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

NCT01751932 | Completed DMC

• 1 other identifier: SPACE2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Mean Absolute Relative Difference (MARD)

  MARD will be assessed as an average of the first 6 days of wear

  up to day 6 of use

Secondary Outcomes (1)

• Accuracy of sensors per glycemic range and trial phase

  up to day 6 of use

Study Arms (1)

CGM Monitoring

EXPERIMENTAL

Fitting of Dexcom G4 Platinum CGM monitor and Medtronic Enlite CGM monitor

Device: CGM Monitoring

Interventions

CGM Monitoring DEVICE

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.

Also known as: Dexcom G4 Platinum and Medtronic Enlite CGM

CGM Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 25132320 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Julia Mader, MD

  Medical University Graz, Austria

  STUDY DIRECTOR

• Thomas Pieber, MD

  Medical University Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 18, 2012
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

NL (1)