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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical College of Wisconsin

About this trial

Cystic Fibrosis (CF) related diabetes (CFRD) is a unique form of diabetes mellitus, different from type 1 diabetes and type 2 diabetes. The diagnosis of CFRD is associated with a decline in pulmonary function, decreased nutritional status, and increased mortality. CFRD is extremely common in people with CF, occurring in approximately 40-50% of adults with CF. Impaired glucose tolerance or dysglycemia is also very common in CF. It is standard of care to screen for CFRD annually from the age of 10 years with a two-hour Oral Glucose Tolerance Test (OGTT) with 75 g dextrose. The gold standard screening for CFRD is the OGTT which is problematic as it is time consuming for patient and staff and adherence to annual screening is low among CF centers.

Survival has improved dramatically with the advent of CFTR modulators and it is presumed that the incidence of CFRD will increase with increased life expectancy. The Cystic Fibrosis Foundation (CFF) has developed the oldest disease specific patient registry, consisting of approximately 35000 patients, so there is vast historical information available on individual patients and larger datasets on the CF community as a whole. Based on the 2021 CFF patient registry data, the current life expectancy for CF patients born between 2017 and 2021 is 53 years - a 15 year increase from a decade ago.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

An adult patient, diagnosed with CF, established with Froedtert Multidisciplinary CF Clinic.

Normal glucose tolerance or impaired glucose tolerance per OGTT completed in 2024.

At healthy baseline status at time of CGM wear and OGTT.

Disqualifiers

Diagnosed with CFRD and treating with diabetogenic medications.

s/p transplant

pregnancy

failure to wear CGM for entirety of 10 days

Trial population

People with Cystic Fibrosis, age 18 years and older, who receive care in the Froedtert and MCW Adult Cystic Fibrosis program.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Access to Dexcom G7 CGM Data

    Device

    Eligible patients will undergo Continuous Glucose Monitoring using the Dexcom G7

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Cystic Fibrosis1 intervention

Trial outcomes

Primary outcomes

1

Blood glucose measurement

Blood glucose levels will be continuously monitored over a ten-day period using a Dexcom G7 continuous glucose monitor (CGM)

Time frame
10 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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