Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05962710
Other study ID # ADC-US-VAL-22221
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 27, 2023
Est. completion date January 31, 2023

Study information

Verified date June 2022
Source Abbott Diabetes Care
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to characterize the FreeStyle Libre 3 Continuous Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.


Description:

This is a pivotal, non-randomized, single arm, multi-center, prospective, nonsignificant risk study to evaluate the FreeStyle Libre 3 Continuous Glucose Monitoring System accuracy and safety. Up to 80 adult subjects (18 years of age or older) and up to 80 pediatric subjects (2-17 years of age) subjects will be enrolled at up to six (6) clinical research sites in the United States. Each subject will wear two sensors for 15 days. Interstitial glucose readings from each Sensor will be obtained with a corresponding smart phone. Subjects will do up to six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects' age and/or weight, subjects will have up to three (3) in- clinic visits during which intravenous blood draws and YSI reference testing will occur.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date January 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria: 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 or inhalations (at least 3 daily). 4. Subject must be able to read and understand English. 5. 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. 6. At the time of enrollment, subject must be available to participate in all study visits. 7. For subjects age 2 to 5: willing to allow medical personnel to perform up to 16 capillary fingersticks to allow for capillary blood samples to be obtained per the study protocol. 8. 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. 9. Subjects aged 18 years and older must be willing and able to provide written signed and dated informed consent. 10. Subjects aged 17 years and younger must have a parent, guardian or legally authorized representative willing and able to provide written informed consent. 11. Subjects aged 7 - 17 years must be willing and able to provide written signed and dated informed assent. Exclusion Criteria: 12. Subjects age 18 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 18 and older). 13. Subjects age 17 and younger: Subject is known to be pregnant or becomes pregnant during the study (only applicable to female subjects age 17 years and younger) 14. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. 15. 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. 16. Subject is currently participating in another clinical trial. 17. Subject has donated blood within 60 days prior to the beginning of the study activities. 18. For subjects aged 6 years and older: subject has a hemoglobin (Hb) level that is 10% or more below the normal range (for reference the low end of the normal range for Hb for adult males is 12.6 g/dL and for adult females is 11.7 g/dL1; for pediatric males and pediatric females aged 6 - 9 years it is 11.5 g/dL1; for pediatric males and pediatric females aged 10 - 12 it is 12.0 g/dL1; for ; for pediatric males aged 13 - 14 it is 12.0 g/dL and pediatric females aged 13 - 14 it is 11.5 g/dL1; and for pediatric males and pediatric females aged 15 - 17 it is 11.7 g/dL1) 19. 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. 20. 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. 21. 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 3
FreeStyle Libre 3 Continuous Glucose Monitoring System

Locations

Country Name City State
United States Rocky Mountain Diabetes & Osteoporosis Center Idaho Falls Idaho
United States Rainier Clinical Research Center 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 characterized with respect to YSI reference venous plasma measurements 46 days
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A