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Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM): An Individualized CGM Integration Program for Older Adults With Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

• Fluent in English

• 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

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Marcy Menard, MS, RD, LDN, CDCES
mmenard@unc.edu
919-843-9977
Backup
Angela Fruik, MPH, RD, LDN
angela.fruik@unc.edu
919-962-6348
Time Frame
Start Date: 2026-08-11
Estimated Completion Date: 2028-06
Participants
Target number of participants: 144
Treatments
Experimental: Intervention
Three-stage CGM integration program
Active_comparator: Comparator A
One-time clinic-based CGM training
Active_comparator: Comparator B
Self-directed CGM training
Sponsors
Collaborators: American Diabetes Association
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov