CEP249 Pediatric Accuracy Study

NCT ID: NCT01991470

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-12-31

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

Conditions

Insulin Requiring Diabetes

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enlite sensors

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.

Group Type: EXPERIMENTAL

Enlite sensors

Intervention Type: DEVICE

Subject wears enlite sensor first and followed by enlite 3 sensor.

Interventions

Enlite sensors

Subject wears enlite sensor first and followed by enlite 3 sensor.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Brazg, MD

Role: PRINCIPAL_INVESTIGATOR

Rainier Clinical Research Center

Timothy Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute

Jeanie Tryggestad, MD

Role: PRINCIPAL_INVESTIGATOR

OUHSC Department of Pediatrics

Linda DiMeglio, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University, Riley Hospital for Children

Larry Fox, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Clinic

Jennifer Sherr, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University, Yale Diabetes Research Program

Robert Slover, MD

Role: PRINCIPAL_INVESTIGATOR

Barbara Davis Center

Eva Tsalikian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa Children Hospital

Bruce Bode, MD

Role: PRINCIPAL_INVESTIGATOR

Atlanta Diabetes Associates

Kevin Kaiserman, MD

Role: PRINCIPAL_INVESTIGATOR

SoCal Diabetes

Mark Christiansen, MD

Role: PRINCIPAL_INVESTIGATOR

Diablo Clinical Research

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30063162 (View on PubMed)

Other Identifiers

CEP249

Identifier Type: -

Identifier Source: org_study_id