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De klinische studie NCT02647905 (PRECISEII) voor Diabetes mellitus is afgerond. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Evaluation of the Accuracy of an Implanted Glucose Sensor (PRECISEII) 90
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De klinische studie NCT02647905 (PRECISEII) was een interventioneel studie bij Diabetes mellitus en is nu afgerond. Er werd gestreefd naar inclusie van 90 deelnemers vanaf 1 januari 2016. De studie werd geleid door Senseonics, Inc. en was gepland te worden voltooid op 1 juli 2016. Laatste update op ClinicalTrials.gov: 6 juni 2018.
Beknopte samenvatting
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.
Officiële titel
A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II
Aandoeningen
Diabetes mellitusAndere studie-ID's
- PRECISEII
- CTP-0023
NCT-ID
Startdatum (Werkelijk)
2016-01
Laatste update geplaatst
2018-06-06
Verwachte einddatum
2016-07
Inschrijving (Geschat)
90
Studietype
Interventioneel
FASE
N.v.t.
Status
Afgerond
Trefwoorden
type 1 diabetes
type 2 diabetes
CGM
implantable
accuracy
longevity
type 2 diabetes
CGM
implantable
accuracy
longevity
Primaire doel
Diagnostisch
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelAccuracy 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 |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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.Geen contactgegevens beschikbaar
9 Studielocaties in 1 landen
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