NCT05337826

The REST Study for CGM Use in Older Adults With Insulin-treated Diabetes

Readiness, Education, and Sustainability for CGM Technology Adoption Model for Older Adults With Insulin-treated Diabetes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Joslin Diabetes Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of the REST model in facilitating adoption and sustained use of CGM, in older adults with Type 1 diabetes (T1D) or Type 2 Diabetes (T2D) on complex insulin regimens. To examine barriers and enablers for the implementation feasibility of the REST intervention model using a mixed-methods approach. To assess the impact of REST model on economic factors and quality of life measures. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model.

Detailed description

Older adults with diabetes on multiple insulin injections are at greater risk of hypoglycemia and its poor outcomes. Use of continuous glucose monitoring (CGM) has shown to improve glycemic control and reduce hypoglycemia in this age group. Despite Medicare coverage for CGM, uptake in this age group is still low. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model. This model will assess Readiness and barriers to CGM initiation and utilization, provide remote Education, and implement a framework for Sustainability of CGM Technology adoption. The study will assess the impact of the REST model and its ability to increase CGM uptake and use in this age group, as well as its effectiveness on improving glycemic metrics. The study will also evaluate the impact of the REST model on economic and health-related quality-of-life measures.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitor	Participants will enroll in a series of remote educational visits conducted by CDCES to assess readiness and barriers to CGM initiation and utilization, with the goal to sustain use of CGM Technology over time in older populations on complex insulin regimen.

Timeline

• Start date: 2022-04-20
• Primary completion: 2025-11-11
• Completion: 2026-05-01
• First posted: 2022-04-20
• Last updated: 2026-04-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study