Status:
COMPLETED
Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 di...
Detailed Description
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04020822
Start Date
July 29 2019
End Date
August 27 2019
Last Update
September 16 2020
Active Locations (2)
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1
Barbara Davis Center for Diabetes
Aurora, Colorado, United States, 80045
2
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318