Diabetes Complications in People with Cystic Fibrosis-Related Diabetes (SPeCTRuM)

Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)

This project will see how common diabetes-related complications (like eye, nerve, and blood vessel problems) are in adolescents and adults living with cystic fibrosis-related diabetes.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Jaeb Center for Health Research (Academic / other)
• Locations: 18 sites (Birmingham, Alabama and 17 other locations)
• Trial ID: NCT06837181 on ClinicalTrials.gov

What this trial studies

SPeCTRuM is a multicenter cross-sectional observational study enrolling adolescents and adults with cystic fibrosis who have had cystic fibrosis–related diabetes (CFRD) for at least five years. Participants undergo a one-time set of clinical evaluations including medical history, blood tests, retinal screening, neuropathy assessments, and noninvasive vascular measures such as pulse wave velocity, and may wear activity trackers and complete patient-reported outcome questionnaires. The aim is to describe the prevalence of microvascular complications (retinopathy, neuropathy) and macrovascular surrogates in an intentionally diverse CFRD population. Study visits occur at academic sites in Birmingham, Los Angeles, and Palo Alto and exclude people with prior organ transplant or pregnancy.

Who should consider this trial

Good fit: Ideal candidates are people aged 12 years or older with a confirmed CF diagnosis and at least five years since CFRD diagnosis who can provide informed consent and complete study procedures.

Not a fit: People with a history of organ transplant, those who are pregnant, or those with a recent CFRD diagnosis of less than five years are unlikely to gain direct benefit from this observational protocol.

Why it matters

Potential benefit: If successful, the results could help clinicians detect and manage diabetes-related complications earlier in people with CFRD by clarifying how common these problems are and which patients are at higher risk.

How similar studies have performed: Some prior studies have reported diabetes complications in the CF population, but comprehensive multicenter cross-sectional data specifically focused on long-standing CFRD complications remain limited.

Eligibility criteria

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.

Where this trial is running

Birmingham, Alabama and 17 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Not_yet_recruiting)
• Keck Medical Center of USC — Los Angeles, California, United States (Not_yet_recruiting)
• Stanford University — Palo Alto, California, United States (Not_yet_recruiting)
• University of California San Diego — San Diego, California, United States (Not_yet_recruiting)
• University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
• University of Miami — Miami, Florida, United States (Not_yet_recruiting)
• Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
• University of Iowa — Iowa City, Iowa, United States (Not_yet_recruiting)
• Tulane University — New Orleans, Louisiana, United States (Not_yet_recruiting)
• Massachusetts — Boston, Massachusetts, United States (Not_yet_recruiting)
• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
• University of New Mexico — Albuquerque, New Mexico, United States (Not_yet_recruiting)
• Columbia University Cystic Fibrosis Program — New York, New York, United States (Not_yet_recruiting)
• Atrium Health Wake Forest Baptist (Wake Forest Baptist) — Winston-Salem, North Carolina, United States (Not_yet_recruiting)
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
• Medical University of South Carolina — Charlestone, South Carolina, United States (Not_yet_recruiting)
• Baylor College of Medicine — Houston, Texas, United States (Not_yet_recruiting)
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Judy Sibayan, MPH, CCRP

Conditions Cystic Fibrosis; Cystic Fibrosis-related Diabetes; Diabetes; Retinopathy; Neuropathy; Nephropathy; Blood Pressure; Cardiovascular Risk