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NCT Number: NCT06837181

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observational study

Other

This is an observational study.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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

Other outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Fonseca, PhD, RDN, LDN

CONTACT

[email protected]

813-975-8690

Judy Sibayan, MPH, CCRP

CONTACT

[email protected]

813-975-8690

Sponsors and collaborators

Lead sponsor

Jaeb Center for Health Research

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Acronym: SPeCTRuM

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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