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NCT Number: NCT05337826

The REST Study for CGM Use in 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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: the REST model

Primary outcomes

  1. The co-primary effectiveness outcomes

    Time frame: Baseline to 6 months

    Change in time spent in hypoglycemia (sensor glucose <70 mg/dL and ii) Change in individualized Time in Range goal

  2. The co-primary implementation outcomes

    Time frame: Baseline vs 6 months

    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

Secondary outcomes

  1. Visits to maintain CGM use

    Time frame: 6 months

    Total time spent and the number of remote and in-person visits needed to initiate and maintain CGM use

  2. Visits to maintain CGM use

    Time frame: Month 12

    Total time spent and the number of remote and in-person visits needed to initiate and maintain CGM use

  3. Resource utilization

    Time frame: Baseline vs 6 months

    Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations)

  4. Resource utilization

    Time frame: 6 months vs 12 months

    Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations)

  5. Time spent in hypoglycemia

    Time frame: 6 months vs 12 months

    Change in time spent in hypoglycemia ( sensor glucose <70 mg/dL)

  6. Cost effectivness

    Time frame: 6 months

    Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care

  7. Cost Effectivness

    Time frame: 12 months

    Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care

  8. Diabetes health related quality of life measures

    Time frame: Baseline vs 6 months

    Change in quality of life measures (diabetes distress, hypoglycemia fear, EQ-5D)

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Cecilia Health
  • State University of New York - Upstate Medical University

Registry information

Official study title

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

Acronym: REST

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2022
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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