Trial Radar IA | ||
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Lo studio clinico NCT05849428 per Diabete di tipo 1, Diabete di tipo 2 è sconosciuto. 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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Blood Glucose Differences Using CGMs Between the Left and Right Arm in Patients With Diabetes 10
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT05849428 è uno studio interventistico per Diabete di tipo 1, Diabete di tipo 2, attualmente sconosciuto. Avviato il 1 maggio 2023, prevede di arruolare 10 partecipanti. Sotto la guida di University of the Pacific, dovrebbe concludersi entro il 1 marzo 2024. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 8 maggio 2023.
Sommario breve
There are multiple CGMs that are FDA approved. However, there are few studies looking at the variability of measurements between the left and right arm, and none looking at this effect in diabetic patients. This study may identify if glucose differences exist in the left and right arm in patients with Type 1 or Type 2 Diabetes. Furthermore, it may point to future directions for research to standardize methods of gluc...Mostra di più
Descrizione dettagliata
The goal of this clinical trial is to determine the time-matched difference in glucose levels between the left arm and right arm in patients with Type 1 or Type 2 diabetes. The main objective aims to answer:
• Is there a difference in time-matched controlled glucose monitoring (CGM) - derived blood glucose between left and right arm in patients with Type 1 or Type 2 diabetes in target range (<70 mg/dL; 70-180 mg/dL...
Mostra di piùTitolo ufficiale
Blood Glucose Differences Between Left Arm and Right Arm in Patients With Type 1 or Type 2 Diabetes Using a Continuous Glucose Monitor
Patologie
Diabete di tipo 1Diabete di tipo 2Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- IRB2023-25
Numero NCT
Data di inizio (effettiva)
2023-05
Ultimo aggiornamento pubblicato
2023-05-08
Data di completamento (stimata)
2024-03
Arruolamento (previsto)
10
Tipo di studio
Interventistico
FASE
N.D.
Stato
Sconosciuto
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 |
|---|---|
AltroMeasuring Arm Participants will wear 2 Freestyle Libre 3 sensors on each arm, 1 on the left and 1 on the right for 2 consecutive weeks (total of 14 days). | Freestyle Libre 3 Freestyle Libre 3 consists of a sensor that is applied to the back of the upper arm. The sensor is a penny-sized flexible filament placed beneath the skin surface to measure interstitial fluid. This sensor is applied utilizing a sensor applicator provided in the packaging. The sensor will continuously read interstitial glucose readings every minute and syncs with the Freestyle View app. At the completion of the study...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients with Type 1 or Type 2 Diabetes below target range (<70 mg/dL). | Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis below the target range (\<70 mg/dL). | 14 days |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients in target range (70-180 mg/dL). | Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis at the target range (70-180 mg/dL). | 14 days |
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients above target range (>180 mg/dL). | Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis at the target range (\>180180 mg/dL). | 14 days |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Adults 18-65 years of age
- Diagnosed with Type 1 or Type 2 Diabetes
- Willing to wear CGMs for 2 weeks on both arms
- Willing to attend 3 virtual calls meetings over the course of the trial
- Have active health insurance
- Willing to refrain from any heat therapy for the duration of the study
- Willing to refrain from consuming ascorbic acid and salicylic acid for the duration of the study due to known interaction with CGMs
- Have access to 2 compatible mobile devices for the Freestyle Libre 3 CGMs
- Not currently using any Freestyle Libre CGM
- Willing to provide HbA1c readings within 3 months of the trial
- Have a baseline HbA1c equal or above 6.5
- Any active dermatologic condition on the upper arms
- Implanted medical devices including another continuous glucose monitoring device (i.e.
pacemaker)
- Critically ill or dialysis patients
- Planned magnetic resonance imaging screening, computed tomography scan, X-ray imaging or high-frequency electrical heat treatment during study period
- Current systemic infections
- Subjects who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
- Refusal to sign the informed consent document
- Pregnant, planned pregnancy during study period, or currently breast-feeding
- Fear of needles to the point where patients cannot self-administer the sensors
- History of allergic reactions or hypersensitivity from adhesives
University of the PacificParte responsabile dello studio
Sachin Shah, Investigatore principale, Professor of Pharmacy, University of the Pacific
Contatti principali dello studio
Contatto: Sarika Mujumdar, PharmD, 209-946-7754, [email protected]
Contatto: Allen Lat, PharmD, 209-946-7754, [email protected]
1 Centri dello studio in 1 paesi
California
University of the Pacific, Stockton, California, 95211, United States
Sachin Shah, Contatto, [email protected]
In arruolamento