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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Continuous Glucose Monitor

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Older adults age ≥65 years
• T1D or T2D with duration longer than 1 year
• Insulin treatment includes: ≥3 insulin injections/day or on insulin pump therapy
• CGM naïve and/or CGM users (Dexcom G6) who are not meeting glycemic goals (per

CGM metrics):

• ≥4% hypoglycemia (sensor glucose ≤70 mg/dL) or
• time in range (70-180 mg/dL) TIR ≤40 %
• Willing to wear CGM Dexcom at all times while in the study
• Willing to use/carry personal or loaned smart phone device to use as Dexcom receiver for continual data upload to cloud

Exclusion Criteria:

• Life expectancy <1 year
• End-stage renal disease (eGFR< 30ml/min)
• On acetaminophen >4 gr/day due to interference with Dexcom G6 sensor readings
• On hydroxyurea therapy due to interference with Dexcom G6 sensor readings
• Impaired vision and hearing which would interfere with participation in remote video visits
• Use of hybrid closed-loop systems (this may require different and additional focused education and will not be addressed in this study).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	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.; Other Names: the REST model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The co-primary effectiveness outcomes	Change in time spent in hypoglycemia (sensor glucose <70 mg/dL and ii) Change in individualized Time in Range goal	Baseline to 6 months
The co-primary implementation outcomes	Change in adoption of CGM by remote education (change in number of CGM users and ii) change in number of hours of CGM use per week	Baseline vs 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visits to maintain CGM use	Total time spent and the number of remote and in-person visits needed to initiate and maintain CGM use	6 months
Visits to maintain CGM use	Total time spent and the number of remote and in-person visits needed to initiate and maintain CGM use	Month 12
Resource utilization	Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations)	Baseline vs 6 months
Resource utilization	Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations)	6 months vs 12 months
Time spent in hypoglycemia	Change in time spent in hypoglycemia ( sensor glucose <70 mg/dL)	6 months vs 12 months
Cost effectivness	Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care	6 months
Cost Effectivness	Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care	12 months
Diabetes health related quality of life measures	Change in quality of life measures (diabetes distress, hypoglycemia fear, EQ-5D)	Baseline vs 6 months

Collaborators and Investigators

• Sponsor: Joslin Diabetes Center
• Collaborators: State University of New York - Upstate Medical University; Cecilia Health

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): November 11, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: older adults; CGM; telehealth; diabetes technology
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: STUDY00000174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared to Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal.
• IPD Sharing Time Frame: Start 6 months after publication and end 5 years after publication
• IPD Sharing Access Criteria: Proposals should be directed to elena.toschi@joslin.harvard.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes