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OpenTrials
Completed

NCT Number: NCT04413578

CGM - Reimagine Primary Care

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Holladay Internal Medicine, Holladay, Utah, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexcom G6

Device

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

Device

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.

Primary outcomes

  1. HbA1c Variation

    Time frame: 6 months

    Coefficient of variation in HbA1c levels before, during and end of study completion.

  2. HbA1c Range

    Time frame: 6 months

    Variation of range in HbA1c levels before, during and end of study completion.

Secondary outcomes

  1. Current Diabetes Standards

    Time frame: 6 months

    Current HEDIS performance on diabetes and behavioral health measures.

  2. Behavioral Changes

    Time frame: 6 months

    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).

  3. Hypoglycemic Events

    Time frame: 6 months

    Frequency of hypoglycemic events during the study.

  4. Healthcare Utilization

    Time frame: 6 months

    Healthcare utilization per count of inpatient/outpatient visits.

  5. Glycemic Variability

    Time frame: 6 months

    Glycemic variability per mean amplitude of glycemic excursion (MAGE)

  6. Emergency Room Visits

    Time frame: 6 months

    Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to.

  7. Healthcare Cost

    Time frame: 6 months

    Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc.

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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