CGM Integration Program for Diabetes

(INSIDE-CGM Trial)

Overseen By Angela Fruik, MPH, RD, LDN

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must be taking: Insulin

Disqualifiers: Dementia, Extreme visual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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 A) will receive a one-time clinic-based CGM training. The second comparator (Comparator B) 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. Lastly, an extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention.

Who Is on the Research Team?

Anna Kahkoska, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

Inclusion Criteria

I am willing to use a smartphone app to check my glucose readings.

I am 65 years old or older.

* 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 residing within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Data Collection

Baseline data collection occurs before randomization

1 week

1 visit (in-person)

Treatment

Participants are randomized to intervention or comparator arms for CGM training over 6 weeks

6 weeks

3 visits (1 in-person, 2 virtual for intervention group); 1 visit (in-person for Comparator A); self-directed for Comparator B

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Extension

Long-term evaluation of CGM use and outcomes at 3 and 6 months post-intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• One-time clinic-based CGM training
• Self-directed CGM training
• Three-stage CGM integration program

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Three-stage CGM integration program

Group II: Comparator B Active Control 1 Intervention

Self-directed CGM training

Group III: Comparator A Active Control 1 Intervention

One-time clinic-based CGM training

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+