Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT02087995
• Lead Sponsor: DexCom, Inc.

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.

Detailed Description

A study to evaluate the performance of a modification to the G4 Platinum CGM system in adults with diabetes.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-02-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Status Verified: 2015-08
• Results First Submitted: 2015-08-04
• Results First Submitted QC: 2017-07-25
• Last Update Submitted: 2017-07-25
• Results First Posted: 2017-08-24
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (3)

John Muir Physician Network Clinical Research; 🇺🇸 Concord, California, United States

AMCR Institute; 🇺🇸 Escondido, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States