CGM - Reimagine Primary Care

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Assessing the Feasibility of Continuous Glucose Monitoring in Reimagine Primary Care Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413578
• Other study ID #: 1050955
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 31, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• Dexcom G6
Continuous Glucose Monitor that, after applied, sends continuous glucose readings to to the patient's smartphone every 5 minutes. This allows the patients to receive more readings over a 24 hour period versus standard of care glucometer finger sticks.
• Contour NextOne
A Standard of Care Glucometer with Bluetooth capability. The patient inserts a test strip into the device, takes a finger stick and collects a small blood sample on the tip of the strip to initiate the device to detect a glucose reading.

Locations

Country	Name	City	State
United States	Holladay Internal Medicine	Holladay	Utah
United States	Intermountain Cottonwood Family Practice	Murray	Utah
United States	Intermountain Senior Clinic	Murray	Utah
United States	Avenues Internal Medicine	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

Ekhlaspour L, Mondesir D, Lautsch N, Balliro C, Hillard M, Magyar K, Radocchia LG, Esmaeili A, Sinha M, Russell SJ. Comparative Accuracy of 17 Point-of-Care Glucose Meters. J Diabetes Sci Technol. 2017 May;11(3):558-566. doi: 10.1177/1932296816672237. Epu — View Citation

Fong Y, Rue H, Wakefield J. Bayesian inference for generalized linear mixed models. Biostatistics. 2010 Jul;11(3):397-412. doi: 10.1093/biostatistics/kxp053. Epub 2009 Dec 4. — View Citation

Lee PA, Greenfield G, Pappas Y. The impact of telehealth remote patient monitoring on glycemic control in type 2 diabetes: a systematic review and meta-analysis of systematic reviews of randomised controlled trials. BMC Health Serv Res. 2018 Jun 26;18(1): — View Citation

Medical Advisory Secretariat. Home telemonitoring for type 2 diabetes: an evidence-based analysis. Ont Health Technol Assess Ser. 2009;9(24):1-38. Epub 2009 Oct 1. — View 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. — View Citation

Verkuilen J. Explanatory Item Response Models: A Generalized Linear and Nonlinear Approach by P. de Boeck and M. Wilson and Generalized Latent Variable Modeling: Multilevel, Longitudinal and Structural Equation Models by A. Skrondal and S. Rabe-Hesketh. P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Variation	Coefficient of variation in HbA1c levels before, during and end of study completion.	6 months
Primary	HbA1c Range	Variation of range in HbA1c levels before, during and end of study completion.	6 months
Secondary	Current Diabetes Standards	Current HEDIS performance on diabetes and behavioral health measures.	6 months
Secondary	Behavioral Changes	Subjects will complete a self reported survey related to behavioral changes at end of study to assess self empowered behavioral changes after using the devices (e.g. feeling more empowered to self-manage care, engaged with changing healthcare behaviors, and patient perceptions of the technology).	6 months
Secondary	Hypoglycemic Events	Frequency of hypoglycemic events during the study.	6 months
Secondary	Healthcare Utilization	Healthcare utilization per count of inpatient/outpatient visits.	6 months
Secondary	Glycemic Variability	Glycemic variability per mean amplitude of glycemic excursion (MAGE)	6 months
Secondary	Emergency Room Visits	Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to.	6 months
Secondary	Healthcare Cost	Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc.	6 months

External Links

•   Diabetes and glucose information
•   Preventing prediabetes
•   What is Diabetes