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Blood Glucose Differences Using CGMs Between the Left and Right Arm in Patients With Diabetes 10

Inconnu
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT05849428 est une étude interventionnel pour Diabète de type 1, Diabète de type 2. Son statut actuel est : inconnu. L'étude a débuté le 1 mai 2023 et vise à recruter 10 participants. Dirigée par University of the Pacific, l'étude devrait être terminée d'ici le 1 mars 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 8 mai 2023.
Résumé succinct
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...Afficher plus
Description détaillée
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...

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Titre officiel

Blood Glucose Differences Between Left Arm and Right Arm in Patients With Type 1 or Type 2 Diabetes Using a Continuous Glucose Monitor

Pathologies
Diabète de type 1Diabète de type 2
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • IRB2023-25
Numéro NCT
NCT05849428
Date de début (réel)
2023-05
Dernière mise à jour publiée
2023-05-08
Date de fin (estimée)
2024-03
Inscription (estimée)
10
Type d'étude
Interventionnel
PHASE
N/A
Statut
Inconnu
Objectif principal
Autre
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
AutreMeasuring 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...Afficher plus
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 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 Pacific logoUniversity of the Pacific
Partie responsable de l'étude
Sachin Shah, Investigateur principal, Professor of Pharmacy, University of the Pacific
Contact central de l'étude
Contact: Sarika Mujumdar, PharmD, 209-946-7754, [email protected]
Contact: Allen Lat, PharmD, 209-946-7754, [email protected]
1 Centres de l'étude dans 1 pays

California

University of the Pacific, Stockton, California, 95211, United States
Sachin Shah, Contact, [email protected]
En recrutement