Diabetes MellitusNCT03257501
FreeStyle Libre Flash Accuracy Study
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 4 sites in United States.
Trial summary
This is a non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System. 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?
- FreeStyle Libre Flash Glucose Monitoring System
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Aug 2017to 8 Jan 2018
- Phase
- Observational
- 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
Study population: Subjects with type 1 or type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII).
Who may be able to join
- Subject must be at least 18 years of age.
- Subject must have type 1 or type 2 diabetes.
- Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
- Willing to perform a minimum of 8 finger sticks per day during the study.
- Subject must be willing to fast five individual times prior to in-clinic visits, each fast lasting a minimum of eight hours.
- Subject must be able to read and understand English.
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- In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
- Subject must be available to participate in all study visits.
- Subject must be willing and able to provide written signed and dated informed consent.
Who cannot join
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).
- Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
- Subject is currently participating in another clinical trial.
- Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
- Subject is anemic as determined by the Investigator.
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- Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to History of HIV, Hepatitis B or C.
- Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
- Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, 83404
Rainier Clinical Research
Renton, Washington, 98057
William Sansum Diabetes Center
Santa Barbara, California, 93105
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: FreeStyle Libre Flash Glucose Monitoring System Accuracy Study
This is a non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.
Read the detailed description
Up to 150 subjects will be enrolled at four (4) clinical research sites in the United States. Subjects will wear two Sensors of three unique sensor lots. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be asked to perform at least 8 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make eight (8) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have five (5) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.
- Conditions
- Diabetes Mellitus
- Being tested
- FreeStyle Libre Flash Glucose Monitoring System
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre Flash Glucose Monitoring SystemDevice
Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
What is being measured
The primary outcome is the main question the study is designed to answer.
System Performance with respect to YSI reference venous plasma sample measurements.
System performance will be characterized with respect to YSI reference venous plasma sample measurements.
Measured: Approximately 35 hours
System Related adverse device effects
System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
Measured: Up to 51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start22 Aug 2017
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shridhara K Alva, PhD, Study director, Abbott Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257501
- Sponsor's protocol ID
- ADC-US-VAL-17166
- Status last verified
- Jan 2018
- First submitted
- 18 Aug 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FreeStyle Libre Flash Glucose Monitoring System Accuracy Study
- ClinicalTrials.gov ID
- NCT03257501
- Acronym / sponsor ID
- ADC-US-VAL-17166
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- 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 a non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.
Detailed description
Up to 150 subjects will be enrolled at four (4) clinical research sites in the United States. Subjects will wear two Sensors of three unique sensor lots. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be asked to perform at least 8 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make eight (8) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have five (5) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with type 1 or type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII).
Key inclusion criteria (9 listed)
- Subject must be at least 18 years of age.
- Subject must have type 1 or type 2 diabetes.
- Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
- Willing to perform a minimum of 8 finger sticks per day during the study.
- Subject must be willing to fast five individual times prior to in-clinic visits, each fast lasting a minimum of eight hours.
Key exclusion criteria (9 listed)
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).
- Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
- Subject is currently participating in another clinical trial.
- Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
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 |
|---|---|---|
| FreeStyle Libre Flash Glucose Monitoring SystemSubjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes. | Device | – |
Primary outcome
System Performance with respect to YSI reference venous plasma sample measurements.
Time frame: Approximately 35 hours
System performance will be characterized with respect to YSI reference venous plasma sample measurements.
System Related adverse device effects
Time frame: Up to 51 days
System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
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 9 Jan 2018.
- 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.
Shridhara K Alva, PhD study director
Abbott Diabetes Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 4 sites in United States.
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 9 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
System Performance with respect to YSI reference venous plasma sample measurements. (time frame: Approximately 35 hours). The study lists 2 primary outcomes in all. 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 9 Jan 2018.