App & Fitbit Monitoring for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Rachel Goode, PhD, MPH, LCSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Major diabetes complications, Weight loss surgery, Pregnant, Substance use treatment, others

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

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a digital app and Fitbit in managing type 2 diabetes among African American adults. Participants will receive diabetes education and learn appetite control through web-based lessons as part of the DSME + ASE intervention (Centering Appetite). The goal is to improve blood sugar levels and reduce binge eating. African American individuals with type 2 diabetes, high blood sugar levels (HbA1c > 7.5), and a smartphone are ideal candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes management strategies.

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 is best to consult with the trial coordinators for specific guidance.

What prior data suggests that this app and Fitbit monitoring method is safe for African American adults with type 2 diabetes?

Research shows that learning to manage diabetes independently, known as Diabetes Self-Management Education (DSME), effectively handles type 2 diabetes. Studies have found that DSME helps individuals better understand diabetes and care for themselves, often leading to improved blood sugar control and weight management.

The Appetite Self-Regulation (ASE) program, which includes mindful eating, has shown promise. It helps individuals with diabetes manage their weight and blood sugar levels effectively.

Digital tools, such as apps and devices like Fitbits, are safe and widely used to track health information. They enable individuals to monitor their activity and stay engaged in their health journey.

Overall, the DSME + ASE program is well-received and considered safe. Research has not reported any major negative side effects, making it a promising option for managing type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DSMES + ASE intervention for type 2 diabetes because it offers a new approach to managing the condition by focusing on appetite self-regulation. Unlike traditional treatments that primarily focus on medication and diet, this method helps participants relearn to recognize their body's hunger and fullness signals, which could lead to more effective glucose management. Additionally, the use of a digital app for delivering interactive lessons and telehealth sessions makes it more accessible and engaging, providing support and education in a convenient and modern way.

What evidence suggests that this app and Fitbit monitoring is effective for type 2 diabetes?

Research shows that learning to manage diabetes independently can significantly benefit people with type 2 diabetes. Studies have found that such education can lower HbA1c levels, a key measure of blood sugar control, by up to 1.27%. This reduction is crucial for managing diabetes. In this trial, participants in the DSMES + ASE intervention arm will practice mindful eating, which has shown promise for controlling weight and blood sugar. By using a digital app and Fitbit, participants can enhance these benefits by tracking physical activity and monitoring progress. Overall, these strategies work together to improve blood sugar levels and reduce binge eating in people with type 2 diabetes. ^{1 2 4 6 7}

Who Is on the Research Team?

Rachel Goode, PhD, MPH, LCSW

Principal Investigator

University of North Carolina at Chapel Hil

Are You a Good Fit for This Trial?

This trial is for African American adults with type 2 diabetes who experience binge eating. They must be over 18, have an HbA1c level above 7.5, and own a working smartphone. It's not for those with major diabetes complications, substance use treatment, involvement in other weight programs, history of weight loss surgery or current pregnancy.

Inclusion Criteria

Your A1c value is higher than 7.5.

You have been screened for binge eating.

I am over 18 years old.

Exclusion Criteria

I have serious complications from type 2 diabetes.

I have had weight loss surgery in the past.

Are currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month digital diabetes self-management education program plus an appetite self-regulation intervention

24 weeks

2 intervention sessions, monthly booster sessions, weekly messages

Follow-up

Participants are monitored for changes in weight, binge eating episodes, blood pressure, and HbA1C

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DSME + ASE intervention (Centering Appetite)

Trial Overview The study tests a digital app called Centering Appetite combined with diabetes education to improve blood sugar control and reduce binge eating. Participants will also use a Fitbit to track physical activity and follow up after six months.

How Is the Trial Designed?

Group I: DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite) Experimental Treatment 1 Intervention

The Diabetes Self-Management Education and Support (DSMES) + Appetite Self-Regulation (ASE) intervention includes two, 45-60-minute group sessions delivered via telehealth. These sessions will enable participants to relearn their stomach's hunger and fullness signals and monitor their appetite. Participants will also learn strategies for glucose monitoring and carbohydrate management. Monthly booster sessions will be devoted to problem-solving, addressing barriers to emotion management, and self-monitoring type 2 diabetes mellitus symptoms. Participants will also receive weekly lessons with interactive activities delivered via a digital app.

Group II: Control Active Control 1 Intervention

Control group participants will attend two remotely delivered DSMES sessions that will offer content commonly. They will also receive weekly emails providing content from the American Association of Diabetes Educators.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

In a study involving 27 participants with type 1 diabetes, an automated insulin delivery (AID) system that used real-time exercise data (exMPC) showed a significant reduction in mean glucose levels during exercise compared to a standard AID system (exAPD), indicating improved glucose management during physical activity.

Both AID systems effectively reduced the time spent in hypoglycemia and maintained glucose levels within the target range, demonstrating that integrating wearable fitness data into insulin dosing can enhance safety and efficacy for individuals with type 1 diabetes during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating metabolic expenditure information from wearable fitness sensors into an AI-augmented automated insulin delivery system: a randomised clinical trial. Jacobs, PG., Resalat, N., Hilts, W., et al.[2023]

The use of digital self-management solutions for Type 2 diabetes, such as DM4All and DiaWatch, led to significant improvements in metabolic outcomes, including reductions in HbA1c, body weight, blood pressure, and cholesterol levels over an average follow-up of 8 months in 100 patients.

Compared to a control group, the ProEmpower participants showed significantly better improvements in cardiovascular risk factors, highlighting the efficacy of digital technologies in enhancing diabetes management and promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus. De Luca, V., Bozzetto, L., Giglio, C., et al.[2023]

In a 12-week pilot study with 39 participants, all groups using self-monitoring (SM) of food intake, whether with or without real-time feedback (FB) or in-person sessions, achieved significant weight loss, averaging around 3% of their body weight.

Adherence to dietary self-monitoring was similar across all groups, indicating that the addition of real-time feedback or in-person sessions did not significantly enhance adherence or weight loss outcomes, suggesting that self-monitoring alone can be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring. Burke, LE., Zheng, Y., Ma, Q., et al.[2022]

A 12-week study involving 90 participants with type 2 diabetes found that both supervised exercise and technology-based programs (mobile app and smartwatch) led to similar improvements in glycemic control, measured by HbA1c levels.

Approximately 46% of participants in the supervised group and 43% in the technology groups achieved a clinically meaningful reduction in HbA1c, indicating that technology can be an effective alternative for diabetes management when supervised programs are not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-based and supervised exercise interventions for individuals with type 2 diabetes: Randomized controlled trial. Timurtas, E., Inceer, M., Mayo, N., et al.[2022]

Digital self-monitoring of diet and physical activity is effective in promoting weight loss, with a mean difference of -2.87 kg and a significant reduction in calorie intake of approximately 182 calories per day, based on a meta-analysis of 12 randomized controlled trials involving adults with obesity or overweight.

Tailored interventions that provide personalized advice were found to be significantly more effective than non-tailored approaches, highlighting the importance of customization in digital self-monitoring programs for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does self-monitoring diet and physical activity behaviors using digital technology support adults with obesity or overweight to lose weight? A systematic literature review with meta-analysis. Berry, R., Kassavou, A., Sutton, S.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8129774/

Effectiveness of diabetes self-management education (DSME ... In conclusion, diabetes self-management education intervention has been shown to be effective in dealing with type 2 diabetes mellitus. Furthermore, DSME ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0738399121004766

Participation in structured diabetes self-management ... To evaluate the relationship between participation in structured diabetes self-management education programs (DSME) and self-management behaviour (SMB) in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836683/

The effectiveness of diabetes self-management education ... Compared with standard care, pooled analysis showed that DSME effectively reduced the HbA1c level by 0.64% (95% CI: 0.45% to 0.83%) and 1.27% ( ...

4. researchgate.net researchgate.net/publication/232718225_Comparative_Effectiveness_of_a_Mindful_Eating_Intervention_to_a_Diabetes_Self-Management_Intervention_among_Adults_with_Type_2_Diabetes_A_Pilot_Study

Comparative Effectiveness of a Mindful Eating Intervention ... Mindful eating offers promise as an effective approach for weight management and glycemic control in people with diabetes.

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-2024-dc076

App & Fitbit Monitoring for Type 2 Diabetes Trial Overview The study tests a digital app called Centering Appetite combined with diabetes education to improve blood sugar control and reduce binge eating.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12375162/

Enhancing diabetes self-management and reducing stress ... This study examined the relationship between food skills, diabetes self-management, and stress with medically underinsured patients with type-2 ...

7. diabetesjournals.org diabetesjournals.org/care/article/47/Supplement_1/S77/153949/5-Facilitating-Positive-Health-Behaviors-and-Well

5. Facilitating Positive Health Behaviors and Well-being to ... DSMES is associated with improved diabetes knowledge and self-care behaviors (17), lower A1C (17–22), lower self-reported weight (23), improved ...