N/A
Completed N=66
A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China
Source: ClinicalTrials.gov NCT03417466 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values) — 85.74 percentage of paired readings
Summary
The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values) |
85.74 | — |
| SECONDARY Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD) |
10.11 | — |
| SECONDARY Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values |
98.4 | — |
| SECONDARY Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values |
99.4 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is 14 - 75 years of age at time of screening
- Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Subject has adequate venous access as assessed by investigator or appropriate staff
- Subject is willing to follow the study procedures and willing to come to study visits.
- Subject is willing to perform at least 4 self-monitoring of blood glucose (SMBG) per day for 6 days
Exclusion Criteria
- Subject will not tolerate tape adhesive in the area of Enlite Sensor placement as assessed by qualified individual.
- Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- Subject is female and has a positive pregnancy screening test
- Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
- Subject is female and plans to become pregnant during the course of the study
- Subject has a hematocrit (Hct) lower than the normal reference range
- Subject may not be on the research staff of those performing this study
Data sourced from ClinicalTrials.gov (NCT03417466). 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.