- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04413578
CGM - Reimagine Primary Care
Assessing the Feasibility of Continuous Glucose Monitoring in Reimagine Primary Care Clinics
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Utah
-
Holladay, Utah, United States, 84121
- Holladay Internal Medicine
-
Murray, Utah, United States, 84107
- Intermountain Cottonwood Family Practice
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Murray, Utah, United States, 84107
- Intermountain Senior Clinic
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Salt Lake City, Utah, United States, 84103
- Avenues Internal Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dexcom 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 (or similar) dashboard for data analysis/comparison
|
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 Comparator: Contour 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 ISO standard (with the most accurate being the Contour Next).
Patients in the control group will be asked to download the Contour Next application which will send data via Bluetooth similar to above.
Data will be aggregated, and protected health information removed prior to analysis (by Intermountain Healthcare and Savvysherpa).
At the end of the study, patients will be asked to complete a short survey in REDCap about their willingness to participate in future studies.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c Variation
Time Frame: 6 months
|
Coefficient of variation in HbA1c levels before, during and end of study completion.
|
6 months
|
HbA1c Range
Time Frame: 6 months
|
Variation of range in HbA1c levels before, during and end of study completion.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Current Diabetes Standards
Time Frame: 6 months
|
Current HEDIS performance on diabetes and behavioral health measures.
|
6 months
|
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).
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6 months
|
Hypoglycemic Events
Time Frame: 6 months
|
Frequency of hypoglycemic events during the study.
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6 months
|
Healthcare Utilization
Time Frame: 6 months
|
Healthcare utilization per count of inpatient/outpatient visits.
|
6 months
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Glycemic Variability
Time Frame: 6 months
|
Glycemic variability per mean amplitude of glycemic excursion (MAGE)
|
6 months
|
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.
|
6 months
|
Healthcare Cost
Time Frame: 6 months
|
Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc.
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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):495. doi: 10.1186/s12913-018-3274-8.
- 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.
- 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. Epub 2016 Oct 3.
- 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. Psychometrika. 2006 Jun;71(2):415-418. doi: 10.1007/s11336-005-1333-7. No abstract available.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1050955
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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