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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Device: CGM Monitoring

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 24
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751932

Locations
Netherlands
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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
  More Information

No publications provided

Responsible Party: J.H. DeVries, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01751932     History of Changes
Other Study ID Numbers: SPACE2
Study First Received: December 13, 2012
Last Updated: December 13, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014