Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Evaluation of Inter-Arm Differences in Continuous Glucose Monitor Glucose Readings in Patients With Type 1 and Type 2 Diabetes
This is a clinical trial looking at differences in continuous glucose monitor (CGM) glucose readings between the left and right arms in adults with type 1 or type 2 diabetes. The study will enroll 60 participants who will wear a CGM sensor on both arms for 14 days.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
This study is a prospective, non-randomized clinical trial designed to evaluate differences in continuous glucose monitor (CGM) glucose readings between the left and right arms in adults with type 1 or type 2 diabetes.
The study will enroll 60 participants. Each participant will wear two FreeStyle Libre 3 Plus CGM sensors simultaneously for 14 days, with one sensor placed on each arm.
The primary objective is to compare the frequency of hypoglycemic events, defined as glucose readings below 70 mg/dL, between the left and right arms. Secondary analyses will evaluate differences in Level 1 and Level 2 hypoglycemia and time below range. Additional analyses will compare time in range, time above range, time below range, and average glucose between the two arms.
CGM data from the two sensors will be collected and compared to evaluate differences in glucose readings between the left and right arms.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Innovative Clinical and Outcomes Research (iCOR)
- Numéro de téléphone: 925-255-5374
- E-mail: icor@pacific.edu
Lieux d'étude
-
-
California
-
Stockton, California, États-Unis, 95211
- University of the Pacific
-
Contact:
- Innovative Clinical and Outcomes Research (iCOR)
- Numéro de téléphone: 9252555374
- E-mail: icor@pacific.edu
-
Chercheur principal:
- Sachin A Shah, PharmD
-
Sous-enquêteur:
- Allen Shek, PharmD
-
Sous-enquêteur:
- Aydin Shek
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adults 18 years of age and over
- Diagnosed with type 1 or 2 diabetes mellitus
- Female participants with childbearing potential must have a negative urine pregnancy stick test, which has been confirmed by investigators
- Willingness to wear a CGM on each arm for 2 weeks
- A1c <7% within the past 6 months
- Willing to attend 3 virtual call meetings over the course of the trial
- Have active health insurance throughout the duration of the study
- Willing to refrain from consuming or using commercial products containing ascorbic acid (vitamin C) or salicylic acid, and certain skincare products for the duration of the study due to their known potential to interfere with CGM readings (exposure via food is allowed)
- Participants must have a mobile phone that is connected to the internet and compatible with both "FreeStyle Libre 3" and "Libre by Abbott" apps
Exclusion Criteria:
- Under the age of 18
- Any active dermatologic condition on the upper arms
- Implanted medical devices (e.g., pacemaker, insulin pump)
- Use of any medical or other devices (e.g., TMS) incompatible with the FreeStyle Libre 3 Plus CGM
- Critically ill or dialysis patients
- Planned high-frequency electrical heat treatment (diathermy) during the study period
- Currently taking hydroxyurea
- History of or planned gastric bypass within the 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 or HIPAA authorization form
- Pregnant, planned pregnancy during study period, or currently breastfeeding
- History of allergic reactions or hypersensitivity to adhesives
- Blood transfusion within the previous 3 months
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Left and Right Arm CGM Wear
Participants will wear two FreeStyle Libre 3 Plus continuous glucose monitors (CGMs) simultaneously for 14 days, with one sensor applied to the back of the upper arm on each arm. Participants will continue their normal daily routine during the study period. CGM data from the left and right arms will be compared. |
Two FreeStyle Libre 3 Plus continuous glucose monitors (CGMs) will be worn simultaneously for 14 days. One sensor will be applied subcutaneously to the back of the upper arm on each arm. The sensors measure glucose in the interstitial fluid, and data from the left and right arms will be collected and compared. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in Frequency of Hypoglycemic Events Between Left and Right Arms
Délai: 14 days
|
Difference in the frequency of hypoglycemic events (<70 mg/dL) between the left arm and right arm. |
14 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in Frequency of Level 1 Hypoglycemic Events Between Left and Right Arms
Délai: 14 days
|
Difference in the frequency of Level 1 hypoglycemic events (54 to <70 mg/dL) between the left arm and right arm. |
14 days
|
|
Difference in Frequency of Level 2 Hypoglycemic Events Between Left and Right Arms
Délai: 14 days
|
Difference in the frequency of Level 2 hypoglycemic events (<54 mg/dL) between the left arm and right arm. |
14 days
|
|
Difference in Percentage of Time Below Range (<70 mg/dL) Between Left and Right Arms
Délai: 14 days
|
Difference in percentage of time below range (TBR) <70 mg/dL between the left and right arms. |
14 days
|
|
Difference in Percentage of Time Below Range (54 to <70 mg/dL) Between Left and Right Arms
Délai: 14 days
|
Difference in percentage of time below range (TBR) from 54 to <70 mg/dL (Level 1 hypoglycemia) between the left and right arms. |
14 days
|
|
Difference in Percentage of Time Below Range (<54 mg/dL) Between Left and Right Arms
Délai: 14 days
|
Difference in percentage of time below range (TBR) <54 mg/dL (Level 2 hypoglycemia) between the left and right arms. |
14 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB2026-284
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data will not be shared with others.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .