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.
Primary analyses
Cost of care for fee-for-value patients (specifically PMPM savings)
Secondary analyses
Frequency of hypoglycemic events, healthcare utilization per count of inpatient/outpatient
visits, cost of care, current HEDIS performance on diabetes and behavioral health measures,
coding specificity for diabetes, emergency department visit per 1000 rate, overall and for
patients with diabetes.
Power analyses
Data from IRB #1050955 has shown significant changes in cost, care and utilization with only
a sample of 50 CGM users. The effect size is currently being calculated by the study
statistician, but most of the outcome variables comparing CGM to standard of care device were
p<0.05. Given that this will now include a much larger population, and 30x participant
increase, the investigators will have sufficient power to deduce differences should they
occur.