Observational Study on Complications in People With Long-Term Cystic Fibrosis-Related Diabetes
Focusing on Microvascular and Cardiovascular Health in Adolescents and Adults
Led by Jaeb Center for Health Research · Updated on 2026-02-10
200
Participants Needed
18
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter observational study to understand the prevalence of diabetes-related complications in adolescents and adults with cystic fibrosis-related diabetes CFRD. The study focuses on both microvascular complications and macrovascular surrogates in people who have had a CFRD diagnosis for more than five years. This research aims to provide a clearer picture of these complications in a diverse population with established CFRD.
Participants diagnosed with CFRD for over five years will be included in the study. The study does not involve any treatment but observes participants to collect data on their condition. The primary outcomes focus on identifying microvascular complications and macrovascular surrogates within approximately four weeks of participation. Secondary outcomes include various assessments such as glucose control through continuous glucose monitoring, liver and kidney function, and other health and lifestyle questionnaires.
During the study, participants will complete multiple questionnaires related to their diabetes management, food security, exercise, and fears related to hypoglycemia. Researchers will also assess blood glucose patterns using continuous glucose monitoring for 3 to 10 days. Additional monitoring includes renal and liver function tests and evaluation of cardiovascular risk factors. Participants data will be collected during their enrollment and up to about four weeks, helping researchers better understand CFRD complications and related health factors in this population.
CONDITIONS
Brief Title
Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
Research Team
J
Judy Sibayan, MPH, CCRP
H
Haley Fonseca, PhD, RDN, LDN
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Written informed consent (and assent when applicable) from participant or authorized representative
Adults must be able to consent on their own
Willing and able to follow study requirements
Age 12 years or older at enrollment
Confirmed cystic fibrosis diagnosis by two CF-causing mutations and/or positive sweat test
Diagnosed with cystic fibrosis-related diabetes for 5 or more years at enrollment
You will not qualify if you...
Any illness or condition that could affect study results or increase risk
History of transplant
Pregnancy at consent or during study participation
Irregular or controlled irregular heart rhythms
Carotid or aortic valve narrowing
Peripheral or leg artery disease
Generalized constriction or spasm of muscular conduit arteries
Limb with intravenous access, arterio-venous shunt, or compromised circulation cannot be used for pressure readings
Pressure readings not allowed on side of body with mastectomy
Other exclusions may be made by investigator's assessment
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Observational Monitoring
Duration - Up to 4 weeks
Participants with cystic fibrosis-related diabetes are observed to assess various health outcomes and diabetes-related measures.
1 to 2 visits depending on assessments
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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