions

Diabetes Mellitus, Type 2

Lifestyle

Hyperglycemia

Physical Inactivity

Eligibility Criteria

Sex: All

Age: 14 - 26

Healthy Volunteers: Not accepted

Interventions

Focused App Prompt

No App Prompt

Study Details

Brief summary:

The goal of this clinical trial is to learn if a new smartphone app that pairs glucose and exercise data will help adolescents and young adults with type 2 diabetes improve glycemic control. It will also study how changes in glycemic control are maintained over time. The main questions it aims to answer are:

  • Does using the app help with short-term glycemic control?
  • Does using the app help with longer-term glycemic control?
  • Does using the app help increase physical activity?

Participants will:

  • Wear a continuous glucose monitoring device for 6 months
  • Wear a physical activity tracker for 6 months
  • Use the study smartphone app for 6 months
  • Complete 3 in-person study visits with fasting blood draws
  • Report dietary intake intermittently throughout the study

Conditions

Diabetes Mellitus, Type 2

Lifestyle

Hyperglycemia

Physical Inactivity

Study ID

NCT06375460

Start date

Sep 20, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 26

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
  • English-speaking (app in English)

Exclusion Criteria:

  • Current pregnancy
  • Hydroxyurea use (CGM sensor inaccuracies)
  • Cognitive impairment or severe psychiatric condition that could interfere with participation in behavioral intervention for diabetes self-management
  • Current or previously diagnosed eating disorder

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Physical Activity Focused App Prompt

The app prompts will ask participants what went well, or did not go well with their physical activity in the previous 24 hours in relation to their blood glucose numbers.

experimental: Diet Focused App Prompt

The app prompts will ask participants what went well, or did not go well with their diet in the previous 24 hours in relation to their blood glucose numbers.

experimental: No App Prompt

No app prompt will be sent to the participant

Interventions

Focused App Prompt

Prompts are designed to develop knowledge and self-efficacy in diabetes-related health behaviors (capability). The paired glycemic and behavior data will provide the opportunity to reflect and to plan diet or exercise for the following day (self-reflective motivation).

No App Prompt

No app prompts are designed to assess whether health behaviors are affected without being prompted to reflect and change those behaviors related to glycemic control.

Primary outcome measure

  • Glucose time above 180mg/dL [ Time Frame: daily during micro randomized trial, 90 days ]
  • Mean daily glucose [ Time Frame: daily during micro randomized trial, 90 days ]
  • Maximum daily glucose [ Time Frame: daily during micro randomized trial, 90 days ]
  • Minimum daily glucose [ Time Frame: daily during micro randomized trial, 90 days ]
  • Glucose coefficient of variability [ Time Frame: daily during micro randomized trial, 90 days ]
  • Mean amplitude of glycemic excursions [ Time Frame: daily during micro randomized trial, 90 days ]
  • Hemoglobin A1c [ Time Frame: through study completion, 6 months average ]
  • Fasting glucose [ Time Frame: through study completion, 6 months average ]
  • Objective physical activity (step count) [ Time Frame: daily during micro randomized trial, 90 days; ]
  • Objective physical activity (moderate-vigorous physical activity) [ Time Frame: daily during micro randomized trial, 90 days; ]
  • Self-reported physical activity [ Time Frame: through study completion, 6 months average ]
  • Diet quality [ Time Frame: through study completion, 6 months average ]
  • Capability [ Time Frame: through study completion, 6 months average ]
  • Healthmine app use [ Time Frame: during microrandomized trial, observational period ]
  • Continuous glucose monitor use use [ Time Frame: during microrandomized trial, observational period ]
  • Motivation to engage in diabetes self-management [ Time Frame: through study completion, 6 months average ]

Central Contacts and Locations

Central contacts

Mary Ellen Vajravelu, MD

412-692-6533vajravelume@upmc.edu

Margaret Zupa, MD

zupamf@upmc.edu

Locations

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Mary Ellen Vajravelu, MD, MSHP

412-692-6533vajravelume@upmc.edu

Nyesha Rainey, BS

412-692-8418raineyns@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.