CEP249 Pediatric Accuracy Study

Medtronic

Status: Completed

Conditions: Insulin Requiring Diabetes

Treatments: Device: Enlite sensors

Study type: Interventional

Funder types: Industry

Identifiers

NCT01991470

CEP249

Details and patient eligibility

About

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.

Full description

This study is a prospective, single arm, multi-center, in-clinic study.. There will be two consecutive phases of the study:

A total of up to 260 subjects (2-18 years old) will be enrolled at up to 15 investigational centers

Subjects will come for clinic visit for YSI reference glucose testing and for Enlite Sensor™ and Enlite 3 Sensor™ testing. SMBG (Self-Monitoring of Blood Glucose) reference measurement is for subjects 2-6 years of age and cannot tolerate YSI.

Study has a run-in period and a study period with a total of 10 visits

Enrollment: 186 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is 2-18 years of age at time of screening
2. Subject has been diagnosed with insulin requiring diabetes mellitus for at least one year.
3. Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily
4. Subject is willing to perform required sensor calibrations
5. Subject is willing to wear the system (Guardian Mobile application, pumps, sensors, meter) continuously throughout the study
6. Adequate venous access as assessed by investigator or appropriate staff

Exclusion criteria

1. Subject is unable to tolerate tape adhesive in the area of sensor placement
2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
3. 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
4. Females of child-bearing potential who have a positive pregnancy test at screening or plans to become pregnant during the course of the study
5. Subjects with hematocrit lower than the normal age specific reference range per central or local lab testing

Trial design

186 participants in 1 patient group

Enlite sensors

Experimental group

Description:

Each subject will first wear enlite sensors and will come for clinic visit for YSI (Yellow Spring Instruments). Then each subject will wear enlite 3 sensors and will come for clinic visit for YSI (Yellow Spring Instruments) or SMBG (Self-Monitoring of Blood Glucose) testing. SMBG testings are for subjects 2-6 years of age and cannot tolerate YSI. In addition. In addition, subjects aged 2-6 years old will not participate in Enlite phase. They only participate in Enlite 3 phase.

Treatment:

Device: Enlite sensors