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

Not Applicable

Active, not recruiting

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.

Recruitment & 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).

Arm && Interventions

Group	Intervention	Description
Single Arm	Continuous Glucose Monitor	-

Primary Outcome Measures

Name	Time	Method
The co-primary effectiveness outcomes	Baseline to 6 months	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	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 Outcome Measures

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

Locations (2): Joslin Diabetes Center
🇺🇸
Boston, Massachusetts, United States
SUNY Upstate Medical University
🇺🇸
Syracuse, New York, United States