Telemedicine for Reach, Education, Access, and Treatment for Diabetes Self-Management Education and Support

NCT ID: NCT06626347

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-08
• Study Completion Date: 2026-05-31

Brief Summary

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.

Detailed Description

Diabetes self-management education and support is considered a cornerstone of care and essential in helping people navigate self-management decisions and activities. Despite evidence that diabetes self-management education and support is a critical component of diabetes care, participation remains low. Emerging adulthood has been described as the distinct period between 18 and 25 years when adolescents work to achieve autonomy and explore life possibilities in moving toward adulthood. Suboptimal self-management has been identified as a major problem in emerging adults with type 1 diabetes, a particularly vulnerable group with an increased risk for poor diabetes-related outcomes. In its current form diabetes self-management education and support has been cited for not meeting the needs of emerging adults, when emerging adults have expressed interest in diabetes self-management education and support delivered with peer-supported, technological and applied learning-driven methods. To address these challenges, we are applying information gained from the literature and key stakeholder groups to our established Telemedicine for Reach, Education, Access and Treatment (TREAT) delivery model with a specific focus on diabetes self-management education and support. TREAT-ED (for self-management EDucation) will be designed to specifically engage emerging adults by integrating diabetes self-management education and support objectives to support informed decision making, self-care, and preparation for transfer to adult care, to improve outcomes. Diabetes care and education specialists will lead TREAT-ED with a cohort of emerging adults and will 1) help to organize and facilitate group sessions delivered through telehealth and 2) use continuous blood glucose monitoring reports as personalized examples to drive established diabetes self-management education and support content. With user-centered design techniques we developed and built and will now evaluate implementation determinants and test the TREAT-ED model. Feasibility assessment of the impact of the model on emerging adult patient participation in diabetes self-management education and support along with clinical, psychosocial and behavioral outcomes will be examined. We hypothesize that models that rely on current day strategies to engage emerging adults at high risk for diabetes-related problems with effective self-management skills will improve diabetes self-management education and support engagement and outcomes. If proven to be effective, this model is one that could be adapted for emerging adults who have transferred to adult diabetes care and other patient populations throughout the United States.

Conditions

Type 1 Diabetes (T1D)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

TREAT-ED

• 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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

TREAT-ED is an innovative group telehealth delivery model designed to engage emerging adults in DSMES services. TREAT-ED sessions are facilitated by a Diabetes Care and Education Specialist and include content centered around the ADCES7 Self-Care Behaviors and applied learning strategies, e.g., case scenarios integrating glucose monitoring, and group discussions to drive knowledge transfer and skill development for diabetes self-care behaviors within the context of issues that are salient to the target population.

Interventions

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

TREAT-ED is an innovative group telehealth delivery model designed to engage emerging adults in DSMES services. TREAT-ED sessions are facilitated by a Diabetes Care and Education Specialist and include content centered around the ADCES7 Self-Care Behaviors and applied learning strategies, e.g., case scenarios integrating glucose monitoring, and group discussions to drive knowledge transfer and skill development for diabetes self-care behaviors within the context of issues that are salient to the target population.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with type 1 diabetes (ICD10 E10.xx, O24.0x)
• 18 to 26 years of age at time of study enrollment
• 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 have a diagnosis of type 1 diabetes (ICD10 E10.xx, O24.0x)
• Less than 18 or older than 26 years old at time of enrollment
• Do not intend to maintain their care at participating clinical sites throughout the duration of the study
• Are unable to communicate via telemedicine
• Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Libman

Associate Professor of Pediatrics and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingrid Libman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Linda Siminerio, RN, PhD, CDCES

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R34DK136020

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY24070160

Identifier Type: -

Identifier Source: org_study_id