FreeStyle Libre Flash Glucose Monitoring System Post Approval Study

June 14, 2021 updated by: Abbott Diabetes Care
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
935

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Sansum Diabetes Research Institute
    • Florida
      • Miami, Florida, United States, 33156
        • Baptist Diabetes Associates, P.A
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes & Osteoporosis Center
    • Iowa
      • Des Moines, Iowa, United States, 50265
        • Iowa Diabetes & Endocrinology Research Center
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • MassResearch, LLC
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience Inc.
    • Texas
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Approximately one year per subject.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Diabetes Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shridhara A Karinka, PhD, Abbott Diabetes Care Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADC-US-PMS-17168-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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