Clinical trial NCT04413578: CGM - Reimagine Primary Care
Official title: Assessing the Feasibility of Continuous Glucose Monitoring in Reimagine Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Continuous Glucose Monitor (CGM)
Dexcom G6
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: To assess the impact of continuous glucose monitoring versus standard of care (e.g. a finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and cost in patients with type I or II diabetes treated within the Reimagine Primary Care clinics.

Detailed description: This is a parallel randomized controlled trial. Eligible patients who consent will be randomized to one of two groups: (1) the intervention group who will be given a Dexcom G6 for CGM, or (2) the control group who will follow their current standard finger-prick protocol via a provided Contour Next ONE glucometer. The CGM group must download the Dexcom G6 and Clarity mobile apps for data capture, whereas the standard of care group will use the Contour Next mobile app for their respective readings.

The Dexcom G6 captures real-time, dynamic glucose data every five minutes. Devices used in this study are FDA approved and commercially available.

Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus with a HbA1c ≥6.5%
* Patients that are currently managing their glucose levels for diabetes with a glucose meter (or will be prescribed one by their healthcare provider)
* Patients that are treated within the four Reimagine Primary Care clinics (Cottonwood Family Medicine, Cottonwood Senior, Avenues Internal Medicine, and Holladay Internal Medicine). • Patients 18-80 years of age

Exclusion Criteria:

* Patients that are not managing their glucose levels for diabetes (and not advised to use a glucose monitor by their physician)
* Patients that are not treated within the four Reimagine Primary Care clinics
* Patients less than 18 years of age, and 81 years of age and older
* Patients with a diagnosis of dementia
* If the patient is currently using a Continuous Glucose Monitor
* Patients with previous hospitalization for hypoglycemia within the last 18 months
* No access to a mobile phone to download the Dexcom or Contour Next applications
* Patients who are pregnant or planning to become pregnant over the course of their six-month participation

Primary outcomes:
measure: HbA1c Variation
timeFrame: 6 months
measure: HbA1c Range
timeFrame: 6 months
Secondary outcomes:
measure: Current Diabetes Standards
timeFrame: 6 months
measure: Behavioral Changes
timeFrame: 6 months
measure: Hypoglycemic Events
timeFrame: 6 months
measure: Healthcare Utilization
timeFrame: 6 months
measure: Glycemic Variability
timeFrame: 6 months
measure: Emergency Room Visits
timeFrame: 6 months
measure: Healthcare Cost
timeFrame: 6 months
Other outcomes:
Locations:
city: Holladay
country: United States
facility: Holladay Internal Medicine
state: Utah
city: Murray
country: United States
facility: Intermountain Cottonwood Family Practice
state: Utah
city: Murray
country: United States
facility: Intermountain Senior Clinic
state: Utah
city: Salt Lake City
country: United States
facility: Avenues Internal Medicine
state: Utah
Study officials:
References:
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citation: Musio M, Sauleau EA, Augustin NH. Resources allocation in healthcare for cancer: a case study using generalised additive mixed models. Geospat Health. 2012 Nov;7(1):83-9. doi: 10.4081/gh.2012.107.