Electronic Diabetes Tune-Up for Type 2 Diabetes

Overseen By Mary de Groot, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Serious mental disorders, Major acute conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

60 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Single-arm waitlist control Experimental Treatment 1 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The education of type-2 diabetics: why not in groups?]. Lozano, ML., Armalé, MJ., Tena Domingo, I., et al.[2016]

A survey of 200 users of the AIDA diabetes simulator revealed that the program is considered educationally valuable, particularly among people with diabetes and their relatives, indicating its effectiveness as a learning tool.

The feedback also highlighted the program's limitations, suggesting that while it is useful, users recognize it as a simulator-based tool that may not cover all aspects of diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective pilot feedback survey of 200 users of the AIDA Version 4 Educational Diabetes Program. 1--Quantitative Survey Data. Lehmann, ED., Chatu, SS., Hashmy, SS.[2015]

The study found that using the Health2Sync (H2S) smartphone application for managing blood glucose levels in type 2 diabetes resulted in fewer failed contacts and reduced time per interaction compared to traditional phone consultations, indicating improved efficiency in communication.

Despite the efficiency gains with the H2S app, there was no significant difference in clinical outcomes, such as HbA1c levels, between the H2S group and the traditional care group, suggesting that while the app is convenient, it does not compromise clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an mHealth intervention for titration of insulin for type 2 diabetes: A pilot study. Bramwell, SE., Meyerowitz-Katz, G., Ferguson, C., et al.[2021]

The telemonitoring group (TMG) showed a slight improvement in HbA1c levels compared to the control group (CG), with a mean decrease of 0.16% (p=0.06), indicating potential benefits of using connected devices for diabetes management.

Frequent users of the telemonitoring and tele-education tools experienced a more significant reduction in HbA1c (up to -0.23%) and notable weight loss in women (p=0.01), suggesting that higher engagement with the technology may enhance diabetes control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Randomised Multicentre Study. Turnin, MC., Gourdy, P., Martini, J., et al.[2021]

The AIDA interactive educational diabetes simulator has been widely used since its launch in 1996, with over 200,000 visits and 40,000 downloads, making it a valuable tool for diabetes education.

The article outlines essential training requirements for health-care professionals to effectively teach using AIDA, emphasizing the need for structured training and feedback to enhance the educational experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the AIDA--www.2aida.org--diabetes simulator. Part 2: recommended training requirements for health-carers planning to teach with the software. Lehmann, ED., Tatti, P.[2011]

The report details a structured program for the effective use of the Guardian RT glucose monitoring system, which provides real-time data to both patients and medical teams.

This program aims to enhance diabetes management by teaching users how to properly insert and remove the monitoring system, ensuring accurate and beneficial use of the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Glucose sensors which provide real time information. Guardian RT/Paradigm RT]. Pérez, S., Martínez, ME., Labiano, R., et al.[2009]

In a 2-year study involving 49 patients with Type 2 diabetes, those receiving Group Care from trained nurses and a dietitian showed significantly better metabolic control, with lower HbA1c and insulin levels compared to those receiving individual care.

Patients in the Group Care model also reported a better quality of life and a more positive attitude towards their health, suggesting that this approach not only improves clinical outcomes but also enhances patient engagement and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled clinical trial of nurse-, dietitian- and pedagogist-led Group Care for the management of Type 2 diabetes. Trento, M., Basile, M., Borgo, E., et al.[2022]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Long-term interactive group education for type 1 diabetic patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The impact of electronic education on metabolic control indicators in patients with diabetes who need insulin: a randomised clinical control trial. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

[The education of type-2 diabetics: why not in groups?]. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Retrospective pilot feedback survey of 200 users of the AIDA Version 4 Educational Diabetes Program. 1--Quantitative Survey Data. [2015]

5. England pubmed.ncbi.nlm.nih.gov

The effect of an mHealth intervention for titration of insulin for type 2 diabetes: A pilot study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Randomised Multicentre Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Using the AIDA--www.2aida.org--diabetes simulator. Part 2: recommended training requirements for health-carers planning to teach with the software. [2011]

8. Spain pubmed.ncbi.nlm.nih.gov

[Glucose sensors which provide real time information. Guardian RT/Paradigm RT]. [2009]

9. Italy pubmed.ncbi.nlm.nih.gov

A randomised controlled clinical trial of nurse-, dietitian- and pedagogist-led Group Care for the management of Type 2 diabetes. [2022]