Diabete Mellitus
Conditions
Brief summary
To characterize the System performance with respect to Yellow Springs Instrument (YSI) reference venous plasma measurements. Safety of the investigational device will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
Detailed description
Up to 200 adult and 250 pediatric (17 years of age or younger) subjects will be enrolled to obtain at least 200 evaluable subjects. At least four (4) subjects between the ages of 2 and 5 will be enrolled. Subjects will wear a total of two (2) sensors, one on the back of each upper arm. Each subject will wear two sensors, from the same Sensor lot, one on the back of each upper arm. One or more unique sensor lots will be evaluated in this study. Subjects will make between four (4) and six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects aged 2 - 5 will have one (1) in-clinic visit where capillary blood testing will be performed. Based on the subjects age and/or weight, subjects age 6 or older, will have up to three in-clinic visits during which intravenous blood draws and YSI reference testing will occur. Based on the subjects' age, blood glucose levels may be manipulated.
Interventions
DEVICEFreeStyle Libre
FreeStyle Libre 2 continuous Glucose Monitoring System
Sponsors
Abbott Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be considered eligible for participation in the study: 1. Subject must be at least 2 years of age. 2. Subject must have type 1 or type 2 diabetes. 3. Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily). 4. Willing to perform a minimum of 4 finger sticks per day while wearing the sensor in the study. 5. Subject and/or guardian must be able to read and understand English. 6. For subjects age between 2 and 5: willing to allow medical personnel to perform up to 16 capillary finger sticks to allow for capillary blood samples to be obtained per the study protocol. 7. For subjects age 6 and older: willing to allow medical personnel to insert an IV catheter in the arm to allow for venous blood samples to be obtained per the study protocol. 8. For subjects age 11 and older: subject is willing to have their blood sugar manipulated during one or more in-clinic sessions. 9. 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. 10. At the time of enrollment, subject must be available to participate in all study visits. 11. Known insulin sensitivity factor (only applicable to subjects age 11 and older) 12. Subjects aged 18 years and older must be willing and able to provide written signed and dated informed consent. 13. Subjects aged 17 years and younger must have a parent, guardian or legally authorized representative willing and able to provide written informed consent. 14. Subjects aged 7 - 17 years of age must be willing and able to provide written signed and dated informed assent.
Exclusion criteria
Subjects must not meet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Performance | 46 Days | System Performance will be evaluated against the reference system, Yellowstone Instrument (YSI) and against Capillary blood Glucose (BG). During several in clinic visits, plasma samples obtained from the subjects at various time intervals will be analyzed using the YSI. Results will be compared with results obtained from the System, to determine the system accuracy. Similarly, capillary Blood Glucose will be measured and compared with results obtained from the system. |
Countries
United States
Outcome results
None listed