N/A
Completed N=161
CEP249 Pediatric Accuracy Study
Insulin Requiring Diabetes
Source: ClinicalTrials.gov NCT01991470 ↗
Enrolled (actual)
161
Serious AEs
0.9%
Results posted
Sep 2018
Primary outcomePrimary: Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump — 15.02 percentage of difference
Summary
The purpose of this study is to evaluate the Enlite Sensor™ and Enlite 3 Sensor performance in pediatric patients with insulin requiring diabetes at the beginning, middle and end of sensor wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump |
15.02 | — |
| PRIMARY Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System |
10.88 | — |
| SECONDARY Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter |
11.08 | — |
| SECONDARY Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump |
17.50 | — |
| SECONDARY Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST |
14.37 | — |
| SECONDARY Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST |
16.94 | — |
| SECONDARY Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST |
10.05 | — |
| SECONDARY Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST |
10.85 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is 2-18 years of age at time of screening
- Subject has been diagnosed with insulin requiring diabetes mellitus for at least one year.
- Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily
- Subject is willing to perform required sensor calibrations
- Subject is willing to wear the system (Guardian Mobile application, pumps, sensors, meter) continuously throughout the study
- Adequate venous access as assessed by investigator or appropriate staff
Exclusion Criteria
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor 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
- Females of child-bearing potential who have a positive pregnancy test at screening or plans to become pregnant during the course of the study
- Subjects with hematocrit lower than the normal age specific reference range per central or local lab testing
Data sourced from ClinicalTrials.gov (NCT01991470). 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.