FreeStyle Libre Flash Glucose Monitoring System Accuracy Study

NCT03141892 | Completed FDA Device

• 1 other identifier: ADC-US-VAL-17164
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• System Performance

  System performance will be characterized with respect to YSI reference venous plasma sample measurements.

  Approximately 32 hours

• System related adverse device effects and serious adverse effects

  System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.

  Up to 42 days

Study Arms (1)

Diabetes Mellitus, Type 1 and Type 2

Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.

Device: FreeStyle Libre Flash Glucose Monitoring System

Interventions

FreeStyle Libre Flash Glucose Monitoring System DEVICE

Blood Glucose Monitoring

Diabetes Mellitus, Type 1 and Type 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (4)

William Sansum Diabetes Center

Santa Barbara, California, 93105, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Rocky Mountain Diabetes & Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shridhara Karinka, PhD

  Abbott Diabetes Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 5, 2017
• Study Start: April 13, 2017
• Primary Completion: May 23, 2017
• Study Completion: May 30, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)