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

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ClinicalTrials.gov Identifier: NCT01751932
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
J.H. DeVries, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date  ICMJE December 13, 2012
First Posted Date  ICMJE December 18, 2012
Last Update Posted Date December 16, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2012)
Mean Absolute Relative Difference (MARD) [ Time Frame: up to day 6 of use ]
MARD will be assessed as an average of the first 6 days of wear
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2012)
Accuracy of sensors per glycemic range and trial phase [ Time Frame: up to day 6 of use ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems
Official Title  ICMJE Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: CGM Monitoring
Fitting of Dexcom G4 Platinum CGM monitor and Medtronic Enlite CGM monitor
Intervention: Device: CGM Monitoring
Publications * Kropff J, Bruttomesso D, Doll W, Farret A, Galasso S, Luijf YM, Mader JK, Place J, Boscari F, Pieber TR, Renard E, DeVries JH. Accuracy of two continuous glucose monitoring systems: a head-to-head comparison under clinical research centre and daily life conditions. Diabetes Obes Metab. 2015 Apr;17(4):343-9. doi: 10.1111/dom.12378. Epub 2014 Sep 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2012)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01751932
Other Study ID Numbers  ICMJE SPACE2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party J.H. DeVries, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date December 2013

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