Cystic Fibrosis - Insulin Deficiency, Early Action
Completed · Phase 3
Conditions studied: Cystic Fibrosis, Diabetes
In brief
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.
Key facts
- Study ID
- NCT01100892
- Run by
- Sydney Children's Hospitals Network
- People needed
- 100
- Starts
- 2010-12-01
- Expected to finish
- 2023-02-01
- Last updated by the study team
- 2023-05-31
Who can join
Age: 5 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with CF aged >=5 yrs attending one of the study sites.
- CFID1 or CFID2 (defined as BGmax >=8.2 and BG120 <11.1mmol/l on OGTT performed within the last 6 months, when respiratory function stable as judged by the treating respiratory team, not taking fluoroquinolone antibiotics, and not taking systemic glucocorticoids).
You may not qualify if…
- Cystic Fibrosis Related Diabetes, defined as CFID3 (BG120 >11.1mmol/L) or CFID4 (fasting BG >7mmol/L). Such patients will be offered insulin treatment as standard clinical care.
- Unstable respiratory disease (hospital admission for treatment of respiratory exacerbation within the last month).
- Treatment with systemic glucocorticoids of more than 1 month duration, within the last 12 months.
Where it is running
- Children's Hospital Colorado — Denver, Colorado, United States
- John Hunter Children's Hospital — New Lambton, New South Wales, Australia
- Sydney Children's Hospital — Randwick, New South Wales, Australia
- Children's Hospital at Westmead — Westmead, New South Wales, Australia
- Lady Cilento Children's Hospital — Brisbane, Queensland, Australia
- Women's and Children's Hospital — Adelaide, South Australia, Australia
Full record on ClinicalTrials.gov
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