Trial record 1 of 1 for:    NCT01161043
Previous Study | Return to List | Next Study

New Glucose Sensor Pediatric

This study has been completed.
Sponsor:
Information provided by:
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01161043
First received: July 9, 2010
Last updated: September 19, 2011
Last verified: March 2011
  Purpose

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.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Evaluation of a New Subcutaneous Glucose Sensor in Pediatric Subjects

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Estimated Enrollment: 60
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pediatric subjects, ages 7-17 inclusive, Type 1 diabetes

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161043

Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35213
United States, California
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
United States, Florida
Endocrinology/ University of South Florida
St. Petersburg, Florida, United States, 33549
United States, Minnesota
University of Minnesota Amplatz Children's Hospital
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Medtronic Diabetes
  More Information

No publications provided

Responsible Party: Francine Kaufman MD, Chief Medical Officer and Vice President, Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01161043     History of Changes
Other Study ID Numbers: CEP232
Study First Received: July 9, 2010
Last Updated: September 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Diabetes:
diabetes
glucose
sensor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014