Diabetes MellitusNCT05962710
FreeStyle Libre 3 Continuous Glucose Monitoring System
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 4 sites in United States.
Trial summary
The purpose of this study is to characterize the FreeStyle Libre 3 Continuous Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- FreeStyle Libre 3
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Jan 2023to 31 Jan 2023
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric subjects with type 1 or type 2 diabetes requiring either prandial rapid acting insulin (administered via injection or inhalation) or continuous subcutaneous insulin infusion (CSII).
Who may be able to join
- Subject must be at least 2 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 or inhalations (at least 3 daily).
- Subject must be able to read and understand English.
- 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.
- At the time of enrollment, subject must be available to participate in all study visits.
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- For subjects age 2 to 5: willing to allow medical personnel to perform up to 16 capillary fingersticks to allow for capillary blood samples to be obtained per the study protocol.
- For subjects age 6 and older: willing to allow medical personnel to insert an IV catheter in the arm to allow for venous blood samples to be obtained per the study protocol.
- Subjects aged 18 years and older must be willing and able to provide written signed and dated informed consent.
- Subjects aged 17 years and younger must have a parent, guardian or legally authorized representative willing and able to provide written informed consent.
- Subjects aged 7 - 17 years must be willing and able to provide written signed and dated informed assent.
Who cannot join
- Subjects age 18 and older: Subject is known to be pregnant, attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to only to female subjects age 18 and older).
- Subjects age 17 and younger: Subject is known to be pregnant or becomes pregnant during the study (only applicable to female subjects age 17 years and younger)
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- 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 60 days prior to the beginning of the study activities.
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- For subjects aged 6 years and older: subject has a hemoglobin (Hb) level that is 10% or more below the normal range (for reference the low end of the normal range for Hb for adult males is 12.6 g/dL and for adult females is 11.7 g/dL1; for pediatric males and pediatric females aged 6 - 9 years it is 11.5 g/dL1; for pediatric males and pediatric females aged 10 - 12 it is 12.0 g/dL1; for ; for pediatric males aged 13 - 14 it is 12.0 g/dL and pediatric females aged 13 - 14 it is 11.5 g/dL1; and for pediatric males and pediatric females aged 15 - 17 it is 11.7 g/dL1)
- Subject has a known concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
- Subject has X-ray, MRI, CT or diathermy 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 Center
Renton, Washington, 98057
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: FreeStyle Libre 3 Continuous Glucose Monitoring System Confirmation Study
The purpose of this study is to characterize the FreeStyle Libre 3 Continuous Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.
Read the detailed description
This is a pivotal, non-randomized, single arm, multi-center, prospective, nonsignificant risk study to evaluate the FreeStyle Libre 3 Continuous Glucose Monitoring System accuracy and safety. Up to 80 adult subjects (18 years of age or older) and up to 80 pediatric subjects (2-17 years of age) subjects will be enrolled at up to six (6) clinical research sites in the United States. Each subject will wear two sensors for 15 days.
Interstitial glucose readings from each Sensor will be obtained with a corresponding smart phone. Subjects will do up to six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects' age and/or weight, subjects will have up to three (3) in- clinic visits during which intravenous blood draws and YSI reference testing will occur.
- Conditions
- Diabetes Mellitus
- Being tested
- FreeStyle Libre 3
- 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 3Device
FreeStyle Libre 3 Continuous Glucose Monitoring System
What is being measured
The primary outcome is the main question the study is designed to answer.
System Performance
System Performance will be characterized with respect to YSI reference venous plasma measurements
Measured: 46 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start27 Jan 2023
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: Study is not required
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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shridhara A Karinka, PhD, Study director, Abbott Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962710
- Sponsor's protocol ID
- ADC-US-VAL-22221
- Status last verified
- Jun 2022
- First submitted
- 19 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FreeStyle Libre 3 Continuous Glucose Monitoring System Confirmation Study
- ClinicalTrials.gov ID
- NCT05962710
- Acronym / sponsor ID
- ADC-US-VAL-22221
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study is not required
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 27 Jul 2023 (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.
The purpose of this study is to characterize the FreeStyle Libre 3 Continuous Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.
Detailed description
This is a pivotal, non-randomized, single arm, multi-center, prospective, nonsignificant risk study to evaluate the FreeStyle Libre 3 Continuous Glucose Monitoring System accuracy and safety. Up to 80 adult subjects (18 years of age or older) and up to 80 pediatric subjects (2-17 years of age) subjects will be enrolled at up to six (6) clinical research sites in the United States. Each subject will wear two sensors for 15 days.
Interstitial glucose readings from each Sensor will be obtained with a corresponding smart phone. Subjects will do up to six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects' age and/or weight, subjects will have up to three (3) 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
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric subjects with type 1 or type 2 diabetes requiring either prandial rapid acting insulin (administered via injection or inhalation) or continuous subcutaneous insulin infusion (CSII).
Key inclusion criteria (11 listed)
- Subject must be at least 2 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 or inhalations (at least 3 daily).
- Subject must be able to read and understand English.
- 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.
Key exclusion criteria (10 listed)
- Subjects age 18 and older: Subject is known to be pregnant, attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to only to female subjects age 18 and older).
- Subjects age 17 and younger: Subject is known to be pregnant or becomes pregnant during the study (only applicable to female subjects age 17 years and younger)
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- 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.
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 3FreeStyle Libre 3 Continuous Glucose Monitoring System | Device | – |
Primary outcome
System Performance
Time frame: 46 days
System Performance will be characterized with respect to YSI reference venous plasma measurements
Results and safety
The study was stopped early (reason given: Study is not required). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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 A Karinka, 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 11 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: stopped early, as of the sponsor's last update on 27 Jul 2023. 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 was stopped early (reason given: Study is not required). Results are not available in the source record.
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 (time frame: 46 days). 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 27 Jul 2023.