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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000068965

Acronym

CF-IDEA

Enrollment

104

Registered

2011-01-19

Start date

2011-01-25

Completion date

2022-01-03

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to 19 Years

Healthy volunteers

Inclusion criteria

(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 criteria

(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.

Outcome results