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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether enhanced telemedicine can improve diabetes care for individuals with type 2 diabetes who use insulin and have at least two other chronic health conditions. The researchers aim to determine if additional support, such as pre-visit planning and extra follow-up calls, enhances outcomes compared to standard telemedicine. Participants will have 2-3 video visits over six months and complete surveys about their experience. This trial suits adults in Pennsylvania with type 2 diabetes, an HbA1c level of 8% or more (a measure of blood sugar control), and access to a smartphone or computer for video calls. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes care solutions.

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 prior data suggests that this enhanced telemedicine intervention is safe for type 2 diabetes care?

Research has shown that telemedicine is generally safe for managing type 2 diabetes. Many studies have found that using telehealth technology for diabetes care is safe and can improve health outcomes, such as controlling blood sugar levels and related conditions.

Furthermore, a meta-analysis, which combines results from several studies, found that remote health monitoring from home is effective for people with type 2 diabetes. This indicates that patients generally handle telemedicine well.

Overall, the evidence supports the safety of using telemedicine for diabetes management. Therefore, joining a trial focused on enhanced telemedicine for type 2 diabetes should not involve unusual safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about enhanced telemedicine care for type 2 diabetes because it offers a more comprehensive approach than standard telemedicine. Unlike usual care, which follows regular clinical protocols, this enhanced method involves a multidisciplinary team supporting the endocrinologist, potentially improving personalized care and patient outcomes. This approach aims to provide more tailored care remotely, which could lead to better management of diabetes without frequent in-person visits.

What evidence suggests that enhanced telemedicine is effective for type 2 diabetes?

Research has shown that telemedicine can help manage type 2 diabetes. Some studies found that video calls can improve HbA1c levels, an important measure of blood sugar control, over time. However, results vary, with some patients experiencing greater improvements than others. In this trial, participants will receive either Enhanced Telemedicine Care, which includes additional support like pre-visit calls and education, or Usual Care via telemedicine. The enhanced approach might offer more personalized care and lead to better outcomes. Overall, while telemedicine is promising, its effectiveness can depend on the level of care and support provided. ^{2 3 6 7 8}

Who Is on the Research Team?

Margaret Zupa, MDMS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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

HbA1c greater than or equal to 8% based on most recent value at time of recruitment

Exclusion Criteria

Visit with an endocrinologist in the prior 3 years

Currently enrolled in another diabetes management intervention study

I am over 80 years old.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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]

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