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

  • United States
    • California
      • Concord, California, United States, 94520
        • John Muir Physician Network Clinical Research
      • Escondido, California, United States, 92026
        • AMCR Institute
      • 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
Device: Continuous Glucose Monitoring
A prescribed clinic session day for participating subjects.
Other Names:
  • CGM System
  • Dexcom G4 CGM System
  • G4 Platinum CGM System

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

DexCom, Inc.

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.

General Publications

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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