An interventional study of TREAT-ED Virtual Group Diabetes Self-Management Education and Support in Type 1 Diabetes (T1D), sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 26 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 49 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* 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
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.
Number of diabetes self-management education and support sessions attended
Possible range is 0 to 4 sessions.
Time frame: From baseline to 6 months
Change from baseline in empowerment at 6 months
Empowerment will be assessed with the 8-item Diabetes Empowerment Scale-Short Form. Individual items are scored from 1 to 5; total scores are the average of all individual items. Higher scores indicate a greater sense of empowerment.
Time frame: Baseline vs. 6 months
Change from baseline in readiness for transition at 6 months
Transition readiness and self-management skill level will be assessed with the Transition Readiness Assessment Questionnaire. Individual items are scored from 1 to 5; total scores are the average of all individual items. The higher the score, the greater the readiness for transition to adult care.
Time frame: Baseline vs. 6 months
Change from baseline in self-efficacy at 6 months
Self-efficacy will be assessed using the 10-item Self-Efficacy for Diabetes Self-Management scale. Individuals items are scored from 1 to 10; total scores are the average of all individual items. Higher scores indicate greater self-efficacy.
Time frame: Baseline vs. 6 months
Change from baseline in diabetes distress at 6 months
Diabetes distress will be assessed with the Type 1 Diabetes Distress Assessment System: CORE SCALE. The CORE SCALE includes 8 items. Individual items are scored from 1 to 5; total scores are the average of all individual items. The higher the score, the greater the level of distress.
Time frame: Baseline vs. 6 months
Change in percentage of patients with glycemic control from baseline to 6 months.
Glycemic control defined as clinically measured hemoglobin A1c value of 7% or less. Values will be identified through medical record review.
Time frame: Baseline vs. 6 months
Percentage of time in target glycemic range (70-180 mg/dL)
Time in target glycemic range (70-180 mg/dL) is evaluated in 14 day periods using data recorded on continuous glucose monitoring systems and documented in the electronic health record system. This data will only be available for participants who use a continuous glucose monitor and provide data for documentation.
Time frame: From baseline to 6 months
Number of acute care visits
Number of emergency room visits and hospital admissions related to type 1 diabetes; documented in the medical record system.
Time frame: From baseline to 6 months
Number of diabetes clinic visits attended
Diabetes clinic visits with an endocrinologist are recommended to occur every three months or more frequently as needed at the participating institution and are documented in the medical record.
Time frame: From baseline to 6 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified IPD that underlies results reported in publication.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh