Trial Outcomes & Findings for CEP249 Pediatric Accuracy Study (NCT NCT01991470)
NCT ID: NCT01991470
Last Updated: 2018-09-27
Results Overview
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.
COMPLETED
NA
186 participants
6 days
2018-09-27
Participant Flow
Two phase study: Enlite and Enlite 3. Some participated only Enlite phase and some only participated in Enlite 3 phase.
Participant milestones
| Measure |
2-18 Years Old Wearing Sensors
2-18 years old wearing Enlite and/or Enlite3 sensors.
|
|---|---|
|
Enlite 1 Period
STARTED
|
161
|
|
Enlite 1 Period
COMPLETED
|
141
|
|
Enlite 1 Period
NOT COMPLETED
|
20
|
|
Enlite 3 Period
STARTED
|
158
|
|
Enlite 3 Period
COMPLETED
|
146
|
|
Enlite 3 Period
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
2-18 Years Old Wearing Sensors
2-18 years old wearing Enlite and/or Enlite3 sensors.
|
|---|---|
|
Enlite 1 Period
Withdrawal by Subject
|
18
|
|
Enlite 1 Period
Adverse Event
|
1
|
|
Enlite 1 Period
Inclusion/Exclusion not met
|
1
|
|
Enlite 3 Period
Lost to Follow-up
|
1
|
|
Enlite 3 Period
Physician Decision
|
8
|
|
Enlite 3 Period
DUE TO MULTIPLE SENSOR ISSUES
|
1
|
Baseline Characteristics
CEP249 Pediatric Accuracy Study
Baseline characteristics by cohort
| Measure |
2-18 Year Olds Wearing Enlite Sensor
n=186 Participants
2-18 years old wearing Enlite and/or Enlite3 sensors.
|
|---|---|
|
Age, Continuous
|
13.2 years
STANDARD_DEVIATION 3.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
186 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 daysPopulation: All subjects wearing Enlite sensor with lower serial number of 530G pump. A total of 30 subjects did not have device data.
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.
Outcome measures
| Measure |
Enlite Sensor Accuracy MARD, Lower Serial Number
n=131 Participants
Enlite Sensor accuracy relative to the YSI 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). Note that results from multiple testing days were pooled together for reporting purpose.
|
|---|---|
|
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump
|
15.02 percentage of difference
Standard Deviation 13.37
|
PRIMARY outcome
Timeframe: 7 daysPopulation: a total of 25 subjects do not have device data
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.
Outcome measures
| Measure |
Enlite Sensor Accuracy MARD, Lower Serial Number
n=133 Participants
Enlite Sensor accuracy relative to the YSI 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). Note that results from multiple testing days were pooled together for reporting purpose.
|
|---|---|
|
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System
|
10.88 percentage of difference
Standard Deviation 10.65
|
SECONDARY outcome
Timeframe: 7 daysPopulation: A total of 41 subjects did not have device data.
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.
Outcome measures
| Measure |
Enlite Sensor Accuracy MARD, Lower Serial Number
n=117 Participants
Enlite Sensor accuracy relative to the YSI 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). Note that results from multiple testing days were pooled together for reporting purpose.
|
|---|---|
|
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter
|
11.08 percentage of difference
Standard Deviation 10.58
|
SECONDARY outcome
Timeframe: 6 DaysPopulation: All subjects wearing Enlite sensors with high serial number 530G pump. A total of 35 subjects did not have device data.
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.
Outcome measures
| Measure |
Enlite Sensor Accuracy MARD, Lower Serial Number
n=126 Participants
Enlite Sensor accuracy relative to the YSI 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). Note that results from multiple testing days were pooled together for reporting purpose.
|
|---|---|
|
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump
|
17.50 percentage of difference
Standard Deviation 19.70
|
SECONDARY outcome
Timeframe: 6 DaysPopulation: A total of 32 subjects did not have device data.
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.
Outcome measures
| Measure |
Enlite Sensor Accuracy MARD, Lower Serial Number
n=129 Participants
Enlite Sensor accuracy relative to the YSI 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). Note that results from multiple testing days were pooled together for reporting purpose.
|
|---|---|
|
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST
|
14.37 percentage of difference
Standard Deviation 12.99
|
SECONDARY outcome
Timeframe: 6 DaysPopulation: A total of 34 subjects did not have device data.
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.
Outcome measures
| Measure |
Enlite Sensor Accuracy MARD, Lower Serial Number
n=127 Participants
Enlite Sensor accuracy relative to the YSI 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). Note that results from multiple testing days were pooled together for reporting purpose.
|
|---|---|
|
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST
|
16.94 percentage of difference
Standard Deviation 18.74
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: A total of 34 subjects did not have device data.
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.
Outcome measures
| Measure |
Enlite Sensor Accuracy MARD, Lower Serial Number
n=124 Participants
Enlite Sensor accuracy relative to the YSI 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). Note that results from multiple testing days were pooled together for reporting purpose.
|
|---|---|
|
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST
|
10.05 percentage of difference
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: A total of 41 subjects did not have device data.
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.
Outcome measures
| Measure |
Enlite Sensor Accuracy MARD, Lower Serial Number
n=117 Participants
Enlite Sensor accuracy relative to the YSI 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). Note that results from multiple testing days were pooled together for reporting purpose.
|
|---|---|
|
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST
|
10.85 percentage of difference
Standard Deviation 10.35
|
Adverse Events
2-18 Year Olds Wearing Enlite Sensors
2-18 Year Olds Wearing Enlite3 Sensors
Serious adverse events
| Measure |
2-18 Year Olds Wearing Enlite Sensors
n=161 participants at risk
2-18 year olds wearing Enlite Sensors
|
2-18 Year Olds Wearing Enlite3 Sensors
n=158 participants at risk
2-18 year olds wearing Enlite3 Sensors
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Infections and infestations
Pilonidal Abscess
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Investigations
Influenzavirus B
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
Other adverse events
| Measure |
2-18 Year Olds Wearing Enlite Sensors
n=161 participants at risk
2-18 year olds wearing Enlite Sensors
|
2-18 Year Olds Wearing Enlite3 Sensors
n=158 participants at risk
2-18 year olds wearing Enlite3 Sensors
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Injury, poisoning and procedural complications
Broken right thumb
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Infections and infestations
Flu symptoms
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Gastrointestinal disorders
Food poisoning.
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Nervous system disorders
Headache
|
0.62%
1/161 • Number of events 1
|
0.63%
1/158 • Number of events 1
|
|
Immune system disorders
Hypersensitivity reaction
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Nervous system disorders
Hypoglycemic Seizure
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
General disorders
Insertion site pain
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Injury, poisoning and procedural complications
Laceration above right knee cap - requiring 9 sutures
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Injury, poisoning and procedural complications
Left Broken Great Toe
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.62%
1/161 • Number of events 1
|
0.63%
1/158 • Number of events 1
|
|
Injury, poisoning and procedural complications
Puncture Wound
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Infections and infestations
Sinus Infection
|
0.62%
1/161 • Number of events 1
|
0.63%
1/158 • Number of events 1
|
|
Infections and infestations
Stomach Virus
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Injury, poisoning and procedural complications
Toe Injury
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Infections and infestations
Upper Resiratory Infection
|
1.9%
3/161 • Number of events 3
|
2.5%
4/158 • Number of events 4
|
|
Infections and infestations
common cold
|
1.2%
2/161 • Number of events 2
|
0.00%
0/158
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.62%
1/161 • Number of events 1
|
1.3%
2/158 • Number of events 2
|
|
Surgical and medical procedures
jaw pain due to wisdom teeth removal
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
General disorders
lowgrade fever, maximum 100.8 degrees
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Metabolism and nutrition disorders
severe hyperglycemia
|
1.2%
2/161 • Number of events 2
|
1.9%
3/158 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.62%
1/161 • Number of events 1
|
0.00%
0/158
|
|
Nervous system disorders
vasovagal response
|
0.62%
1/161 • Number of events 2
|
0.00%
0/158
|
|
Injury, poisoning and procedural complications
Abrasion on right arm and right leg
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Infections and infestations
Cold sore
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Immune system disorders
Food Allergy: Shellfish Positive FPIES (Food PRotein Induced Enterocolitis Syndrome)
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/161
|
1.3%
2/158 • Number of events 2
|
|
Infections and infestations
Influenza
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Investigations
Staff Infection left upper arm
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
contact dermatitis
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
General disorders
fatigue
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Infections and infestations
hand, foot, mouth disease 0
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Injury, poisoning and procedural complications
sprain of left wrist
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Gastrointestinal disorders
stomach ache
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
|
Nervous system disorders
vasovagal event
|
0.00%
0/161
|
0.63%
1/158 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place