Recruiting

Observational Study

Sponsor:

Jaeb Center for Health Research

Code:

NCT06837181

Conditions

Cystic Fibrosis (CF)

Cystic Fibrosis-related Diabetes

Diabetes

Retinopathy

Neuropathy

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

observational study

Study Details

Brief summary:

This multicenter cross-sectional study will include a diverse population of adolescents and adults with CF.

The overall Aim is to describe prevalence of diabetes microvascular complications and macrovascular surrogates in people with established CFRD.

Conditions

Cystic Fibrosis (CF)

Cystic Fibrosis-related Diabetes

Diabetes

Retinopathy

Neuropathy

Study ID

NCT06837181

Start date

Sep 18, 2025

Status verified date

Feb, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Written informed consent (and assent when applicable) obtained from participant or participant's legally authorized representative
  • For Adults: Must be able to consent on one own's behalf (i.e., cannot lack cognitive capacity to consent due to the required patient-reported outcomes)
  • Be willing and able to adhere to the study protocol requirements
  • Age ≥ 12 years at time of enrollment
  • CF diagnosis based on two CF causing mutations and/or positive sweat test according to CFF diagnostic criteria
  • CFRD diagnosis ≥ 5 years at time of enrollment

Exclusion Criteria:

  • History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject
  • History of transplant
  • Pregnancy reported by participant at time of consent or at any point during active study participation

Pulse Wave Velocity Exclusion Criteria:

  • Erratic, accelerated or mechanically controlled irregular heart rhythms including arrhythmias
  • Carotid or aortic valve stenosis
  • Peripheral artery disease or leg artery disease
  • Generalized constriction or localized spasm of muscular conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery or accompanying Raynaud's phenomena or intense cold.
  • Possible exclusions based on investigator medical provider assessment (additional precautions may be followed to allow inclusion):

  • Pressure reading should not be conducted on a limb where there is intravenous access, arterio-venous shunt, or where circulation is compromised.
  • Pressure reading should not be conducted on the side of the body that a mastectomy was done.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals with Cystic Fibrosis-Related Diabetes

Individuals diagnosed with Cystic Fibrosis-Related Diabetes for more than 5 years before enrollment

Interventions

observational study

This is an observational study.

Primary outcome measure

  • Microvascular Complications [ Time Frame: From enrollment to the end of the participant's participation or 4 weeks ]
  • Macrovascular Surrogates [ Time Frame: From enrollment to the end of the participant's participation or 4 weeks ]

Central Contacts and Locations

Central contacts

Judy Sibayan, MPH, CCRP

813-975-8690jsibayan@jaeb.org

Haley Fonseca, PhD, RDN, LDN

813-975-8690hfonseca@jaeb.org

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Christine Chan, MD

720-777-6128christinel.chan@childrenscolorado.org

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Tanicia Daley, MD MPH

404-727-2503tanicia.daley@emory.edu

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Amir Moheet, MD

617-624-3209mohee002@umn.edu

The Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

Andrea Kelly, MD

215-590-3174kellya@chop.edu

The University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Maria Rayas, MD

210-567-5283rayas@uthscsa.edu

More Information

Sponsor

Jaeb Center for Health Research

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Cystic Fibrosis
  • CFRD
  • Cystic Fibrosis-Related Diabetes
  • Observational
  • Physical Activity Tracker
  • Continuous glucose monitoring
  • CGM
  • Diabetes
  • blood pressure
  • cardiovascular risk
  • microvascular
  • diabetes complications
  • social determinants of health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Jaeb Center for Health Research on 2026-02-10.