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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with diabetes wearing Guardian™ Sensor (3). C algorithm applied retrospectively | Experimental | Subjects wear Guardian™ Sensor (3) over 7 days and undergo one frequent sample test (FST). C sensor algorithm applied retrospectively to raw sensor data. |
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| Subjects with diabetes wearing Guardian™ Sensor (3). Zeus algorithm applied retrospectively | Experimental | Subjects wear Guardian™ Sensor (3) over 7 days and undergo one FST. Zeus sensor algorithm applied retrospectively to raw sensor data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. C sensor algorithm applied retrospectively to raw sensor data. | Device | Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when C sensor algorithm is used. |
| Measure | Description | Time Frame |
|---|---|---|
| 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]. | Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported |
| Measure | Description | Time Frame |
|---|---|---|
| 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%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institue | Escondido | California | 92026 | United States | ||
| Sansum Diabetes Research Institute |
104 subjects consented and enrolled in the overall study. Of them, 102 subjects were eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2020 | Mar 5, 2021 |
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| Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. Zeus sensor algorithm applied retrospectively to raw sensor data. | Device | Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when Zeus sensor algorithm is used. |
|
| Acetominophen | Drug | One time administration of acetaminophen. |
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| 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 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%. | Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported |
| Santa Barbara |
| California |
| 93105 |
| United States |
| Diablo Clinical Research | Walnut Creek | California | 92025 | United States |
| Barbara Davis Center - Adults | Aurora | Colorado | 80045 | United States |
| "Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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]. | Subjects with at least 1 sensor-YSI paired point during the 1 hour before and 5 hours after ingestion of acetaminophen | Posted | Mean | Standard Deviation | mg/dL | Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported |
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| 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%). | Subjects with at least 1 sensor-YSI paired point during the 1 hour before and 5 hours after ingestion of acetaminophen | Posted | Mean | Standard Deviation | Percent | Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported |
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| 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%. | Subjects with at least 1 sensor-YSI paired point during the 1 hour before and 5 hours after ingestion of acetaminophen | Posted | Mean | Standard Deviation | Percentage of readings | Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported |
|
Throughout the course of the study, with an average of 25 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 102 | 0 | 102 | 6 | 102 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site pruritus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site haemorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Mottackel | Medtronic Diabetes | 8185764886 | robin.e.mottackel@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2020 | Mar 5, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Unknown or Not Reported |
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| (0,1] hour |
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| (1,2] hour |
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| (2,3] hour |
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| (3,4] hour |
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| (4,5] hour |
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| OG002 | Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | 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. |
| OG003 | Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | 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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| OG002 | Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm | 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. |
| OG003 | Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen | 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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