Freestyle Libre Flash Glucose Monitoring System

NCT03607448 | Completed FDA Device

• 1 other identifier: ADC-US-VAL-18174
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to characterize the Freestyle Libre Flash Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• System Performance

  System Performance will be characterized with respect to YSI reference venous plasma measurements

  approximately 45 days

Secondary Outcomes (1)

• System Related Adverse Device Effects

  Up to 45 days

Study Arms (1)

Diabetes Mellitus Type 1 and Type 2

Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and expected to perform at least 8 capillary BG test per day. Site Staff will determine when subject will undergo either a hypoglycemia induction or a hyperglycemia induction. Study staff will perform IV blood draw to obtain blood plasma for YSI sampling every 15 min when glucose as measured by YSI is above 70mg/dL and below 240 mg/dL.

Device: Freestyle Libre Flash Glucose Monitoring System

Interventions

Freestyle Libre Flash Glucose Monitoring System DEVICE

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

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 while wearing the sensor in the study.
• Subject must be able to read and understand English.
• Willing to have their blood sugar manipulated during in-clinic sessions.
• 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.
• At the time of enrollment, subject must be available to participate in all study visits.
• Subject must be willing and able to provide written signed and dated informed consent.
• Additional criteria for hypoglycemia induction.
• Known insulin sensitivity factor.

You may not qualify if:

• Subject has a history of hypoglycemia unawareness.
• 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 has had an episode of severe hypoglycemia requiring intervention from a health care professional (i.e. EMT assistance, emergency room visit, or hospital admission) within the last three (3) months.
• 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 has both hemoglobin (Hb) and hematocrit levels that are 10% or more below the normal ranges (For reference low end of the normal range for Hb for males is 14 g/dL and for females is 12 g/dL; low end of the normal hematocrit is 40% for men and 36% for women).
• Subject has concomitant medical condition which, in the opinion of the investigator, could 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, CT or diathermy 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 (5)

AMCR

Escondido, California, 92025, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 94502, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Related Publications (1)

• Alva S, Bailey T, Brazg R, Budiman ES, Castorino K, Christiansen MP, Forlenza G, Kipnes M, Liljenquist DR, Liu H. Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes. J Diabetes Sci Technol. 2022 Jan;16(1):70-77. doi: 10.1177/1932296820958754. Epub 2020 Sep 19.

  PMID: 32954812 DERIVED

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: July 27, 2018
• First Posted: July 31, 2018
• Study Start: July 23, 2018
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

US (5)