FreeStyle Libre Flash Glucose Monitoring System Accuracy

FreeStyle Libre Flash Glucose Monitoring System Accuracy Study

This is a non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.

Study Overview

• Status: Completed
• Conditions: Diabete Mellitus
• Intervention / Treatment: Device: Device: FreeStyle Libre Flash Glucose Monitoring System

Detailed Description

Up to 60 subjects will be enrolled at up to six clinical research sites in the United States. Subjects will wear two Sensors of Three unique sensor lots. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be asked to perform at least 8 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will follow the same BG testing schedule during in-clinic visits. Subjects will be instructed to report any problems with the device. Subjects will make seven (7) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have four (4) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93105
      • William Sansum Diabetes Center
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes & Osteoporosis Center
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with type 1 or type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII).

Description

Inclusion Criteria

• Subject must be at least 18 years of age.
• Subject must have type 1 or type 2 diabetes.
• Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
• Willing to perform a minimum of 8 finger sticks per day during the study.
• Subject must be willing to fast four individual times prior to in-clinic visits, each fast lasting a minimum of eight hours.
• 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 be available to participate in all study visits.
• Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria

• Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
• Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).
• Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
• Subject currently is participating in another clinical trial.
• Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
• Subject is anemic.

• 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. Such conditions include but are not limited to:

  o History of HIV, Hepatitis B or C

• Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
• Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Performance	System performance will be characterized with respect to YSI reference venous plasma sample measurements.	Approximately 32 hours
System Related adverse device effects	System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.	Up to 42 days

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Investigators: Study Director: Shridhara Karinka, PhD, Abbott Diabetes Care

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2017
• Primary Completion (Actual): July 18, 2017
• Study Completion (Actual): August 24, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: ADC-US-VAL-17165

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