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OpenTrials
Completed

NCT Number: NCT02087995

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Muir Physician Network Clinical Research, Concord, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous glucose monitoring

Device

A prescribed clinic session day for participating subjects.

Other names: CGM System, G4 Platinum CGM System, Dexcom G4 CGM System

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.

    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.

Sponsors and collaborators

Lead sponsor

DexCom, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2014
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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