Diabetes Telecoaching for Type 2 Diabetes

Overseen By Mohanraj Thirumalai, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Depression, Cardiac event, Hypertension, Tachycardia, Renal failure, Neuropathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new AI-assisted lifestyle program called AI4DM, designed to help people with disabilities manage Type 2 diabetes. The goal is to improve blood sugar control through a personalized, family-focused plan. Participants will be divided into two groups: one using the new AI program and another receiving standard support. Ideal candidates are those with Type 2 diabetes who live with a permanent physical disability. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could significantly enhance diabetes management for individuals with disabilities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this AI-assisted telecoaching program is safe for glycemic control in people with disabilities?

Research has shown that AI4DM is a new program designed to help people with disabilities manage their diabetes through lifestyle changes. Specific safety information from past studies is limited because AI4DM remains under testing. However, this trial focuses on exploring AI's role in supporting diabetes management, rather than testing a drug or medical device.

Since AI4DM involves lifestyle changes and remote coaching, it is likely well-tolerated. No major side effects have been directly linked to the program, suggesting its safety. Nonetheless, discussing any concerns with the study team is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of AI4DM, an innovative telecoaching method for managing Type 2 diabetes. Unlike traditional treatments that rely heavily on medication and frequent in-person consultations, AI4DM leverages artificial intelligence to provide personalized coaching and support remotely. This approach could enhance patient engagement and self-management, leading to better glucose control and potentially reducing the need for constant clinical visits. The integration of AI in diabetes care is a promising step forward, aiming to make management more accessible and tailored to individual needs.

What evidence suggests that this trial's treatments could be effective for glycemic control in people with disabilities?

Research has shown that the AI4DM program, which participants in this trial may receive, might help people with disabilities manage type 2 diabetes by stabilizing blood sugar levels. Past participants have found that telecoaching, or remote coaching using technology, supports the lifestyle changes needed for better diabetes management. The AI4DM approach focuses on the family and tailors to each person, potentially increasing its effectiveness. While specific data on AI4DM is still being gathered, similar programs have shown promise in helping people make lasting improvements to their health habits. Using AI to guide and personalize these programs may enhance their effectiveness. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for people with Type 2 Diabetes who also have a permanent physical disability like spinal cord injury or multiple sclerosis. Participants must be able to speak and read English but can't join if they've had severe heart issues, kidney failure, untreated depression recently, are in another diabetes study, don't have a smartphone, or have uncontrolled blood pressure.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes.

I live with a permanent physical disability like SCI or MS.

Ability to converse and read in English

Exclusion Criteria

You do not have a smartphone.

Your heart beats too fast when you are resting.

I have severe nerve pain or numbness in my hands or feet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AI-assisted telecoaching support for lifestyle modification

24 weeks

Weekly and bi-weekly telecoaching calls

Follow-up

Participants have access to technology but no telecoaching calls

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AI4DM
• Attention-control

Trial Overview The study is testing an AI-assisted program called AI4DM designed to help individuals with disabilities manage their diabetes through lifestyle changes. It's compared against standard attention-control methods to see how effective it is at controlling blood sugar levels.

How Is the Trial Designed?

Group I: AI4DM Intervention Group Experimental Treatment 1 Intervention

Group II: Attention-control Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Patients with type 2 diabetes who actively engaged with the Diabetes Connect program showed a significant reduction in their hemoglobin A1c (HbA1c) levels, with an average decrease of 1.5%, compared to only 0.4% in non-engaged patients, indicating the program's efficacy in improving diabetes management.

Early and consistent engagement with the program, along with active participation from healthcare providers, was crucial for achieving better clinical outcomes, highlighting the importance of both patient and provider involvement in diabetes self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes connect: an evaluation of patient adoption and engagement in a web-based remote glucose monitoring program. Jethwani, K., Ling, E., Mohammed, M., et al.[2022]

A nurse-led telecoaching program for type 2 diabetes involving 287 patients showed high satisfaction rates, with 97.5% of participants reporting positive experiences, indicating its potential effectiveness in improving diabetes management.

While patients appreciated the program's flexibility and evidence-based approach, healthcare providers expressed concerns about patient motivation and the lack of a supportive framework for telecare, highlighting barriers to broader implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and provider acceptance of telecoaching in type 2 diabetes: a mixed-method study embedded in a randomised clinical trial. Odnoletkova, I., Buysse, H., Nobels, F., et al.[2019]

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]

A randomized controlled trial with 574 participants showed that nurse-led telecoaching significantly reduced HbA1c levels in people with Type 2 diabetes, with a notable decrease of 2 mmol/mol overall and 4 mmol/mol in those with elevated baseline levels after 6 months.

The telecoaching intervention also led to improvements in BMI and total cholesterol levels, with sustained benefits in glycaemic control observed 12 months after the intervention ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing diabetes control in people with Type 2 diabetes through nurse-led telecoaching. Odnoletkova, I., Goderis, G., Nobels, F., et al.[2022]

The Diabetes My Way (DMW) digital platform is being tested in Greater Manchester to improve Type 2 Diabetes (T2D) care by providing accessible self-management and educational resources, addressing barriers like low attendance in traditional programs.

As of May 2021, 316 participants have been recruited for the quantitative study, with the aim of assessing the effectiveness and cost-effectiveness of DMW in improving T2D outcomes compared to a matched control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Interventions Supporting Self-care in People With Type 2 Diabetes Across Greater Manchester (Greater Manchester Diabetes My Way): Protocol for a Mixed Methods Evaluation. Goldthorpe, J., Allen, T., Brooks, J., et al.[2022]

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 meta-analysis of 10 studies involving 380 interventions showed that distance education and SMS reminders significantly reduced HbA1c levels in type-2 diabetes patients, with an overall effect size of -0.49%.

The same interventions also improved medication adherence, with a strong effect size of 0.96, indicating that texting reminders can be an effective strategy for managing diabetes over the first 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of short message service intervention to improve glycated hemoglobin control and medication adherence in type-2 diabetes: A meta-analysis of prospective studies. Zhuang, Q., Chen, F., Wang, T.[2022]

A pilot program using a diabetes education chatbot showed high satisfaction and engagement among 150 adults with type 2 diabetes, with 87% reporting increased self-care confidence.

Participants who engaged in multiple chats experienced a significant drop in A1C levels by an average of -1.04%, while those who engaged less had a slight increase, indicating the chatbot's potential effectiveness in improving diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Behavioral and Clinical Efficacy of a Diabetes Education Chatbot Pilot Among Adults With Type 2 Diabetes. Nassar, CM., Dunlea, R., Montero, A., et al.[2023]

A one-year feasibility study involving 14 type 2 diabetes patients demonstrated that self-titration of oral glucose-lowering medication, guided by a mobile telehealth platform, is feasible and can lead to improvements in glycemic control.

At the 6-month mark, the intervention group showed a median reduction in HbA1c of -10 mmol/mol (-0.9%), compared to -5 mmol/mol (-0.5%) in the control group, suggesting that the telehealth approach may enhance diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepwise self-titration of oral glucose-lowering medication using a mobile telephone-based telehealth platform in type 2 diabetes: a feasibility trial in primary care. Nagrebetsky, A., Larsen, M., Craven, A., et al.[2021]

In a 6-month study involving 43 adults with type 2 diabetes, the integration of a diabetes management app (DMA) and peer support from lay health coaches led to a significant reduction in mean hemoglobin A1c levels from 9.93% to 8.86%.

The majority of participants (88.4%) engaged with the DMA, using it to track their health, while also benefiting from coaching support, indicating that these two approaches work well together to enhance diabetes self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementarity of Digital Health and Peer Support: "This Is What's Coming". Tang, PY., Duni, J., Peeples, MM., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04927377

Accessible and Inclusive Diabetes Telecoaching Self ... ... (AI4DM) for glycemic control in people with disabilities. Detailed Description. The AI4DM study will use a two-arm randomized control trial design. Eligible ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8463947/

Disability-Inclusive Diabetes Self-management Telehealth ... The AI4DM study is a 2-arm randomized controlled trial for evaluating the delivery of a 12-month intervention, which will involve telecoaching, diabetes ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34505831/

Disability-Inclusive Diabetes Self-management Telehealth ... Conclusions: The AI4DM study will improve our understanding of the feasibility and efficacy of a web-based diabetes self-management program for ...

4. trialx.com trialx.com/clinical-trials/listings/270593/accessible-and-inclusive-diabetes-telecoaching-self-management-program/

Accessible and Inclusive Diabetes Telecoaching Self- ... The purpose of this study is to develop and pilot test an accessible and inclusive Artificial Intelligence (AI)-assisted, individualized, family ...

5. withpower.com withpower.com/trial/diabetes-telecoaching-for-type-2-diabetes-a7a76

Diabetes Telecoaching for Type 2 Diabetes The study is testing an AI-assisted program called AI4DM designed to help individuals with disabilities manage their diabetes through lifestyle changes.

6. researchprotocols.org researchprotocols.org/2021/9/e31689/

Disability-Inclusive Diabetes Self-management Telehealth ... The AI4DM study is a 2-arm randomized controlled trial for evaluating the delivery of a 12-month intervention, which will involve telecoaching, diabetes ...