Function of Implanted Glucose Sensor 2 (FIGS-2)

GlySens

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Model 100 Sensor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02345967

PR13-004

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Study Group

Experimental group

Description:

Device: Model 100 Sensor

Treatment:

Device: Model 100 Sensor