Electronic Diabetes Tune-Up for Type 2 Diabetes
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual treatment, but it's best to confirm with the trial organizers.
What data supports the effectiveness of the Electronic Diabetes Tune-Up treatment for Type 2 Diabetes?
What makes the Electronic Diabetes Tune-Up treatment unique for managing Type 2 diabetes?
The Electronic Diabetes Tune-Up treatment is unique because it combines real-time glucose monitoring with lifestyle education software, allowing patients to manage their diabetes more effectively from home. This approach integrates technology to provide continuous feedback on glucose levels, weight, physical activity, and food intake, which is not typically included in standard diabetes care.46789
What is the purpose of this trial?
The primary aims of this study are:1. To test the acceptability and feasibility of the electronic DTU intervention (eDTU) that has been adapted for cultural relevance and online delivery compared to waitlist control and the in-person DTU (iDTU). The hypothesis is that the adapted intervention will be culturally acceptable (by participant satisfaction scores) and well-subscribed (intervention attendance rates).2. To test differences in diabetes distress and A1c change scores between intervention (changes in T2 to T4) and waitlist control (change in T1 to T2) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control). The hypothesis is that both the eDTU and iDTU groups will show significant improvements in diabetes distress and A1c compared to waitlist control. In order to conserve sample size and budget, participants in each intervention group will serve as their own waitlist control.Secondary Objective. The secondary aim of the study is to evaluate changes in depressive symptoms, diabetes self-efficacy, and general and diabetes-specific quality of life in intervention (T2-T3 \& T4) compared to waitlist control (T1-T2). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (T2-T3 \& T4). The hypothesis is that both groups will show comparable improvements in diabetes distress and A1c.
Eligibility Criteria
This trial is for African Americans with diabetes, including Type 2 Diabetes. Participants should be interested in joining a group program to manage their condition either online or in-person. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and commit to the study's schedule.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Waitlist Control
Participants are placed on a waitlist for 3 months before starting the intervention
Intervention
Participants undergo the eDTU or iDTU intervention for diabetes management, adapted for cultural relevance and online delivery
Follow-up
Participants are monitored for changes in diabetes distress, A1c, and quality of life after the intervention
Treatment Details
Interventions
- Diabetes Tune-Up Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Indiana University Health
Collaborator