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Insulin

Once-daily insulin detemir for Cystic Fibrosis (CF-IDEA Trial)

Phase 3
Waitlist Available
Led By Charles Verge, MBBS PhD
Research Sponsored by Sydney Children's Hospitals Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

CF-IDEA Trial Summary

This trial will help determine if starting insulin treatment earlier than when diabetes is diagnosed will improve the health of children with CF.

Eligible Conditions
  • Cystic Fibrosis
  • Diabetes

CF-IDEA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Weight SDS (Standard Deviation Score)
Change in lung function (FEV1, FVC)
Secondary outcome measures
Bacterial colonisation of sputum
Body composition by DEXA. Patients at CHW will also have pQCT.
Change in Grip-strength
+5 more

CF-IDEA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Once-daily insulin detemirExperimental Treatment1 Intervention
Once-daily insulin detemir
Group II: Control groupActive Control1 Intervention
Observation only. Does not receive once-daily insulin detemir.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin detemir
FDA approved

Find a Location

Who is running the clinical trial?

Sydney Children's Hospitals NetworkLead Sponsor
35 Previous Clinical Trials
43,146 Total Patients Enrolled
John Hunter Children's HospitalOTHER
3 Previous Clinical Trials
220 Total Patients Enrolled
Lady Cilento Children's Hospital, BrisbaneOTHER
1 Previous Clinical Trials
150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this research project be open to people who are senior citizens?

"According to the study's requirements, children aged 5-19 are eligible to participate."

Answered by AI

Might I be a right candidate for this clinical trial?

"This cystic fibrosis clinical trial is looking for around 100 individuals that are currently 5 to 19 years old."

Answered by AI

How does Once-daily insulin detemir compare to other treatments?

"At this moment, 9 separate clinical trials are underway to study the effects of Once-daily insulin detemir. 1 of those trials is currently in Phase 3. Although the majority of these studies are taking place in New Lambton, New South Wales, Once-daily insulin detemir is being studied at 17 different locations."

Answered by AI

Are there any unfilled spots in this experiment for testing new treatments?

"Information on clinicaltrials.gov reveals that this study is not presently looking for participants. This trial was initially posted on December 1st, 2010 and was updated on October 17th, 2020. There are 617 other trials accepting patients at this time."

Answered by AI

What are the risks associated with Once-daily insulin detemir?

"Detemir is a novel insulin that Power rates a 3 in terms of safety. This is due to Phase 3 data supporting its efficacy and multiple rounds of data confirming its safety."

Answered by AI
Recent research and studies
Diabetes CareJournal
Early Glucose Abnormalities in Cystic Fibrosis Are Preceded by Poor Weight Gain
Hameed, Shihab, John R. Morton, Adam Jaffé, Penny I. Field, Yvonne Belessis, Terence Yoong, Tamarah Katz, and Charles F. Verge. 2009. “Early Glucose Abnormalities in Cystic Fibrosis Are Preceded by Poor Weight Gain”. Diabetes Care. American Diabetes Association. doi:10.2337/dc09-1492.
Archives of Disease in ChildhoodJournal
Once Daily Insulin Detemir in Cystic Fibrosis with Insulin Deficiency
Hameed, Shihab, John R Morton, Penny I Field, Yvonne Belessis, Terence Yoong, Tamarah Katz, Helen J Woodhead, et al.. 2011. “Once Daily Insulin Detemir in Cystic Fibrosis with Insulin Deficiency”. Archives of Disease in Childhood. BMJ. doi:10.1136/adc.2010.204636.
Pediatric PulmonologyJournal
Cystic Fibrosis Related Diabetes (cfrd)-the End Stage of Progressive Insulin Deficiency
Hameed, Shihab, Adam Jaffé, and Charles F. Verge. 2011. “Cystic Fibrosis Related Diabetes (cfrd)-the End Stage of Progressive Insulin Deficiency”. Pediatric Pulmonology. Wiley. doi:10.1002/ppul.21495.
clinicaltrials.govStudy
Cystic Fibrosis - Insulin Deficiency, Early Action
Dr Charles Verge 2010. "Cystic Fibrosis - Insulin Deficiency, Early Action". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01100892.
~7 spots leftby Apr 2025
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