NCT07463209
Integrating New Skills Into Diabetes Education With CGM
Recruiting · Not Applicable · University of North Carolina, Chapel Hill · registry updated 2026-10-05
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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. Willing to use a loaner smartphone or receiver if personal smartphone is not compatible with CGM phone app.
- Fluent in English
Exclusion
- 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