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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing type 2 diabetes using an electronic Diabetes Tune-Up program. The main goal is to determine if this online program is user-friendly and effective in reducing diabetes-related stress and improving blood sugar levels compared to delayed treatment. The study also evaluates whether the online option is as effective as in-person group sessions. The trial seeks Black or African American women who have had type 2 diabetes for at least a year and frequently struggle with blood sugar management. As an unphased trial, it offers a unique opportunity to explore innovative diabetes management methods.

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 prior data suggests that this electronic Diabetes Tune-Up intervention is safe?

Research has shown that the Diabetes Tune-Up Group (DTU) is generally easy for participants to handle. Studies have found that this group-based program can help lower A1C levels, which check blood sugar control, and reduce the stress of managing diabetes. Participants reported feeling more confident in managing their diabetes. These studies reported no major side effects, suggesting that the DTU is safe. The program has successfully engaged and benefited many participants, further supporting its safety and acceptability. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Tune-Up Group because it offers flexibility and personalization that are not typically found in standard treatments for Type 2 Diabetes. Unlike current options, which often include medications and lifestyle changes that require rigorous adherence, this approach allows participants to choose between an online or in-person intervention. This adaptability can improve engagement and adherence, potentially leading to better health outcomes. Additionally, the integration of continuous glucose monitoring throughout the intervention provides real-time data, enabling participants to make more informed decisions about their diabetes management.

What evidence suggests that the Diabetes Tune-Up Group interventions could be effective for Type 2 Diabetes?

Research has shown that electronic education can help people with Type 2 diabetes improve their health. Studies have found that managing diabetes digitally at home can lower blood sugar levels and body weight. One study showed that participants experienced a noticeable drop in their A1C levels, a measure of long-term blood sugar, with an average decrease of 0.39% after three months. This method also reduced the stress of managing diabetes. In this trial, participants can choose between online (eDTU) and in-person (iDTU) Diabetes Tune-Up programs, both of which could effectively manage diabetes. ^{2 3 4 5 6}

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

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]

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]

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]

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]

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]

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 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]

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]

Citations

1.

withpower.com

withpower.com/trial/phase-diabetes-complications-9-2023-2057b

Electronic Diabetes Tune-Up for Type 2 Diabetes

The study suggests that electronic education can effectively improve metabolic control in diabetes patients, enhancing health outcomes and patient satisfaction ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11914849/

Effectiveness of Digital Diabetes Management Technology on ...

Digital diabetes management has been shown to effectively improve blood glucose levels and BMI in individuals with T2DM in home settings.

3.

journals.sagepub.com

journals.sagepub.com/doi/abs/10.1177/26350106231151405

A Multidisciplinary Approach to Improve Diabetes Distress ...

At 3-month follow-up, significant improvements were observed in A1C values (mean decrease = 0.39%). Diabetes distress improved significantly from baseline (mean ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36661126/

A Multidisciplinary Approach to Improve Diabetes Distress ...

At 3-month follow-up, significant improvements were observed in A1C values (mean decrease = 0.39%). Diabetes distress improved significantly ...

5.

researchgate.net

researchgate.net/publication/367297305_The_Diabetes_Tune-Up_Group_A_Multidisciplinary_Approach_to_Improve_Diabetes_Distress_and_A1C_Among_Adults_With_Type_1_and_Type_2_Diabetes

A Multidisciplinary Approach to Improve Diabetes Distress ...

At 3-month follow-up, significant improvements were observed in A1C values (mean decrease = 0.39%). Diabetes distress improved significantly from baseline (mean ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06321029?cond=Endocrinology&locStr=United+States&country=United+States&aggFilters=status:%2Cages:adult

Electronic Diabetes Tune-Up Group (eDTU) for African ...

Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...