FreeStyle Libre Flash Glucose Monitoring System Post Approval Study

Diabetes Mellitus Clinical Trial

Official title:

FreeStyle Libre Flash Glucose Monitoring System Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448380
• Other study ID #: ADC-US-PMS-17168-001
• Status: Completed
• Start date: February 27, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: June 2021
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 935
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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).

Locations

Country	Name	City	State
United States	Albuquerque Neuroscience Inc.	Albuquerque	New Mexico
United States	Iowa Diabetes & Endocrinology Research Center	Des Moines	Iowa
United States	Henry Ford Medical Center	Detroit	Michigan
United States	Rocky Mountain Diabetes & Osteoporosis Center	Idaho Falls	Idaho
United States	Baptist Diabetes Associates, P.A	Miami	Florida
United States	Texas Diabetes & Endocrinology	Round Rock	Texas
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	MassResearch, LLC	Waltham	Massachusetts
United States	Metabolic Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the FreeStyle Libre Flash Glucose Monitoring System	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.