Diabetes Mellitus, Type 1FACT-CGMNCT02843503
Factors in Accuracy Studies Influencing Measured CGM Performance.
A study testing Arterialized-venous reference (YSI), Venous reference measurement (YSI) and Capillary reference (SMBG) in people with Diabetes Mellitus, Type 1, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Primary objective is to assess the impact of different reference glucose measurement methods on the measured performance of a CGM system, aiming at further standardization for the assessment of CGM systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Arterialized-venous reference (YSI), Venous reference measurement (YSI) and Capillary reference (SMBG)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2016to Jan 2017
- 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
- diagnosed with type 1 DM 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 requires regular use of acetaminophen (paracetamol) while participating in the study due to known negative impact on CGM performance.
- patient is actively enrolled in another clinical trial or took part in a study within 30 days.
- known adrenal gland problem, panhypopitutarism, gastroparesis, migraine, epilepsy or ischemic heart disease or other cardiovascular event in the year previous to study participation .
- inability of the patient to comply with all study procedures.
Show all 10Show fewer
- inability of the patient to understand the patient information.
- patient donated blood in the last 3 months.
- 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.
- is assessed by the investigators to have difficult intravenous (IV) access .
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105AZ
About this study
Official title: Factors in Accuracy Studies Influencing Measured CGM Performance: a Comparison of Measured Continuous Glucose Monitor Performance Using Venous, Arterialized-venous and Capillary Reference Glucose Samples.
Primary objective is to assess the impact of different reference glucose measurement methods on the measured performance of a CGM system, aiming at further standardization for the assessment of CGM systems. Secondary objective is to describe the relationship between glucose concentration of venous, capillary and arterialized-venous measurement samples.
Study design: Open-label trial. Study population: Nineteen patients with type 1 diabetes aged 18 years and older will be included.
Intervention: The study will use the Dexcom G5 Mobile CGM. The participant will visit the clinical research center (CRC) twice during a 6 day period. These visits will have a duration of 8 hours. Blood will be drawn for the determination of glucose concentrations using venous, arterialized-venous and capillary sampling techniques. The patient will receive his usual breakfast and an increased insulin bolus will be administered to correct the breakfast glucose excursion with the aim of inducing a period of minor hypoglycemia. Blood sampling will continue until the end of the admission. The sensor will be worn until the end of the second 8-hour CRC session, which will be planned on day 6 or earlier depending on patient preference. The sensor will be removed and their sensor and blood glucose meter data downloaded from the devices. In the case of sensor failure before the first CRC session, patients will be instructed to insert a new sensor per the manufacturer's instruction and to notify study staff of the event. In case of failure of the sensor after the first CRC session but before the second CRC session, patients will return to the CRC for sensor removal and for data download.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Arterialized-venous reference (YSI), Venous reference measurement (YSI), Capillary reference (SMBG)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterialized-venous reference (YSI)Device
All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive an iv-catheter to sample venous blood. The samples will be arterialized using a heated-hand-box (arterialized-venous reference (YSI). Blood will be drawn for the determination of glucose concentrations using arterialized-venous sampling techniques per YSI.
Venous reference measurement (YSI)Device
All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive an iv-catheter to sample venous blood. Blood will be drawn for the determination of glucose concentrations using venous sampling techniques measured per YSI.
Capillary reference (SMBG)Device
All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive vingerstick measurements to sample capillary blood measured per Self Monitoring of Blood Glucose (SMBG) device.
| Study group | Role | What they receive |
|---|---|---|
| Arterialized-venous reference YSI | Experimental | CGM monitoring performance per arterialized venous reference measurement (YSI) Receives: Device: Arterialized-venous reference (YSI) |
| Venous reference samples YSI | Experimental | CGM monitoring performance per venous reference measurement (YSI) Receives: Device: Venous reference measurement (YSI); Device: Capillary reference (SMBG) |
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 per average of the 8 hour arterialization and regular venous study visit.
Measured: up to day 6 of use
Secondary outcomes (5)
Accuracy of sensors (MARD) per hypoglycemic range
Accuracy of the sensor in the hypoglycaemic (defined as a blood glucose value ≤70 mg/dL) area as an average of the first six days of use.
Measured: up to day 6 of use
Accuracy (MARD) of sensors per hyperglycemic range
Accuracy of the sensor in the hyperglycaemic (defined as a blood glucose value >180 mg/dL) area as an average of the first six days of use.
Measured: up to day 6 of use
Glucose content (mg/dL) of venous reference samples.
Glucose content of venous reference samples will be measured per YSI.
Measured: Up day 6 of study during both intervention visits
Glucose content (mg/dL) of venous-arterialized reference samples.
Glucose content of venous-arterialized reference samples will be measured per YSI.
Measured: up day 6 of study during both intervention visits
Glucose content (mg/dL) of capillary reference samples.
Glucose content of capillary reference samples will be measured per SMBG.
Measured: up day 6 of study during both intervention visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, J.H. DeVries, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843503
- Sponsor's protocol ID
- NL57491.018.16
- Acronym
- FACT-CGM
- Status last verified
- Jan 2017
- First submitted
- 19 Jul 2016
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors in Accuracy Studies Influencing Measured CGM Performance: a Comparison of Measured Continuous Glucose Monitor Performance Using Venous, Arterialized-venous and Capillary Reference Glucose Samples.
- ClinicalTrials.gov ID
- NCT02843503
- Acronym / sponsor ID
- FACT-CGM / NL57491.018.16
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Jul 2016 (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.
Primary objective is to assess the impact of different reference glucose measurement methods on the measured performance of a CGM system, aiming at further standardization for the assessment of CGM systems. Secondary objective is to describe the relationship between glucose concentration of venous, capillary and arterialized-venous measurement samples.
Study design: Open-label trial. Study population: Nineteen patients with type 1 diabetes aged 18 years and older will be included.
Intervention: The study will use the Dexcom G5 Mobile CGM. The participant will visit the clinical research center (CRC) twice during a 6 day period. These visits will have a duration of 8 hours. Blood will be drawn for the determination of glucose concentrations using venous, arterialized-venous and capillary sampling techniques. The patient will receive his usual breakfast and an increased insulin bolus will be administered to correct the breakfast glucose excursion with the aim of inducing a period of minor hypoglycemia. Blood sampling will continue until the end of the admission. The sensor will be worn until the end of the second 8-hour CRC session, which will be planned on day 6 or earlier depending on patient preference. The sensor will be removed and their sensor and blood glucose meter data downloaded from the devices. In the case of sensor failure before the first CRC session, patients will be instructed to insert a new sensor per the manufacturer's instruction and to notify study staff of the event. In case of failure of the sensor after the first CRC session but before the second CRC session, patients will return to the CRC for sensor removal and for data download.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arterialized-venous reference YSI | Experimental | Device: Arterialized-venous reference (YSI)CGM monitoring performance per arterialized venous reference measurement (YSI) |
| Venous reference samples YSI | Experimental | Device: Venous reference measurement (YSI), Device: Capillary reference (SMBG)CGM monitoring performance per venous reference measurement (YSI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosed with type 1 DM 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
Key exclusion criteria (10 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 requires regular use of acetaminophen (paracetamol) while participating in the study due to known negative impact on CGM performance.
- patient is actively enrolled in another clinical trial or took part in a study within 30 days.
- known adrenal gland problem, panhypopitutarism, gastroparesis, migraine, epilepsy or ischemic heart disease or other cardiovascular event in the year previous to study participation .
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 |
|---|---|---|
| Arterialized-venous reference (YSI)All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive an iv-catheter to sample venous blood. The samples will be arterialized using a heated-hand-box (arterialized-venous reference (YSI). Blood will be drawn for the determination of glucose concentrations using arterialized-venous sampling techniques per YSI. | Device | Arterialized-venous reference YSI |
| Venous reference measurement (YSI)All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive an iv-catheter to sample venous blood. Blood will be drawn for the determination of glucose concentrations using venous sampling techniques measured per YSI. | Device | Venous reference samples YSI |
| Capillary reference (SMBG)All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive vingerstick measurements to sample capillary blood measured per Self Monitoring of Blood Glucose (SMBG) device. | Device | Venous reference samples YSI |
Primary outcome
Mean Absolute Relative Difference (MARD)
Time frame: up to day 6 of use
MARD will be assessed per average of the 8 hour arterialization and regular venous study visit.
5 secondary outcomes
Accuracy of sensors (MARD) per hypoglycemic range
Time frame: up to day 6 of use
Accuracy (MARD) of sensors per hyperglycemic range
Time frame: up to day 6 of use
Glucose content (mg/dL) of venous reference samples.
Time frame: Up day 6 of study during both intervention visits
Glucose content (mg/dL) of venous-arterialized reference samples.
Time frame: up day 6 of study during both intervention visits
Glucose content (mg/dL) of capillary reference samples.
Time frame: up day 6 of study during both intervention visits
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 24 Jan 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterialized-venous reference (YSI), Venous reference measurement (YSI) and Capillary reference (SMBG) in people with Diabetes Mellitus, Type 1, 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 5 inclusion and 10 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 24 Jan 2017. 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?
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 24 Jan 2017.