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Lo studio clinico NCT04436822 per Diabete mellito di tipo 1, Diabete mellito di tipo 2 è completato. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics 317 Pediatrico Adolescenti
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La sperimentazione clinica NCT04436822 è stata uno studio interventistico per Diabete mellito di tipo 1, Diabete mellito di tipo 2, attualmente completato. Avviato il 15 luglio 2020, prevedeva di arruolare 317 partecipanti. Sotto la guida di Medtronic Diabetes, si è concluso il 12 aprile 2022. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 2 giugno 2023.
Sommario breve
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
Descrizione dettagliata
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
This is a multi-center study.
Titolo ufficiale
Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
Patologie
Diabete mellito di tipo 1Diabete mellito di tipo 2Altri ID dello studio
- CIP330
Numero NCT
Data di inizio (effettiva)
2020-07-15
Ultimo aggiornamento pubblicato
2023-06-02
Data di completamento (stimata)
2022-04-12
Arruolamento (previsto)
317
Tipo di studio
Interventistico
FASE
N.D.
Stato
Completato
Scopo principale
Altro
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleSubjects with diabetes wearing DS5 Subjects wearing DS5 over 7 days and participating in FSTs. | Monitoraggio continuo del glucosio CGM and frequent sample testing |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Percentage of Readings Within 20% Agreement | Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL \[1.1 mmol/L\] when sensor values \< 80 mg/dL) \[4.4 mmol/L\]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data. | 7 days (170 hours) |
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
2 Years
Sessi idonei
Tutti
Individual is 2 - 80 years of age at time of enrollment.
Subject has a clinical diagnosis of type 1 or type 2 diabetes:
- If subject is 14-80 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
- If subject is 2-13 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
If subject is participating in YSI™* FST , subject has adequate venous access as assessed by investigator or appropriate staff.
Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity factor(s). Subjects without ratios may participate under observation only.
- Subject will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
- Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
- Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.)
- Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
- Subject is a sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by investigator.
- Subject is female and plans to become pregnant during the course of the study.
- Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment.
- Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
- Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
- Subject has a history of a seizure disorder.
- Subject has central nervous system or cardiac disorder resulting in syncope.
- Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- If subject is 7-80 years of age, subject has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
- Subject has a history of adrenal insufficiency.
- Subject is a member of the research staff involved with the study.
Medtronic DiabetesNessun dato di contatto
18 Centri dello studio in 2 paesi
California
AMCR Institute, Escondido, California, 92025, United States
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
SoCal Diabetes, Torrance, California, 90505, United States
Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States
Colorado
Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States
Barbara Davis Center for Diabetes, Aurora, Colorado, 80045, United States
Florida
University of South Florida, Tampa, Florida, 33612, United States
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States
Idaho
Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States
Tennessee
AM Diabetes and Endocrinology Center, Bartlett, Tennessee, 38133, United States
Texas
Texas Diabetes & Endocrinology, Austin, Texas, 78749, United States
Virginia
University of Virginia Center for Diabetes Technology, Charlottesville, Virginia, 22903, United States
Washington
Rainier Clinical Research Center, Inc., Renton, Washington, 98057, United States
Jiangsu
Nanjing First Hospital, Nanjing, Jiangsu, 210008, China
Liaoning
Dalian Municiple Central Hospital, Dalian, Liaoning, 116089, China
Shanghai Municipality
Shanghai Sixth People's Hospital, Shanghai, Shanghai Municipality, 200233, China
Children's Hospital of Fudan University, Shanghai, Shanghai Municipality, 201102, China
Zhejiang
The Children's Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310005, China