Blood Pressure, Cardiovascular Risk, Cystic Fibrosis (CF), Cystic Fibrosis-related Diabetes, Diabetes, Microvascular, Nephropathy, Neuropathy, Retinopathy
Conditions
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
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.
Interventions
OTHERobservational study
This is an observational study.
Sponsors
Jaeb Center for Health Research
Cystic Fibrosis Foundation
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microvascular Complications | From 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 Surrogates | From 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PhenX English Proficiency | From enrollment to the end of the participant's participation or 4 weeks | 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 | From enrollment to the end of the participant's participation or 4 weeks | 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 | From enrollment to the end of the participant's participation or 4 weeks | This questionnaire ask questions regarding participants' physical activity, sleeping habits and substance use. |
| Pubertal Self-Assessment | From enrollment to the end of the participant's participation or 4 weeks | A self-evaluation questionnaire to assess child's pubertal development. |
| Beverage Questionnaire (BEVQ15) | From enrollment to the end of the participant's participation or 4 weeks | A questionnaire that asks the frequency and amount of beverage intake for the past month. |
| CFRD Care & Technology | From enrollment to the end of the participant's participation or 4 weeks | This is a questionnaire that asks participants regarding their CFRD care and the technology they use to help them manage diabetes. |
| Diabetes Management Experience | From enrollment to the end of the participant's participation or 4 weeks | This is a questionnaire that asks how participants manage their diabetes for the past 12 months. |
| Problem Areas in Diabetes (PAID) | From enrollment to the end of the participant's participation or 4 weeks | Questionnaire that asks participants about possible diabetes-related issues they have experienced. |
| Problem Areas in Diabetes Parents of Teens (P-PAID-T) | From enrollment to the end of the participant's participation or 4 weeks | Questionnaire about what the parent or guardian of a participant may experience with their child's diabetes and rating how true it is for them over the past month. |
| Hypoglycemia Fear Survey (Child) | From enrollment to the end of the participant's participation or 4 weeks | A survey that consists of 25 questions and selecting from scale (0 = never to 4 = always) about how low blood sugar makes children feel and do. |
| Hypoglycemia Fear Survey (Parent) | From enrollment to the end of the participant's participation or 4 weeks | Survey that consists of 25 questions about the frequency of things parents of children with diabetes sometimes do to keep from having low blood sugar. |
| Hypoglycemia Fear Survey (Adult-Short Form)/Worry (HFS-II-Worry) | From enrollment to the end of the participant's participation or 4 weeks | A survey about various scenarios that may happen to the participant and rating how true it is for them over the past 6 months. |
| Gold Score | From enrollment to the end of the participant's participation or 4 weeks | A 7 item scale that measures hypoglycemia awareness |
| All of Us | From enrollment to the end of the participant's participation or 4 weeks | A questionnaire that consists of 14 questions asking about the participant, their work and their home life. |
| 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 | 3-10 days | This will be measured using a continuous glucose monitor that will be worn by the participant for 3 to 10 days. |
| Diversity of participants enrolled and barriers to enrollment | From enrollment to the end of the participant's participation or 4 weeks | This will be measured using the patient-related outcomes questionnaires. |
| Renal function by eGFR | From enrollment to the end of the participant's participation or 4 weeks | Function will be assessed by collection of creatinine and Cystatin-C |
| Liver function | From enrollment to the end of the participant's participation or 4 weeks | This will be measured by liver enzymes and complete blood count (CBC); APRI and EMR data for liver imaging |
Countries
United States
Contacts
CONTACTJudy Sibayan, MPH, CCRP
CONTACTHaley Fonseca, PhD, RDN, LDN
Outcome results
None listed