Electronic Diabetes Tune-Up for Type 2 Diabetes

N/A

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to test differences in dds-17 change scores between intervention (changes in baseline to 3-month follow-up) and waitlist control (change in enrollment to baseline) by intervention group (edtu vs. waitlist control; idtu vs. waitlist control).

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a culturally adapted electronic diabetes intervention compared to in-person intervention and a waitlist control group. The study will assess the intervention's acceptability, feasibility, and effectiveness in improving diabetes

Who is the study for?

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.

What is being tested?

The study is testing an electronic 'Diabetes Tune-Up' group intervention (eDTU) adapted for cultural relevance and online delivery against a waitlist control and an in-person version of the same program (iDTU). It aims to see if these programs can reduce diabetes distress and improve blood sugar control as measured by A1c levels.

What are the potential side effects?

Since this trial involves educational interventions rather than medications, traditional side effects are not expected. However, participants may experience varying levels of stress or emotional discomfort related to managing their diabetes during the course of the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to test differences in dds-17 change scores between intervention (changes in baseline to 3-month follow-up) and waitlist control (change in enrollment to baseline) by intervention group (edtu vs. waitlist control; idtu vs. waitlist control).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to test differences in dds-17 change scores between intervention (changes in baseline to 3-month follow-up) and waitlist control (change in enrollment to baseline) by intervention group (edtu vs. waitlist control; idtu vs. waitlist control).

This trial's timeline: 3 weeks for screening, Varies for treatment, and to test differences in dds-17 change scores between intervention (changes in baseline to 3-month follow-up) and waitlist control (change in enrollment to baseline) by intervention group (edtu vs. waitlist control; idtu vs. waitlist control). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of intervention (content and delivery modality)

Diabetes Distress Scale-17 (DDS-17)

Feasibility of intervention and delivery modality

+1 more

Secondary study objectives

Confidence in Diabetes Self-Care (CDSC)

Diabetes Therapy-Related Quality of Life Questionnaire

Patient Health Questionnaire-9 (PHQ-9)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-arm waitlist controlExperimental Treatment1 Intervention

The initial assessment will take place at the time of study enrollment (T1). Participants will be offered a choice of assignment to either the eDTU (online Diabetes Tune-Up Group intervention participation) or iDTU (in-person Diabetes Tune-Up Group intervention participation) series. After a 3-month waiting period, participants will complete baseline assessment (T2). The group intervention will then take place over the next 6 to 8 weeks. Immediately following completion of the intervention, participants will complete surveys (T3). A final assessment will be completed 3 months after baseline, approximately 4 to 6 weeks following the completion of the intervention (T4). The participant will participate in one series of the DTU intervention either, in person or online, at the participant's choosing. The intervention will take place over the course of 6 to 8 weeks. Participants will wear their continuous glucose monitor throughout the course of the intervention.

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