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Идёт набор NCT07696273

Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia

Без фазы С лечением Diabetes Hyperglycemia Hypoglycemia (Diabetic)

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: Sensing Device and Tedlar Bags.
Кому может быть актуально
Состояния в реестре: Diabetes, Hyperglycemia, Hypoglycemia (Diabetic). Базовые параметры: 7 лет — 25 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

Miniaturized Smart Sensor Device for the Detection of Hypo- and Hyperglycemic Events in Persons Diagnosed 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 (VOCs) in exhaled breath.

Подробное описание

At this stage, the team will deploy two different analytical platforms in parallel in a clinical study to survey exhaled breath volatile organic compound (VOC) profiles at a diabetes youth camp. The ultimate objective is to determine whether a miniaturized laboratory device incorporating metal oxide gas sensors can reliably distinguish specific VOCs associated with glycemic events under real-world conditions. Sensor responses will be validated through parallel breath collection using Tedlar (plastic) bags, followed by confirmatory analysis via gas chromatography-mass spectrometry (GC-MS).

Вмешательства

  • Устройство Sensing Device and Tedlar Bags
    Children diagnosed with diabetes that wear a continuous glucose monitor (CGM) will provide breath samples into the miniaturized sensing device (as well as Tedlar bags for GC-MS analysis) during euglycemia, hypoglycemia, and hyperglycemia. The breath data will be analyzed to draw correlations with blood glucose levels measured via CGMs and finger prick tests.

Первичные конечные точки

  • Sensor Features Correlate with Blood Glucose Measurements [Срок оценки: 1 week for the summer camp.]
Вторичные конечные точки (1)
  • GC-MS Analysis of VOCs Correlate with Blood Glucose and Sensor Data [Срок оценки: 1 week for the summer camp.]

Критерии участия

Критерии включения

  • Who are diagnosed with T1D or T2D.
  • Who are between 7-25 years of age.
  • That use a Dexcom (G6 or G7) CGM device.
  • That have an established working CGM for at least 12 hours.
  • That are willing to share their CGM data for the study duration.
  • That are willing and able to fill up a breath collection bag.
  • That are attending a diabetes camp in the state of Indiana.

Критерии исключения

  • That are smokers or who live with someone who smokes in their vicinity (including prior to attending camp).
  • That have a condition or abnormality other than T1D/T2D that in the opinion of the Investigators would compromise the safety of the subject or the quality of the data.
  • That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19 (or other viral/bacterial infections).
  • That follow a "ketogenic diet".
  • That are unable or unwilling to cooperate with either of the sample collection modes.

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
  • Jameson Camp — Indianapolis

Публикации

  • Woollam M, Christensen A, Schulz E, Eckerle S, Davis MD, Sanders DB, Agarwal M. Systematic comparison of methods for offline breath sampling. Anal Bioanal Chem. 2025 Sep;417(22):5061-5076. doi: 10.1007/s00216-025-06025-5. Epub 2025 Aug 5. PMID 40762732
  • Heranjal S, Maciel M, Kamalapally SNR, Ramrakhiani I, Schulz E, Cao S, Liu X, Relich RF, Wek R, Woollam M, Agarwal M. Establishing Healthy Breath Baselines With Tin Oxide Sensors: Fundamental Building Blocks for Noninvasive Health Monitoring. Mil Med. 2024 Aug 19;189(Suppl 3):221-229. doi: 10.1093/milmed/usae078. PMID 39160864
  • Woollam M, Angarita-Rivera P, Thakur S, Daneshkhah A, Siegel AP, Hardin DS, Agarwal M. Steps toward clinical validation of exhaled volatile organic compound biomarkers for hypoglycemia in persons with type 1 diabetes. Sci Rep. 2025 May 25;15(1):18257. doi: 10.1038/s41598-025-00284-z. PMID 40414890
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT07696273 · 31571

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗