Trial Radar AI | ||
|---|---|---|
De klinische studie NCT05849428 voor Type 1 diabetes, Type 2 diabetes is onbekend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Blood Glucose Differences Using CGMs Between the Left and Right Arm in Patients With Diabetes 10
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT05849428 is een interventioneel studie bij Type 1 diabetes, Type 2 diabetes met de status onbekend. Het doel is om 10 deelnemers te includeren vanaf 1 mei 2023. De studie wordt geleid door University of the Pacific en de voltooiing is gepland op 1 maart 2024. Laatste update op ClinicalTrials.gov: 8 mei 2023.
Beknopte samenvatting
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...Toon meer
Uitgebreide beschrijving
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...
Toon meerOfficiële titel
Blood Glucose Differences Between Left Arm and Right Arm in Patients With Type 1 or Type 2 Diabetes Using a Continuous Glucose Monitor
Aandoeningen
Type 1 diabetesType 2 diabetesPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- IRB2023-25
NCT-ID
Startdatum (Werkelijk)
2023-05
Laatste update geplaatst
2023-05-08
Verwachte einddatum
2024-03
Inschrijving (Geschat)
10
Studietype
Interventioneel
FASE
N.v.t.
Status
Onbekend
Primaire doel
Overige
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
OverigeMeasuring 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...Toon meer |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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 PacificVerantwoordelijke instantie
Sachin Shah, Hoofdonderzoeker, Professor of Pharmacy, University of the Pacific
Centraal Contactpersoon
Contact: Sarika Mujumdar, PharmD, 209-946-7754, [email protected]
Contact: Allen Lat, PharmD, 209-946-7754, [email protected]
1 Studielocaties in 1 landen
California
University of the Pacific, Stockton, California, 95211, United States
Sachin Shah, Contact, [email protected]
Rekruterend