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CompletedNCT03257501Updated Jan 9, 2018

FreeStyle Libre Flash Accuracy Study

An observational study in Diabetes Mellitus, sponsored by Abbott Diabetes Care. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by Abbott Diabetes Care · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
104
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Up to 150 subjects will be enrolled at four (4) 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 be instructed to report any problems with the device. Subjects will make eight (8) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have five (5) in-clinic visits during which intravenous blood draws and YSI reference testing will occur.

02

Conditions studied

  • Diabetes Mellitus
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

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 five 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

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 is currently 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 as determined by the Investigator.
  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
104 participants (actual)
Patient registry
No

Interventions

  • DeviceFreeStyle Libre Flash Glucose Monitoring System

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

05

What researchers measure

Primary outcomes

  1. System Performance with respect to YSI reference venous plasma sample measurements.

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

    Time frame: Approximately 35 hours

  2. System Related adverse device effects

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

    Time frame: Up to 51 days

06

Study locations

4 sites
  • William Sansum Diabetes Center
    Santa Barbara, California 93105, United States
  • Diablo Clinical Research
    Walnut Creek, California 94598, United States
  • Rocky Mountain Diabetes & Osteoporosis Center
    Idaho Falls, Idaho 83404, United States
  • Rainier Clinical Research
    Renton, Washington 98057, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03257501
Lead sponsor
Abbott Diabetes Care
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Aug 22, 2017
Primary completion
Jan 8, 2018
Completion
Jan 8, 2018
Last update
Jan 9, 2018

Study contacts

Shridhara K Alva, PhD
study director · Abbott Diabetes Care

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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