Diabetes Mellitus
Conditions
Keywords
older adults, CGM, diabetes technology, telehealth
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.
Interventions
DEVICEContinuous 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.
Sponsors
Joslin Diabetes Center
State University of New York - Upstate Medical University
Cecilia Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Visits to maintain CGM use | 6 months | Total time spent and the number of remote and in-person visits needed to initiate and maintain CGM use |
| Resource utilization | Baseline vs 6 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) |
| Cost effectivness | 6 months | Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care |
| Cost Effectivness | 12 months | Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care |
| Diabetes health related quality of life measures | Baseline vs 6 months | Change in quality of life measures (diabetes distress, hypoglycemia fear, EQ-5D) |
Countries
United States
Outcome results
None listed