Trial Outcomes & Findings for A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China (NCT NCT03710083)

Results Overview

Percentage of Guardian™ Sensor (3) Values that are within 20% agreement of Yellow Springs Instrument (YSI) plasma glucose values (±20 mg/dL (1.1 mmol/L) when reference blood glucose (YSI) less than or equal to (≤) 80 mg/dL (4.4 mmol/L) ) during YSI frequent sampling testing (FST) days.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

168 Hours

Results posted on

2020-09-09

Participant Flow

72 subjects consented and enrolled in the overall study. Of the 72, 3 subjects failed screening, 3 subjects didn't utilize any Guardian™ Sensor (3) , 66 subjects utilized Guardian™ Sensor (3) and were considered to have started in the study.

Participant milestones

Participant milestones
Measure	Study Arm Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
Overall Study STARTED	66
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Arm Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
Overall Study Withdrawal by Subject	2
Overall Study Unsuccessful Procedure	1

Baseline Characteristics

A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Arm n=66 Participants Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
Age, Continuous	45.67 years STANDARD_DEVIATION 17.10 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Race/Ethnicity, Customized Han Chinese	64 Participants n=5 Participants
Race/Ethnicity, Customized Hui Chinese	1 Participants n=5 Participants
Race/Ethnicity, Customized Man Chinese	1 Participants n=5 Participants
BMI	23.51 kg/m^2 STANDARD_DEVIATION 3.61 • n=5 Participants

PRIMARY outcome

Timeframe: 168 Hours

Population: A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement.

Percentage of Guardian™ Sensor (3) Values that are within 20% agreement of Yellow Springs Instrument (YSI) plasma glucose values (±20 mg/dL (1.1 mmol/L) when reference blood glucose (YSI) less than or equal to (≤) 80 mg/dL (4.4 mmol/L) ) during YSI frequent sampling testing (FST) days.

Outcome measures

Outcome measures
Measure	Study Arm n=63 Participants Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
Percentage of Guardian™ Sensor (3) Values That Are Within 20% Agreement of YSI	93.2 percentage of paired readings Interval 92.1 to 94.4

PRIMARY outcome

Timeframe: 168 Hours

Population: A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement.

A mean rate in Zone A+B of Consensus Error Grid between Guardian Sensor (3) values and YSI™\* plasma glucose values during YSI™\* FST days was evaluated. 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

Outcome measures
Measure	Study Arm n=63 Participants Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
Consensus Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B	100 percentage of paired readings Interval 100.0 to 100.0

PRIMARY outcome

Timeframe: 168 Hours

Population: A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement.

A mean rate in Zone A+B of Clarke Error Grid between Guardian Sensor (3) values and YSI™\* plasma glucose values during YSI™\* FST days was evaluated. Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B.

Outcome measures

Outcome measures
Measure	Study Arm n=63 Participants Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
Clarke Error Grid Analysis of Mean Rate of Paired Sensor Values and YSI Values in Zone A+B	99.8 percentage of paired readings Interval 99.5 to 100.0

PRIMARY outcome

Timeframe: 168 Hours

Population: A total of 63 subjects who had Guardian™ Sensor (3) inserted and had at least one paired Guardian™ Sensor (3) value and YSI measurement.

Mean absolute relative difference (MARD) between Guardian Sensor (3) values and YSI™\* plasma glucose values during YSI™\* FST days was evaluated. 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 FST days were pooled together for reporting purpose.

Outcome measures

Outcome measures
Measure	Study Arm n=63 Participants Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-5, or 7). Guardian™ Sensor (3): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
Mean Absolute Relative Difference (MARD)	8.11 percentage of difference Standard Deviation 4.02

Adverse Events

Study Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vivian Chen, Statistician

Medtronic Minimed

Phone: 8185763309

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER