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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Innovative Clinical and Outcomes Research (iCOR)
- Número de teléfono: 925-255-5374
- Correo electrónico: icor@pacific.edu
Ubicaciones de estudio
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California
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Stockton, California, Estados Unidos, 95211
- University of the Pacific
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Contacto:
- Innovative Clinical and Outcomes Research (iCOR)
- Número de teléfono: 9252555374
- Correo electrónico: icor@pacific.edu
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Investigador principal:
- Sachin A Shah, PharmD
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Sub-Investigador:
- Allen Shek, PharmD
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Sub-Investigador:
- Aydin Shek
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference in Frequency of Hypoglycemic Events Between Left and Right Arms
Periodo de tiempo: 14 days
|
Difference in the frequency of hypoglycemic events (<70 mg/dL) between the left arm and right arm. |
14 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference in Frequency of Level 1 Hypoglycemic Events Between Left and Right Arms
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 14 days
|
Difference in percentage of time below range (TBR) <54 mg/dL (Level 2 hypoglycemia) between the left and right arms. |
14 days
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB2026-284
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared with others.
Información sobre medicamentos y dispositivos, documentos del estudio
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