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

Phase 2

Active, not recruiting

• Conditions: Cystic Fibrosis; Insulin Deficiency; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12611000068965
• Lead Sponsor: Sydney Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-19
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 95

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevention of decline in weight and lung function assessed by Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC).[0, 6, 12 months]