Trial Outcomes & Findings for A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China (NCT NCT03417466)
NCT ID: NCT03417466
Last Updated: 2019-08-20
Results Overview
Primary endpoint is the mean percentage of Enlite Sensor Values from primary sensor that are within 20% agreement of YSI plasma glucose values (within 20 mg/dL if YSI \<= 80 mg/dL) during YSI frequent sampling testing (FST) days.
COMPLETED
NA
72 participants
YSI FST days (Day 1, 3-4, or 6 of sensor wear)
2019-08-20
Participant Flow
A total of 72 subjects signed the informed consent form and completed the screening. Five subjects failed the screening. One subject withdrew before wearing the sensor.
Participant milestones
| Measure |
Study Arm
Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China
Baseline characteristics by cohort
| Measure |
Study Arm
n=66 Participants
Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
|
|---|---|
|
Age, Continuous
|
52.82 years
STANDARD_DEVIATION 12.56 • n=99 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
66 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
China
|
66 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: YSI FST days (Day 1, 3-4, or 6 of sensor wear)Population: Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement.
Primary endpoint is the mean percentage of Enlite Sensor Values from primary sensor that are within 20% agreement of YSI plasma glucose values (within 20 mg/dL if YSI \<= 80 mg/dL) during YSI frequent sampling testing (FST) days.
Outcome measures
| Measure |
Study Arm
n=65 Participants
Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
|
|---|---|
|
Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values)
|
85.74 percentage of paired readings
Standard Deviation 22.26
|
SECONDARY outcome
Timeframe: YSI FST days (Day 1, 3-4, or 6 of sensor wear)Population: Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement.
Enlite sensor values from primary sensor were compared to YSI plasma glucose values during YSI FST days (Day 1, 3-4, or 6). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%).
Outcome measures
| Measure |
Study Arm
n=65 Participants
Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
|
|---|---|
|
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD)
|
10.11 percentage of difference
Standard Deviation 8.16
|
SECONDARY outcome
Timeframe: YSI FST days (Day 1, 3-4, or 6 of sensor wear)Population: Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement.
Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A represents a region where sensor values that are within 20% of YSI reference values, or both sensor and YSI reference values are less than 70 mg/dL. Values in Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B represents sensor values that deviate YSI reference values by more than 20%, but "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B.
Outcome measures
| Measure |
Study Arm
n=65 Participants
Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
|
|---|---|
|
Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values
|
98.4 percentage of paired readings
Interval 97.8 to 99.0
|
SECONDARY outcome
Timeframe: YSI FST days (Day 1, 3-4, or 6 of sensor wear)Population: Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement.
Consensus Error Grid (or Parkes error grid) compared the paired primary sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of "clinical accurate measurements with no effect on clinical action", Zone B as "altered clinical action with little or no effect on clinical outcome". Ideal situation is 100% in Zone A + B.
Outcome measures
| Measure |
Study Arm
n=65 Participants
Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
|
|---|---|
|
Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values
|
99.4 percentage of paired readings
Interval 99.0 to 99.8
|
Adverse Events
Study Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Arm
n=66 participants at risk
Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6)
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/66 • Number of events 1 • 6 days
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/66 • Number of events 1 • 6 days
|
|
Vascular disorders
Haemorrhage
|
3.0%
2/66 • Number of events 2 • 6 days
|
|
Injury, poisoning and procedural complications
Injury
|
1.5%
1/66 • Number of events 1 • 6 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators are required to submit any proposed publications to the study sponsor for review and approval at least 60 days prior to submitting the materials for external publication.
- Publication restrictions are in place
Restriction type: OTHER