Function of Implanted Glucose Sensor 2

Completed · Not applicable

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.

Key facts

Study ID

NCT02345967

Run by

GlySens Incorporated

People needed

20

Starts

2015-01-01

Expected to finish

2018-05-30

Last updated by the study team

2018-06-13

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become pregnant
• Diabetes diagnosis of type 1, or type 2 using insulin
• Under the routine care of a physician for diabetes treatment
• Able to understand and follow directions
• History of compliance with diabetes care regimen
• Able to comply with study requirements regarding planned clinical visits and exams
• In good physical condition without major medical concerns or blood chemistry abnormalities

You may not qualify if…

• Mental disorders that might affect compliance to protocols
• Diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin or (2) insulin use restricted to a single daily injection of long-acting insulin or (3) control by diet/exercise regimen alone
• History of intolerance or sensitivity to any of the device materials
• History of any adverse reaction or allergy to any of the drugs/agents utilized in the study procedures
• History of recurrent skin infections

Where it is running

• Profil Institute for Clinical Research — Chula Vista, California, United States
• AMCR Institute — Escondido, California, United States

Full record on ClinicalTrials.gov

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