Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to characterize the impact of acetaminophen ingestion on the performance of the Guardian™ Sensor (3) (i.e., C algorithm and Zeus algorithm) in subjects age 18 - 80 years.
Detailed description
The study is a multi-center, prospective, study without controls. The purpose of this study is to characterize the impact of acetaminophen ingestion on the performance of the Guardian™ Sensor (3) (i.e., C algorithm and Zeus algorithm) in subjects age 18 - 80 years.
Interventions
DEVICEGuardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. C sensor algorithm applied retrospectively to raw sensor data.
Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when C sensor algorithm is used.
DEVICEGuardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. Zeus sensor algorithm applied retrospectively to raw sensor data.
Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when Zeus sensor algorithm is used.
DRUGAcetominophen
One time administration of acetaminophen.
Sponsors
Medtronic Diabetes
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Individual is 18 - 80 years of age at time of enrollment. 2. Subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis. 3. Subject has adequate venous access as assessed by investigator or appropriate staff.
Exclusion criteria
1. Subject has history of allergy to acetaminophen or has been told by a health care provider they may not ingest acetaminophen 2. Subject reports history of liver cirrhosis or liver problems that a health care provider told them they should not use acetaminophen because of liver disorder. 3. Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual. 4. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection). 5. Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.) 6. Subject is female of child-bearing potential and has a pregnancy screening test that is positive. 7. Subject is female of child-bearing potential and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator. 8. Subject is female and plans to become pregnant during the course of the study. 9. Subject is breast feeding. 10. Subject has a chronic heavy alcohol use as determined by investigator. 11. Subject has a history of a seizure disorder. 12. Subject has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents). 13. Subject has a history of adrenal insufficiency. 14. Subject is a member of the research staff involved with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported | 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 \[Guardian™ Sensor (3) values - YSI™ plasma glucose values\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported | 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%). |
| Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported | 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%. |
Countries
United States
Participant flow
Pre-assignment details
104 subjects consented and enrolled in the overall study. Of them, 102 subjects were eligible.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Subjects With Diabetes Wearing Guardian™ Sensor (3) |
|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 15.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 102 |
| other Total, other adverse events | 6 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
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 \[Guardian™ Sensor (3) values - YSI™ plasma glucose values\].
Time frame: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
Population: Subjects with at least 1 sensor-YSI paired point during the 1 hour before and 5 hours after ingestion of acetaminophen
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (3,4] hour | 17.22 mg/dL | Standard Deviation 14.33 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (0,1] hour | 19.57 mg/dL | Standard Deviation 19.35 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (4,5] hour | 13.40 mg/dL | Standard Deviation 13.8 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (1,2] hour | 29.92 mg/dL | Standard Deviation 19.9 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (-1,0] hour | 0.86 mg/dL | Standard Deviation 15.71 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (2,3] hour | 21.85 mg/dL | Standard Deviation 15.31 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (0,1] hour | 10.64 mg/dL | Standard Deviation 14.89 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (-1,0] hour | -4.78 mg/dL | Standard Deviation 9.79 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (4,5] hour | 4.93 mg/dL | Standard Deviation 12.49 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (3,4] hour | 8.77 mg/dL | Standard Deviation 12.36 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (2,3] hour | 13.52 mg/dL | Standard Deviation 12.26 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (1,2] hour | 18.86 mg/dL | Standard Deviation 15.19 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (4,5] hour | 4.35 mg/dL | Standard Deviation 13.7 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (-1,0] hour | -4.45 mg/dL | Standard Deviation 12.22 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (0,1] hour | 13.28 mg/dL | Standard Deviation 19.56 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (1,2] hour | 21.99 mg/dL | Standard Deviation 21.27 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (2,3] hour | 14.52 mg/dL | Standard Deviation 15.31 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose | (3,4] hour | 8.98 mg/dL | Standard Deviation 12.95 |
Secondary
Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
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%).
Time frame: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
Population: Subjects with at least 1 sensor-YSI paired point during the 1 hour before and 5 hours after ingestion of acetaminophen
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (4, 5] hour | 13.87 Percent | Standard Deviation 11.53 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (2, 3] hour | 18.44 Percent | Standard Deviation 12.12 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (-1, 0] hour | 8.38 Percent | Standard Deviation 7.37 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (1, 2] hour | 24.22 Percent | Standard Deviation 15.73 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (0, 1] hour | 18.02 Percent | Standard Deviation 12.41 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (3, 4] hour | 15.87 Percent | Standard Deviation 11.78 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (0, 1] hour | 13.22 Percent | Standard Deviation 8.17 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (1, 2] hour | 15.83 Percent | Standard Deviation 12.89 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (2, 3] hour | 12.24 Percent | Standard Deviation 9.4 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (4, 5] hour | 8.52 Percent | Standard Deviation 6.12 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (3, 4] hour | 9.60 Percent | Standard Deviation 7.28 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (-1, 0] hour | 5.99 Percent | Standard Deviation 4.24 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (3, 4] hour | 10.06 Percent | Standard Deviation 7.92 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (4, 5] hour | 8.70 Percent | Standard Deviation 7.72 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (0, 1] hour | 16.09 Percent | Standard Deviation 9.92 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (2, 3] hour | 12.92 Percent | Standard Deviation 10.16 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (-1, 0] hour | 6.56 Percent | Standard Deviation 4.92 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose | (1, 2] hour | 18.60 Percent | Standard Deviation 15.02 |
Secondary
Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values
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%.
Time frame: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
Population: Subjects with at least 1 sensor-YSI paired point during the 1 hour before and 5 hours after ingestion of acetaminophen
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm | 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 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (1, 2] hour | 47.37 Percentage of readings | Standard Deviation 42.56 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (-1, 0] hour | 94.44 Percentage of readings | Standard Deviation 21.49 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (3, 4] hour | 73.91 Percentage of readings | Standard Deviation 41.88 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (2, 3] hour | 64.64 Percentage of readings | Standard Deviation 45.14 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (4, 5] hour | 75.97 Percentage of readings | Standard Deviation 40.11 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (0, 1] hour | 67.82 Percentage of readings | Standard Deviation 27.45 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (4, 5] hour | 93.44 Percentage of readings | Standard Deviation 17.67 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (0, 1] hour | 77.97 Percentage of readings | Standard Deviation 20.64 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (2, 3] hour | 78.92 Percentage of readings | Standard Deviation 36.93 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (1, 2] hour | 72.08 Percentage of readings | Standard Deviation 39.05 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (-1, 0] hour | 99.03 Percentage of readings | Standard Deviation 5.33 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (3, 4] hour | 88.27 Percentage of readings | Standard Deviation 25.64 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (1, 2] hour | 65.43 Percentage of readings | Standard Deviation 42.64 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (-1, 0] hour | 96.40 Percentage of readings | Standard Deviation 16.29 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (0, 1] hour | 73.70 Percentage of readings | Standard Deviation 25.44 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (4, 5] hour | 91.03 Percentage of readings | Standard Deviation 24.17 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (2, 3] hour | 78.91 Percentage of readings | Standard Deviation 35.92 |
| Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values | (3, 4] hour | 87.97 Percentage of readings | Standard Deviation 27.98 |