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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

Tracking Information
First Submitted Date June 14, 2021
First Posted Date July 13, 2021
Last Update Posted Date July 13, 2021
Actual Study Start Date June 1, 2021
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2021)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FSL2 Post Approval Study for Pediatric Patients
Official Title FreeStyle Libre 2 Flash Glucose Monitoring System Intervention Phase Study for Pediatric Patients - FreeStyle Libre 2
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Diabete Mellitus
Intervention Device: FreeStyle Libre 2
The FreeStyle Libre 2 Flash Glucose Monitoring
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 9, 2021)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Mohamed Nada, PhD 510-749-5416 adc.clinical@abbott.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04959552
Other Study ID Numbers ADC-US-PMS-20196
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Abbott Diabetes Care
Study Sponsor Abbott Diabetes Care
Collaborators Not Provided
Investigators
Study Director: Shridhara Karinka, PhD Abbott Diabetes Care
PRS Account Abbott Diabetes Care
Verification Date July 2021