ClinicalTrials.gov
ClinicalTrials.gov Menu

FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03448367
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Brief 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.

Condition or disease Intervention/treatment
Diabetes Mellitus Device: FreeStyle Libre Flash Glucose Monitoring System

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 Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
SMBG/FreeStyle Libre
During the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring System for 6 months to managed their diabetes.
Device: FreeStyle Libre Flash Glucose Monitoring System
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).




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03448367


Contacts
Contact: Mohamed A Nada, PhD 510-749-5416 mohamed.nada@abbott.com

Locations
United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Contact: Kristin Castorino, DO    805-682-7638      
United States, Idaho
Rocky Mountain Diabetes & Osteoporosis Center Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: David Liljenquist, MD         
Principal Investigator: David Liljenquist, MD         
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
Study Director: Shridhara A Karinka, PhD Abbott Diabetes Care

Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT03448367     History of Changes
Other Study ID Numbers: ADC-US-PMS-17168-002
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases