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NCT07463209
Integrating New Skills Into Diabetes Education With CGM
Conditions: Insulin Dependent Diabetes, Diabetes (DM), Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes Education, Diabetes Care, Type 1 Diabetes (T1D), Type 2 Diabetes Mellitus (T2DM)
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 144
Sponsor: University of North Carolina, Chapel Hill
Location: University of North Carolina at Chapel Hill Chapel Hill North Carolina
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 Criteria
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
* 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 \
Source: ClinicalTrials.gov (NCT07463209). StuddyBuddy aggregates publicly available trial information.