Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

Study Overview
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Brief Summary
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The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin requiring diabetes,18-75 years of age.

Detailed Description
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The study is a multi-center, prospective single-arm design without controls. All subjects will be assigned to treatment for 11 days of sensor wear. Each subject will wear 4 Guardian Sensor (3)s, and each will be connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter. Subjects will not use sensor glucose values for diabetes management. On days 1, 3, 5, and 6, subjects will be asked to measure blood glucose (BG) using a home glucose meter approximately every 20 minutes for 5 hours. Subjects will be asked to take one gram of acetaminophen orally on days 3, 5, and 6 of sensor wear. On day 11, devices will be removed, data uploaded from the study meter and transmitter or recorder, skin assessment will be performed, and the subject's participation in the study will be completed.

Official Title
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Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices - Phase 3 Group

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Device: Guardian Sensor (3)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18-75 years of age at time of screening A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator, for at least the last 12 months Subject is using insulin to treat their diabetes Subject agrees to comply with the study protocol requirements Subject is willing to perform self-monitoring of blood glucose approximately every 20 minutes during FST Exclusion Criteria: Subject has history of allergy to acetaminophen or has been told by health care provider they may not ingest acetaminophen Subject reports history of liver cirrhosis or problems with liver that a health care provider told them they should not use acetaminophen because of liver disorder. Subject is unable to tolerate tape adhesive in the area of sensor placement 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 or plans to enroll in an investigational study (drug or device), other than this study, wherein they have received treatment from an investigational drug or device Subject has a positive urine pregnancy test at time of screening Subject is female, sexually active without the use of contraception, able to become pregnant or plans to become pregnant during the course of the study Subject is unwilling to participate in study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects Wearing Guardian Sensor (3)s<br>Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear. | Device: Guardian Sensor (3)<br>* Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor Glucose Before and After Acetaminophen Administration | Accuracy (mean absolute relative difference) between the primary sensor values and meter BG values during the hour leading to and two hours after ingestion of acetaminophen. Primary sensor will be assigned to sensor number one (inserted in arm). Mean Absolute Relative Difference = Mean of ((absolute difference of meter and sensor blood glucose values / meter glucose values) * 100). Note that the results reported below for one hour leading to and two hours after acetaminophen ingestion were pooled together across multiple testing days (days 3, 5, and 6). | Assessed up to 11 days, frequent sample testing recordings from the three-hour period leading to and after Acetaminophen ingestion on days 3, 5, and 6 reported | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetaminophen