No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
144 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Other
Who this trial is looking for
This trial is looking for older adults who take insulin to learn new skills for managing diabetes. Participants will take part in educational sessions about using a continuous glucose monitor (CGM) over 6 weeks.
Are You a Good Fit for This Trial?
Must be takingInsulin
You may be able to join if
I am 65 years or older.
I visit a UNC Health or UNC Physicians Network clinic regularly.
I take insulin at least once daily.
I have not used a continuous glucose monitor in the last year.
I can use a smartphone to check glucose readings.
I speak English fluently.
You may not be able to join if
I have a clinical diagnosis of dementia.
I am currently receiving dialysis.
I have extreme vision or hearing problems affecting my participation.
I have a serious medical condition that may affect the study.
I am unavailable for the 6-week study duration.
I am not fluent in English.
I cannot consent to recording of sessions.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-repor…
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.
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.
Trial Locations
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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).…
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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