💬In plain words
What the trial is, and whether it could suit you
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 skil
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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. Willing to use a loaner smartphone or receiver if personal smartphone is not compatible with 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
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