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CompletedNCT01991470Updated Sep 27, 2018Results posted

CEP249 Pediatric Accuracy Study

An interventional study of Enlite sensors in Insulin Requiring Diabetes, sponsored by Medtronic Diabetes. Completed at 11 sites in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-09-27.

Sponsored by Medtronic Diabetes · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
186
Ages
2 Years to 18 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Insulin Requiring Diabetes

Keywords

  • Insulin requiring diabetes
  • Children
  • Sensor
  • Accuracy
03

In context

Lead sponsor

Medtronic Diabetes is the lead sponsor of 61 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 21 (95%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
186 participants (actual)

Study arms

  • Experimental
    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.

    Device: Enlite sensors

Interventions

  • DeviceEnlite sensors

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

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 6 days

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

    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.

    Time frame: 7 days

Secondary outcomes

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

    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.

    Time frame: 7 days

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

    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.

    Time frame: 6 Days

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

    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.

    Time frame: 6 Days

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

    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.

    Time frame: 6 Days

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

    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.

    Time frame: 7 Days

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

    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.

    Time frame: 7 Days

07

Results

Posted Sep 27, 2018

Participant flow

Enlite 1 Period
Participant flow — Enlite 1 Period
Milestone2-18 Years Old Wearing Sensors
Started161
Completed141
Not completed20
Withdrew: Withdrawal by subject18
Withdrew: Adverse event1
Withdrew: Inclusion/exclusion not met1
Enlite 3 Period
Participant flow — Enlite 3 Period
Milestone2-18 Years Old Wearing Sensors
Started158
Completed146
Not completed12
Withdrew: Lost to follow-up1
Withdrew: Physician decision2
Withdrew: Physician decision8
Withdrew: Due to multiple sensor issues1

Outcome measures

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

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.

Time frame:
6 days
Reported as:
Mean · percentage of difference
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump
percentage of differenceEnlite Sensor Accuracy MARD, Lower Serial Number
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump15.02 ± 13.37
PrimaryEnlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System

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.

Time frame:
7 days
Reported as:
Mean · percentage of difference
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System
percentage of differenceEnlite 3 Sensor Accuracy MARD, Guardian Mobile
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System10.88 ± 10.65
SecondaryEnlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter

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.

Time frame:
7 days
Reported as:
Mean · percentage of difference
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter
percentage of differenceEnlite 3 Sensor Accuracy MARD,GST 3C
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter11.08 ± 10.58
SecondaryEnlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump

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.

Time frame:
6 Days
Reported as:
Mean · percentage of difference
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump
percentage of differenceEnlite Sensor Accuracy MARD, Higher Serial Number
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump17.50 ± 19.70
SecondaryEnlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST

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.

Time frame:
6 Days
Reported as:
Mean · percentage of difference
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST
percentage of differenceEnlite Sensor Accuracy MARD, Lower Serial Number
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST14.37 ± 12.99
SecondaryEnlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST

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.

Time frame:
6 Days
Reported as:
Mean · percentage of difference
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST
percentage of differenceEnlite Sensor Accuracy MARD, Higher Serial Number
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST16.94 ± 18.74
SecondaryEnlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST

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.

Time frame:
7 Days
Reported as:
Mean · percentage of difference
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST
percentage of differenceEnlite 3 MARD, Guardian Mobile, One Additional Fingerstick
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST10.05 ± 9.26
SecondaryEnlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST

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.

Time frame:
7 Days
Reported as:
Mean · percentage of difference
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST
percentage of differenceEnlite 3 MARD,GST 3C, One Additional Fingerstick
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST10.85 ± 10.35

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
2-18 Year Olds Wearing Enlite Sensors0/161 (0%)2/161 (1.2%)25/161 (15.5%)
2-18 Year Olds Wearing Enlite3 Sensors0/158 (0%)1/158 (0.6%)23/158 (14.6%)
Most frequent serious events
Most frequent serious events
Event2-18 Year Olds Wearing Enlite Sensors2-18 Year Olds Wearing Enlite3 Sensors
Influenzavirus BInvestigations0/1611/158
Diabetic KetoacidosisMetabolism and nutrition disorders1/1610/158
Pilonidal AbscessInfections and infestations1/1610/158
Most frequent other events
Showing 10 of 41
Most frequent other events
Event2-18 Year Olds Wearing Enlite Sensors2-18 Year Olds Wearing Enlite3 Sensors
Upper Resiratory InfectionInfections and infestations3/1614/158
severe hyperglycemiaMetabolism and nutrition disorders2/1613/158
coughRespiratory, thoracic and mediastinal disorders1/1612/158
GastroenteritisInfections and infestations0/1612/158
common coldInfections and infestations2/1610/158
HeadacheNervous system disorders1/1611/158
Nasal CongestionRespiratory, thoracic and mediastinal disorders1/1611/158
Sinus InfectionInfections and infestations1/1611/158
Abrasion on right arm and right legInjury, poisoning and procedural complications0/1611/158
Cold soreInfections and infestations0/1611/158

Baseline characteristics

a total of 186 subjects participated the study

Age, Continuous
Age, Continuous(years)2-18 Year Olds Wearing Enlite Sensor
Mean13.2 ± 3.79
Sex: Female, Male
Sex: Female, Male(Participants)2-18 Year Olds Wearing Enlite Sensor
Female83
Male103
Region of Enrollment
Region of Enrollment(participants)2-18 Year Olds Wearing Enlite Sensor
United States186
08

Study locations

11 sites
  • AMCR Institute
    Escondido, California 92025, United States
  • SoCal Diabetes
    Torrance, California 90505, United States
  • Diablo Clinical Research
    Walnut Creek, California 94598, United States
  • Barbara Davis Center
    Aurora, Colorado 80045, United States
  • Yale University, Yale Diabetes Research Program
    New Haven, Connecticut 06511, United States
  • Nemours Children's Clinic
    Jacksonville, Florida 32207, United States
  • "Atlanta Diabetes Associates
    Atlanta, Georgia 30318, United States
  • Indiana University, Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
  • University of Iowa Children Hospital
    Iowa City, Iowa 52242, United States
  • OUHSC Department of Pediatrics
    Oklahoma City, Oklahoma 73104, United States
  • Rainier Clinical Research Center
    Renton, Washington 98057, United States
09

References and documents

Publications

  • 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. PubMed 30063162 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01991470
Lead sponsor
Medtronic Diabetes
Responsible party
Sponsor
First posted
Nov 25, 2013
Start date
Mar 2015
Primary completion
Dec 2016
Completion
Dec 2016
Results posted
Sep 27, 2018
Last update
Sep 27, 2018

Study contacts

Ronald Brazg, MD
principal investigator · Rainier Clinical Research Center
Timothy Bailey, MD
principal investigator · AMCR Institute
Jeanie Tryggestad, MD
principal investigator · OUHSC Department of Pediatrics
Linda DiMeglio, MD
principal investigator · Indiana University, Riley Hospital for Children
Larry Fox, MD
principal investigator · Nemours Children's Clinic
Jennifer Sherr, MD
principal investigator · Yale University, Yale Diabetes Research Program
Robert Slover, MD
principal investigator · Barbara Davis Center
Eva Tsalikian, MD
principal investigator · University of Iowa Children Hospital
Bruce Bode, MD
principal investigator · Atlanta Diabetes Associates
Kevin Kaiserman, MD
principal investigator · SoCal Diabetes
Mark Christiansen, MD
principal investigator · Diablo Clinical Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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