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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

Who can join

Ages 65 and older · All sexes

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

About the study

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.

What is being tested

• Three-stage CGM integration program (behavioral)
• One-time clinic-based CGM training (behavioral)
• Self-directed CGM training (behavioral)

Sponsor: University of North Carolina, Chapel Hill · Participants: 144 · Started: Aug 11, 2026

Contact the study team

• Marcy Menard, MS, RD, LDN, CDCES · Phone: 919-843-9977
• Angela Fruik, MPH, RD, LDN · Phone: 919-962-6348

Official record on ClinicalTrials.gov — NCT07463209

Locations in the U.S.

Conditions

• Type 1 Diabetes
• Diabetes
• Type 2 Diabetes

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.