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INSIDE-CGMOlder Adults Diabetes Management with CGM Integration Program

Study Aim

This study aims to help older adults manage their diabetes by integrating a Continuous Glucose Monitoring (CGMs) system, with the main objectives being to observe if participants are using the CGM at the 6-week mark and to calculate the percentage of time the CGM is in use during the 6-week intervention period.

What is being tested

Three-stage CGM integration program

+ One-time clinic-based CGM training

+ Self-directed CGM training

Behavioral

Who is being recruted

Autoimmune Diseases+6

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

Over 65 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2026

See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill

Study ContactMarcy Menard, MS, RD, LDN, CDCESMore contacts

Last updated: March 12, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on older adults with diabetes who use insulin. It aims to evaluate the effectiveness of a special program that helps integrate a continuous glucose monitor (CGM) into their daily routine. A CGM is a device that tracks blood sugar levels throughout the day and night. The study compares this program to two usual care methods: a one-time clinic-based CGM training and a self-directed CGM training. The goal is to improve the safety and quality of life for older adults with diabetes by helping them better understand and manage their blood sugar levels. Participants in this study will receive a CGM and will be divided into three groups. One group will attend three training sessions, with the first being in-person and the rest being virtual. These sessions will teach them how to use the CGM and interpret its data. The second group will receive a one-hour training at a clinic, while the third group will get a pamphlet and online resources for self-training. All participants will be encouraged to consult their usual diabetes care team for any questions or issues. At the end of the 6-week study, all participants will provide data on how often and how long they used the CGM. Additionally, the study will assess patient-reported outcomes and glycemic metrics to understand the impact of the CGM program.

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

NCT07463209

Principal SponsorUniversity of North Carolina, Chapel Hill

Study ContactMarcy Menard, MS, RD, LDN, CDCESMore contacts

Last updated: March 12, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 inclusion criteria required to participate

Adults 65 years and older at time of consent

Using any insulin

Fluent in English

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

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5 exclusion criteria prevent from participating

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)

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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants in this group will attend three sessions over four weeks to learn how to use a Continuous Glucose Monitor (CGM). They will receive technical training, understand CGM data, and learn strategies to improve safety and quality of life using CGM.

Group II

Active Comparator

Participants in this group get a one-hour training session with a clinic educator on using Continuous Glucose Monitoring (CGM) on the first day of the trial. They will receive basic CGM training and are advised to consult their regular diabetes care team for any questions or issues during the 6-week trial period.

Group III

Active Comparator

Participants in this group receive a comprehensive informational pamphlet about Continuous Glucose Monitoring (CGM) and a list of online resources for self-training. They are advised to follow up with their usual diabetes care team for any questions or issues during the 6-week trial period.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of North Carolina at Chapel Hill

Chapel Hill, United StatesOpen University of North Carolina at Chapel Hill in Google Maps

Recruiting soonOne Study Center