Clinical Trials Directory

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RecruitingNCT06740435

Enhancing Telemedicine for T2D

Pilot Study Enhancing Telemedicine Care Delivery for Adults With Complex Type 2 Diabetes

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
University of Pittsburgh · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is: Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible? Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes. Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.

Detailed description

This pilot study will compare an intervention to deliver high-quality diabetes care through telemedicine for adults with type 2 diabetes who have additional chronic health conditions and use insulin with usual telemedicine care. The investigators will assess feasibility, patient satisfaction, and preliminary clinical outcomes. Fifty adults will be recruited from primary care practices. Once patients are confirmed eligible, they will be consented and enrolled. Patients will be randomized to the intervention arm or usual telemedicine care, stratified by age (above or below 65 years) and rurality, as these factors are associated with technological literacy and broadband access, which may impact telemedicine use and outcomes. Both groups will complete baseline survey measures and baseline clinical data will be collected via chart review. As this is a pragmatic pilot trial, intervention components will be delivered by usual clinical providers and staff for the intervention group. The telemedicine care intervention will include 2-3 synchronous visits with endocrinology providers over 6 months plus additional visits with multidisciplinary providers on an individualized basis. Telemedicine care will proceed as usual for the control group. The investigators will focus pilot trial outcomes on standard metrics to assess feasibility for a future large trial. The investigators will also measure preliminary clinical outcomes.

Conditions

Interventions

TypeNameDescription
OTHEREnhanced Telemedicine for Type 2 DiabetesTelemedicine-based endocrinology specialty care for type 2 diabetes with multidisciplinary diabetes care team support including pre-visit preparation, in-visit support and self-management education, and post-visit follow-up.
OTHERUsual Telemedicine Endocrinology Care for T2DRoutine telemedicine-based endocrinology specialty care for type 2 diabetes, generally consisting of synchronous virtual visit with an endocrinologist and additional support including self-management education on an individualized basis.

Timeline

Start date
2025-02-03
Primary completion
2026-04-30
Completion
2026-07-30
First posted
2024-12-18
Last updated
2025-06-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06740435. Inclusion in this directory is not an endorsement.