NCT05251116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

February 10, 2022

Last Update Submit

August 2, 2023

Conditions

Diabete Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

only one Arm is included in this study

OTHER

This is a non-randomized, single arm study. All subjects will use the System. Results from the System will be compared to reference instrument.

Device: FreeStyle Libre

Interventions

FreeStyle LibreDEVICE

FreeStyle Libre 2 continuous Glucose Monitoring System

only one Arm is included in this study

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be at least 2 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 4 finger sticks per day while wearing the sensor in the study.
  • Subject and/or guardian must be able to read and understand English.
  • 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.
  • 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.
  • For subjects age 11 and older: subject is willing to have their blood sugar manipulated during one or more 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.
  • Known insulin sensitivity factor (only applicable to subjects age 11 and older)
  • Subjects aged 18 years and older must be willing and able to provide written signed and dated informed consent.
  • Subjects aged 17 years and younger must have a parent, guardian or legally authorized representative willing and able to provide written informed consent.
  • Subjects aged 7 - 17 years of age must be willing and able to provide written signed and dated informed assent.

You may not qualify if:

  • Subject has a history of hypoglycemia unawareness (only applicable to subjects age 11 and older).
  • Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  • 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).
  • 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)
  • 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 six (6) months (only applicable to subjects age 11 and older).
  • Subject has had an episode of diabetic ketoacidosis (DKA) within the last three (3) months (only applicable to subjects age 11 and older).
  • 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.
  • 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).
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Rocky Mountain Diabetes & Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

Rainier Clinical Research

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Shridhara A Karinka, PhD

    Abbott Diabetes Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 22, 2022

Study Start

December 11, 2021

Primary Completion

July 20, 2022

Study Completion

August 15, 2022

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(5)