This trial has been completed.

Condition insulin requiring diabetes
Treatment sensor
Sponsor Medtronic Diabetes
Start date March 2015
End date December 2016
Trial size 191 participants
Trial identifier NCT01991470, CEP249


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Each subject will wear enlite and / or enlite 3 sensors and will undergo 1 or 2 frequent sample tests, in-clinic
Subject wears both enlite and enlite 3 sensors

Primary Outcomes

Sensor accuracy with minimum calibrations
time frame: 6 days/7days

Eligibility Criteria

Male or female participants from 2 years up to 18 years old.

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

Additional Information

Official title A Performance Evaluation of the Enlite™ and Enlite 3 Glucose Sensor to Support Use in Children
Principal investigator Ronald Brazg, MD
Description This study is a prospective, single arm, multi-center, in-clinic study with one treatment group assignment. There will be two consecutive phases of the study: A total of up to 260 subjects will be enrolled at up to 15 investigational centers Subjects will come for clinic visit for YSI testing Study has a run-in period and a study period with a total of 10 visits
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Medtronic Diabetes.