Clinical trial NCT05337826: The REST Study for CGM Use in Older Adults With Insulin-treated Diabetes
Official title: Readiness, Education, and Sustainability for CGM Technology Adoption Model for Older Adults With Insulin-treated Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: older adults
CGM
diabetes technology
telehealth
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: State University of New York - Upstate Medical University
name: Cecilia Health
First posted: 2022-04-20
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: The co-primary effectiveness outcomes
timeFrame: Baseline to 6 months
measure: The co-primary implementation outcomes
timeFrame: Baseline vs 6 months
Secondary outcomes:
measure: Visits to maintain CGM use
timeFrame: 6 months
measure: Visits to maintain CGM use
timeFrame: Month 12
measure: Resource utilization
timeFrame: Baseline vs 6 months
measure: Resource utilization
timeFrame: 6 months vs 12 months
measure: Time spent in hypoglycemia
timeFrame: 6 months vs 12 months
measure: Cost effectivness
timeFrame: 6 months
measure: Cost Effectivness
timeFrame: 12 months
measure: Diabetes health related quality of life measures
timeFrame: Baseline vs 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
References: