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FreeStyle Libre Continuous Glucose Monitoring System Accuracy Study 85 Pädiatrisch

Abgeschlossen
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT04464772 untersuchte Diabetes mellitus als beobachtungsstudie und hat den Status abgeschlossen. Die Studie begann am 10. Juli 2020 mit 85 Teilnehmern. Sie wurde durchgeführt von Abbott und am 22. September 2020 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 18. November 2020 aktualisiert.
Kurzbeschreibung
The purpose of this study is to characterize the Freestyle Libre Glucose Monitoring System in pediatric and adult subjects with respect to YSI reference venous plasma sample measurements.
Ausführliche Beschreibung
Up to 100 subjects will be enrolled at up to six (6) clinical research sites in the United States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be given to the subject. Subjects will be asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary Reader.

Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immedi...

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Offizieller Titel

FreeStyle Libre Continuous Glucose Monitoring System Accuracy Study

Erkrankungen
Diabetes mellitus
Weitere Studien-IDs
  • ADC-US-VAL-20192
NCT-Nummer
NCT04464772
Studienbeginn (tatsächlich)
2020-07-10
Zuletzt aktualisiert
2020-11-18
Studienende (vorauss.)
2020-09-22
Geplante Rekrutierung
85
Studientyp
Beobachtungsstudie
Status
Abgeschlossen
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Nicht zutreffend
FreeStyle Libre 3
FreeStyle Libre 3 Continuous Glucose Monitoring System
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
System Performance
System Performance will be characterized with respect to YSI reference venous plasma measurements
45 days
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
4 Years
Zugelassene Geschlechter
Alle
  1. Subject must be at least 4 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 must be able to read and understand English.
  6. 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.
  7. 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.
  8. At the time of enrollment, subject must be available to participate in all study visits.
  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 of age must be willing and able to provide written signed and dated informed assent.

  1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  2. 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).
  3. 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)
  4. 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.
  5. Subject is currently participating in another clinical trial.
  6. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
  7. 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/dL; for pediatric males and pediatric 13.0 g/dL; for pediatric females aged 12 - 17 it is 12.0 g/dL2).
  8. 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.
  9. 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.
  10. Subject is unsuitable for participation due to any other cause as determined by the Investigator.
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4 Studienstandorte in 1 Ländern

California

AMCR Institute, Escondido, California, 92026, United States
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States

Idaho

Rocky Mountain Diabetes & Osteoporosis Center, Idaho Falls, Idaho, 83404, United States

Washington

Rainier Clinical Research, Renton, Washington, 98057, United States