Trials / Not Yet Recruiting

Not Yet RecruitingNCT07463209

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 150 (estimated)

Sponsor: University of North Carolina, Chapel Hill · Academic / Other
Sex: All
Age: 65 Years
Healthy volunteers: Not accepted

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. Lastly, an extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention.

Detailed description

This study will assess the preliminary effectiveness of a continuous glucose monitor (CGM) integration program ("intervention") in a 6-week randomized pilot study among 150 older adults with diabetes using insulin. The CGM integration program will be compared to two versions of usual care: 1) one-time clinic-based CGM training (Comparator A) and 2) self-directed CGM training (Comparator B). Following a screening visit and baseline data collection, participants will be randomized to one of the three groups in a 1:1:1 ratio by computer-generated sequence. All participants will be provided with 60-days of unblinded CGM sensors. Participants who are randomized to the intervention group will attend three closed group sessions over 4 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 held virtually 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 held virtually 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. Participants 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. 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. At the end of the 6-week trial, all participants will provide primary endpoint data related to wear-time and use of the CGM device. In addition, secondary patient-reported outcomes and glycemic metrics will be assessed. We will conduct semi-structured interviews with a subset of purposively sampled participants and their care partners (N=50) after their final endpoint visit to probe effective aspects of the intervention, challenges, struggles, and needs that were not addressed by the intervention, and strategies to improve the accessibility, acceptability, and effectiveness of the intervention for future older adults. Lastly, we will conduct an extension study in which we evaluate the following metrics at 3- and 6-months post-intervention: 1) CGM prescribing patterns post-study, including the proportion of participants with a CGM order at 3 and 6 months after study endpoint; 2) Clinical and patient-reported outcomes, such as glycemic indicators, severe hypoglycemia, device satisfaction (if applicable), barriers to sustained CGM access, integration of CGM into care and self-management, and unmet needs; 3) provider documentation of clinical rationale, perceived benefits, and barriers to CGM use across diverse care settings (internal medicine, family medicine, geriatrics, endocrinology).

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Three-stage CGM integration program	Participants 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.
BEHAVIORAL	One-time clinic-based CGM training	Participants 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.
BEHAVIORAL	Self-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.

Timeline

Start date: 2026-06-01
Primary completion: 2028-01-01
Completion: 2028-06-01
First posted: 2026-03-11
Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07463209. Inclusion in this directory is not an endorsement.