Diabetes MellitusNCT03820050
FreeStyle LIbre Flash Glucose Monitoring System Pediatric Accuracy Study
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 Flash Glucose Monitoring System in pediatric subjects with respect to YSI reference venous plasma sample measurements. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- 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
- 144 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jan 2019to 14 Jun 2019
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric subjects aged 4-17 with Type 1 or Type 2 diabetes.
Who may be able to join
- Subject must be between the ages of 4 and 17 years of age at the time of study enrollment.
- Subject must have type 1 or type 2 diabetes.
- Subjects age 11 and older 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 4 finger sticks per day while wearing the sensor in the study.
- Subject and/or guardian must be able to read and understand English.
- For subjects age 6 and older: willing to allow medical personnel to insert an IV catheter in the arm to allow for venous blood flow samples to be obtained per the study protocol.
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- For subjects age 11 and older: subject is willing to have their blood sugar manipulated during one or more in-clinic sessions.
- 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.
- Known insulin sensitivity factor (only applicable to subjects age 11 and older).
- Subject's parent, guardian or legally authorized representative must be willing and able to provide written informed consent.
- Subject must be willing and able to provide written signed and dated informed assent when appropriate.
Who cannot join
- Subject is 18 years of age or older.
- Subject has a history of hypoglycemia unawareness (only applicable to subjects age 11 and older).
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is known to be pregnant or becomes pregnant during the study (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 has had an episode of severe hypoglycemia requiring intervention from a health care professional(i.e. EMT assistance, emergency room visit, or hospital admission) within the last six (6) months (only applicable to subjects age 11 or older).
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- Subject has had an episode of diabetic ketoacidosis (DKA) within the last (3) months (only applicable to subjects age 11 or older).
- 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 (only applicable to subjects age 6 and older).
- Subject has both hemoglobin (Hb) and hematocrit levels that are below the normal ranges (only applicable to subjects age 6 and older). The low end of the normal range for Hb is as follows: for males and females aged 6-12 years old it is 11.5 g/dL; for males aged 12-17 it is 13.0 g/dL; for females aged 12-17 it is 12.0 g/dL. The low end of the normal hematocrit for males and females aged 6-12 is 35%; 37% for males aged 12-17 and 36% for females aged 12- 17).
- 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
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 94502
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
The purpose of this study is to characterize the Freestyle Libre Flash Glucose Monitoring System in pediatric subjects with respect to YSI reference venous plasma sample measurements.
Read the detailed description
Up to 250 subjects will be enrolled at up to six (6) clinical research sites in the United States. Subjects will wear two Sensors. 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 4 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 three (3), four (4) or five (5) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects weight, subjects will have up to two (2) 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
System Performance will be characterized with respect to YSI reference venous plasma measurements
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: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start29 Jan 2019
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
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.
- 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shridhara Karinka, Ph.D., Study director, Abbott Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820050
- Sponsor's protocol ID
- ADC-US-VAL-18175
- Status last verified
- Jun 2019
- First submitted
- 25 Jan 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Alva S, Bailey T, Brazg R, Budiman ES, Castorino K, Christiansen MP, Forlenza G, Kipnes M, Liljenquist DR, Liu H. Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes. J Diabetes Sci Technol. 2022 Jan;16(1):70-77. doi: 10.1177/1932296820958754. Epub 2020 Sep 19.
PubMed 32954812
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FreeStyle LIbre Flash Glucose Monitoring System Pediatric Accuracy Study
- ClinicalTrials.gov ID
- NCT03820050
- Acronym / sponsor ID
- ADC-US-VAL-18175
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 29 Jan 2019 (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 Flash Glucose Monitoring System in pediatric subjects with respect to YSI reference venous plasma sample measurements.
Detailed description
Up to 250 subjects will be enrolled at up to six (6) clinical research sites in the United States. Subjects will wear two Sensors. 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 4 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 three (3), four (4) or five (5) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects weight, subjects will have up to two (2) 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
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric subjects aged 4-17 with Type 1 or Type 2 diabetes.
Key inclusion criteria (12 listed)
- Subject must be between the ages of 4 and 17 years of age at the time of study enrollment.
- Subject must have type 1 or type 2 diabetes.
- Subjects age 11 and older 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 4 finger sticks per day while wearing the sensor in the study.
- Subject and/or guardian must be able to read and understand English.
Key exclusion criteria (12 listed)
- Subject is 18 years of age or older.
- Subject has a history of hypoglycemia unawareness (only applicable to subjects age 11 and older).
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is known to be pregnant or becomes pregnant during the study (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.
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 SystemSystem Performance will be characterized with respect to YSI reference venous plasma measurements | Device | – |
Primary outcome
System Performance
Time frame: 45 days
System Performance will be characterized with respect to YSI reference venous plasma measurements
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 18 Jun 2019.
- Derived from this study: PubMed 32954812Alva S, Bailey T, Brazg R, Budiman ES, Castorino K, Christiansen MP, Forlenza G, Kipnes M, Liljenquist DR, Liu H. Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes. J Diabetes Sci Technol. 2022 Jan;16(1):70-77. doi: 10.1177/1932296820958754. Epub 2020 Sep 19.
- 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 Karinka, Ph.D. 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 12 inclusion and 12 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 18 Jun 2019. 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 (time frame: 45 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 NCT03820050, 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 18 Jun 2019.