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COMPLETED Phase 3

Cystic Fibrosis - Insulin Deficiency, Early Action

NCT01100892 · View on ClinicalTrials.gov ↗

Study Summary

Cystic Fibrosis (CF) is the most common life-threatening genetic condition affecting Australian children. As well as repeated lung infections, children with CF develop insulin deficiency and eventually diabetes. The CF-IDEA trial (Cystic Fibrosis - Insulin Deficiency, Early Action) will determine whether starting insulin treatment before the onset of diabetes (earlier than current practice) will improve the health of children with CF by improving body weight and lung function.

Conditions Studied

Interventions

  • DRUG Once-daily insulin detemir

Study Locations (6)

New South Wales

  • John Hunter Children's Hospital — New Lambton
  • Sydney Children's Hospital — Randwick
  • Children's Hospital at Westmead — Westmead

Colorado

  • Children's Hospital Colorado — Denver

Queensland

  • Lady Cilento Children's Hospital — Brisbane

South Australia

  • Women's and Children's Hospital — Adelaide

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2010-12
Est. Completion 2023-02
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01100892

The ClinicalTrials.gov registry entry for NCT01100892 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sydney Children's Hospitals Network, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention — of which Once-daily insulin detemir is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01100892 reports 6 study locations spanning 4 distinct geographic areas — top geographies include New South Wales, Colorado, Queensland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01100892 about?

NCT01100892 is a clinical study titled "Cystic Fibrosis - Insulin Deficiency, Early Action". Cystic Fibrosis (CF) is the most common life-threatening genetic condition affecting Australian children. As well as repeated lung infections, children with CF develop insulin deficiency and eventually diabetes. The CF-IDEA trial (Cystic Fibrosis - Insulin Deficiency, Early Action) will determine wh...

What is the current status of trial NCT01100892?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2010-12. Estimated completion is 2023-02.

What conditions does trial NCT01100892 study?

This clinical trial studies the following conditions: Diabetes, Cystic Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01100892?

The interventions under investigation include: Once-daily insulin detemir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01100892?

This trial is sponsored by Sydney Children's Hospitals Network, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01100892 being conducted?

This trial has 6 study locations across Colorado, New South Wales, Queensland, South Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial