- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02087995
Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm
July 25, 2017 updated by: DexCom, Inc.
To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A study to evaluate the performance of a modification to the G4 Platinum CGM system in adults with diabetes.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Concord, California, United States, 94520
- John Muir Physician Network Clinical Research
-
Escondido, California, United States, 92026
- AMCR Institute
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Walnut Creek, California, United States, 94598
- Diablo Clinical Research, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 18 years or older
- Diagnosis of Type 1 diabetes or Type 2 diabetes on Intensive Insulin Therapy (ITT)
- Willing to participate in a clinic session
Exclusion Criteria:
- Use of Acetaminophen during study period
- Pregnancy
- Hematocrit (HCT) <35% (females) and 38% (males)
- Dialysis, history of cardiovascular disease, epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia within the last 6 months.
- Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose and excessive risk to study staff.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous Glucose Monitoring System
Single-Arm, CGM Device Glucose challenge performed during a clinic session to obtain accuracy data for the CGM system compared to a venous reference measurement
|
A prescribed clinic session day for participating subjects.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.
Time Frame: 7-day wear period
|
The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels > 80 mg/dL or within 20 mg/dL at the reference glucose levels < 80 mg/dL.
|
7-day wear period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Andy Balo, DexCom, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
February 3, 2014
First Submitted That Met QC Criteria
March 12, 2014
First Posted (Estimate)
March 14, 2014
Study Record Updates
Last Update Posted (Actual)
August 24, 2017
Last Update Submitted That Met QC Criteria
July 25, 2017
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTL901100
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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