No phaseRecruiting
Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM)
Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM): An Individualized CGM Integration Program for Older Adults With Diabetes
- Sponsor
- University of North Carolina, Chapel Hill (Academic or other)
- Enrolment
- 144 planned
- 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)
- Interventions
- Three-stage CGM integration program; One-time clinic-based CGM training; Self-directed CGM training
- Ages
- older adults
- Registry
- NCT07463209
From the registry
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.…
Primary outcomes
- CGM Wear Time