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Function of Implanted Glucose Sensor 2 (FIGS-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE January 20, 2015
First Posted Date  ICMJE January 26, 2015
Last Update Posted Date June 13, 2018
Study Start Date  ICMJE January 2015
Actual Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
Number of Adverse Events [ Time Frame: From enrollment to 2-weeks post-explant ]
Incidence of adverse events related to the Intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02345967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Function of Implanted Glucose Sensor 2
Official Title  ICMJE Function of Implanted Glucose Sensor 2
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Device: Model 100 Sensor
One Model 100 Sensor to be implanted per subject.
Study Arms Experimental: Study Group
Device: Model 100 Sensor
Intervention: Device: Model 100 Sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date May 30, 2018
Actual Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02345967
Other Study ID Numbers  ICMJE PR13-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlySens Incorporated
Study Sponsor  ICMJE GlySens Incorporated
Collaborators  ICMJE
  • Profil Institute for Clinical Research, Inc.
  • AMCR Institute
Investigators  ICMJE
Principal Investigator: Linda Morrow, MD Profil Institute for Clinical Research, Inc.
PRS Account GlySens Incorporated
Verification Date June 2018

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