Actively Recruiting

Age: 18Years +
All Genders
ID06560463

Comparison of Continuous Glucose Monitoring and Oral Glucose Tolerance Test as Screening Tools for Cystic Fibrosis-Related Diabetes

Led by Medical College of Wisconsin · Updated on 2025-09-03

30

Participants Needed

1

Research Sites

30 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying Cystic Fibrosis-related diabetes (CFRD), a unique form of diabetes that differs from type 1 and type 2 diabetes. CFRD is common in adults with cystic fibrosis (CF) and is linked to worsening lung function, poor nutrition, and higher risk of death. Because survival in CF has greatly improved with new treatments, the number of people with CFRD is expected to rise. Annual screening for CFRD using the two-hour Oral Glucose Tolerance Test (OGTT) is the current standard but is time-consuming and has low adherence. This study provides participants with a Dexcom G7 continuous glucose monitor (CGM) to wear for 10 days during their routine CF clinic visit while also completing the annual OGTT and hemoglobin A1c test. A clinic dietitian helps participants apply the CGM sensor, set up phone apps to track glucose and carbohydrate intake, and reviews the glucose reports with them. Data collected from CGM, OGTT, and other clinical measures like lung function and body weight will be entered into a database for comparison of CGM performance against the OGTT. Participants will attend routine clinic visits where their glucose levels, lung function, body weight, and other health data will be assessed. The research team will analyze blood glucose trends over the 10-day CGM period, evaluating measures such as time in range and episodes of low or high blood sugar. The study aims to determine if CGM is an effective screening tool for CFRD. Participation lasts for the duration of the CGM wear and routine annual testing, with ongoing collection of clinical data for analysis.

CONDITIONS

Brief Title

Continuous Glucose Monitoring and OGTT Screen for Cystic Fibrosis Related Diabetes in Cystic Fibrosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults diagnosed with cystic fibrosis and established patients at the Froedtert Multidisciplinary CF Clinic
  • Have normal or impaired glucose tolerance based on an Oral Glucose Tolerance Test completed in 2024
  • Are at a healthy baseline status at the time of continuous glucose monitoring wear and OGTT
Not Eligible

You will not qualify if you...

  • Diagnosed with cystic fibrosis-related diabetes and treated with diabetes medications
  • Have had a transplant
  • Are pregnant
  • Unable to wear the continuous glucose monitor for the entire 10-day period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Monitoring

Duration - 10 days

Participants wear the Dexcom G7 continuous glucose monitor for 10 days during routine CF clinic visits and track dietary carbohydrate intake using the phone app.

1 baseline visit for sensor application and education; monitoring occurs remotely over 10 days

Surveillance

Duration - Ongoing annual assessments

Participants undergo annual Oral Glucose Tolerance Test (OGTT) and HgbA1c as part of standard CF care, with data collected for comparison to continuous glucose monitoring results.

1 annual visit for OGTT and HgbA1c

Trial Site Locations

Total: 1 location

1

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

J

julie A. Biller, MD

P

Patricia Pfahler, RN

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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