NCT02087995

Brief Summary

To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

August 24, 2017

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

February 3, 2014

Results QC Date

August 4, 2015

Last Update Submit

July 25, 2017

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.

    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

Study Arms (1)

Continuous Glucose Monitoring System

EXPERIMENTAL

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

Interventions

Continuous Glucose MonitoringDEVICE

A prescribed clinic session day for participating subjects.

Also known as: CGM System, G4 Platinum CGM System, Dexcom G4 CGM System
Continuous Glucose Monitoring System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

John Muir Physician Network Clinical Research

Concord, California, 94520, United States

Location

AMCR Institute

Escondido, California, 92026, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Related Publications (1)

  • Peyser TA, Nakamura K, Price D, Bohnett LC, Hirsch IB, Balo A. Hypoglycemic Accuracy and Improved Low Glucose Alerts of the Latest Dexcom G4 Platinum Continuous Glucose Monitoring System. Diabetes Technol Ther. 2015 Aug;17(8):548-54. doi: 10.1089/dia.2014.0415. Epub 2015 May 11.

    PMID: 25961446DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Results Point of Contact

Title
Andrew Balo/ EVP
Organization
Dexcom, Inc
abalo@dexcom.com
8582000203

Study Officials

  • Andy Balo

    DexCom, Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2014

First Posted

March 14, 2014

Study Start

December 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 24, 2017

Results First Posted

August 24, 2017

Record last verified: 2015-08

Locations

US(3)