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New Glucose Sensor Pediatric

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: NCT01161043
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : September 20, 2011
Sponsor:
Information provided by:
Medtronic Diabetes

Tracking Information
First Submitted Date July 9, 2010
First Posted Date July 13, 2010
Last Update Posted Date September 20, 2011
Study Start Date July 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title New Glucose Sensor Pediatric
Official Title An Evaluation of a New Subcutaneous Glucose Sensor in Pediatric Subjects
Brief Summary The purpose of this study is to assess performance of a new subcutaneous glucose sensor over a seven day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performance of the new sensor will be calculated for use of the new sensor with proposed new devices using new calibration algorithms.
Detailed Description The first generation Medtronic MiniMed Subcutaneous Glucose Sensor (Sof-Sensor) was originally approved by the FDA for commercialization as part of the Continuous Glucose Monitoring System (CGMS) on June 15, 1999 (PMA 980022). The Sensor is composed of a microelectrode with a thin coating of glucose oxidase beneath several layers of biocompatible membrane. This same sensor was used as part of subsequent continuous glucose monitoring (CGM) systems, such as the Guardian REAL-Time and Paradigm REAL-Time sensor augmented insulin pump. The current configuration of sensor has undergone in vitro and in vivo testing. A new second-generation glucose sensor (herein referred to as the Comfort Sensor) has been developed. The first-generation glucose sensor was approved with reported sensor accuracy (MAD) of 18%; it was labeled for maximum use duration of 72 hours, using only the abdomen as an insertion site. The new sensor is shorter and has a smaller diameter, with a smaller gauge introducer needle. The new sensor inserter is designed to be used with the new sensor. The objectives of this study are to 1) Assess performance of the Comfort Sensor when used over a period of seven days with currently available devices, and 2) Assess performance of the Comfort Sensor when used over a period of seven days using new calibration algorithms (post-processed with algorithm for future devices). Accuracy data will be calculated based on comparing calibrated glucose sensor values to glucose meter values during in-home testing. The devices that will be used for gathering sensor data during this study will be: 1) the Comfort Sensor, 2) the MiniLink (Transmitter), and 3) the Guardian REAL-Time Display Device.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric subjects, ages 7-17 inclusive, Type 1 diabetes
Condition Type 1 Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Completed
Estimated Enrollment
 (submitted: July¬†12,¬†2010)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date November 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Males and females aged 7 through 17 inclusive
  2. Diagnosed with Type 1 Diabetes Mellitus
  3. Willingness to perform required study and data collection procedures and to adhere to operating requirements of the Guardian REAL-TIME System
  4. Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-TIME System
  5. Subject agrees to comply with the study protocol requirements
  6. Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject and/or parent/guardian
  7. The Subject is willing to wear the Guardian REAL-Time System for 14 days (~340 hours).

Exclusion Criteria:

  1. The Subject has a history of tape allergies that have not been resolved at time of enrollment
  2. The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of sensor placement that have not been resolved at the time of enrollment and would inhibit them from wearing the sensors
  3. Subject has a positive pregnancy test on enrollment
  4. Subject is currently participating in an investigational study (drug or device)
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01161043
Other Study ID Numbers CEP232
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Francine Kaufman MD, Chief Medical Officer and Vice President, Medtronic Diabetes
Study Sponsor Medtronic Diabetes
Collaborators Not Provided
Investigators Not Provided
PRS Account Medtronic Diabetes
Verification Date March 2011