MOSAIC Mobile Program for Type 2 Diabetes

(MOSAIC Trial)

Enrolling by invitation at 1 trial location

Overseen By Erin M Bergner, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must be taking: Diabetes medications

Disqualifiers: Pregnancy, Cancer, Renal disease, others

Compensation: Varies

Number of Visits: 4

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a mobile phone program designed to help people manage type 2 diabetes, comparing it to traditional print materials. The researchers aim to determine if the mobile program more effectively improves blood sugar control, reduces diabetes-related stress, and boosts overall well-being. Participants with type 2 diabetes who have been prescribed daily medication and own a mobile phone might be a good fit. The study includes regular check-ins and allows the mobile program to adapt to each participant's needs over 16 months. As an unphased trial, this study offers participants the opportunity to contribute to innovative diabetes management research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since participants must be prescribed at least one daily diabetes medication, it seems likely that you can continue your current diabetes treatment.

What prior data suggests that the MOSAIC mobile program is safe for managing type 2 diabetes?

Research has shown that mobile health programs, such as the MOSAIC program, are generally safe and user-friendly. For instance, a study on a similar smartphone program for individuals with type 2 diabetes found it effectively managed blood sugar levels and was safe for users. The study reported no major side effects, suggesting that using a mobile app for diabetes management can be a safe option for many. Since the MOSAIC program employs mobile phone support and is tailored to individual needs, it is expected to be equally well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MOSAIC program because it offers a fresh approach to managing Type 2 Diabetes by combining technology with personalized support. Unlike typical treatments that focus primarily on medication or lifestyle changes, MOSAIC integrates monthly phone coaching and text message support to help patients stick to their goals and medications. This method emphasizes ongoing, personalized interaction, which could lead to better adherence and outcomes for patients. Additionally, involving support partners with educational materials and optional coaching adds another layer of encouragement and accountability, potentially transforming how patients live with diabetes.

What evidence suggests that the MOSAIC mobile program is effective for managing type 2 diabetes?

Studies have shown that mobile apps can help people with type 2 diabetes improve their motivation, habits, and health outcomes. In this trial, participants in the MOSAIC arm will receive components such as monthly phone coaching and text message support to enhance diabetes management by supporting medication adherence and self-care routines. Research indicates that digital health programs like MOSAIC effectively improve patients' ability to manage their diabetes and the quality of their care. Initial findings suggest that mobile support can lead to better control of blood sugar levels and reduced stress related to diabetes. These results indicate that using a mobile phone for personalized diabetes support can effectively manage type 2 diabetes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who are interested in managing their condition. Participants will be involved in a 16-month study, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am 18-75, have type 2 diabetes, take daily medication for it, and own a mobile phone.

Exclusion Criteria

Support persons: Demonstrated inability to receive & respond to a text, unable to communicate by phone

I have diabetes but none of the listed conditions or limitations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MOSAIC mobile phone-delivered intervention or print materials for 12 months

12 months

Monthly coaching sessions and ongoing text message support

Follow-up

Participants are monitored for sustained effects on glycemic management and psychosocial well-being

4 months

Assessments every 4 months

What Are the Treatments Tested in This Trial?

Interventions

• MOSAIC

Trial Overview The trial tests an adaptive mobile phone-delivered intervention called MOSAIC against traditional print materials for diabetes education and support. It measures effectiveness by looking at blood sugar control, emotional well-being, self-confidence in managing diabetes, and self-care actions.

How Is the Trial Designed?

Group I: MOSAIC Experimental Treatment 2 Interventions

PWD participants will receive MOSAIC components (monthly phone coaching and text message support for goals and medication adherence) for 12 months. PWD participants will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes. All SP participants invited by PWD participants assigned to MOSAIC will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes. SPs may participate in monthly phone coaching and/or receive text message support tailored to the goal set by the linked PWD.

Group II: Print Materials Placebo Group 1 Intervention

PWD participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on health living with diabetes.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

The 12-week Healthy at Home digital health coaching program significantly improved insulin resistance in individuals with type 2 diabetes, showing a reduction in HOMA2-IR scores compared to usual care (p = 0.029).

This pilot study suggests that digital health coaching can be an effective and accessible intervention for under-resourced patients with type 2 diabetes, potentially leading to better diabetes management and clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home. Azelton, KR., Crowley, AP., Vence, N., et al.[2021]

The Few Touch application, developed for people with type 2 diabetes, effectively integrates a blood glucose meter, step counter, and food tracking software, demonstrating good usability and motivating users to adjust their medication and lifestyle habits over a 6-month period.

User feedback indicated that the blood glucose sensor was the most valued feature, highlighting the importance of real-time health monitoring in encouraging self-management and lifestyle changes in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone-based self-management tools for type 2 diabetes: the few touch application. Arsand, E., Tatara, N., Østengen, G., et al.[2021]

Diabetes-related apps combined with virtual coaching can significantly improve glycemic control and promote meaningful behavior changes compared to using apps alone, addressing common treatment barriers effectively.

Users of these enhanced apps report high satisfaction and prolonged engagement, suggesting that virtual coaching may be a valuable tool in diabetes education, although further research is needed to explore its long-term effects across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Coaching to Enhance Diabetes Care. Ramchandani, N.[2020]

A systematic review of diabetes mobile applications found that while usability ratings from users and experts ranged from 38% to 80%, significant usability issues such as complex navigation and limited functionality were common.

Despite these usability challenges, diabetes apps showed some clinical effectiveness, with reductions in HbA1c levels between 0.15% and 1.9%, indicating potential for improving glycemic control in adults with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review. Fu, H., McMahon, SK., Gross, CR., et al.[2022]

In a 6-month study involving 100 adults with type 1 diabetes, the use of the iBGStar® glucose meter combined with an iPhone led to a significant reduction in A1c levels compared to traditional self-monitoring methods (-0.51 vs. -0.16, p = 0.04).

Both groups showed improvements in hypoglycemia fear scores, but the iBGStar® group did not experience an increased risk of hypoglycemia, indicating that this mobile technology can enhance glycemic control without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management. Garg, SK., Shah, VN., Akturk, HK., et al.[2020]

Using the Diahome smartphone app for diabetes management led to a significant reduction in fasting blood glucose levels among users, from 156 mg/dl to 129 mg/dl, compared to conventional treatment.

App users also showed a greater percentage improvement in HbA1c levels (15.8%) compared to non-app users (10.4%), indicating that the app may enhance glycaemic control in patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in glycaemic control in patients with type 2 diabetes with treatment using an interactive mobile application - A pilot study from India. Raghavan, A., Nanditha, A., Satheesh, K., et al.[2022]

Citations

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A Systematic Review and Meta-Analysis Our study shows that app-based interventions can improve outcomes (i.e., motivation, behavior, and clinical parameters) in individuals with ...

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What do healthcare professionals need to turn risk models ... What do healthcare professionals need to turn risk models for type 2 diabetes into usable computerized clinical decision support systems?

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Safety of a co-designed cognitive behavioural therapy ... Forty adults with T1DE (Hba1c < 15%, body mass index 15–35 kg/m2, age ≥ 18 years) were randomised. STEADY was delivered in 12 sessions by a CBT-trained Diabetes ...