Diabetes MellitusSPACE2NCT01751932
Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems
A study testing CGM Monitoring in people with Diabetes Mellitus, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- CGM Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105AZ
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- CGM Monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM MonitoringDevice
Also called Dexcom G4 Platinum and Medtronic Enlite CGM
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.
| Study group | Role | What they receive |
|---|---|---|
| CGM Monitoring | Experimental | Fitting of Dexcom G4 Platinum CGM monitor and Medtronic Enlite CGM monitor Receives: Device: CGM Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Relative Difference (MARD)
MARD will be assessed as an average of the first 6 days of wear
Measured: up to day 6 of use
Secondary outcomes (1)
Accuracy of sensors per glycemic range and trial phase
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.
Measured: up to day 6 of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.H. DeVries, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- J. Hans DeVries, MD, PhD, Principal investigator, Academic Medical Center - Department of Internal Medicine, Amsterdam, The NetherlandsEric Renard, PhD, Principal investigator, Medical University Montpellier, FranceAngelo Avogaro, PhD, Principal investigator, Medical University Padova, ItalyJulia Mader, MD, Study director, Medical University Graz, AustriaThomas Pieber, MD, Principal investigator, Medical University Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751932
- Sponsor's protocol ID
- SPACE2
- Acronym
- SPACE2
- Status last verified
- Dec 2013
- First submitted
- 13 Dec 2012
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25132320
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems
- ClinicalTrials.gov ID
- NCT01751932
- Acronym / sponsor ID
- SPACE2 / SPACE2
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM Monitoring | Experimental | Device: CGM MonitoringFitting of Dexcom G4 Platinum CGM monitor and Medtronic Enlite CGM monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGM MonitoringAlso: Dexcom G4 Platinum and Medtronic Enlite CGMAll 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. | Device | CGM Monitoring |
Primary outcome
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
1 secondary outcome
Accuracy of sensors per glycemic range and trial phase
Time frame: up to day 6 of use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Derived from this study: PubMed 25132320Kropff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Hans DeVries, MD, PhD principal investigator
Academic Medical Center - Department of Internal Medicine, Amsterdam, The Netherlands
Eric Renard, PhD principal investigator
Medical University Montpellier, France
Angelo Avogaro, PhD principal investigator
Medical University Padova, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM Monitoring in people with Diabetes Mellitus, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Absolute Relative Difference (MARD) (time frame: up to day 6 of use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01751932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.