Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-24
SponsorUniversity of Pittsburgh
About this trial
This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
HbA1c ≥7.0%, stable medication use
HbA1c 6.0-6.9% without short-acting insulin, any other stable diabetes medication use
English-speaking (app in English)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Focused App Prompt
BehavioralPrompts 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
BehavioralNo app prompts are designed to assess whether health behaviors are affected without being prompted to reflect and change those behaviors related to glycemic control.
Outreach for Missing Data
BehavioralFor participants randomized to proactive outreach, after 3 or more days of missing CGM data, the study team will reach out to participants by phone and/or text message to troubleshoot and support participants in re-connecting with CGM and apps. For participants randomized to not receive proactive outreach, participants will be instructed to reach out to the study team at their discretion when help is needed related to CGM or app connection.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Physical Activity Focused App PromptExperimental treatment 1 intervention
Group B: Diet Focused App PromptExperimental treatment 1 intervention
Group C: No App PromptExperimental treatment 1 intervention
Group D: Outreach for Missing DataExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Glucose time above 180mg/dL
measured using continuous glucose monitor
Time frame
daily during micro randomized trial, 90 days2
Mean daily glucose
measured using continuous glucose monitor; mg/dL
Time frame
daily during micro randomized trial, 90 days3
Maximum daily glucose
measured using continuous glucose monitor; mg/dL
Time frame
daily during micro randomized trial, 90 days4
Minimum daily glucose
measured using continuous glucose monitor; mg/dL
Time frame
daily during micro randomized trial, 90 daysSecondary outcomes
1
Body Mass Index (BMI)
weight and height will be combined to report BMI in kg/m\^2
Time frame
through study completion, 6 months average2
Diabetes distress
Measured via Problem Areas in Diabetes Scale (PAID-5). Score ranges from 0-20; a total score of 8 or more indicates possible diabetes related emotional distress.
Time frame
through study completion; 6 months averageSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Dartmouth College
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Michigan
Collaborator
San Diego State University
Collaborator
Emory University
Collaborator
Source ClinicalTrials.gov
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