Clinical trial NCT01161043: New Glucose Sensor Pediatric
Official title: An Evaluation of a New Subcutaneous Glucose Sensor in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: diabetes
glucose
sensor
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2010-07-13
Enrollment: 83
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Glucose Sensor Accuracy When Compared to SMBG: Proportion of Glucose Sensor Readings That Met Accuracy Criteria [Time Frame: Days One Through Six of Sensor Use]
timeFrame: Days one through six of sensor use
Secondary outcomes:
measure: Device Related Moderate or Device Related Severe Adverse Events
timeFrame: days one through six of sensor wear
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Saint Petersburg
country: United States
facility: Endocrinology/ University of South Florida
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota Amplatz Children's Hospital
state: Minnesota
Study officials:
References: