Telemedicine Education for Type 1 Diabetes

(TREAT-ED Trial)

Overseen By Jodi Krall, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-type 1 diabetes, Age, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help young adults with type 1 diabetes manage their condition more effectively. By using group telemedicine sessions, the researchers aim to make diabetes education more engaging and accessible, ultimately improving health outcomes. Participants will join virtual group sessions to learn and share experiences about managing diabetes. This trial suits individuals diagnosed with type 1 diabetes, aged 18 to 26, who are comfortable using video calls. As an unphased trial, it offers a unique opportunity to engage with innovative diabetes management strategies and connect with peers.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on education and support rather than medication changes.

What prior data suggests that this telemedicine education method is safe for emerging adults with type 1 diabetes?

Research has shown that using telemedicine to manage diabetes is generally safe and well-received. Studies have found that learning to manage diabetes virtually can be effective without causing significant side effects. Reviews of telehealth tools for diabetes management suggest they help patients control their condition with minimal risk.

One study on a complete telehealth approach for diabetes showed that participants managed their diabetes better without major safety issues. This indicates that virtual methods for diabetes education and support are both effective and safe.

These findings reassure those considering joining a trial that uses telemedicine for diabetes self-management education, such as the TREAT-ED program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TREAT-ED because it offers a fresh approach to managing type 1 diabetes through virtual group education and support. Unlike traditional in-person diabetes management education, TREAT-ED allows emerging adults to engage in sessions online, making it more convenient and accessible. The flexibility for participants to schedule sessions based on their preferences also helps personalize the experience, potentially improving engagement and outcomes. By leveraging technology, this approach could bridge gaps in support, particularly for those who face barriers to accessing traditional care.

What evidence suggests that this telemedicine education is effective for type 1 diabetes?

Research has shown that diabetes self-management education and support (DSMES) can significantly lower glycated hemoglobin levels, an important measure of blood sugar control. Studies have found that telehealth tools for diabetes management improve patient engagement and condition management. A review of research found that remote diabetes education effectively reduces HbA1c, the marker for long-term blood sugar levels. This trial will evaluate the TREAT-ED virtual group sessions, which could help young adults with type 1 diabetes better manage their condition by providing convenient and effective education. ^{2 3 4 6 7}

Who Is on the Research Team?

Ingrid Libman, MD

Principal Investigator

University of Pittsburgh

Linda Siminerio, RN, PhD, CDCES

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for emerging adults with Type 1 Diabetes who may struggle to attend clinic appointments. It's designed to help them learn and manage their diabetes better using group telemedicine sessions.

Inclusion Criteria

Able to communicate via videoconferencing platform

Intending to maintain status as a patient at participating clinical sites throughout the study duration

Able to provide informed consent

Exclusion Criteria

Do not intend to maintain their care at participating clinical sites throughout the duration of the study

I do not have type 1 diabetes.

Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in diabetes self-management education and support through group telemedicine sessions

6 months

4 group sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TREAT-ED Virtual Group Diabetes Self-Management Education and Support

Trial Overview The study tests a new method called TREAT-ED, which uses virtual group meetings for diabetes self-management education and support, aiming to improve engagement and overall diabetes outcomes.

How Is the Trial Designed?

Group I: TREAT-ED Experimental Treatment 1 Intervention

* Emerging adult patients with type 1 diabetes assigned to groups of eight participants on average. * Four diabetes self-management education and support group sessions delivered virtually each session lasting 30-45 minutes. * Group sessions scheduled at intervals decided up on by participants.

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

A 9-month study involving 93 young adults with type 1 diabetes showed that telemedicine support, including real-time feedback and nurse assistance, led to a significant reduction in median blood glucose levels compared to a control group.

While both groups experienced reductions in HbA1c levels, the difference between the intervention and control groups was not statistically significant, suggesting that additional support for medication and lifestyle adjustments may be necessary for more substantial improvements in glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effect of real-time telemedicine support on glycemic control in young adults with type 1 diabetes (ISRCTN 46889446). Farmer, AJ., Gibson, OJ., Dudley, C., et al.[2022]

A structured program led by certified diabetes educators significantly reduced hemoglobin A1c (HbA1c) levels in children with type 1 diabetes (T1D) during the first 18 months after diagnosis, indicating improved short-term management of the disease.

However, the benefits of this program were not observed in families with lower socioeconomic status, suggesting that additional support may be needed for these families to achieve similar outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured 1-year education program for children with newly diagnosed type 1 diabetes improves early glycemic control. Hawkes, CP., Willi, SM., Murphy, KM.[2022]

Effective management of Type 1 diabetes requires a collaborative approach involving patients, families, and healthcare teams, emphasizing the importance of person-centered education and support.

The COVID-19 pandemic has heightened the need for remote diabetes self-management education, prompting a shift towards virtual programs like the FIT course, which is designed to enhance diabetes management skills and confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID: The Missing Trigger to Start a Remote FIT Course. Dos Santos Mamed, M., Gastaldi, G.[2023]

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]

Citations

1. withpower.com withpower.com/trial/telemedicine-education-for-type-1-diabetes-990e5

Telemedicine Education for Type 1 Diabetes ... This pilot study aims to test a novel approach to diabetes self-management education and support that incorporates technological and applied learning-driven ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05026528

Digital Diabetes Self Management Education and Support ... A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10899831/

Telehealth Technologies in Diabetes Self-management ... This review focuses on self-educational telehealth tools available for diabetes self-management, their advantages and disadvantages, and factors that need to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11650839/

Online diabetes self-management education application for ... This meta-analysis study aims to evaluate the Diabetes Self-Management Education and Support (DSMES) online application for reducing glycated hemoglobin levels.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dme.70002

Diabetes self‐management education and support ... This systematic review and meta-analysis showed that unidirectional diabetes self-management education and support delivered is effective in reducing HbA1c.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05756829

Type 1 Diabetes Virtual Self-management Education and ... A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2810132

Comprehensive Telehealth Model to Support Diabetes Self ... This cohort study examines glycemic outcome data for adults with type 1 or type 2 diabetes who participated in a virtual endocrinology ...