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.
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
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
Individuals with CFRD diagnosis ≥ 5 years at time of enrollment
Cohort
Cross-sectional
observational study
Other interventionThis is an observational study.
Microvascular Complications
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 Surrogates
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.
PhenX English Proficiency
This questionnaire will be used to describe the social determinants of health in the study population and their cross-sectional relationships with microvascular complications and macrovascular surrogates will largely be explored.
PhenX Food Security & Prescription Accessibility
This questionnaire will be used to describe the social determinants of health in the study population and their cross-sectional relationships with microvascular complications and macrovascular surrogates will largely be explored.
Exercise and Substance Use
This questionnaire ask questions regarding participants' physical activity, sleeping habits and substance use.
Pubertal Self-Assessment
A self-evaluation questionnaire to assess child's pubertal development.
Exploratory Outcome - Participant diversity
This will measure diversity of individuals who were approached for study inclusion, who were recruited, who consented and who partially or fully completed study procedures as well as barriers and facilitators to recruitment.
Cardiovascular sub-study - Pulse Wave Velocity and Pulse Wave Analysis (PWV & PWA)
A Sphygmocor XCEL device will be used to measure PWV/PWA (m/sec), pulse pressure amplification and augmentation index (Aix) and Aix adjusted to a HR of 75 (Aix-75).
Exploratory Outcome - HbA1c and CGM metrics with nutritional intake
The participant will complete 3-day recall of food intake using NIH's Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.
Exploratory Outcome - HbA1c and CGM metrics with physical activity
The participant will be required to wear an accelerometer device for 3 to 10 days to assess physical activity.
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Jaeb Center for Health Research
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
