EICHORCondition: Insulin Dependent Diabetes · Diabetes (DM) · Diabetes (Insulin-requiring, Type 1 or Type 2) · Sponsor: University of North Carolina, Chapel Hill
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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 associate…
This description comes directly from the study's public registry record.
Marcy Menard, MS, RD, LDN, CDCES · 919-843-9977 · mmenard@unc.edu
Angela Fruik, MPH, RD, LDN · 919-962-6348 · angela.fruik@unc.edu
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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 \<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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07463209