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Studying Complications in Cystic Fibrosis-related Diabetes (SPeCTRuM)

This observational study, called SPeCTRuM, is looking at the presence of diabetes complications in people with Cystic Fibrosis (CF) and Cystic Fibrosis-related Diabetes (CFRD). It's not testing a new medicine, but rather observing participants to understand how common certain issues like eye problems (retinopathy) and nerve damage (neuropathy) are. Researchers will be looking at microvascular complications (problems with small blood vessels) and macrovascular surrogates (indicators of problems with large blood vessels). You can join if you are 12 years or older, can give informed consent, and are willing to follow the study's requirements. The study aims to include a diverse group of adolescents and adults with CF. The current status of the study is unclear.

Study design
This is an observational study that plans to include 200 participants. It is a multicenter cross-sectional study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be observed from enrollment to the end of their participation, or for 4 weeks, to measure complications.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06837181

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

Recruiting
Not specifiedAges 12+Observational
Jaeb Center for Health Research
~200 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:observational study

At a glance

Recruiting sites
5 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Microvascular Complications
Measured over From enrollment to the end of the participant's participation or 4 weeks
+1 more outcome measured

Conditions

Cystic Fibrosis (CF)
Cystic Fibrosis-related Diabetes
Diabetes
Retinopathy
Neuropathy
Nephropathy
Blood Pressure
Cardiovascular Risk
Microvascular

Explore related trials

Cystic FibrosisCystic Fibrosis-related DiabetesCFTR Gene

Where it's being run

18 sites across 15 states
California3
Texas2
Alabama1
Colorado1
Florida1
Georgia1
Iowa1
Louisiana1

Who to contact

Judy Sibayan, MPH, CCRP
[email protected]
813-975-8690
Email the study team

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Eligibility criteria

Inclusion

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

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
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.

What this trial measures

  • Microvascular ComplicationsFrom enrollment to the end of the participant's participation or 4 weeks

    To describe the rates of microvascular complications (retinopathy, nephropathy, and peripheral neuropathy) and their relationships with HbA1c and diabetes duration in diverse cohort of adolescents and adults with CFRD for ≥5 years.

  • Macrovascular SurrogatesFrom enrollment to the end of the participant's participation or 4 weeks

    To describe macrovascular surrogates (resting blood pressure (BP), fasting lipids) and their relationship with HbA1c, diabetes duration and BMI in a diverse cohort with established CFRD.