Clinical trial NCT01991470: CEP249 Pediatric Accuracy Study
Official title: A Performance Evaluation of the Enlite™ and Enlite 3 Glucose Sensor to Support Use in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Requiring Diabetes
Keywords: Insulin requiring diabetes
Children
Sensor
Accuracy
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 186
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump
timeFrame: 6 days
measure: Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System
timeFrame: 7 days
Secondary outcomes:
measure: Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter
timeFrame: 7 days
measure: Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump
timeFrame: 6 Days
measure: Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST
timeFrame: 6 Days
measure: Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST
timeFrame: 6 Days
measure: Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST
timeFrame: 7 Days
measure: Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST
timeFrame: 7 Days
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Torrance
country: United States
facility: SoCal Diabetes
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: New Haven
country: United States
facility: Yale University, Yale Diabetes Research Program
state: Connecticut
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Atlanta
country: United States
facility: "Atlanta Diabetes Associates
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University, Riley Hospital for Children
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Children Hospital
state: Iowa
city: Oklahoma City
country: United States
facility: OUHSC Department of Pediatrics
state: Oklahoma
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Rainier Clinical Research Center
name: Ronald Brazg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OUHSC Department of Pediatrics
name: Jeanie Tryggestad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University, Riley Hospital for Children
name: Linda DiMeglio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nemours Children's Clinic
name: Larry Fox, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University, Yale Diabetes Research Program
name: Jennifer Sherr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barbara Davis Center
name: Robert Slover, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa Children Hospital
name: Eva Tsalikian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Diabetes Associates
name: Bruce Bode, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SoCal Diabetes
name: Kevin Kaiserman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diablo Clinical Research
name: Mark Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Slover RH, Tryggestad JB, DiMeglio LA, Fox LA, Bode BW, Bailey TS, Brazg R, Christiansen MP, Sherr JL, Tsalikian E, Kaiserman KB, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2018 Sep;20(9):576-584. doi: 10.1089/dia.2018.0109. Epub 2018 Jul 31.