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.
Study Type
OBSERVATIONAL
Enrollment
200
This is an observational study.
University of Alabama at Birmingham
Birmingham, Alabama, United States
NOT_YET_RECRUITINGKeck Medical Center of USC
Los Angeles, California, United States
NOT_YET_RECRUITINGStanford University
Palo Alto, California, United States
NOT_YET_RECRUITINGUniversity of California San Diego
San Diego, California, United States
NOT_YET_RECRUITINGUniversity of Colorado Denver
Aurora, Colorado, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
NOT_YET_RECRUITINGEmory University School of Medicine
Atlanta, Georgia, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
NOT_YET_RECRUITINGTulane University
New Orleans, Louisiana, United States
NOT_YET_RECRUITINGMassachusetts
Boston, Massachusetts, United States
NOT_YET_RECRUITING...and 8 more locations
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.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
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.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
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.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
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.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Exercise and Substance Use
This questionnaire ask questions regarding participants' physical activity, sleeping habits and substance use.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Pubertal Self-Assessment
A self-evaluation questionnaire to assess child's pubertal development.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Beverage Questionnaire (BEVQ15)
A questionnaire that asks the frequency and amount of beverage intake for the past month.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
CFRD Care & Technology
This is a questionnaire that asks participants regarding their CFRD care and the technology they use to help them manage diabetes.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Diabetes Management Experience
This is a questionnaire that asks how participants manage their diabetes for the past 12 months.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Problem Areas in Diabetes (PAID)
Questionnaire that asks participants about possible diabetes-related issues they have experienced.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Problem Areas in Diabetes Parents of Teens (P-PAID-T)
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.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Child)
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.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Parent)
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.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Adult-Short Form)/Worry (HFS-II-Worry)
A survey about various scenarios that may happen to the participant and rating how true it is for them over the past 6 months.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Gold Score
A 7 item scale that measures hypoglycemia awareness
Time frame: From enrollment to the end of the participant's participation or 4 weeks
All of Us
A questionnaire that consists of 14 questions asking about the participant, their work and their home life.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
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
This will be measured using a continuous glucose monitor that will be worn by the participant for 3 to 10 days.
Time frame: 3-10 days
Diversity of participants enrolled and barriers to enrollment
This will be measured using the patient-related outcomes questionnaires.
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Renal function by eGFR
Function will be assessed by collection of creatinine and Cystatin-C
Time frame: From enrollment to the end of the participant's participation or 4 weeks
Liver function
This will be measured by liver enzymes and complete blood count (CBC); APRI and EMR data for liver imaging
Time frame: From enrollment to the end of the participant's participation or 4 weeks
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