Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm
Not Applicable
Completed
- Conditions
- Diabetes Mellitus
- Interventions
- Device: Continuous Glucose Monitoring
- 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.
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
- Arm && Interventions
Group Intervention Description Continuous Glucose Monitoring System Continuous Glucose Monitoring 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
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
AMCR Institute
🇺🇸Escondido, California, United States
John Muir Physician Network Clinical Research
🇺🇸Concord, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States