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Идёт набор NCT06893341

Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

Без фазы С лечением Diabetes Hyperglycemia Hypoglycemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The Sensing Device.
Кому может быть актуально
Состояния в реестре: Diabetes, Hyperglycemia, Hypoglycemia. Базовые параметры: 12 лет — 19 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Monitoring Volatile Organic Compound Profiles in Exhaled Breath to Noninvasively Detect Glycemic Events in Patients With Diabetes

Обзор

The purpose of this study is to determine whether an array of biosensors can noninvasively identify hyperglycemic or hypoglycemic events in persons diagnosed with diabetes through noninvasive detection of volatile organic compounds in exhaled breath.

Подробное описание

A device has been developed for sensing volatile organic compounds (VOCs) from human breath. VOCs are chemicals in the air that make up scents and smells, and many VOCs are endogenously produced inside the human body. Trained dogs can smell exhaled breath to determine if someone has diabetes and can even distinguish hypo- or hyperglycemic events (low or high blood sugar). The purpose of this study is to determine if the sensor device can identify hypo- or hyperglycemic events in persons with diabetes through detecting VOCs in breath noninvasively. The data obtained from the VOC sensor will be compared to the information that is also gathered from a continuous glucose monitor (CGM) to establish correlations between blood glucose and exhaled VOC measurements.

Вмешательства

  • Устройство The Sensing Device
    Children diagnosed with diabetes that wear a continuous glucose monitor will be given the Sensing Device. The subjects will provide breath samples into the device during euglycemia, hypoglycemia, and hyperglycemia, and the breath data will be analyzed to draw correlations with blood glucose levels.

Первичные конечные точки

  • Correlation between Breath Sensor Data and Blood Glucose [Срок оценки: While wearing the device, up to 72 hours]

Критерии участия

Критерии включения

  • Who are diagnosed with type 1 diabetes.
  • Who are between 12-19 years of age.
  • That utilize a Dexcom (G6 or G7) continuous glucose monitoring device.
  • That have an established working CGM for at least 12 hours (that does not need to be replaced within 24 hours).
  • That are willing to share their daily CGM data for the study.
  • That are the only individuals in their household with any type of diabetes diagnosis (type 1 or type 2).
  • That are willing to return the device within 24-48 hours of study completion.
  • That are located in Indianapolis, IN or its suburban areas.

Критерии исключения

  • That are smokers or use tobacco products or who live with someone who smokes in their vicinity.
  • That have a condition or abnormality other than type 1 diabetes that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
  • That utilize closed-loop diabetes management systems.
  • That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19.
  • That themselves or a close family member (living within the same household at the time of the data collection period) is on a "ketogenic diet".
  • That themselves or a close family member is working in an industry with high and continuous exposure to exogenous VOCs. Examples of such industries include beauty salons and paint manufacturers.
  • That are unable or unwilling to cooperate with sample collection.

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
  • Indiana University — Indianapolis

Публикации

  • Siegel AP, Daneshkhah A, Hardin DS, Shrestha S, Varahramyan K, Agarwal M. Analyzing breath samples of hypoglycemic events in type 1 diabetes patients: towards developing an alternative to diabetes alert dogs. J Breath Res. 2017 Jun 1;11(2):026007. doi: 10.1088/1752-7163/aa6ac6. PMID 28569238
  • Woollam M, Angarita-Rivera P, Siegel AP, Kalra V, Kapoor R, Agarwal M. Exhaled VOCs can discriminate subjects with COVID-19 from healthy controls. J Breath Res. 2022 May 6;16(3). doi: 10.1088/1752-7163/ac696a. PMID 35453137
  • Daneshkhah A, Shrestha S, Siegel A, Varahramyan K, Agarwal M. Cross-Selectivity Enhancement of Poly(vinylidene fluoride-hexafluoropropylene)-Based Sensor Arrays for Detecting Acetone and Ethanol. Sensors (Basel). 2017 Mar 15;17(3):595. doi: 10.3390/s17030595. PMID 28294961

Идентификаторы

NCT: NCT06893341 · 22467

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗