Clinical trial NCT06837181: Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
Official title: Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cystic Fibrosis (CF)
Cystic Fibrosis-related Diabetes
Diabetes
Retinopathy
Neuropathy
Nephropathy
Blood Pressure
Cardiovascular Risk
Microvascular
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
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2025-02-20
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with CFRD diagnosis ≥ 5 years at time of enrollment

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.


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.

Primary outcomes:
measure: Microvascular Complications
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Macrovascular Surrogates
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
Secondary outcomes:
measure: PhenX English Proficiency
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: PhenX Food Security & Prescription Accessibility
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Exercise and Substance Use
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Pubertal Self-Assessment
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Beverage Questionnaire (BEVQ15)
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: CFRD Care & Technology
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Diabetes Management Experience
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Problem Areas in Diabetes (PAID)
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Problem Areas in Diabetes Parents of Teens (P-PAID-T)
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Hypoglycemia Fear Survey (Child)
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Hypoglycemia Fear Survey (Parent)
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Hypoglycemia Fear Survey (Adult-Short Form)/Worry (HFS-II-Worry)
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Gold Score
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: All of Us
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Continuous glucose monitoring (CGM)-defined glycemic control (time-in-range, time-above-range, time-below-range, glucose variability), and the relationships between CGM metrics and HbA1c, in a diverse population of people with established CFRD
timeFrame: 3-10 days
measure: Diversity of participants enrolled and barriers to enrollment
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Renal function by eGFR
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Liver function
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
Other outcomes:
measure: Exploratory Outcome - Participant diversity
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Cardiovascular sub-study - Pulse Wave Velocity and Pulse Wave Analysis (PWV & PWA)
timeFrame: 1 study visit day
measure: Exploratory Outcome - HbA1c and CGM metrics with nutritional intake
timeFrame: 3 days
measure: Exploratory Outcome - HbA1c and CGM metrics with physical activity
timeFrame: 3-10 days
measure: Cardiovascular sub-study - Ambulatory Blood Pressure Monitoring
timeFrame: 24 hours
measure: Fecal Collection
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
measure: Sample Collection for Biorepository
timeFrame: From enrollment to the end of the participant's participation or 4 weeks
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
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