Integrating New Skills Into Diabetes Education With CGM

This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program ("intervention") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches ("comparators"). Following a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator 1) will receive a one-time clinic-based CGM training. The second comparator (Comparator 2) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks. The study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention. Lastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.

NCT Number	NCT07463209
Lead Sponsor	University of North Carolina, Chapel Hill Collaborators: American Diabetes Association
Conditions	Insulin Dependent Diabetes, Diabetes (DM), Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes Education, Diabetes Care, Type 1 Diabetes (T1D), Type 2 Diabetes Mellitus (T2DM)
Enrollment	144 participants
Start Date	2026-08-11
Primary Completion	2028-02 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-14