CEP249 Pediatric Accuracy Study

Completed · Not applicable

Conditions studied: Insulin Requiring Diabetes

In brief

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.

Key facts

Study ID

NCT01991470

Run by

Medtronic MiniMed, Inc.

People needed

186

Starts

2015-03-01

Expected to finish

2016-12-01

Last updated by the study team

2018-09-27

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AMCR Institute — Escondido, California, United States
• SoCal Diabetes — Torrance, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Barbara Davis Center — Aurora, Colorado, United States
• Yale University, Yale Diabetes Research Program — New Haven, Connecticut, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• "Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Indiana University, Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Iowa Children Hospital — Iowa City, Iowa, United States
• OUHSC Department of Pediatrics — Oklahoma City, Oklahoma, United States
• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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