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

9 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • New York
      • New York, New York, Stati Uniti, 11042
        • Reclutamento
        • Northwell Health
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 10 anni a 25 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Selezione
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Average Blood Glucose Level from Continuous Glucose Monitoring
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Time Glucose Exceeds 150 mg/dL from Continuous Glucose Monitoring
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 giugno 2025

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

29 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 novembre 2026

Primo Inserito (Effettivo)

12 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 24-0945-CCMC

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .