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

Primary Purpose

Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitor
Sponsored by
Joslin Diabetes Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring older adults, CGM, diabetes technology, telehealth

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Joslin Diabetes CenterRecruiting
  • SUNY Upstate Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
April 5, 2022
Last Updated
October 5, 2023
Sponsor
Joslin Diabetes Center
Collaborators
State University of New York - Upstate Medical University, Cecilia Health
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1. Study Identification

Unique Protocol Identification Number
NCT05337826
Brief Title
The REST Study for CGM Use in Older Adults With Insulin-treated Diabetes
Acronym
REST
Official Title
Readiness, Education, and Sustainability for CGM Technology Adoption Model for Older Adults With Insulin-treated Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joslin Diabetes Center
Collaborators
State University of New York - Upstate Medical University, Cecilia Health

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
older adults, CGM, diabetes technology, telehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitor
Other Intervention Name(s)
the REST model
Intervention Description
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.
Primary Outcome Measure Information:
Title
The co-primary effectiveness outcomes
Description
Change in time spent in hypoglycemia (sensor glucose <70 mg/dL and ii) Change in individualized Time in Range goal
Time Frame
Baseline to 6 months
Title
The co-primary implementation outcomes
Description
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
Time Frame
Baseline vs 6 months
Secondary Outcome Measure Information:
Title
Visits to maintain CGM use
Description
Total time spent and the number of remote and in-person visits needed to initiate and maintain CGM use
Time Frame
6 months
Title
Visits to maintain CGM use
Description
Total time spent and the number of remote and in-person visits needed to initiate and maintain CGM use
Time Frame
Month 12
Title
Resource utilization
Description
Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations)
Time Frame
Baseline vs 6 months
Title
Resource utilization
Description
Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations)
Time Frame
6 months vs 12 months
Title
Time spent in hypoglycemia
Description
Change in time spent in hypoglycemia ( sensor glucose <70 mg/dL)
Time Frame
6 months vs 12 months
Title
Cost effectivness
Description
Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care
Time Frame
6 months
Title
Cost Effectivness
Description
Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care
Time Frame
12 months
Title
Diabetes health related quality of life measures
Description
Change in quality of life measures (diabetes distress, hypoglycemia fear, EQ-5D)
Time Frame
Baseline vs 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Toschi, MD
Phone
617-309-4648
Email
Elena.Toschi@joslin.harvard.edu
First Name & Middle Initial & Last Name & Degree
Christine Slyne
Phone
617-309-4683
Email
christine.slyne@joslin.harvard.edu
First Name & Middle Initial & Last Name & Degree
Elena Toschi, MD
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Weinstock, MD
Phone
315-464-5726
Email
weinstor@upstate.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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