Three-stage CGM integration program for older adults with insulin-dependent diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pilot study tests a three-stage CGM integration program for adults 65 and older who use insulin. Participants are randomized to the three-stage intervention, a one-time clinic-based CGM training, or self-directed CGM training for 6 weeks, with all groups receiving CGM sensors for the study period. The intervention includes in-person CGM setup, virtual data skills training, and remote assessments to tailor CGM use to safety and quality of life. Outcomes focus on CGM wear-time, glycemic metrics, and participant-reported measures, using a 144-participant sample across three arms. The trial seeks preliminary signals of efficacy to inform future larger studies.

Why it matters

Who can join: the full rules

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

Where it's running

• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Anna Kahkoska, MD, PhD — University of North Carolina, Chapel Hill
• Study coordinator: Marcy Menard, MS, RD, LDN, CDCES
• Email: mmenard@unc.edu
• Phone: 919-843-9977

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.