CompletedPhase 2Phase 3ACTRN12611000068965

CF-IDEA (Cystic Fibrosis - Insulin Deficiency, Early Action): Randomised controlled trial of once-daily insulin detemir in patients with cystic fibrosis and early insulin deficiency

Randomised controlled trial to determine whether once-daily insulin detemir slows decline in weight and lung function in patients with cystic fibrosis and early insulin deficiency


Sponsor

Sydney Children's Hospital

Enrollment

100 participants

Start Date

Jan 25, 2011

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 19 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a daily insulin injection can help children and teenagers (ages 5-19) with cystic fibrosis who are showing early signs of insulin problems but do not yet have diabetes. The goal is to see if early treatment can improve health outcomes before full diabetes develops.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Once-daily insulin detemir (Levemir) administered by subcutaneous injection for 12 months. Commencing dose 0.1 units/kg/day, titrated in 0.5 unit increments according to the results of home blood glu

Once-daily insulin detemir (Levemir) administered by subcutaneous injection for 12 months. Commencing dose 0.1 units/kg/day, titrated in 0.5 unit increments according to the results of home blood glucose monitoring.


Locations(1)

Colorado, United States of America

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