Continuous Glucose Monitoring Parameter and Oral Glucose Tolerance Testing (OGTT) Parameters in Children and Young Adults With Cystic Fibrosis (CF)
As modulator therapies extend the lifespan of CF patients, the detection of complications like Cystic Fibrosis Related Diabetes (CFRD) becomes increasingly vital. The current gold standard for CFRD screening, the 2-hour OGTT, is cumbersome and suffers from low compliance. This study proposes that Continuous Glucose Monitoring (CGM) could offer a more comprehensive, easier, and potentially more compliant screening method. The research aims to correlate various CGM parameters (e.g., time in hyperglycemia) with traditional glycemic markers like OGTT glucose levels, GMI, average glucose, variability, and HbA1c. Additionally, the research seeks to understand patient and parent/guardian preferences for CFRD screening modalities. This prospective observational study will involve CF patients wearing a Dexcom CGM around the time of standard OGTT and HbA1c tests, followed by surveys, with the ultimate goal of paving the way for CGM to improve early detection and management of dysglycemia in CF children.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
As modulator therapy changes the landscape of cystic fibrosis (CF), children with CF will live longer and healthier lives with less pulmonary exacerbations. Still, other complications like Cystic Fibrosis Related Diabetes and underlying dysglycemia may become more apparent as lifespans of CF patients increase. It is therefore essential that clinicians have the tools to understand early stages of dysglycemia to prevent long term complications of CFRD. At present, 2 hours 75-gram OGTT remains the gold standard annual screen for CFRD. This test is both cumbersome for patients and limits a clinician's interpretation of glycemic control to a limited time frame. Although OGTT is currently used to diagnose CFRD, it can be cumbersome for patients and time consuming. OGTT compliance is therefore not surprisingly low in the CF population with about 49 % of CF centers having a more than 50% completion of annual OGTT. Continuous glucose monitoring (CGM), on the other hand, offers the ability to obtain more data on longer time periods in a much easier fashion. Thus, CGMs have the potential to glean a more fine-tuned understanding of a patient's glycemic control. Moreover, CGMs can make glycemic testing easier on patients, thereby increasing compliance of annual glycemic testing. The investigators hypothesize the correlation of CGM parameters of hyperglycemia like % of time > 180 mg/dl, % of time> 150 mg/dL with 1- and 2-hour OGTT glucose levels, Glucose Management Indicator (GMI), average glucose, glucose variability, and HbA1c levels. The investigators also aim to explore patient views and preferences of OGTT and CGM for screening of CFRD through surveys after CGM wear.
The investigators hope to be able to correlate 1- and 2-hour glucose values on OGTT to % in range parameters on a continuous glucose monitor. This will pave the way to better understand glycemic control in children with CF and risk for CFRD with data from a CGM even without an OGTT in the future. The investigators also hope to understand patient and parent/guardian preferences towards CFRD screening modalities.
Study Design: Prospective observational study. Eligible patients will have a CGM placed for up to10-day wear within the 3 months before or after clinically appropriate OGTT and A1c. OGTT testing will include 1- and 2-hour glucose levels and HbA1c as per standard of care. A Dexcom CGM will be placed in clinic onto the subjects upper arm. Survey exploring patient and parent/guardian preference will be provided after the CGM is removed.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jennifer Apsan, MD
- Номер телефона: 516-472-3750
- Электронная почта: japsan@northwell.edu
Места учебы
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New York
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New York, New York, Соединенные Штаты, 11042
- Рекрутинг
- Northwell Health
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Контакт:
- Ishrat Ghani
- Номер телефона: 516-472-3692
- Электронная почта: ighani@Northwell.edu
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Patients with Cystic Fibrosis
- 10-25 years of age who have obtained or will obtain a OGTT within 3 months of recruitment and CGM placement.
Exclusion Criteria:
- Diagnosis of diabetes mellitus type 1 or type 2
- Use of the following medication: steroid course, Metformin therapy,
- Concurrent CV disease or malignancy, kidney failure, lung transplant.
- Does not have access to personal Bluetooth device compatible with Dexcom G7 application.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Скрининг
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Pediatric Cystic Fibrosis Patients Undergoing Concurrent CGM Monitoring and OGTT Testing
Pediatric Cystic Fibrosis patients (ages 10-25 years) will wear a continuous glucose monitor (Dexcom G7) for up to 10 days within 3 months of an annual Oral Glucose Tolerance Test (OGTT) and complete a survey to evaluate correlations between CGM parameters and OGTT values and assess patient/guardian preferences for CFRD screening methods. |
Continuous glucose monitors, such as Dexcom, have been established as a standard component of clinical care for continuous blood glucose monitoring. These devices are widely utilized in diabetes management clinics and demonstrate a robust safety and efficacy profile. The intervention also includes administration of a patient preference survey as outlined in the study protocol. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Average Blood Glucose Level from Continuous Glucose Monitoring
Временное ограничение: Up to 10 days of CGM wear (within 3 months of the Oral Glucose Tolerance Test).
|
Mean glucose level recorded over the continuous glucose monitoring (CGM) wear period (mg/dL) |
Up to 10 days of CGM wear (within 3 months of the Oral Glucose Tolerance Test).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Time Glucose Exceeds 150 mg/dL from Continuous Glucose Monitoring
Временное ограничение: Up to 10 days of CGM wear (within 3 months of the Oral Glucose Tolerance Test).
|
The proportion of time during the CGM wear period that glucose levels were above 150 mg/dL (%) |
Up to 10 days of CGM wear (within 3 months of the Oral Glucose Tolerance Test).
|
|
Percentage of Time Glucose Exceeds 180 mg/dL from Continuous Glucose Monitoring
Временное ограничение: Up to 10 days of CGM wear (within 3 months of the Oral Glucose Tolerance Test).
|
The proportion of time during the CGM wear period that glucose levels were above 180 mg/dL (%) |
Up to 10 days of CGM wear (within 3 months of the Oral Glucose Tolerance Test).
|
|
Fasting Plasma Glucose Level from Oral Glucose Tolerance Test
Временное ограничение: Single measurement at the start of the OGTT (within 3 months of CGM wear).
|
Plasma glucose level measured after an overnight fast, as part of the Oral Glucose Tolerance Test (OGTT) (mg/dL) |
Single measurement at the start of the OGTT (within 3 months of CGM wear).
|
|
1 hour Plasma Glucose Level from Oral Glucose Tolerance Test
Временное ограничение: Single measurement 1 hour after glucose load (within 3 months of CGM wear).
|
Plasma glucose level measured 1 hour after glucose administration as part of the Oral Glucose Tolerance Test (OGTT) (mg/dL) |
Single measurement 1 hour after glucose load (within 3 months of CGM wear).
|
|
2-Hour Plasma Glucose Level from Oral Glucose Tolerance Test
Временное ограничение: Single measurement 2 hours after glucose load (within 3 months of CGM wear).
|
Plasma glucose level measured 2 hours after glucose load administration during the OGTT (mg/dL) |
Single measurement 2 hours after glucose load (within 3 months of CGM wear).
|
|
Forced Expiratory Volume in 1 Second (FEV1) as a Percentage of Predicted
Временное ограничение: Within 3 months of CGM placement (standard of care assessment).
|
Lung function parameter reflecting the volume of air exhaled in the first second during a forced breath, expressed as a percentage of the predicted value. (%) |
Within 3 months of CGM placement (standard of care assessment).
|
|
Forced Vital Capacity (FVC) as a Percentage of Predicted
Временное ограничение: Within 3 months of CGM placement (standard of care assessment).
|
Lung function parameter reflecting the total volume of air exhaled during a forced breath, expressed as a percentage of the predicted value (%) |
Within 3 months of CGM placement (standard of care assessment).
|
|
Hemoglobin A1c (HbA1c) Level
Временное ограничение: At the time of OGTT (within 3 months of CGM wear).
|
A measure of average blood glucose level (%) |
At the time of OGTT (within 3 months of CGM wear).
|
|
Body Mass Index (BMI) Z-Score
Временное ограничение: Within 3 months of CGM placement (standard of care assessment).
|
Age- and sex-adjusted Body Mass Index standardized score, reflecting nutritional status (z-score) |
Within 3 months of CGM placement (standard of care assessment).
|
|
Response to Survey Question on CFRD Screening Preferences
Временное ограничение: After 10 days of CGM wear
|
Participant's (and/or parent/guardian's) response to the Likert scale questions regarding preferences for Cystic Fibrosis Related Diabetes |
After 10 days of CGM wear
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Moran A, Brunzell C, Cohen RC, Katz M, Marshall BC, Onady G, Robinson KA, Sabadosa KA, Stecenko A, Slovis B; CFRD Guidelines Committee. Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society. Diabetes Care. 2010 Dec;33(12):2697-708. doi: 10.2337/dc10-1768. No abstract available.
- Prentice BJ, Ooi CY, Strachan RE, Hameed S, Ebrahimkhani S, Waters SA, Verge CF, Widger J. Early glucose abnormalities are associated with pulmonary inflammation in young children with cystic fibrosis. J Cyst Fibros. 2019 Nov;18(6):869-873. doi: 10.1016/j.jcf.2019.03.010. Epub 2019 Apr 26.
- Chan CL, Pyle L, Vigers T, Zeitler PS, Nadeau KJ. The Relationship Between Continuous Glucose Monitoring and OGTT in Youth and Young Adults With Cystic Fibrosis. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e548-e560. doi: 10.1210/clinem/dgab692.
- Walshaw M. Routine OGTT screening for CFRD - no thanks. J R Soc Med. 2009 Jul;102 Suppl 1(Suppl 1):40-4. doi: 10.1258/jrsm.2009.s19009. No abstract available.
- Prentice B, Hameed S, Verge CF, Ooi CY, Jaffe A, Widger J. Diagnosing cystic fibrosis-related diabetes: current methods and challenges. Expert Rev Respir Med. 2016 Jul;10(7):799-811. doi: 10.1080/17476348.2016.1190646. Epub 2016 Jun 13.
- Hicks R, Ode KL, Vigers T, Chan CL. A provider survey of cystic fibrosis related diabetes screening and management practices at North American CF centers. Front Endocrinol (Lausanne). 2023 May 18;14:1183288. doi: 10.3389/fendo.2023.1183288. eCollection 2023.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 24-0945-CCMC
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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