Back to resultsImpact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
Primary Purpose
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. C sensor algorithm applied retrospectively to raw sensor data.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. Zeus sensor algorithm applied retrospectively to raw sensor data.
Acetominophen
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Individual is 18 - 80 years of age at time of enrollment.
- 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.
- Subject has adequate venous access as assessed by investigator or appropriate staff.
Exclusion Criteria:
- Subject has history of allergy to acetaminophen or has been told by a health care provider they may not ingest acetaminophen
- 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.
- Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual.
- Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
- 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.)
- Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
- 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.
- Subject is female and plans to become pregnant during the course of the study.
- Subject is breast feeding.
- Subject has a chronic heavy alcohol use as determined by investigator.
- Subject has a history of a seizure disorder.
- 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).
- Subject has a history of adrenal insufficiency.
- Subject is a member of the research staff involved with the study.
Sites / Locations
- AMCR Institue
- Sansum Diabetes Research Institute
- Diablo Clinical Research
- Barbara Davis Center - Adults
- "Atlanta Diabetes Associates
- Rainier Clinical Research Center, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Subjects with diabetes wearing Guardian™ Sensor (3). C algorithm applied retrospectively
Subjects with diabetes wearing Guardian™ Sensor (3). Zeus algorithm applied retrospectively
Arm Description
Subjects wear Guardian™ Sensor (3) over 7 days and undergo one frequent sample test (FST). C sensor algorithm applied retrospectively to raw sensor data.
Subjects wear Guardian™ Sensor (3) over 7 days and undergo one FST. Zeus sensor algorithm applied retrospectively to raw sensor data.
Outcomes
Primary Outcome Measures
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].
Secondary Outcome Measures
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%).
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%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04378114
Brief Title
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
Official Title
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
July 17, 2020 (Actual)
Study Completion Date
July 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with diabetes wearing Guardian™ Sensor (3). C algorithm applied retrospectively
Arm Type
Experimental
Arm Description
Subjects wear Guardian™ Sensor (3) over 7 days and undergo one frequent sample test (FST). C sensor algorithm applied retrospectively to raw sensor data.
Arm Title
Subjects with diabetes wearing Guardian™ Sensor (3). Zeus algorithm applied retrospectively
Arm Type
Experimental
Arm Description
Subjects wear Guardian™ Sensor (3) over 7 days and undergo one FST. Zeus sensor algorithm applied retrospectively to raw sensor data.
Intervention Type
Device
Intervention Name(s)
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. C sensor algorithm applied retrospectively to raw sensor data.
Intervention Description
Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when C sensor algorithm is used.
Intervention Type
Device
Intervention Name(s)
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. Zeus sensor algorithm applied retrospectively to raw sensor data.
Intervention Description
Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when Zeus sensor algorithm is used.
Intervention Type
Drug
Intervention Name(s)
Acetominophen
Intervention Description
One time administration of acetaminophen.
Primary Outcome Measure Information:
Title
Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
Description
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
Secondary Outcome Measure Information:
Title
Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
Description
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
Title
Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individual is 18 - 80 years of age at time of enrollment.
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.
Subject has adequate venous access as assessed by investigator or appropriate staff.
Exclusion Criteria:
Subject has history of allergy to acetaminophen or has been told by a health care provider they may not ingest acetaminophen
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.
Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual.
Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
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.)
Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
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.
Subject is female and plans to become pregnant during the course of the study.
Subject is breast feeding.
Subject has a chronic heavy alcohol use as determined by investigator.
Subject has a history of a seizure disorder.
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).
Subject has a history of adrenal insufficiency.
Subject is a member of the research staff involved with the study.
Facility Information:
Facility Name
AMCR Institue
City
Escondido
State/Province
California
ZIP/Postal Code
92026
Country
United States
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Barbara Davis Center - Adults
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
"Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Rainier Clinical Research Center, Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
12. IPD Sharing Statement
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Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
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