Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05251116
Other study ID # ADC-US-VAL-21206
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 11, 2021
Est. completion date August 15, 2022

Study information

Verified date August 2023
Source Abbott Diabetes Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 332
Est. completion date August 15, 2022
Est. primary completion date July 20, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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 exclusion criteria to be considered eligible for participation in the study. The subject will be excluded from the study if: 15. Subject has a history of hypoglycemia unawareness (only applicable to subjects age 11 and older). 16. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. 17. Subjects age 11 and older: Subject is known to be pregnant, attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to only to female subjects age 11 and older). 18. Subjects age 10 and younger: Subject is known to be pregnant or becomes pregnant during the study (only applicable to female subjects age 10 years and younger) 19. 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. 20. 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 six (6) months (only applicable to subjects age 11 and older). 21. Subject has had an episode of diabetic ketoacidosis (DKA) within the last three (3) months (only applicable to subjects age 11 and older). 22. Subject is currently participating in another clinical trial. 23. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities. 24. For subjects age 6 and older: subject has a hemoglobin (Hb) level that is below the normal range (for reference the low end of the normal range for Hb for adult males is 14 g/dL and for adult females is 12 g/dL1; for pediatric males and pediatric females aged 6 - 12 years old it is 11.5 g/dL; for pediatric males aged 12 - 17 it is 13.0 g/dL; for pediatric females aged 12 - 17 it is 12.0 g/dL2). 25. Subject has a known 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. 26. 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. 27. Subject is unsuitable for participation due to any other cause as determined by the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
FreeStyle Libre
FreeStyle Libre 2 continuous Glucose Monitoring System

Locations

Country Name City State
United States Atlanta Diabetes Associates Atlanta Georgia
United States Rocky Mountain Diabetes & Osteoporosis Center Idaho Falls Idaho
United States Rainier Clinical Research Renton Washington
United States Diabetes and Glandular Disease Clinic San Antonio Texas
United States Sansum Diabetes Research Institute Santa Barbara California

Sponsors (1)

Lead Sponsor Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary System Performance 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. 46 Days
See also
  Status Clinical Trial Phase
Recruiting NCT05563090 - Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
Recruiting NCT05333159 - The Efficacy of SGLT-2 Inhibitor in Patients With CAD and DM Undergoing PCI.
Active, not recruiting NCT03119584 - Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation Phase 4
Completed NCT04409171 - Glucose Metabolism After Partial Pancreatectomy
Recruiting NCT06060392 - Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus N/A
Completed NCT05144971 - StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
Completed NCT03914183 - Can mCPN Intervention Improve Injection Site Rotation N/A
Completed NCT03781232 - Non-invasive Glucose Measurement With Raman Technology in Patients With Type 1 and Type 2 Diabetes N/A
Not yet recruiting NCT06150508 - Randomized Controlled Trial of the Smart O2O Model Development for Chronic Diseases Management Through Digital Health N/A
Completed NCT01252810 - Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure Phase 2
Active, not recruiting NCT04171557 - Bicycling and Mortality Among Individuals With diabetesNutrition (EPIC)
Active, not recruiting NCT03155594 - CGM to Aid Transition From Inpatient to Outpatient N/A
Completed NCT04864327 - Smoking Intervention Among Patients With Diabetes N/A
Completed NCT04407182 - Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients Infected by SARS-Cov-2 With COVID-19 Phase 2
Completed NCT05752591 - Hypothalamic-pituitary Dysfunction in Diabetes
Completed NCT03159546 - FreeStyle Libre Flash Glucose Monitoring System Accuracy N/A
Completed NCT03953092 - A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699 Phase 1
Not yet recruiting NCT06262854 - Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study N/A
Completed NCT03934281 - Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient N/A
Not yet recruiting NCT03341026 - Metronom Continuous Glucose Monitoring System N/A