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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378114
• Other study ID #: CIP333
• Status: Completed
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: July 17, 2020

Study information

• Verified date: August 2023
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 17, 2020
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Device:
• Guardian™ 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.
• Guardian™ 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.

Drug:
• Acetominophen
One time administration of acetaminophen.

Locations

Country	Name	City	State
United States	"Atlanta Diabetes Associates	Atlanta	Georgia
United States	Barbara Davis Center - Adults	Aurora	Colorado
United States	AMCR Institue	Escondido	California
United States	Rainier Clinical Research Center, Inc.	Renton	Washington
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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].	Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
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%).	Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
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%.	Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported