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

Diabetes Mellitus Clinical Trial

— REST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337826
• Other study ID #: STUDY00000174
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (3)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Cecilia Health, State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Resource utilization	Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations)	Baseline vs 6 months
Secondary	Resource utilization	Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations)	6 months vs 12 months
Secondary	Time spent in hypoglycemia	Change in time spent in hypoglycemia ( sensor glucose <70 mg/dL)	6 months vs 12 months
Secondary	Cost effectivness	Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care	6 months
Secondary	Cost Effectivness	Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care	12 months
Secondary	Diabetes health related quality of life measures	Change in quality of life measures (diabetes distress, hypoglycemia fear, EQ-5D)	Baseline vs 6 months