Enhanced Telemedicine for Type 2 Diabetes

Overseen By Margaret Zupa, MD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must be taking: Insulin

Disqualifiers: Age over 80, Dementia, ESRD, Malignancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is: Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible? Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes. Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.

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 current medications, especially since the trial involves managing diabetes with insulin.

What data supports the effectiveness of the treatment Enhanced Telemedicine for Type 2 Diabetes?

Research shows that telemedicine can help improve blood sugar control in people with diabetes by allowing real-time monitoring and management. Programs like Project ECHO have successfully improved health outcomes for patients with complex diabetes, especially in underserved areas. ^{1 2 3 4 5}

How is the Enhanced Telemedicine treatment for Type 2 Diabetes different from other treatments?

Enhanced Telemedicine for Type 2 Diabetes is unique because it uses technology to provide real-time support and data sharing between patients and healthcare providers, which can improve glucose control and reduce the need for frequent in-person visits. This approach is particularly beneficial for those who have limited access to traditional healthcare services. ^{1 5 6 7 8}

Research Team

Margaret Zupa, MDMS

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults with type 2 diabetes who use insulin and have multiple chronic conditions. Participants will engage in telemedicine visits over about 6 months. They must be willing to complete surveys during their care visits.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

Patients must own or have access to a smart phone, tablet, or home computer with data or internet connection that allows access to video-based visits

I am 18 years old or older.

Exclusion Criteria

Visit with an endocrinologist in the prior 3 years

I am over 80 years old.

Currently enrolled in another diabetes management intervention study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline survey measures and clinical data collection via chart review

1-2 weeks

1 visit (virtual)

Treatment

Participants receive enhanced telemedicine intervention or usual care for type 2 diabetes

6 months

2-3 visits (virtual) with additional individualized visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enhanced Telemedicine for Type 2 Diabetes

Trial Overview The study compares usual telemedicine endocrinology care with an enhanced version for managing type 2 diabetes. The enhanced program includes pre-visit calls, education, support, and post-visit follow-ups to see if it improves patient satisfaction or clinical outcomes.

Participant Groups

Group I: Enhanced Telemedicine Care Experimental Treatment 1 Intervention

Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist, with additional multidisciplinary support from the diabetes care team.

Group II: Usual Care Active Control 1 Intervention

Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist following usual clinical care protocols.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

In a study of 123 insulin-treated patients with type 1 and type 2 diabetes, the web-based telemedicine system Glucoonline® significantly improved glucose control, reducing HbA1c levels by 0.38% after 6 months compared to no change in the standard care group.

After 3 months, a higher percentage of patients using the Glucoonline® system achieved HbA1c levels below 7% (28.6% vs 11.1%), demonstrating the effectiveness of telemedicine in enhancing diabetes self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telemedicine-based approach with real-time transmission of blood glucose data improves metabolic control in insulin-treated diabetes: the DIAMONDS randomized clinical trial. Di Molfetta, S., Patruno, P., Cormio, S., et al.[2022]

Project ECHO is a telementoring program that enhances the management of complex diseases like diabetes in underserved areas by allowing multiple patients to benefit from shared expertise, rather than just one-on-one specialist consultations.

The Endo ECHO program, specifically designed for patients with complex diabetes in rural New Mexico, is undergoing a 4-year evaluation to assess its impact on health outcomes, healthcare utilization, and cost-effectiveness, potentially serving as a model for similar initiatives globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking Telemedicine to the Next Level in Diabetes Population Management: a Review of the Endo ECHO Model. Bouchonville, MF., Paul, MM., Billings, J., et al.[2018]

In a study involving 338 older patients with diabetes over 36 months, telemedicine case management effectively identified and addressed 67 medically urgent situations, averaging 1.9 events per month.

The telemedicine approach facilitated timely intervention for potentially life-threatening issues, such as major drug contraindications and unstable angina, demonstrating its efficacy in improving patient care and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection and remediation of medically urgent situations using telemedicine case management for older patients with diabetes mellitus. Izquierdo, R., Meyer, S., Starren, J., et al.[2021]

A pilot study involving 38 participants in a rural Arkansas community showed that a telemedicine-based diabetes self-management education program (DSME-T) significantly improved participants' knowledge about diabetes (from 39% to 83%) and self-efficacy (from 54% to 86%).

66% of participants completed the program, and those who did reported more frequent self-care practices, indicating that DSME-T could be an effective way to support diabetes management in underserved rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of diabetes education via telemedicine in a rural underserved community--opportunities and challenges: a continuous quality improvement process. Balamurugan, A., Hall-Barrow, J., Blevins, MA., et al.[2022]

The EpxDiabetes digital health intervention significantly reduced HbA1c levels by an average of 1.15% in patients with high baseline HbA1c (>8%) over a 4-month period, compared to almost no change prior to its implementation.

The intervention achieved a high patient engagement rate, with 95.6% of patients responding to messages at least once a month, indicating its potential as a sustainable tool for managing uncontrolled diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Glycemic Control With a Standardized Text-Message and Phone-Based Intervention: A Community Implementation. Peters, RM., Lui, M., Patel, K., et al.[2020]

A telehealth system was tested with 23 patients with uncontrolled type 2 diabetes, showing a significant reduction in HbA1c levels by 0.52% over three months, indicating improved blood sugar control with insulin adjustments.

Patients and clinicians found the telehealth technology acceptable and beneficial, suggesting it could enhance support for insulin initiation and management in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of telehealth support for patients with type 2 diabetes using insulin treatment: an exploratory study. Turner, J., Larsen, M., Tarassenko, L., et al.[2019]

A study involving 309 women with type 2 diabetes showed that diabetes medical group visits (DMGVs) conducted through an immersive telemedicine platform were as effective as in-person visits in improving hemoglobin A1c (HbA1c) levels after 6 months.

While both groups experienced a reduction in diabetes distress and depressive symptoms, there were no significant improvements in physical activity levels, indicating that while telemedicine is effective for glycemic control, additional strategies may be needed to enhance physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Immersive Telemedicine Platform for Delivering Diabetes Medical Group Visits for African American, Black and Hispanic, or Latina Women With Uncontrolled Diabetes: The Women in Control 2.0 Noninferiority Randomized Clinical Trial. Mitchell, SE., Bragg, A., De La Cruz, BA., et al.[2023]

The RENEWING HEALTH study aims to evaluate the effectiveness of a mobile diabetes diary app combined with health counseling for improving metabolic control and quality of life in patients with type 2 diabetes, involving 151 participants in a randomized controlled trial.

The study will assess key outcomes such as hemoglobin A1c levels and behavior change over a year, highlighting the potential role of telemedicine in enhancing self-management for diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity self-management intervention for persons with type 2 diabetes using a mobile phone-based diabetes diary, with and without health counseling and motivational interviewing: protocol for a randomized controlled trial. Ribu, L., Holmen, H., Torbjørnsen, A., et al.[2022]

References

1. Italy pubmed.ncbi.nlm.nih.gov

A telemedicine-based approach with real-time transmission of blood glucose data improves metabolic control in insulin-treated diabetes: the DIAMONDS randomized clinical trial. [2022]

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

Taking Telemedicine to the Next Level in Diabetes Population Management: a Review of the Endo ECHO Model. [2018]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Detection and remediation of medically urgent situations using telemedicine case management for older patients with diabetes mellitus. [2021]

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

A pilot study of diabetes education via telemedicine in a rural underserved community--opportunities and challenges: a continuous quality improvement process. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Improving Glycemic Control With a Standardized Text-Message and Phone-Based Intervention: A Community Implementation. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Implementation of telehealth support for patients with type 2 diabetes using insulin treatment: an exploratory study. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of an Immersive Telemedicine Platform for Delivering Diabetes Medical Group Visits for African American, Black and Hispanic, or Latina Women With Uncontrolled Diabetes: The Women in Control 2.0 Noninferiority Randomized Clinical Trial. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Low-intensity self-management intervention for persons with type 2 diabetes using a mobile phone-based diabetes diary, with and without health counseling and motivational interviewing: protocol for a randomized controlled trial. [2022]