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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Colorado Denver
  Aurora, Colorado, United States Recruiting
• Emory University School of Medicine
  Atlanta, Georgia, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• The Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• The University of Texas Health Science Center at San Antonio
  San Antonio, Texas, United States Recruiting
• University of Alabama at Birmingham
  Birmingham, Alabama, United States Not yet recruiting

Study contacts

• Study coordinator: Judy Sibayan, MPH, CCRP
• Email: jsibayan@jaeb.org
• Phone: 813-975-8690

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.