Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes

Официальное название

A pH-Responsive Hydrogel Microneedle Patch for Continuous Measurement of Ketone Bodies and Glucose: CGM-CKM

Обзор

The goal of this study is to evaluate a CGM-CKM device during insulin suspension in patients with type 1 diabetes. 10 patients with T1D will be recruited for a pilot study. The patients will visit CTRU at Stanford Medical School. The CGM-CKM device will be applied to the upper arm area of patients and baseline ketone and glucose measurement will be performed for one hour prior to suspending or disconnecting the pump. Upon baseline measurement, the pump will be disconnected for 3 hours while the electrochemical signals are collected from the CGM-CKM device. During the 3 hours of pump disconnection, blood samples will be collected every 5 minutes from participants for analyzing their insulin and glucagon using conventional ELISA kits and glucose and ketone using standard meters.

Подробное описание

This is a non-significant risk (NSR) device study not conducted under an IDE, in accordance with 21 CFR 812.2(b)

Вмешательства

• Поведенческое Temporary Insulin Suspension
  Participants will suspend insulin delivery from their personal insulin pumps for up to 3 hours. Insulin suspension is temporary and participant-driven under supervision.
• Устройство Glucose and ketone sensor
  The participants wear a prototype continuous glucose-ketone monitoring (CGM-CKM) device using painless hydrogel microneedles for 4 hours.

Первичные конечные точки

• Concentration of Glucose Measured by Experimental CGM-CKM Sensor Compared to Blood Glucose [Срок оценки: 5 hours]
• Concentration of Ketones Measured by Experimental CGM-CKM Sensor Compared to Blood Ketones [Срок оценки: 5 hours]

Вторичные конечные точки (2)

• Plasma Insulin Concentration Measured by Mercodia ELISA Assay [Срок оценки: 5 hours]
• Plasma Glucagon Concentration Measured by Mercodia ELISA Assay [Срок оценки: 5 hours]

Критерии участия

Критерии включения

• Clinical diagnosis of type 1 diabetes for at least 1 year without significant endogenous insulin production
• Currently using insulin pump
• Understanding and willingness to follow the protocol and sign informed consent.
• Willingness to sign a consent for release of medical information at the time of enrollment
• Ability to speak, read and write in the language of the investigators.

Критерии исключения

• History of DKA or severe hypoglycemia within the past 6 months
• eGFR <45 mL/min/1.73 m2 or other significant renal impairment
• Pregnancy or breastfeeding
• Current use of non-insulin medications affecting ketone production, including SGLT2 inhibitors
• Active skin infections or conditions affecting sensor application sites
• Known skin allergies to tapes or adhesives
• Current use of any long-acting insulin analogs
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Stanford University — Palo Alto

Публикации

• Ausri IR, Sadeghzadeh S, Biswas S, Zheng H, GhavamiNejad P, Huynh MDT, Keyvani F, Shirzadi E, Rahman FA, Quadrilatero J, GhavamiNejad A, Poudineh M. Multifunctional Dopamine-Based Hydrogel Microneedle Electrode for Continuous Ketone Sensing. Adv Mater. 2024 Aug;36(32):e2402009. doi: 10.1002/adma.202402009. Epub 2024 Jun 16. PMID 38847967
• GhavamiNejad P, GhavamiNejad A, Zheng H, Dhingra K, Samarikhalaj M, Poudineh M. A Conductive Hydrogel Microneedle-Based Assay Integrating PEDOT:PSS and Ag-Pt Nanoparticles for Real-Time, Enzyme-Less, and Electrochemical Sensing of Glucose. Adv Healthc Mater. 2023 Jan;12(1):e2202362. doi: 10.1002/adhm.202202362. Epub 2022 Oct 13. PMID 36183355

Идентификаторы

NCT: NCT06977633 · 76354

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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