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Continuous Glucose Monitoring Parameter and Oral Glucose Tolerance Testing (OGTT) Parameters in Children and Young Adults With Cystic Fibrosis (CF)

2026年11月9日 更新者:Northwell Health

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • New York
      • New York、New York、アメリカ、11042
        • 募集
        • Northwell Health
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

10年~25年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Patients with Cystic Fibrosis
  2. 10-25 years of age who have obtained or will obtain a OGTT within 3 months of recruitment and CGM placement.

Exclusion Criteria:

  1. Diagnosis of diabetes mellitus type 1 or type 2
  2. Use of the following medication: steroid course, Metformin therapy,
  3. Concurrent CV disease or malignancy, kidney failure, lung transplant.
  4. Does not have access to personal Bluetooth device compatible with Dexcom G7 application.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ふるい分け
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Average Blood Glucose Level from Continuous Glucose Monitoring
時間枠: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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Time Glucose Exceeds 150 mg/dL from Continuous Glucose Monitoring
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年6月23日

一次修了 (推定)

2027年8月1日

研究の完了 (推定)

2027年8月1日

試験登録日

最初に提出

2026年6月29日

QC基準を満たした最初の提出物

2026年11月9日

最初の投稿 (実際)

2026年11月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月9日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 24-0945-CCMC

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