Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

Completed · Not applicable

Conditions studied: Type 1 Diabetes, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT04020822

Run by

Medtronic MiniMed, Inc.

People needed

19

Starts

2019-07-29

Expected to finish

2019-08-27

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Barbara Davis Center for Diabetes — Aurora, Colorado, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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