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Function of Implanted Glucose Sensor 2 (FIGS-2)

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ClinicalTrials.gov Identifier: NCT02345967
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
Profil Institute for Clinical Research, Inc.
AMCR Institute
Information provided by (Responsible Party):
GlySens Incorporated

January 20, 2015
January 26, 2015
June 13, 2018
January 2015
May 30, 2018   (Final data collection date for primary outcome measure)
Number of Adverse Events [ Time Frame: From enrollment to 2-weeks post-explant ]
Incidence of adverse events related to the Intervention
Same as current
Complete list of historical versions of study NCT02345967 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Function of Implanted Glucose Sensor 2
Function of Implanted Glucose Sensor 2
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Diabetes Mellitus
Device: Model 100 Sensor
One Model 100 Sensor to be implanted per subject.
Experimental: Study Group
Device: Model 100 Sensor
Intervention: Device: Model 100 Sensor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
May 30, 2018
May 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02345967
PR13-004
Not Provided
Not Provided
Not Provided
GlySens Incorporated
GlySens Incorporated
  • Profil Institute for Clinical Research, Inc.
  • AMCR Institute
Principal Investigator: Linda Morrow, MD Profil Institute for Clinical Research, Inc.
GlySens Incorporated
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP