An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor

Not Applicable

Completed

Conditions: Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus

Interventions: Device: Sensor wear

Registration Number: NCT01112696

Lead Sponsor: Medtronic Diabetes

Brief Summary: The purpose of the study is to assess the performance of a new subcutaneous glucose sensor over a seven-day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performance 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 a 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 a "gold standard" (YSI plasma glucose values) in adult subjects during in-clinic testing, and 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), 3) the Guardian REAL-Time Display Device and 4) the CGMS iPro.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

Males and females aged 18 through 75 inclusive
Diagnosed with Type 1 or type 2 Diabetes Mellitus, using insulin to treat their diabetes (Each site's and overall study enrollment of subjects with Type 2 diabetes will target 20% of the total number)
Willingness to perform required study and data collection procedures and to adhere to operating requirements of the Guardian REAL-TIME and CGMS iPro Systems
Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-TIME and CGMS iPro Systems
Willingness to participate in a 10 hour frequent blood sampling session during the study
Subject agrees to comply with the study protocol requirements
Informed Consent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject
The Subject is willing to wear both the Guardian REAL-Time and CGMS iPro Systems for 14 days (~340 hours)

Exclusion Criteria

The Subject has a history of tape allergies that have not been resolved
The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) that has not been resolved and would inhibit them from wearing the sensors
Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the Subject from completing the study
Subject is currently participating in an investigational study (drug or device)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sensor	Sensor wear	All subjects that wear sensors (all subjects)

Primary Outcome Measures

Name	Time	Method
Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria	Days one through six of sensor use	The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI \<80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.

Secondary Outcome Measures

Name	Time	Method
Device Related Moderate or Device Related Severe Adverse Events	days one through six of sensor wear	Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy. Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device.

Trial Locations

Locations (3): AMCR Institute, Inc.
🇺🇸
Escondido, California, United States
Sansum Diabetes Research Institute
🇺🇸
Santa Barbara, California, United States
Rainier Clinical Research Center, Inc.
🇺🇸
Renton, Washington, United States