New Glucose Sensor Pediatric

NCT ID: NCT01161043

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2010-11-30

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sensor

All subjects that wear sensors (all subjects)

Group Type: EXPERIMENTAL

Sensor wear

Intervention Type: DEVICE

All subjects to wear sensors

Interventions

Sensor wear

All subjects to wear sensors

Intervention Type: DEVICE

Other Intervention Names

Enlite Sensor

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

Sutter Institute for Medical Research

Sacramento, California, United States

Endocrinology/ University of South Florida

St. Petersburg, Florida, United States

University of Minnesota Amplatz Children's Hospital

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

CEP232

Identifier Type: -

Identifier Source: org_study_id