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
Sydney Children's Hospital
100 participants
Jan 25, 2011
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
Inclusion Criteria2
- (1) Patients with Cystic Fibrosis aged >5 yrs attending Sydney Children’s Hospital (SCH), Children’s Hospital Westmead (CHW), John Hunter Children’s Hospital (JHCH), Lady Cilento Children's Hospital Brisbane (LCCB), or Women's and Children's Hospital Adelaide (WCHA).
- (2) Cystic Fibrosis Insulin Deficiency Stage 1 or 2 (defined as peak blood glucose >=8.2 and 120-minute blood glucose <11.1mmol/l on OGTT performed within the last 6 months, when respiratory function stable, as judged by the treating respiratory team.
Exclusion Criteria4
- (1) Diabetes, defined as 120-minute blood glucose on OGTT >=11.1mmol/L or fasting blood glucose >= 7mmol/L. Such patients will be offered insulin treatment as standard clinical care.
- (2) Unstable respiratory disease (hospital admission for treatment of respiratory exacerbation within the last month)
- (3) Current treatment with systemic glucocorticoids or treatment with systemic glucocorticoids of more than 1 month duration, within the last 12 months.
- (4) Current treatment with fluoroquinolone antibiotics.
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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 glucose monitoring.
Locations(1)
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ACTRN12611000068965