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

NCT05337826 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY00000174
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus

Keywords

older adults; CGM; diabetes technology; telehealth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Visits to maintain CGM use

  6 months

• Visits to maintain CGM use

  Month 12

• Resource utilization

  Baseline vs 6 months

• Resource utilization

  6 months vs 12 months

• Time spent in hypoglycemia

  6 months vs 12 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Device: Continuous Glucose Monitor

Interventions

Continuous Glucose Monitor DEVICE

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.

Also known as: the REST model

Single Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Cecilia Health: collaborator
• State University of New York - Upstate Medical University: collaborator

Study Sites (2)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 20, 2022
• Study Start: April 20, 2022
• Primary Completion: November 11, 2025
• Study Completion: May 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Start 6 months after publication and end 5 years after publication
• 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.

Locations

US (2)