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

NCT06626347 | Active Not Recruiting

• 2 other identifiers: STUDY24070160R34DK136020
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes (T1D)

Keywords

Type 1 Diabetes; Emerging Adults; Telemedicine; Health Care Delivery; Diabetes Self-Management Education and Support; Visit Attendance

Outcome Measures

Primary Outcomes (1)

• Number of diabetes self-management education and support sessions attended

  Possible range is 0 to 4 sessions.

  From baseline to 6 months

Secondary Outcomes (8)

• Change from baseline in empowerment at 6 months

  Baseline vs. 6 months

• Change from baseline in readiness for transition at 6 months

  Baseline vs. 6 months

• Change from baseline in self-efficacy at 6 months

  Baseline vs. 6 months

• Change from baseline in diabetes distress at 6 months

  Baseline vs. 6 months

• Change in percentage of patients with glycemic control from baseline to 6 months.

  Baseline vs. 6 months

Study Arms (1)

TREAT-ED

EXPERIMENTAL

* 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.

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

Interventions

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

TREAT-ED

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with type 1 diabetes (ICD10 E10.xx, O24.0x)
• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Pittsburgh: lead

Study Sites (1)

UPMC Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ingrid Libman, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Linda Siminerio, RN, PhD, CDCES

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics and Epidemiology

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: November 8, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available after publication of primary results; available indefinitely.
• Access Criteria: Investigators whose proposed research has received IRB approval will be able to access de-identified IPD that underlies published results, study protocol, SAP, and ICF.

Locations

US (1)