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Standardized Procedure for the Assessment of new-to-market Continuous glucosE monitoring systems
ISRCTN ISRCTN01687353
DOI 10.1186/ISRCTN01687353
ClinicalTrials.gov identifier
EudraCT number
Public title Standardized Procedure for the Assessment of new-to-market Continuous glucosE monitoring systems
Scientific title Standardized Procedure for the Assessment of new-to-market Continuous glucosE monitoring systems: an open-label study
Acronym SPACE
Serial number at source WP1.1/SPACE
Study hypothesis For the development of a closed loop system, continuous glucose monitoring (CGM) systems with an acceptable accuracy and reliability need to be available. It has been shown that accuracy of needle-type CGM systems can be poor, especially in the hypoglycemic range. As of yet, there is no standardized procedure to assess the accuracy and reliability of CGM systems that are introduced into the market. Most pre-market assessments of CGM systems have been done by means of Clarke Error Grid Analysis and assessment of correlation between CGM reported glucose values and reference blood glucose values. We want to evaluate a more comprehensive method for CGM system assessment.
Lay summary Lay summary under review 1
Ethics approval 1. Medical Ethics Review Academic Medical Center Amsterdam (Medisch Ethische Toetsingscommissie Academisch Medisch Centrum Amsterdam), approved on 18 July 2010, reference number 2010_336.
2. Ethics Committee of the Medical University of Graz (Ethikkommission der Medizinischen Universität Graz), approved on 2 August 2011
3. Committee to Protect People southern Mediterranean IV (Comité de Protection des Personnes Sud Méditerranée IV), approved on 10 August 2011
4. Hospital and University of Padua Ethics Committee for Experimentation (Azienda Ospedaliera e Università degli Studi di Padova Comitato Etico per la Sperimentazione), approved on 24 August 2011
5. Ethics Committee of the Medical Association of North (Ethikkommission der Ärztekammer Nordrhein), approved on 07 July 2011
Study design Multinational open-label study
Countries of recruitment Austria, France, Germany, Italy, Netherlands
Disease/condition/study domain Diabetes Mellitus Type 1
Participants - inclusion criteria 1.Aged 18 years or above
2. Diagnosed with Type 1 diabetes mellitus (DM) at least 6 months according to the WHO definition
3. Body Mass Index (BMI) <35 kg/m²
4. Willing and able to wear a CGM device for the duration of the study and undergo all study procedures
5. HbA1c <10%
6. Signed informed consent form prior to study entry
Participants - exclusion criteria 1. Patient is pregnant, or breast feeding during the period of the study
2. 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
3. Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the patientís safety or successful participation in the study
4. Patient is actively enrolled in another clinical trial or took part in a study within 30 days
5. Known adrenal gland problem, pancreatic tumour, or insulinoma
6. Inability of the patient to comply with all study procedures
7. Inability of the patient to understand the patient information
8. Patient donated blood in the last 3 months
Anticipated start date 01/09/2011
Anticipated end date 01/08/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 20
Interventions The study will use three marketed CGM systems (Animas Vibe (Animas Corp, USA and Dexcom Inc, USA), Abbott Navigator (Abbott Diabetes Care, USA) and the Medtronic Minimed Guardian / Paradigm system (Medtronic, USA)). All three CGM sensors will be worn by the participant during the visit to the clinical research center (CRC). This visit will have a duration of 4 hours.

Blood will be drawn for the determination of glucose levels. The patient will receive his usual breakfast and postpone his usual morning insulin injection. A delayed and increased insulin bolus (aiming at 5 IU or 60% in excess of the patientís 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. Pressure will be applied to the sensors during the last 2 hours of the CRC visit to determine the effect of pressure on CGM accuracy. At the end of this CRC part, the patient will continue to wear two of the three sensors at home, which ones will be determined by randomization. Sensors will be worn until the end-of-life of the sensor. Patients will be asked to perform at least 5 fingersticks per day for blood glucose measurements with the study glucometer. If the sensor has reached its manufacturer-specified lifetime end, the sensor will remain in situ and it will be attempted to re-activate the sensor within the CGM system to assess the sensor beyond its manufacturer specified lifetime. The study will end when the sensors cannot be reactivated anymore. In case of sensor failure, patients will return to the CRC to have the sensor removed and their CGM sensor and blood glucometer data downloaded from the devices.
Primary outcome measure(s) 1. Blood glucose values
2. Sensor glucose values and
3. Duration of sensor life

From the sensor glucose values the Mean and Median Absolute Relative Difference (MARD) compared to blood glucose values will be determined. Blood glucose values will consist of Yellow Springs Instruments (YSI) values during the CRC period and fingerstick values thereafter
Secondary outcome measure(s) 1. Accuracy of the sensor in the hypoglycaemic and hyperglycaemic area
2. Analysis to assess sensor performance and accuracy per day of sensor life, before and after approved time of use
Sources of funding The European Commission (EU) - FP7 Program (Belgium) ref: 247138
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23650900
Contact name Dr  J Hans  DeVries
  Address Academic Medical Centre
Room F4-215
PO Box 22660
  City/town Amsterdam
  Zip/Postcode 1100DD
  Country Netherlands
Sponsor Academic Medical Centre (Netherlands)
  Address c/o Dr J. Hans DeVries
PO Box 22660
Room F4-215
  City/town Amsterdam
  Zip/Postcode 1100DD
  Country Netherlands
  Sponsor website: http://www.amc.nl
Date applied 25/06/2012
Last edited 17/03/2014
Date ISRCTN assigned 02/08/2012
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