NCT04020822

Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 diabetes,18-75 years of age.

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 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.

Conditions

• Type 1 Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Guardian Sensor (3)	Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.

Timeline

• Start date: 2019-07-29
• Primary completion: 2019-08-27
• Completion: 2019-08-27
• First posted: 2019-07-16
• Last updated: 2020-09-16
• Results posted: 2020-09-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study