Recruiting

Continuous Glucose Monitoring

Sponsor:

Northwell Health

Code:

NCT07930884

Conditions

Cystic Fibrosis Related Diabetes

CGM

Eligibility Criteria

Sex: All

Age: 10 - 25

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitor

Study Details

Brief summary:

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.

Conditions

Cystic Fibrosis Related Diabetes

CGM

Study ID

NCT07930884

Start date

Jun 23, 2025

Status verified date

Oct, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 25

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Continuous Glucose Monitor

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.

Primary outcome measure

  • Average Blood Glucose Level from Continuous Glucose Monitoring [ Time Frame: Up to 10 days of CGM wear (within 3 months of the Oral Glucose Tolerance Test). ]

Central Contacts and Locations

Central contacts

Jennifer Apsan, MD

516-472-3750japsan@northwell.edu

Locations

Northwell Health

Recruiting

New York, New York, United States, 11042

Contacts

Ishrat Ghani

516-472-3692ighani@Northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Nov 12, 2026

Last verified

Oct, 2026

Keywords

  • Cystic Fibrosis Related Diabetes
  • CGM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.