Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM) (SPeCTRuM)

February 9, 2026 updated by: Jaeb Center for Health Research

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Haley Fonseca, PhD, RDN, LDN
  • Phone Number: 813-975-8690
  • Email: hfonseca@jaeb.org

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • University of Alabama at Birmingham
        • Contact:
    • California
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • Keck Medical Center of USC
        • Contact:
      • Palo Alto, California, United States, 94304
        • Not yet recruiting
        • Stanford University
        • Contact:
      • San Diego, California, United States, 92103
        • Not yet recruiting
        • University of California San Diego
        • Contact:
    • Colorado
    • Florida
      • Miami, Florida, United States, 33136
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School of Medicine
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Not yet recruiting
        • Tulane University
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Not yet recruiting
        • University of New Mexico
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University Cystic Fibrosis Program
        • Contact:
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Not yet recruiting
        • Atrium Health Wake Forest Baptist (Wake Forest Baptist)
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Recruiting
        • The Children's Hospital of Philadelphia
        • Contact:
    • South Carolina
      • Charlestone, South Carolina, United States, 29425
        • Not yet recruiting
        • Medical University of South Carolina
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Baylor College of Medicine
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The University of Texas Health Science Center at San Antonio
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with CFRD diagnosis ≥ 5 years at time of enrollment

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals with Cystic Fibrosis-Related Diabetes
Individuals diagnosed with Cystic Fibrosis-Related Diabetes for more than 5 years before enrollment
Other: observational study
This is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microvascular Complications
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
Macrovascular Surrogates
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PhenX English Proficiency
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
PhenX Food Security & Prescription Accessibility
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
Exercise and Substance Use
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
Pubertal Self-Assessment
Time Frame: From enrollment to the end of the participant's participation or 4 weeks
A self-evaluation questionnaire to assess child's pubertal development.
From enrollment to the end of the participant's participation or 4 weeks
Beverage Questionnaire (BEVQ15)
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
CFRD Care & Technology
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
Diabetes Management Experience
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
Problem Areas in Diabetes (PAID)
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
Problem Areas in Diabetes Parents of Teens (P-PAID-T)
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Child)
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Parent)
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
Hypoglycemia Fear Survey (Adult-Short Form)/Worry (HFS-II-Worry)
Time Frame: 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.
From enrollment to the end of the participant's participation or 4 weeks
Gold Score
Time Frame: From enrollment to the end of the participant's participation or 4 weeks
A 7 item scale that measures hypoglycemia awareness
From enrollment to the end of the participant's participation or 4 weeks
All of Us
Time Frame: 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.
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
Time Frame: 3-10 days
This will be measured using a continuous glucose monitor that will be worn by the participant for 3 to 10 days.
3-10 days
Diversity of participants enrolled and barriers to enrollment
Time Frame: From enrollment to the end of the participant's participation or 4 weeks
This will be measured using the patient-related outcomes questionnaires.
From enrollment to the end of the participant's participation or 4 weeks
Renal function by eGFR
Time Frame: From enrollment to the end of the participant's participation or 4 weeks
Function will be assessed by collection of creatinine and Cystatin-C
From enrollment to the end of the participant's participation or 4 weeks
Liver function
Time Frame: 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
From enrollment to the end of the participant's participation or 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Outcome - Participant diversity
Time Frame: From enrollment to the end of the participant's participation or 4 weeks
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.
From enrollment to the end of the participant's participation or 4 weeks
Cardiovascular sub-study - Pulse Wave Velocity and Pulse Wave Analysis (PWV & PWA)
Time Frame: 1 study visit day
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).
1 study visit day
Exploratory Outcome - HbA1c and CGM metrics with nutritional intake
Time Frame: 3 days
The participant will complete 3-day recall of food intake using NIH's Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.
3 days
Exploratory Outcome - HbA1c and CGM metrics with physical activity
Time Frame: 3-10 days
The participant will be required to wear an accelerometer device for 3 to 10 days to assess physical activity.
3-10 days
Cardiovascular sub-study - Ambulatory Blood Pressure Monitoring
Time Frame: 24 hours
An oscillometric Spacelab monitors will be used to measure variables including SBP/DBP and BP load (%BP above 95th percentile for sex and height) for the 24-hour period and awake/sleep period. Sleep time will be determined from actigraphy and participant documentation.
24 hours
Fecal Collection
Time Frame: From enrollment to the end of the participant's participation or 4 weeks
Participant stool sample will be obtained for fecal elastase only for those for pancreatic sufficiency status is unclear.
From enrollment to the end of the participant's participation or 4 weeks
Sample Collection for Biorepository
Time Frame: From enrollment to the end of the participant's participation or 4 weeks
Blood, urine and stool will be collected for biorepository.
From enrollment to the end of the participant's participation or 4 weeks
Information Collection for Geocoding
Time Frame: from enrollment
The study will use the participants' addresses or part of their addresses (such as their zip codes) to allow researchers to look at how where they live might be related to their health through geocoding.
from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

Cystic Fibrosis Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPECTRUM
  • 007365A124 (Other Grant/Funding Number: Cystic Fibrosis Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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