Diabetes MellitusNCT03448367
FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients
An observational study of Diabetes Mellitus, run by Abbott Diabetes Care at 4 sites in United States.
Trial summary
This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in pediatric patients with diabetes. 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
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Feb 2018to 13 Oct 2020
- 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 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 50% of the study population will be age 4-12 years of age.
Who may be able to join
- Subject must be 4 - 17 years of age.
- Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
- Subject is currently using SMBG for managing their diabetes.
- Subject and/or caregiver must be able to read and understand English .
- In the investigator's opinion, the subject and/or caregiver 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 and/or caregiver must have access to an internet connected computer for uploading data from the blood glucose meter and FreeStyle Libre system.
- Subject must have an overnight companion (caregiver 18 years or older) present in the same home during participation of the study.
- Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.
Who cannot join
- Subject and/or caregiver is a member of the Site Staff.
- Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
- Subject is on dialysis at the time of enrollment.
- 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.
- Subject currently is participating in another clinical trial.
- 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
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, 83404
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in pediatric patients with diabetes.
Read the detailed description
Up to 400 pediatric subjects aged 4-17 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 314 subjects who complete the final visit. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects and/or their caregivers will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.
- 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 utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase).
| Study group | Role | What they receive |
|---|---|---|
| SMBG/FreeStyle Libre | During the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring System for 6 months to managed their diabetes. Receives: Device: FreeStyle Libre Flash Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the FreeStyle Libre Flash Glucose Monitoring System
The study is designed to characterize the safety of the FreeStyle Libre Flash Glucose Monitoring System when used in the pediatric patient population.
Measured: Approximately one year per subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start27 Feb 2018
- Primary completion17 Jul 2020
- Study completion13 Oct 2020
Why it stopped: Due to lower than anticipated enrollment
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
- 19 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
- NCT03448367
- Sponsor's protocol ID
- ADC-US-PMS-17168-002
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2018
- Last updated
- 5 Feb 2021
- 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients
- ClinicalTrials.gov ID
- NCT03448367
- Acronym / sponsor ID
- ADC-US-PMS-17168-002
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to lower than anticipated enrollment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 28 Feb 2018 (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 prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in pediatric patients with diabetes.
Detailed description
Up to 400 pediatric subjects aged 4-17 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 314 subjects who complete the final visit. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects and/or their caregivers will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMBG/FreeStyle Libre | – | Device: FreeStyle Libre Flash Glucose Monitoring SystemDuring the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring System for 6 months to managed their diabetes. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 50% of the study population will be age 4-12 years of age.
Key inclusion criteria (8 listed)
- Subject must be 4 - 17 years of age.
- Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
- Subject is currently using SMBG for managing their diabetes.
- Subject and/or caregiver must be able to read and understand English .
- In the investigator's opinion, the subject and/or caregiver 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 (8 listed)
- Subject and/or caregiver is a member of the Site Staff.
- Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
- Subject is on dialysis at the time of enrollment.
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 utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). | Device | SMBG/FreeStyle Libre |
Primary outcome
Safety of the FreeStyle Libre Flash Glucose Monitoring System
Time frame: Approximately one year per subject.
The study is designed to characterize the safety of the FreeStyle Libre Flash Glucose Monitoring System when used in the pediatric patient population.
Results and safety
The study was stopped early (reason given: Due to lower than anticipated enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- 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 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 8 inclusion and 8 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 5 Feb 2021. 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: Due to lower than anticipated enrollment). 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?
Safety of the FreeStyle Libre Flash Glucose Monitoring System (time frame: Approximately one year per subject.). 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 5 Feb 2021.