Trial Outcomes & Findings for Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults (NCT NCT04378114)
NCT ID: NCT04378114
Last Updated: 2023-09-08
Results Overview
Bias (mg/dL) between the Guardian™ Sensor (3) values and YSI™ plasma glucose values 1 hour before through 5 hours after ingestion of acetaminophen; results are reported hourly. Bias = Mean of \[Guardian™ Sensor (3) values - YSI™ plasma glucose values\].
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
Results posted on
2023-09-08
Participant Flow
104 subjects consented and enrolled in the overall study. Of them, 102 subjects were eligible.
Participant milestones
| Measure |
Subjects With Diabetes Wearing Guardian™ Sensor (3)
Subjects wearing two Guardian™ Sensor (3) on the arm and abdomen over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using Zeus and C Algorithm was characterized.
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|---|---|
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Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Subjects With Diabetes Wearing Guardian™ Sensor (3)
Subjects wearing two Guardian™ Sensor (3) on the arm and abdomen over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using Zeus and C Algorithm was characterized.
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|---|---|
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Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
Baseline characteristics by cohort
| Measure |
Subjects With Diabetes Wearing Guardian™ Sensor (3)
n=102 Participants
Subjects wearing two Guardian™ Sensor (3) on the arm and abdomen over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using Zeus and C Algorithm was characterized.
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|---|---|
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Age, Continuous
|
46.7 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reportedPopulation: Subjects with at least 1 sensor-YSI paired point during the 1 hour before and 5 hours after ingestion of acetaminophen
Bias (mg/dL) between the Guardian™ Sensor (3) values and YSI™ plasma glucose values 1 hour before through 5 hours after ingestion of acetaminophen; results are reported hourly. Bias = Mean of \[Guardian™ Sensor (3) values - YSI™ plasma glucose values\].
Outcome measures
| Measure |
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the arm over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using Zeus Algorithm was characterized.
|
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the abdomen over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using Zeus Algorithm was characterized.
|
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the arm over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using C Algorithm was characterized.
|
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the abdomen over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using C Algorithm was characterized.
|
|---|---|---|---|---|
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Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
(4,5] hour
|
11.12 mg/dL
Standard Deviation 14.81
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13.40 mg/dL
Standard Deviation 13.80
|
4.93 mg/dL
Standard Deviation 12.49
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4.35 mg/dL
Standard Deviation 13.70
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Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
(1,2] hour
|
25.42 mg/dL
Standard Deviation 18.74
|
29.92 mg/dL
Standard Deviation 19.90
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18.86 mg/dL
Standard Deviation 15.19
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21.99 mg/dL
Standard Deviation 21.27
|
|
Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
(2,3] hour
|
19.60 mg/dL
Standard Deviation 16.74
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21.85 mg/dL
Standard Deviation 15.31
|
13.52 mg/dL
Standard Deviation 12.26
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14.52 mg/dL
Standard Deviation 15.31
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Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
(3,4] hour
|
14.70 mg/dL
Standard Deviation 15.29
|
17.22 mg/dL
Standard Deviation 14.33
|
8.77 mg/dL
Standard Deviation 12.36
|
8.98 mg/dL
Standard Deviation 12.95
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Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
(-1,0] hour
|
-0.46 mg/dL
Standard Deviation 16.05
|
0.86 mg/dL
Standard Deviation 15.71
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-4.78 mg/dL
Standard Deviation 9.79
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-4.45 mg/dL
Standard Deviation 12.22
|
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Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
(0,1] hour
|
14.83 mg/dL
Standard Deviation 20.23
|
19.57 mg/dL
Standard Deviation 19.35
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10.64 mg/dL
Standard Deviation 14.89
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13.28 mg/dL
Standard Deviation 19.56
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SECONDARY outcome
Timeframe: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reportedPopulation: Subjects with at least 1 sensor-YSI paired point during the 1 hour before and 5 hours after ingestion of acetaminophen
Mean absolute relative difference (MARD, %) between the Guardian™ Sensor (3) values and YSI™ plasma glucose 1 hour before through 5 hours after ingestion of acetaminophen; results are reported hourly. Mean Absolute Relative Difference = Mean of (\[absolute difference of Guardian™ Sensor (3) values and YSI™ plasma glucose / YSI™ plasma glucose\] \* 100%).
Outcome measures
| Measure |
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the arm over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using Zeus Algorithm was characterized.
|
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the abdomen over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using Zeus Algorithm was characterized.
|
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the arm over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using C Algorithm was characterized.
|
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the abdomen over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using C Algorithm was characterized.
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|---|---|---|---|---|
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Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
(0, 1] hour
|
16.65 Percent
Standard Deviation 10.72
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18.02 Percent
Standard Deviation 12.41
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13.22 Percent
Standard Deviation 8.17
|
16.09 Percent
Standard Deviation 9.92
|
|
Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
(1, 2] hour
|
21.26 Percent
Standard Deviation 15.16
|
24.22 Percent
Standard Deviation 15.73
|
15.83 Percent
Standard Deviation 12.89
|
18.60 Percent
Standard Deviation 15.02
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|
Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
(-1, 0] hour
|
8.45 Percent
Standard Deviation 6.52
|
8.38 Percent
Standard Deviation 7.37
|
5.99 Percent
Standard Deviation 4.24
|
6.56 Percent
Standard Deviation 4.92
|
|
Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
(2, 3] hour
|
17.72 Percent
Standard Deviation 12.95
|
18.44 Percent
Standard Deviation 12.12
|
12.24 Percent
Standard Deviation 9.40
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12.92 Percent
Standard Deviation 10.16
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|
Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
(3, 4] hour
|
15.58 Percent
Standard Deviation 11.16
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15.87 Percent
Standard Deviation 11.78
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9.60 Percent
Standard Deviation 7.28
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10.06 Percent
Standard Deviation 7.92
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Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
(4, 5] hour
|
13.98 Percent
Standard Deviation 10.48
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13.87 Percent
Standard Deviation 11.53
|
8.52 Percent
Standard Deviation 6.12
|
8.70 Percent
Standard Deviation 7.72
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SECONDARY outcome
Timeframe: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reportedPopulation: Subjects with at least 1 sensor-YSI paired point during the 1 hour before and 5 hours after ingestion of acetaminophen
Percentage of Guardian™ Sensor (3) values within 20% of YSI™ plasma glucose value (±20 mg/dL \[1.1 mmol/L\] when YSI™ value less than or equal to (≤) 80 mg/dL \[4.4 mmol/L\]) during the 1 hour before through 5 hours after ingestion of acetaminophen; results are reported hourly. 20% agreement = Number of Guardian™ Sensor (3) values within 20% (±20 mg/dL) of YSI™ plasma glucose value / Total number of paired Guardian™ Sensor (3) and YSI™ plasma glucose points \* 100%.
Outcome measures
| Measure |
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the arm over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using Zeus Algorithm was characterized.
|
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the abdomen over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using Zeus Algorithm was characterized.
|
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the arm over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using C Algorithm was characterized.
|
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen
n=102 Participants
Subjects wearing Guardian™ Sensor (3) on the abdomen over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using C Algorithm was characterized.
|
|---|---|---|---|---|
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Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values
(-1, 0] hour
|
93.27 Percentage of readings
Standard Deviation 21.36
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94.44 Percentage of readings
Standard Deviation 21.49
|
99.03 Percentage of readings
Standard Deviation 5.33
|
96.40 Percentage of readings
Standard Deviation 16.29
|
|
Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values
(0, 1] hour
|
68.90 Percentage of readings
Standard Deviation 29.84
|
67.82 Percentage of readings
Standard Deviation 27.45
|
77.97 Percentage of readings
Standard Deviation 20.64
|
73.70 Percentage of readings
Standard Deviation 25.44
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Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values
(1, 2] hour
|
54.82 Percentage of readings
Standard Deviation 44.92
|
47.37 Percentage of readings
Standard Deviation 42.56
|
72.08 Percentage of readings
Standard Deviation 39.05
|
65.43 Percentage of readings
Standard Deviation 42.64
|
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Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values
(2, 3] hour
|
66.57 Percentage of readings
Standard Deviation 43.87
|
64.64 Percentage of readings
Standard Deviation 45.14
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78.92 Percentage of readings
Standard Deviation 36.93
|
78.91 Percentage of readings
Standard Deviation 35.92
|
|
Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values
(3, 4] hour
|
73.05 Percentage of readings
Standard Deviation 40.85
|
73.91 Percentage of readings
Standard Deviation 41.88
|
88.27 Percentage of readings
Standard Deviation 25.64
|
87.97 Percentage of readings
Standard Deviation 27.98
|
|
Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values
(4, 5] hour
|
76.88 Percentage of readings
Standard Deviation 40.13
|
75.97 Percentage of readings
Standard Deviation 40.11
|
93.44 Percentage of readings
Standard Deviation 17.67
|
91.03 Percentage of readings
Standard Deviation 24.17
|
Adverse Events
Subjects With Diabetes Wearing Guardian™ Sensor (3)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects With Diabetes Wearing Guardian™ Sensor (3)
n=102 participants at risk
Subjects wearing two Guardian™ Sensor (3) on the arm and abdomen over 7 days and undergoing one Frequent Sample Testing (FST).
One time acetaminophen (1000 mg) ingestion was administered while wearing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. The impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) using Zeus and C Algorithm was characterized.
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|---|---|
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Gastrointestinal disorders
Infusion site pruritus
|
0.98%
1/102 • Number of events 1 • Throughout the course of the study, with an average of 25 days
|
|
General disorders
Medical device site erythema
|
2.0%
2/102 • Number of events 2 • Throughout the course of the study, with an average of 25 days
|
|
General disorders
Medical device site haemorrhage
|
0.98%
1/102 • Number of events 1 • Throughout the course of the study, with an average of 25 days
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.98%
1/102 • Number of events 1 • Throughout the course of the study, with an average of 25 days
|
|
Renal and urinary disorders
Urinary retention
|
0.98%
1/102 • Number of events 1 • Throughout the course of the study, with an average of 25 days
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.98%
1/102 • Number of events 1 • Throughout the course of the study, with an average of 25 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60