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.
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
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
Parallel
Three-stage CGM integration program
BehavioralParticipants (and their consented care partner, if applicable) who are randomized to the intervention group will attend three closed group sessions over four weeks. Session 1 (Day 1) will be held in-person, where participants will receive technical training related to CGM sensor insertion, transmitter pairing, and receiver operation. Session 2 (Day 14) will be hybrid and will consist of training in how to read and understand CGM data, customize target ranges, alerts, and alarms, export and review historical data, and share CGM data with care partners. Session 3 (Day 28) will also be hybrid and will consist of training in strategies to utilize CGM for improved safety and quality of life. Between each session, participants will be remotely assessed for CGM use and glucose trends. Based on these remote assessments, participants may receive 1-2 additional individualized training sessions to review CGM technical skills, as well as data and self-management strategies associated with CGM use.
One-time clinic-based CGM training
BehavioralParticipants (and their consented care partner, if applicable) randomized to the one-time clinic-based CGM training group (Comparator A) will complete a one-hour visit with a clinic-based educator on Day 1 of the trial. This group will be provided with basic CGM training and be advised to follow up with their usual diabetes care team as needed for questions or issues throughout the 6-week trial period.
Self-directed CGM training
BehavioralParticipants randomized to the self-directed CGM training (Comparator B) will be provided with a comprehensive informational pamphlet about CGM on Day 1 of the trial. They will also be provided with a list of online resources for CGM self-training and be advised to follow up with their usual diabetes care team as needed for questions or issues throughout the 6-week trial period. Consented care partners will not be directly involved, as there is no session visit to attend.
CGM Wear Time
CGM wear time will be calculated as the percentage of time that the sensor is in use and providing data, relative to the total time it could have been worn, with a total of 6-weeks of total possible wear during the active intervention period.
CGM Use at 6 Weeks
CGM use will be determined as a yes/no binary response as to whether the study participant is wearing a CGM at the 6-week endpoint of the study intervention.
Change in Core Diabetes Distress using the Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score
The T1-DDAS will be administered to participants with Type 1 Diabetes. Self-reported core diabetes distress will be measured using the 30-item Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score. The scale yields a core score that is the average of all core questions (first 8 items) responses rated on a 5-point Likert scale for all 8 items, ranging from 1 (not a problem) to 5 (a very serious problem). Higher scores indicate higher distress. A score \>= 2.0 is considered clinically significant diabetes distress.
Change in Core Diabetes Distress using the Type 2 Diabetes Distress Assessment System (T2-DDAS) Core Score
The T2-DDAS will be administered to participants with Type 2 Diabetes. Self-reported core diabetes distress will be measured using the 29-item Type 2 Diabetes Distress Assessment System (T2-DDAS) Core Score. The scale yields a core score that is the average of all core questions (first 8 items) responses rated on a 5-point Likert scale for all 8 items, ranging from 1 (not a problem) to 5 (a very serious problem). Higher scores indicate higher distress. A score \>= 2.0 is considered clinically significant diabetes distress.
Change in Sources of Diabetes Distress using the Type 1 Diabetes Distress Assessment System (T1-DDAS) Source Score
The T1-DDAS will be administered to participants with Type 1 Diabetes. Self-reported sources of diabetes distress will be measured using the 30-item Type 1 Diabetes Distress Assessment System (T1-DDAS) source scale. Responses are rated on a 5-point Likert scale, ranging from 1 (not a problem) to 5 (a very serious problem). Higher scores indicate higher impact that the source is likely to have in contributing to diabetes distress.
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University of North Carolina, Chapel Hill
Lead sponsor
American Diabetes Association
Collaborator
