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

Completed · Not applicable

Conditions studied: Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT02087995

Run by

DexCom, Inc.

People needed

51

Starts

2013-12-01

Expected to finish

2014-03-01

Last updated by the study team

2017-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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