drugset / Trial / NCT01100892
Cystic Fibrosis - Insulin Deficiency, Early Action
Phase 3
Completed
100 enrolled
Sydney Children's Hospitals Network
Children's Hospital Colorado · collabJohn Hunter Children's Hospital · collabLady Cilento Children's Hospital, Brisbane · collabWomen's and Children's Hospital, Adelaide · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-12
- Primary completion
- 2023-02
- Completion
- 2023-02
Publications
- Background Hameed S, Morton JR, Jaffe A, Field PI, Belessis Y, Yoong T, Katz T, Verge CF. Early glucose abnormalities in cystic fibrosis are preceded by poor weight gain. Diabetes Care. 2010 Feb;33(2):221-6. doi: 10.2337/dc09-1492. Epub 2009 Nov 12.
- Background Hameed S, Morton JR, Field PI, Belessis Y, Yoong T, Katz T, Woodhead HJ, Walker JL, Neville KA, Campbell TA, Jaffe A, Verge CF. Once daily insulin detemir in cystic fibrosis with insulin deficiency. Arch Dis Child. 2012 May;97(5):464-7. doi: 10.1136/adc.2010.204636. Epub 2011 Apr 14.
- Background Hameed S, Jaffe A, Verge CF. Cystic fibrosis related diabetes (CFRD)--the end stage of progressive insulin deficiency. Pediatr Pulmonol. 2011 Aug;46(8):747-60. doi: 10.1002/ppul.21495. Epub 2011 May 27.
- Hameed S, Barnes EH, Briody J, Wainwright CE, Hilton J, Field PI, Tai A, Belessis Y, Chan CL, Selvadurai H, Prentice B, Katz T, McMahon SK, Neylan M, Pena A, Jaffe A, Verge CF. Insulin for early glycaemic abnormality in children with cystic fibrosis without cystic fibrosis-related diabetes (CF-IDEA): a randomised controlled trial. Lancet Child Adolesc Health. 2025 Jun;9(6):371-382. doi: 10.1016/S2352-4642(25)00099-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin detemir | Protein / enzyme biologic | 0.1 iu/kg | Subcutaneous |