Trial Radar KI | ||
|---|---|---|
Die klinische Studie NCT02647905 (PRECISEII) für Diabetes mellitus ist abgeschlossen. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Evaluation of the Accuracy of an Implanted Glucose Sensor (PRECISEII) 90
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 NCT02647905 (PRECISEII) untersuchte Diabetes mellitus als interventionsstudie und hat den Status abgeschlossen. Die Studie begann am 1. Januar 2016 mit 90 Teilnehmern. Sie wurde durchgeführt von Senseonics, Inc. und am 1. Juli 2016 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 6. Juni 2018 aktualisiert.
Kurzbeschreibung
The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics CGM System usage.
Offizieller Titel
A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II
Erkrankungen
Diabetes mellitusWeitere Studien-IDs
- PRECISEII
- CTP-0023
NCT-Nummer
Studienbeginn (tatsächlich)
2016-01
Zuletzt aktualisiert
2018-06-06
Studienende (vorauss.)
2016-07
Geplante Rekrutierung
90
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Abgeschlossen
Stichwörter
type 1 diabetes
type 2 diabetes
CGM
implantable
accuracy
longevity
type 2 diabetes
CGM
implantable
accuracy
longevity
Primäres Ziel
Diagnostisch
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellAccuracy assessment, CGMS To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days | Continuous Glucose Monitoring System Accuracy and safety assessment of a continuous glucose monitoring device |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
CGM Relative Difference to Laboratory Reference Reported as MARD | Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison. | 90 days |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Adult subjects, age ≥18 years
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form and is willing to comply with protocol requirements
- History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.
- A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.
- Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e,g, CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.
- Hematocrit <30% or >55%
- History of hepatitis B, hepatitis C, or HIV
- Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study.
Senseonics, Inc.Keine Kontaktdaten vorhanden
9 Studienstandorte in 1 Ländern
California
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States
AMCR Institute, Escondido, California, 92025, United States
Diablo Clinical Research, Walnut Creek, California, 94598, United States
Georgia
Atlanta Diabetes Care, Atlanta, Georgia, 30318, United States
New York
Mount Sinai Diabetes Center, New York, New York, 10029, United States
Texas
Worldwide Clinical Trials, San Antonio, Texas, 78217, United States
Clinical Trials of Texas, San Antonio, Texas, 78229, United States
Virginia
UVA Diabetes and Endocrine Clinic, Charlottesville, Virginia, 22903, United States
Washington
Rainier Clinical Research, Renton, Washington, 98057, United States