Expanding Continuous CGM Usage to Improve Outcomes in a Shorter Duration in Utah Valley Clinics
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,500
- Primary Endpoint
- Cost of care for fee-for-value patients (specifically PMPM savings)
Study Overview
Brief Summary
The purpose of this study is to replicate the positive impact observed in IRB #1050955, but conduct this over a shorter period to potentially maximize patient outcomes and make care more affordable. Intermountain intends to build a diabetes program with CGM based on the findings. Senior stakeholders, clinicians and operators are aligned on this vision including the Community Based Care triad, Executive Leadership Team, and our Diabetes Prevention Program.
Detailed Description
Overview
Approximately 30 million Americans, or 9% of the population has diabetes, a condition in which a person does not make enough insulin, or the body cannot use its own to effectively manage blood glucose levels. Improper diabetes management is associated with severe comorbidities which include: heart disease, stroke, kidney disease, ocular problems, dental disease, nerve damage, and vascularity issues. The epidemic continues to challenge systems like Intermountain Healthcare, an accountable care organization (ACO), since diabetes cost $327 billion per year (representing $1 in every $7 dollars spent) on healthcare in the United States. Furthermore, people with diagnosed diabetes incur average medical expenditures of $16,752 per year, of which about $9,601 is directly attributed to diabetes. New treatment options are needed to manage population health, especially with 84 million adults having been diagnosed with prediabetes diabetes.
In an effort to reduce the physical, economic and social burden of diabetes, several healthcare systems have evaluated the use of telehealth to monitor glucose levels. In a previous metanalysis, the authors demonstrated that telehealth interventions produced a small, but significant improvement in hemoglobin A1c (HbA1c) levels compared with usual care (mean difference: -0.55, 95% CI: -0.73 to - 0.36). The Ontario Health Technology Advisory Committee also showed that the blood glucose home telemonitoring technologies they used yielded a statistically significant reduction in HbA1c of ~0.50% in comparison to usual care when used adjunctively to a broader telemedicine initiative for adults with type 2 diabetes.
1.2 Previous Work
Intermountain Healthcare conducted a pilot study in the Reimagine Primary Care (RPC) clinics to evaluate if six months of CGM could improve patient outcomes (IRB #1050955). A total of 99 patients remained enrolled for the full time period (n=50 CGM, n=49 standard of care (SOC)), and data showed a improvement in glucose levels, less primary care and specialty appointments, a reduction in emergency department (ED) encounters, less labs ordered, and a cumulative body mass index (BMI) improvement. Furthermore, nearly all participants reported being willing to engage in another future pilot, and the vast improvements were attributed to subjects use of real-time data.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients (18-80 years of age) with type ll diabetes, having an HbA1c ≥6.5%, treated within five Intermountain Healthcare Utah Valley clinics. Patients must have access to a smart phone to download applications, have Bluetooth capabilities for data sharing, and log/view their continuous glucose monitor (CGM) data.
Exclusion Criteria
- •Patients who are pregnant, not classified as having diabetes based on A1c levels, and age ≤ 17 or ≥ 81 years, or diagnosis of dementia.
Outcomes
Primary Outcomes
Cost of care for fee-for-value patients (specifically PMPM savings)
Time Frame: 1 April 2020 - 30 April 2021
For each patient, measure total variable cost of associated healthcare services and visits. Then compare the distribution of costs between randomized groups using the Wilcoxon rank-sum test, a non-parametric analogue of Student's t-test.
Secondary Outcomes
- The count of primary care, specialist, and emergency department visits or hospital stays for those using CGM compared to historical utilization and the broader T2DM cohort within Intermountain Healthcare.(1 April 2020 - 30 April 2021)
- Evaluation of HEDIS performance for those using CGM compared to historical utilization and the broader T2DM cohort within Intermountain Healthcare.(1 April 2020 - 30 April 2021)