48 Participants Needed

Telemedicine Education for Type 1 Diabetes

(TREAT-ED Trial)

IL
JK
Overseen ByJodi Krall, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment TREAT-ED Virtual Group Diabetes Self-Management Education and Support for type 1 diabetes?

Research shows that telemedicine, which involves using technology to provide healthcare remotely, can help people with type 1 diabetes manage their condition better. For example, studies have found that telemedicine can improve blood sugar control and provide effective diabetes education, especially in young adults and children.12345

Is telemedicine education for type 1 diabetes generally safe for humans?

Research on telemedicine interventions for type 1 diabetes, including a study on adults using insulin pumps, has shown that these methods are safe over a 12-month period. Additionally, a telemedicine protocol during the COVID-19 pandemic helped reduce acute complications in high-risk patients, suggesting it is a safe approach for managing diabetes.36789

How is the TREAT-ED Virtual Group Diabetes Self-Management Education and Support treatment different from other treatments for type 1 diabetes?

The TREAT-ED Virtual Group Diabetes Self-Management Education and Support treatment is unique because it uses telemedicine to provide group education and support, making it accessible to people in rural or underserved areas. This approach focuses on increasing knowledge, skills, and confidence in managing diabetes through remote, person-centered interventions led by a team of diabetes care experts.310111213

What is the purpose of this trial?

Emerging adults with type 1 diabetes are a vulnerable population. While diabetes self-management and education is known to offer opportunities to develop self-management skills required to achieve and maintain short- and long-term diabetes outcomes, emerging adults are reported to have poor clinic attendance and in turn low participation in diabetes self-management education and support services. This pilot study aims to test a novel approach to diabetes self-management education and support that incorporates technological and applied learning-driven methods delivered through group telemedicine visits to improve emerging adults engagement in diabetes self-management education and support with the ultimate goal of improving diabetes outcomes.

Research Team

Dr. Ingrid Libman DeGordon, MD, PhD ...

Ingrid Libman, MD

Principal Investigator

University of Pittsburgh

LS

Linda Siminerio, RN, PhD, CDCES

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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
See 1 more

Exclusion Criteria

I do not have type 1 diabetes.
Do not intend to maintain their care at participating clinical sites throughout the duration of the study
Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TREAT-EDExperimental Treatment1 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.

Find a Clinic Near You

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

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

References

School-centered telemedicine for children with type 1 diabetes mellitus. [2022]
A randomized controlled trial of the effect of real-time telemedicine support on glycemic control in young adults with type 1 diabetes (ISRCTN 46889446). [2022]
Group diabetes education administered through telemedicine: tools used and lessons learned. [2022]
Home Telemedicine (CoYoT1 Clinic): A Novel Approach to Improve Psychosocial Outcomes in Young Adults With Diabetes. [2020]
Telemedicine in paediatric patients with poorly controlled type 1 diabetes. [2022]
Effectiveness of Internet and Phone-Based Interventions on Diabetes Management of Children and Adolescents With Type 1 Diabetes: A Systematic Review. [2022]
A randomized controlled trial comparing a telemedicine therapeutic intervention with routine care in adults with type 1 diabetes mellitus treated by insulin pumps. [2019]
A novel telemedicine protocol improved outcomes for high-risk patients with type 1 diabetes: A 3-month quality improvement project during the COVID-19 pandemic. [2021]
Telehealth technologies: changing the way we deliver efficacious and cost-effective diabetes self-management education. [2018]
A structured 1-year education program for children with newly diagnosed type 1 diabetes improves early glycemic control. [2022]
COVID: The Missing Trigger to Start a Remote FIT Course. [2023]
Educational needs of type 1 diabetes mellitus T1DM children and adolescents in Morocco: A qualitative study. [2023]
13.United Statespubmed.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]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security