Integrating New Skills Into Diabetes Education With CGM

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 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.

Conditions

• Insulin Dependent Diabetes
• Diabetes (DM)
• Diabetes (Insulin-requiring, Type 1 or Type 2)
• Diabetes Education
• Diabetes Care
• Type 1 Diabetes (T1D)
• Type 2 Diabetes Mellitus (T2DM)

Interventions

BEHAVIORAL

Three-stage CGM integration program

Participants 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.

BEHAVIORAL

One-time clinic-based CGM training

Participants 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.

BEHAVIORAL

Self-directed CGM training

Participants 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.

Sponsors & Collaborators

• American Diabetes Association

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Anna Kahkoska, MD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2028-01-31

Completion

2028-06-30

Countries

• United States

Study Locations