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FreeStyle Libre Flash Glucose Monitoring System Post Approval Study

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ClinicalTrials.gov Identifier: NCT03448380
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : September 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 people with diabetes.

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

Detailed Description:
Up to 920 adult subjects, aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 736 subjects who complete the final visit. 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). Subjects 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 : 920 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FreeStyle Libre Flash Glucose Monitoring System Post Approval Study
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
SMBG and 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 intended study population.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 20% of the study population will be age 30 or below and 15% will be age 65 or older.
Criteria

Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • Subject must have a diagnosis of type 1 or type 2 diabetes mellitus.
  • Subject is currently using SMBG for managing their diabetes.
  • Subject must be able to read and understand English
  • 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.
  • Subject must have access to an internet connected computer for uploading data from the blood glucose meter and FreeStyle Libre system.
  • Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria:

  • Subject 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 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): NCT03448380


Contacts
Contact: Mohamed A Nada, PhD 5107495416 mohamed.nada@abbott.com

Locations
United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Principal Investigator: Kristin Castorino, DO         
United States, Idaho
Rocky Mountain Diabetes & Osteoporosis Center Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: David Liljenquist, MD         
Principal Investigator: David Liljenquist, MD         
United States, New Mexico
Albuquerque Neuroscience Inc. Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Paula Lane, MD    505-848-3773      
United States, Texas
Clinical Trials of Texas Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Douglas S Denham, DO    210-949-0122      
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
Study Director: Shridhara A Karinka, PhD Abbott Diabetes care, Inc.

Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT03448380     History of Changes
Other Study ID Numbers: ADC-US-PMS-17168-001
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 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
Product Manufactured in and Exported from the U.S.: No

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