Diabetes Type 1NCT02734745
Accuracy of Freestyle Libre
A study testing flash glucose monitoring in people with Diabetes Type 1, run by University of Padova at 1 site in Italy.
Trial summary
This is an open-label, mono-centre, interventional study.The aim of this trial is to assess accuracy and reliability of a flash glucose monitoring system, the freestyle Libre (Abbott, CA, USA), in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 1
- What is being tested?
- flash glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2016to 1 Dec 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
- Age > 18 years
- Diagnosis of diabetes mellitus type 1 ( diagnosed according to World Health Organization criteria ) for at least one year
- Body Mass Index ( BMI ) < 35 kg / m²
- Willingness to wear the device and to comply with the study protocol during the entire duration of the same
- No restrictions linked to glycated hemoglobin ( HbA1c )
- Signature of informed consent before any study-related procedure
Who cannot join
- Pregnancy, breast-feeding, planning pregnancy, or refuse to use contraception during the study period (for female subjects).
- Known allergies to patches or skin disinfectants used during the study.
- skin lesions, irritation, redness, edema, in the possible application of the sensor sites that may interfere with the placement of the device or the detection accuracy of test results.
- blood donations in the 3 months preceding the study.
- Use of drugs that can interfere with glucose metabolism (such as steroids) unless it is chronic therapies whose dosage has remained stable over the last 3 months and is expected to remain stable during the study period.
- serious medical or psychological conditions that in the opinion of the medical team could compromise patient safety during study participation.
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- Patients enrolled in other clinical trials.
- known disorders of the adrenal glands, pancreatic tumors, or insulinomas
- Inability of the patient to comply with the study procedures
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Padova
Padova
Daniela Bruttomesso, MD, PHD, daniela.bruttomesso@unipd.it
About this study
Official title: Accuracy of Flash Glucose Monitoring Freestyle Libre (Abbott) in Home Setting and In-patient Setting During Hypo - Hyperglycemia
This is an open-label, mono-centre, interventional study.The aim of this trial is to assess accuracy and reliability of a flash glucose monitoring system, the freestyle Libre (Abbott, CA, USA), in patients with type 1 diabetes.
Read the detailed description
Objective: To assess accuracy and reliability of a new-to-market flash glucose monitoring system, the freestyle Libre (Abbott, CA, USA), in patients with type 1 diabetes.
Study design: open-label, mono-centre interventional study. Patients will wear freestyle Libre for 14 days in the home setting. There will be no limitations in food intake or in physical activity, but patients will have at least 7 finger-stick/days. Patients will have 2 visits in our clinical center and in these visits we'll compare freestyle Libre values with blood sampling to determine glucose values with YSI, during euglycemia and during glucose excursion and induced hypo-hyperglycemia.
Study population: 48 patients will be included in this trial. Every patient will wear device for 14 days at home and during 2 visits at CRC Study endpoints: main endpoint will be the evaluation of freestyle Libre accuracy during real life compared to glucometer values and to YSI glucose values (during 2 visits). A separate analysis will be performed on the accuracy of the freestyle Libre 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). Additionally, a separate analysis will be performed to assess device performance and accuracy per day of device life.
If patients enrolled in the study use Dexcom G4 or G5 (CGM) and wanted to continue to use it, he/she can do so. In this case we can compare the accuracy of Libre even towards Dexcom G4/G5 device.
- Conditions
- Diabetes Type 1
- Being tested
- flash glucose monitoring
- Keywords
- diabetes type 1, flash glucose monitoring
- 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.
flash glucose monitoringDevice
Patients will use Freestyle Libre for 14 days at home, during this period they will have to perform at least 7 measurements of capillary blood glucose per day . Patients also will go to our clinical center on two separate occasions , to run a test breakfast. In one of the two occasions it will be specifically induced a moderate initial hyperglycemia and subsequent hypoglycemia . During the test meal and in the subsequent hours for a total of 6 hours , will be carried out frequent blood sampling for measurement of blood glucose using the Yellow Springs glucose analyzer ( YSI system ) , simultaneous measurements with Freestyle Libre and with glucometer.
| Study group | Role | What they receive |
|---|---|---|
| flash glucose monitoring | Experimental | Patients will use a device: Freestyle Libre for 14 days Receives: Device: flash glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of freestyle Libre flash monitoring
accuracy of freestyle Libre flash monitoring measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glucometer during home setting
Measured: 14 days
Secondary outcomes (3)
Evaluate the accuracy of the Free Style Libre for each day of use and during normoglycaemia ( between 70 and 180 mg / dl )
accuracy of freestyle Libre flash monitoring during normoglycaemia (between 70 and 180 mg / dl) measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glocometer during home setting, accuracy for each day of use measured as MARD respect to glucometer
Measured: 14 days
Evaluate the accuracy of the Free Style Libre for each day of use and during hypoglicaemia ( < 70 mg / dl )
accuracy of freestyle Libre flash monitoring during hypogliacemia (< 70 mg / dl) measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glucometer during home setting,
Measured: 14 days
Evaluate the accuracy of the Free Style Libre for each day of use and during hyperglicemia ( >180 mg / dl )
accuracy of freestyle Libre flash monitoring measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glucometer during home setting,
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start1 Apr 2016
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Bruttomesso, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734745
- Sponsor's protocol ID
- 3724/AO/16
- Status last verified
- Apr 2017
- First submitted
- 6 Apr 2016
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Boscari F, Galasso S, Acciaroli G, Facchinetti A, Marescotti MC, Avogaro A, Bruttomesso D. Head-to-head comparison of the accuracy of Abbott FreeStyle Libre and Dexcom G5 mobile. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):425-427. doi: 10.1016/j.numecd.2018.01.003. Epub 2018 Jan 31. No abstract available.
PubMed 29502924Fadini GP, Boscari F, Cappellari R, Galasso S, Rigato M, Bonora BM, D'Anna M, Bruttomesso D, Avogaro A. Effects of Hypoglycemia on Circulating Stem and Progenitor Cells in Diabetic Patients. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1048-1055. doi: 10.1210/jc.2017-02187.
PubMed 29300991Boscari F, Galasso S, Facchinetti A, Marescotti MC, Vallone V, Amato AML, Avogaro A, Bruttomesso D. FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):180-186. doi: 10.1016/j.numecd.2017.10.023. Epub 2017 Nov 11.
PubMed 29258716
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Flash Glucose Monitoring Freestyle Libre (Abbott) in Home Setting and In-patient Setting During Hypo - Hyperglycemia
- ClinicalTrials.gov ID
- NCT02734745
- Acronym / sponsor ID
- 3724/AO/16
- Conditions
- Diabetes Type 1
- Keywords
- diabetes type 1, flash glucose monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 12 Apr 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.
This is an open-label, mono-centre, interventional study.The aim of this trial is to assess accuracy and reliability of a flash glucose monitoring system, the freestyle Libre (Abbott, CA, USA), in patients with type 1 diabetes.
Detailed description
Objective: To assess accuracy and reliability of a new-to-market flash glucose monitoring system, the freestyle Libre (Abbott, CA, USA), in patients with type 1 diabetes.
Study design: open-label, mono-centre interventional study. Patients will wear freestyle Libre for 14 days in the home setting. There will be no limitations in food intake or in physical activity, but patients will have at least 7 finger-stick/days. Patients will have 2 visits in our clinical center and in these visits we'll compare freestyle Libre values with blood sampling to determine glucose values with YSI, during euglycemia and during glucose excursion and induced hypo-hyperglycemia.
Study population: 48 patients will be included in this trial. Every patient will wear device for 14 days at home and during 2 visits at CRC Study endpoints: main endpoint will be the evaluation of freestyle Libre accuracy during real life compared to glucometer values and to YSI glucose values (during 2 visits). A separate analysis will be performed on the accuracy of the freestyle Libre 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). Additionally, a separate analysis will be performed to assess device performance and accuracy per day of device life.
If patients enrolled in the study use Dexcom G4 or G5 (CGM) and wanted to continue to use it, he/she can do so. In this case we can compare the accuracy of Libre even towards Dexcom G4/G5 device.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| flash glucose monitoring | Experimental | Device: flash glucose monitoringPatients will use a device: Freestyle Libre for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Diagnosis of diabetes mellitus type 1 ( diagnosed according to World Health Organization criteria ) for at least one year
- Body Mass Index ( BMI ) < 35 kg / m²
- Willingness to wear the device and to comply with the study protocol during the entire duration of the same
- No restrictions linked to glycated hemoglobin ( HbA1c )
Key exclusion criteria (9 listed)
- Pregnancy, breast-feeding, planning pregnancy, or refuse to use contraception during the study period (for female subjects).
- Known allergies to patches or skin disinfectants used during the study.
- skin lesions, irritation, redness, edema, in the possible application of the sensor sites that may interfere with the placement of the device or the detection accuracy of test results.
- blood donations in the 3 months preceding the study.
- Use of drugs that can interfere with glucose metabolism (such as steroids) unless it is chronic therapies whose dosage has remained stable over the last 3 months and is expected to remain stable during the study period.
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 |
|---|---|---|
| flash glucose monitoringPatients will use Freestyle Libre for 14 days at home, during this period they will have to perform at least 7 measurements of capillary blood glucose per day . Patients also will go to our clinical center on two separate occasions , to run a test breakfast. In one of the two occasions it will be specifically induced a moderate initial hyperglycemia and subsequent hypoglycemia . During the test meal and in the subsequent hours for a total of 6 hours , will be carried out frequent blood sampling for measurement of blood glucose using the Yellow Springs glucose analyzer ( YSI system ) , simultaneous measurements with Freestyle Libre and with glucometer. | Device | flash glucose monitoring |
Primary outcome
accuracy of freestyle Libre flash monitoring
Time frame: 14 days
accuracy of freestyle Libre flash monitoring measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glucometer during home setting
3 secondary outcomes
Evaluate the accuracy of the Free Style Libre for each day of use and during normoglycaemia ( between 70 and 180 mg / dl )
Time frame: 14 days
Evaluate the accuracy of the Free Style Libre for each day of use and during hypoglicaemia ( < 70 mg / dl )
Time frame: 14 days
Evaluate the accuracy of the Free Style Libre for each day of use and during hyperglicemia ( >180 mg / dl )
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Derived from this study: PubMed 29502924Boscari F, Galasso S, Acciaroli G, Facchinetti A, Marescotti MC, Avogaro A, Bruttomesso D. Head-to-head comparison of the accuracy of Abbott FreeStyle Libre and Dexcom G5 mobile. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):425-427. doi: 10.1016/j.numecd.2018.01.003. Epub 2018 Jan 31. No abstract available.
- Derived from this study: PubMed 29300991Fadini GP, Boscari F, Cappellari R, Galasso S, Rigato M, Bonora BM, D'Anna M, Bruttomesso D, Avogaro A. Effects of Hypoglycemia on Circulating Stem and Progenitor Cells in Diabetic Patients. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1048-1055. doi: 10.1210/jc.2017-02187.
- Derived from this study: PubMed 29258716Boscari F, Galasso S, Facchinetti A, Marescotti MC, Vallone V, Amato AML, Avogaro A, Bruttomesso D. FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):180-186. doi: 10.1016/j.numecd.2017.10.023. Epub 2017 Nov 11.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flash glucose monitoring in people with Diabetes Type 1, run by University of Padova at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 4 Oct 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Bruttomesso, MD (+390498212183, daniela.bruttomesso@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of freestyle Libre flash monitoring (time frame: 14 days). 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 NCT02734745, which also lists 3 linked publications.
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 4 Oct 2017.