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Cystic Fibrosis - Insulin Deficiency, Early Action

NCT01100892 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-05-31

No results posted yet for this 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

Interventions

DRUG

Once-daily insulin detemir

Insulin detemir is a long-acting insulin analog. Starting dose 0.1 units/kg/day (titrated according to the results of home blood glucose monitoring).

Sponsors & Collaborators

  • John Hunter Children's Hospital

    collaborator OTHER

  • Lady Cilento Children's Hospital, Brisbane

    collaborator OTHER

  • Women's and Children's Hospital, Adelaide

    collaborator UNKNOWN

  • Children's Hospital Colorado

    collaborator OTHER

  • Sydney Children's Hospitals Network

    lead OTHER

Principal Investigators

  • Charles Verge, MBBS PhD · Endocrinology, Sydney Children's Hospital Randwick; School of Women's and Children's Health, University of NSW

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01100892 on ClinicalTrials.gov