60 Participants Needed

Electronic Diabetes Tune-Up for Type 2 Diabetes

BM
Md
Overseen ByMary de Groot, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that group education programs for diabetics can improve blood sugar control and understanding of the disease. Additionally, electronic education has been found to positively impact metabolic control in diabetes patients who need insulin.12345

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

A1c ≥ 7.0% in the past year per medical record or patient report
I am 21 years old or older.
I have been diagnosed with type 2 diabetes for at least a year.
See 3 more

Exclusion Criteria

Presence of serious mental health disorder (e.g., psychotic disorders or severe mood disorders with suicidal ideation)
I am not starting any new major treatments for other health issues.
I was diagnosed with a major health issue like a heart attack, stroke, or advanced cancer in the last 3 months.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants are placed on a waitlist for 3 months before starting the intervention

12 weeks
1 visit (in-person) for baseline assessment

Intervention

Participants undergo the eDTU or iDTU intervention for diabetes management, adapted for cultural relevance and online delivery

6-8 weeks
6 sessions (online or in-person)

Follow-up

Participants are monitored for changes in diabetes distress, A1c, and quality of life after the intervention

4-6 weeks
1 visit (in-person) for final assessment

Treatment Details

Interventions

  • Diabetes Tune-Up Group
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Indiana University Health

Collaborator

Trials
35
Recruited
18,500+

Findings from Research

Participation in the Interactive Educational and Support Group (IESG) program led to a significant improvement in metabolic control, as evidenced by a reduction in HbA(1c) levels from 7.7% to 7.2% over one year among 96 type 1 diabetes patients, while control groups showed no change.
After two years, participants not only maintained their improved HbA(1c) levels but also reported a significant enhancement in diabetes-related quality of life compared to baseline, indicating the program's long-term benefits.
Long-term interactive group education for type 1 diabetic patients.Mannucci, E., Pala, L., Rotella, CM.[2022]
A randomized clinical trial involving 48 insulin-dependent diabetes patients showed that a 12-week electronic education program significantly reduced hemoglobin A1C levels (p < 0.001) and low-density lipoprotein cholesterol (p < 0.002) in the intervention group.
The study suggests that electronic education can effectively improve metabolic control in diabetes patients, enhancing health outcomes and patient satisfaction while reducing the need for additional training personnel.
The impact of electronic education on metabolic control indicators in patients with diabetes who need insulin: a randomised clinical control trial.Moattari, M., Hashemi, M., Dabbaghmanesh, MH.[2022]
A two-year group education program for 243 type-2 diabetics significantly reduced baseline glucaemia by 17.1 mg/dl and glycosylated hemoglobin by 0.5, while also increasing self-monitoring of glucaemia by 14.2%.
The program successfully engaged 75% of the target population and improved understanding of diabetes, although knowledge declined in the second year, indicating the need for ongoing education to maintain metabolic control.
[The education of type-2 diabetics: why not in groups?].Lozano, ML., Armalé, MJ., Tena Domingo, I., et al.[2016]

References

Long-term interactive group education for type 1 diabetic patients. [2022]
The impact of electronic education on metabolic control indicators in patients with diabetes who need insulin: a randomised clinical control trial. [2022]
[The education of type-2 diabetics: why not in groups?]. [2016]
Retrospective pilot feedback survey of 200 users of the AIDA Version 4 Educational Diabetes Program. 1--Quantitative Survey Data. [2015]
The effect of an mHealth intervention for titration of insulin for type 2 diabetes: A pilot study. [2021]
Impact of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Randomised Multicentre Study. [2021]
Using the AIDA--www.2aida.org--diabetes simulator. Part 2: recommended training requirements for health-carers planning to teach with the software. [2011]
[Glucose sensors which provide real time information. Guardian RT/Paradigm RT]. [2009]
A randomised controlled clinical trial of nurse-, dietitian- and pedagogist-led Group Care for the management of Type 2 diabetes. [2022]
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