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| Name | Class |
|---|---|
| State University of New York - Upstate Medical University | OTHER |
| Cecilia Health | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Visits to maintain CGM use | Total time spent and the number of remote and in-person visits needed to initiate and maintain CGM use |
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Inclusion Criteria:
CGM metrics):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States | ||
| SUNY Upstate Medical University |
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.
Start 6 months after publication and end 5 years after publication
Proposals should be directed to elena.toschi@joslin.harvard.edu. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Month 12 |
| Resource utilization | Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations) | Baseline vs 6 months |
| Resource utilization | Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations) | 6 months vs 12 months |
| Time spent in hypoglycemia | Change in time spent in hypoglycemia ( sensor glucose <70 mg/dL) | 6 months vs 12 months |
| Cost effectivness | Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care | 6 months |
| Cost Effectivness | Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care | 12 months |
| Diabetes health related quality of life measures | Change in quality of life measures (diabetes distress, hypoglycemia fear, EQ-5D) | Baseline vs 6 months |
| Syracuse |
| New York |
| 13210 |
| United States |