Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems (SPACE2)
The purpose of this study is to assess the accuracy of two continuous glucose monitoring devices (the Dexcom G4 Platinum and Medtronic Enlite systems) in patients with type 1 diabetes mellitus.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems|
- Mean Absolute Relative Difference (MARD) [ Time Frame: up to day 6 of use ] [ Designated as safety issue: No ]MARD will be assessed as an average of the first 6 days of wear
- Accuracy of sensors per glycemic range and trial phase [ Time Frame: up to day 6 of use ] [ Designated as safety issue: No ]Accuracy of the sensor in the hypoglycaemic (defined as a blood glucose value ≤3.9 mmol/L) and hyperglycaemic area (defined as a blood glucose value ≥10.0 mmol/L) as an average of the first six days of use. Additionally, a separate analysis will be performed to assess sensor performance and accuracy per day of sensor life.
|Study Start Date:||January 2013|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: CGM Monitoring
Fitting of Dexcom G4 Platinum CGM monitor and Medtronic Enlite CGM monitor
Device: CGM Monitoring
All patients will be fitted with the two study CGM systems. Paradigm Veo will be configured to use the CGM part only if another pump is used.
Other Name: Dexcom G4 Platinum and Medtronic Enlite CGM
The study will use two CE marked Continuous Glucose Monitoring (CGM) systems; Dexcom G4 Platinum CGM CE-marked 2012 (Dexcom, USA) and the Medtronic Paradigm Veo system with Enlite Sensor CE-marked 2011 (Medtronic, USA). Both the Dexcom G4 Platinum and the Medtronic Enlite sensors will be obtained through normal commercial channels rather than directly from the manufacturer. The two CGM sensors will be worn concomitantly by the participant during the visit to the Clinical Research Center (CRC). This visit will have a duration of 6 hours. Blood will be drawn for the determination of glucose levels. The patient will receive his usual breakfast and an increased insulin bolus (180% of the patient's calculated mealtime dose) will be administered to correct the breakfast glucose excursion with the aim of inducing a period of minor hypoglycaemia. Blood sampling will continue until the end of the admission. At the end of this CRC part, the patient will continue to wear the two sensors at home. In the case of sensor failure before the CRC session on the third day into the study, patients will be instructed to insert a new sensor per the manufacturer's instruction for use and to notify study coordinators of the event. Sensors will be worn until the end of the six day study duration. Patients will be asked to perform at least 6 fingersticks per day for blood glucose measurements with the study glucometer. The study will end on the 6th day after initial sensor insertion. Patients will return to the CRC to have the sensor removed and their CGM sensor and blood glucometer data downloaded from the devices. In case of failure of both sensors after the CRC session but before the scheduled six day study duration, patients will return to the CRC for sensor removal and for data download.
|Academic Medical Center|
|Amsterdam, Noord-Holland, Netherlands, 1105AZ|
|Principal Investigator:||J. Hans DeVries, MD, PhD||Academic Medical Center - Department of Internal Medicine, Amsterdam, The Netherlands|
|Principal Investigator:||Eric Renard, PhD||Medical University Montpellier, France|
|Principal Investigator:||Angelo Avogaro, PhD||Medical University Padova, Italy|
|Study Director:||Julia Mader, MD||Medical University Graz, Austria|
|Principal Investigator:||Thomas Pieber, MD||Medical University Graz, Austria|