RecruitingNot ApplicableNCT07463209

Integrating New Skills Into Diabetes Education With 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

Enrollment

144 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Mellitus (T2DM)Insulin Dependent Diabetes Diabetes (Insulin-requiring, Type 1 or Type 2)Diabetes (DM)Diabetes Education Type 1 Diabetes (T1D)Diabetes Care

Summary

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 A) will receive a one-time clinic-based CGM training. The second comparator (Comparator B) 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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called One-time clinic-based CGM training, a behavioral approach called Self-directed CGM training, and others for people with diabetes (dm), diabetes (insulin-requiring, type 1 or type 2), and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALThree-stage CGM integration program

Participants (and their consented care partner, if applicable) who are randomized to the intervention group will attend three closed group sessions over four weeks. Session 1 (Day 1) will be held in-person, where participants will receive technical training related to CGM sensor insertion, transmitter pairing, and receiver operation. Session 2 (Day 14) will be hybrid and will consist of training in how to read and understand CGM data, customize target ranges, alerts, and alarms, export and review historical data, and share CGM data with care partners. Session 3 (Day 28) will also be hybrid and will consist of training in strategies to utilize CGM for improved safety and quality of life. Between each session, participants will be remotely assessed for CGM use and glucose trends. Based on these remote assessments, participants may receive 1-2 additional individualized training sessions to review CGM technical skills, as well as data and self-management strategies associated with CGM use.

BEHAVIORALOne-time clinic-based CGM training

Participants (and their consented care partner, if applicable) randomized to the one-time clinic-based CGM training group (Comparator A) will complete a one-hour visit with a clinic-based educator on Day 1 of the trial. This group will be provided with basic CGM training and be advised to follow up with their usual diabetes care team as needed for questions or issues throughout the 6-week trial period.

BEHAVIORALSelf-directed CGM training

Participants randomized to the self-directed CGM training (Comparator B) will be provided with a comprehensive informational pamphlet about CGM on Day 1 of the trial. They will also be provided with a list of online resources for CGM self-training and be advised to follow up with their usual diabetes care team as needed for questions or issues throughout the 6-week trial period. Consented care partners will not be directly involved, as there is no session visit to attend.