Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
• Interventions: Device: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. C sensor algorithm applied retrospectively to raw sensor data.; Device: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. Zeus sensor algorithm applied retrospectively to raw sensor data.; Drug: Acetominophen

• Registration Number: NCT04378114
• Lead Sponsor: Medtronic Diabetes

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.

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-07
• Study Start: 2020-05-18
• Primary Completion: 2020-07-17
• Study Completion: 2020-07-17
• Disposition First Submitted: 2021-06-25
• Results First Submitted: 2023-06-25
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-12
• Last Update Submitted: 2023-08-12
• Results First Posted: 2023-09-08
• Disposition First Posted: 2023-09-08
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Subjects with diabetes wearing Guardian™ Sensor (3). C algorithm applied retrospectively	Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. C sensor algorithm applied retrospectively to raw sensor data.	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 with diabetes wearing Guardian™ Sensor (3). C algorithm applied retrospectively	Acetominophen	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 with diabetes wearing Guardian™ Sensor (3). Zeus algorithm applied retrospectively	Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. Zeus 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.
Subjects with diabetes wearing Guardian™ Sensor (3). Zeus algorithm applied retrospectively	Acetominophen	Subjects wear Guardian™ Sensor (3) over 7 days and undergo one FST. Zeus sensor algorithm applied retrospectively to raw sensor data.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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%.

Trial Locations

Locations (6)

Barbara Davis Center - Adults; 🇺🇸 Aurora, Colorado, United States

"Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

Rainier Clinical Research Center, Inc.; 🇺🇸 Renton, Washington, United States

AMCR Institue; 🇺🇸 Escondido, California, United States

Sansum Diabetes Research Institute; 🇺🇸 Santa Barbara, California, United States

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States