FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03369899|
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : July 30, 2018
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Diabete Mellitus||Device: FreeStyle Libre Flash Glucose Monitoring System|
|Study Type :||Observational|
|Actual Enrollment :||72 participants|
|Official Title:||Effectiveness and Safety Study of the FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations|
|Actual Study Start Date :||December 11, 2017|
|Actual Primary Completion Date :||May 23, 2018|
|Actual Study Completion Date :||May 23, 2018|
- Device: FreeStyle Libre Flash Glucose Monitoring System
Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
- System Performance [ Time Frame: Up to 14 days ]
System performance will be characterized with respect to YSI reference venous plasma sample measurements for subjects aged 6 and older. Capillary blood glucose (BG) reference will be used for subjects aged less than 6 years of age.
For subjects age 6 years and older, point accuracy of the system will be evaluated as the proportion of System readings that are within ±20% of the YSI reference value for YSI glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL. For subjects of age less than 6 years, ages 4 and older the system will be evaluated as the proportion of System readings that are within ±20% of the BG reference value for BG glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG glucose levels <80 mg/dL.
- System Related adverse device effects [ Time Frame: up to 45 days ]System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||4 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Subject must be at least 4 years of age.
- Subject must have a diagnosis of type 1 or type 2 diabetes mellitus
- Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
- Subject must be currently performing at least four (4) capillary blood glucose tests per day.
- Subject is willing to perform a minimum of 4 finger sticks per day during the study.
- If 6 year of age or older and weighing at least 19 kg (41.8 lbs.), willing to allow medical personnel to insert at IV catheter in the arm to allow for venous blood samples to be obtained per the study protocol
- Subject and/or guardian 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 assent (subjects aged 13 to 17 only).
- Subject's parent, guardian or legally authorized representative must be willing and able to provide written informed consent.
- Subject is 18 years of age or older.
- Subject is 6 years or older and weighs less than 19 kg (subjects unable to complete 4 hours of YSI testing).
- Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Subject is known to be pregnant or becomes pregnant during the study (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 had significant blood loss within 112 days (3.7 months) prior to the beginning of the study activities subjects.
- Subject is anemic (only applicable to subjects age 6 or older and weighing at least 19 kg) defined as hemoglobin levels below 11.5 g/dL for subjects aged 6-11 years old, less than 12.0 g/dL for subjects aged 12-15 years old, less than 12.0 g/dL for females aged 15-17 and less than 13.0 g/dL for males aged 15-171, or as determined by investigator.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369899
|United States, California|
|Sansum Diabetes Research Institute|
|Santa Barbara, California, United States, 93105|
|Study Director:||Shridhara A Karinka, Ph.D.||Abbott Diabetes Care|
|Responsible Party:||Abbott Diabetes Care|
|Other Study ID Numbers:||
|First Posted:||December 12, 2017 Key Record Dates|
|Last Update Posted:||July 30, 2018|
|Last Verified:||January 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|
Glucose Metabolism Disorders
Endocrine System Diseases