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CGM - Reimagine Primary Care Phase 4 101

Completed
Clinical Trial NCT04413578 was designed to study Treatment for Diabetes Mellitus, Type 2. This was a Phase 4 interventional study that is now completed. The study started on 1 December 2018, with plans to enroll 101 participants. Led by Intermountain Health Care, Inc., the expected completion date was 31 December 2019. The latest data from ClinicalTrials.gov was last updated on 4 June 2020.
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 ...Show More
Official Title

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

Conditions
Diabetes Mellitus, Type 2
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 1050955
NCT ID Number
NCT04413578
Start Date (Actual)
2018-12-01
Last Update Posted
2020-06-04
Completion Date (Estimated)
2019-12-31
Enrollment (Estimated)
101
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Keywords
Continuous Glucose Monitor (CGM)
Dexcom G6
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDexcom G6 (Intervention Group)
• Intervention group: CGM using a Dexcom G6 to measure glycosylated hemoglobin levels every five minutes. Patients will be asked to download the Dexcom G6 and Clarity applications (to have access to their real-time data) and be given a link to complete an exit survey in REDCap near the end of their study participation. Data will be sent via Bluetooth and then exported by the Intermountain research team into a Tableau...Show More
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.
Placebo ComparatorContour NextOne (Standard of Care) Glucometer
• Control group: A standard finger-prick protocol that will require patients to continue with their daily fingerprick regimen established by their physician. This group will be given a Contour Next One meter to ensure that each patient is receiving the same level of accuracy by the same device. A review by Ekhlaspour et al of 17 glucose meters demonstrated wide variability, with only two devices achieving the 2013 IS...Show More
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
HbA1c Variation
Coefficient of variation in HbA1c levels before, during and end of study completion.
6 months
HbA1c Range
Variation of range in HbA1c levels before, during and end of study completion.
6 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Current Diabetes Standards
Current HEDIS performance on diabetes and behavioral health measures.
6 months
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
Hypoglycemic Events
Frequency of hypoglycemic events during the study.
6 months
Healthcare Utilization
Healthcare utilization per count of inpatient/outpatient visits.
6 months
Glycemic Variability
Glycemic variability per mean amplitude of glycemic excursion (MAGE)
6 months
Emergency Room Visits
Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to.
6 months
Healthcare Cost
Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc.
6 months
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
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4 Study Locations in 1 Countries

Utah

Holladay Internal Medicine, Holladay, Utah, 84121, United States
Intermountain Cottonwood Family Practice, Murray, Utah, 84107, United States
Intermountain Senior Clinic, Murray, Utah, 84107, United States
Avenues Internal Medicine, Salt Lake City, Utah, 84103, United States