Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-26
SponsorUniversity of Pittsburgh
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
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.
Treatment groups
100 Participants
are divided into 3 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
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