Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems (SPACE2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
J.H. DeVries, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01751932
First received: December 13, 2012
Last updated: December 13, 2013
Last verified: December 2013

December 13, 2012
December 13, 2013
January 2013
September 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01751932 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems
Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
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
Experimental: CGM Monitoring
Fitting of Dexcom G4 Platinum CGM monitor and Medtronic Enlite CGM monitor
Intervention: Device: CGM Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • aged 18 years or above
  • diagnosed with Type 1 diabetes mellitus at least 6 months according to the WHO definition
  • Body Mass Index (BMI) <35 kg/m²
  • willing and able to wear a CGM device for the duration of the study and undergo all study procedures
  • HbA1c <10%
  • signed informed consent form prior to study entry

Exclusion Criteria:

  • Patient is pregnant, or breast feeding during the period of the study.
  • Patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
  • Patient may not use acetaminophen (paracetamol) while participating in the study
  • Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
  • Patient is actively enrolled in another clinical trial or took part in a study within 30 days
  • Known adrenal gland problem, pancreatic tumour, or insulinoma
  • Inability of the patient to comply with all study procedures
  • Inability of the patient to understand the patient information.
  • Patient donated blood in the last 3 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01751932
SPACE2
Yes
J.H. DeVries, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Not Provided
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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP