Recruiting

CGM IntegrationIntegrating New Skills Into Diabetes Education With CGM

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07463209

Conditions

Insulin Dependent Diabetes

Diabetes (DM)

Diabetes (Insulin-requiring, Type 1 or Type 2)

Diabetes Education

Diabetes Care

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Three-stage CGM integration program

One-time clinic-based CGM training

Self-directed CGM training

Study Details

Brief 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 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.

Conditions

Insulin Dependent Diabetes

Diabetes (DM)

Diabetes (Insulin-requiring, Type 1 or Type 2)

Diabetes Education

Diabetes Care

Study ID

NCT07463209

Start date

Aug 11, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Participant Inclusion Criteria:

Adults 65 years and older at time of consent
Actively receiving care at a UNC Health or UNC Physicians Network clinic (defined as 2 or more visits in primary care, family medicine, internal medicine, geriatrics, or endocrinology clinics within the past 365 days). Locality for care is defined as receiving care within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.
Using any insulin at least once daily
No continuous glucose monitor (CGM) use within the previous 365 days
Willing to use a smartphone to access glucose readings using CGM phone app
Fluent in English

Participant Exclusion Criteria:

Clinical diagnosis of dementia, assessed through chart review and self-report on screening visit (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)
Currently receiving dialysis, assessed through chart review and self-report on screening visit
Extreme visual or hearing impairment that would impair ability to use real-time CGM or attend and participate in an in-person or virtual group intervention session, assessed at screening visit
The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of <1 year, assessed at screening visit
Unavailable for 6-week study duration (such as planned surgery or procedure, planned vacation, etc.) or unwilling to comply with study procedures
Not fluent in English
Unable to consent to recording of sessions

Care Partner Inclusion Criteria:

Live in the same household as the study participant
Age 18 years or older
Fluent in English
Be willing to attend sessions alongside the study participant and learn how they can better support their partner participant to manage diabetes
Consent to recording of sessions

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Three-stage CGM integration program

active comparator: Comparator A

One-time clinic-based CGM training

active comparator: Comparator B

Self-directed CGM training

Interventions

Three-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.

One-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.

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. Consented care partners will not be directly involved, as there is no session visit to attend.

Primary outcome measure

CGM Wear Time [ Time Frame: Over 6 Weeks ]

Central Contacts and Locations

Central contacts

Marcy Menard, MS, RD, LDN, CDCES

919-843-9977 mmenard@unc.edu

Angela Fruik, MPH, RD, LDN

919-962-6348 angela.fruik@unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Marcy Menard, MS, RD, LDN, CDCES

919-843-9977 mmenard@unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

Continuous Glucose Monitor
Diabetes
Insulin Dependent
Older Adults (65 years and older)
CGM
Diabetes Education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-08-14.