N/A
Completed N=51
Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm
Source: ClinicalTrials.gov NCT02087995 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement. — 93 Units analyzed% matched pairs w/i %20/20
Summary
To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement. |
93 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02087995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.