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Completed

NCT Number: NCT01991470

CEP249 Pediatric Accuracy Study

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.

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Key information

Conditions

Insulin Requiring Diabetes

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMCR Institute, Escondido, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Enlite sensors

Device

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

Primary outcomes

  1. Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump

    Time frame: 6 days

    Enlite Sensor accuracy relative to the YSI (Yellow Spring Instruments) reference. Each subject wore two 530G pumps. The results for the lower serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the primary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.

  2. Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System

    Time frame: 7 days

    Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG (Self-Monitoring of Blood Glucose) reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.

Secondary outcomes

  1. Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter

    Time frame: 7 days

    Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.

  2. Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump

    Time frame: 6 Days

    Enlite Sensor accuracy relative to the YSI reference. Each subject wore two 530G pumps. The results for the higher serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the secondary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.

  3. Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST

    Time frame: 6 Days

    Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.

  4. Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST

    Time frame: 6 Days

    Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.

  5. Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST

    Time frame: 7 Days

    Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.

  6. Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST

    Time frame: 7 Days

    Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.

Sponsors and collaborators

Lead sponsor

Medtronic MiniMed, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2013
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.