Function of Implanted Glucose Sensor 2

Diabetes Mellitus Clinical Trial

— FIGS-2  

Official title:

Function of Implanted Glucose Sensor 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345967
• Other study ID #: PR13-004
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: May 30, 2018

Study information

• Verified date: June 2018
• Source: GlySens Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Model 100 Sensor
One Model 100 Sensor to be implanted per subject.

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research	Chula Vista	California
United States	AMCR Institute	Escondido	California

Sponsors (3)

Lead Sponsor	Collaborator
GlySens Incorporated	AMCR Institute, Profil Institute for Clinical Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	Incidence of adverse events related to the Intervention	From enrollment to 2-weeks post-explant