CEP249 Pediatric Accuracy Study



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:2 - 18
Updated:9/29/2018
Start Date:March 2015
End Date:December 2016

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A Performance Evaluation of the Enlite™ and Enlite 3 Glucose Sensor to Support Use in Children

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.

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

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
We found this trial at
11
sites
166
mi
from 43215
Indianapolis, IN
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
671
mi
from 43215
Jacksonville, FL
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Atlanta, Georgia 30309
432
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from 43215
Atlanta, GA
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Aurora, Colorado 80010
1155
mi
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Aurora, CO
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Escondido, California 92026
1935
mi
from 43215
Escondido, CA
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Iowa City, Iowa 52242
460
mi
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Iowa City, IA
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537
mi
from 43215
New Haven, CT
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Oklahoma City, Oklahoma 73104
848
mi
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Oklahoma City, OK
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Renton, Washington 98057
2000
mi
from 43215
Renton, WA
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Torrance, California 90505
1984
mi
from 43215
Torrance, CA
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Walnut creek, California 94598
2083
mi
from 43215
Walnut creek, CA
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