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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05337826
Study type Interventional
Source Joslin Diabetes Center
Contact
Status Recruiting
Phase N/A
Start date April 20, 2022
Completion date May 2025

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