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FSL2 Post Approval Study for Pediatric Patients

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ClinicalTrials.gov Identifier: NCT04959552
Recruitment Status : Recruiting
First Posted : July 13, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Brief Summary:
This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in a pediatric patient population.

Condition or disease Intervention/treatment
Diabete Mellitus Device: FreeStyle Libre 2

Detailed Description:
Approximately 400 subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. Subjects and/or their caregivers will utilize he FreeStyle Libre 2 Flash Glucose Monitoring System for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of Adverse Events experienced during the duration of the study. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FreeStyle Libre 2 Flash Glucose Monitoring System Intervention Phase Study for Pediatric Patients - FreeStyle Libre 2
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : September 2023

Intervention Details:
  • Device: FreeStyle Libre 2
    The FreeStyle Libre 2 Flash Glucose Monitoring


Primary Outcome Measures :
  1. Characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in a pediatric patient population [ Time Frame: Six Months ]

    Incidence rate of severe hypoglycemic occurrences requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization and moderate hypoglycemia in which the patient required the assistance of another person (e.g. as a result of confusion, coma, or seizure) during the study will be collected.

    The incidence rate of severe hypoglycemia associated with FSL2 use from this study will be compared with the incidence rate observed from self-monitoring blood glucose (SMBG) use observed during clinical study NCT04577976.




Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric subjects aged 4-17 years 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.
Criteria

Inclusion Criteria:

  1. Subject must be 4 - 17 years of age.
  2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
  3. Subject is currently using Self Monitoring of Blood Glucose (SMBG) for managing their diabetes.
  4. Subject has completed participation in clinical study ADC-US-PMS-20194.
  5. Subject and/or caregiver must be able to read and understand English.
  6. 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.
  7. Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.

    Exclusion Criteria:

  8. Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months.
  9. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  10. Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
  11. Subject is on dialysis at the time of enrollment.
  12. 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.
  13. Subject currently is participating in another clinical trial.
  14. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04959552


Contacts
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Contact: Mohamed Nada, PhD 510-749-5416 adc.clinical@abbott.com

Locations
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United States, Nevada
The DOCS Recruiting
Las Vegas, Nevada, United States, 89113
Contact: Asheesh Devan, MD         
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
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Study Director: Shridhara Karinka, PhD Abbott Diabetes Care
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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT04959552    
Other Study ID Numbers: ADC-US-PMS-20196
First Posted: July 13, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Pediatric Postmarket Surveillance of a Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases