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CGM in Utah Valley (CGM)

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ClinicalTrials.gov Identifier: NCT04313803
Recruitment Status : Unknown
Verified March 2020 by Intermountain Health Care, Inc..
Recruitment status was:  Not yet recruiting
First Posted : March 18, 2020
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Device: CGM

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.

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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Expanding Continuous CGM Usage to Improve Outcomes in a Shorter Duration in Utah Valley Clinics
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : April 30, 2021

Group/Cohort Intervention/treatment
American Fork
CGM usage months 1 and 3
Device: CGM
Dexcom CGM system

Central Orem
CGM usage for month 1
Device: CGM
Dexcom CGM system

North Canyon, Saratoga Springs, and Lehi
CGM usage for 1-3 months
Device: CGM
Dexcom CGM system




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. [ Time Frame: 1 April 2020 - 30 April 2021 ]
    Frequency of hypoglycemic events and healthcare utilization per count of inpatient/outpatient and emergency department visits per 1000 rate, overall and for patients with diabetes

  2. Evaluation of HEDIS performance for those using CGM compared to historical utilization and the broader T2DM cohort within Intermountain Healthcare. [ Time Frame: 1 April 2020 - 30 April 2021 ]
    Current HEDIS performance on diabetes and behavioral health measures



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with type II diabetes treated at Intermountain Healthcare
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313803


Contacts
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Contact: Elizabeth Joy, MD, MPH (801) 442-3721 liz.joy@imail.org
Contact: Brad Isaacson, PhD, MBA, MSF, PMP (801) 442-5737 brad.isaacson@imail.org

Sponsors and Collaborators
Intermountain Health Care, Inc.
DexCom, Inc.
Investigators
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Principal Investigator: Elizabeth Joy, MD, MPH Intermountain Health Care, Inc.
Study Director: Brad Isaacson, PhD, MBA, MSF, PMP Intermountain Health Care, Inc.
Publications:
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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT04313803    
Other Study ID Numbers: IHC IRB#: 1051315
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intermountain Health Care, Inc.:
Continuous glucose monitor (CGM)
diabetes
glucose
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases