Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01100892




Registration number
NCT01100892
Ethics application status
Date submitted
31/03/2010
Date registered
9/04/2010
Date last updated
31/05/2023

Titles & IDs
Public title
Cystic Fibrosis - Insulin Deficiency, Early Action
Scientific title
Cystic Fibrosis - Insulin Deficiency, Early Action
Secondary ID [1] 0 0
CF-IDEA
Universal Trial Number (UTN)
Trial acronym
CF-IDEA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Diabetes 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Once-daily insulin detemir

No intervention: Control group - Observation only. Does not receive once-daily insulin detemir.

Experimental: Once-daily insulin detemir - Once-daily insulin detemir


Treatment: Drugs: Once-daily insulin detemir
Insulin detemir is a long-acting insulin analog. Starting dose 0.1 units/kg/day (titrated according to the results of home blood glucose monitoring).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Weight SDS (Standard Deviation Score)
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Change in lung function (FEV1, FVC)
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Reduced rate of decline in glycaemic category, comparing OGTT at baseline and 12 months.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Reduced frequency of hospitalisation for acute respiratory illness
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Change in glycaemic status assessed by HbA1c and CGM
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Body composition by DEXA. Patients at CHW will also have pQCT.
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Change in Grip-strength
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Improved quality of life, measured by a validated CF QOL questionnaire
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Bacterial colonisation of sputum
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Change in effort-dependent lung function: MIP, MEP, SnIP
Timepoint [8] 0 0
12 months

Eligibility
Key inclusion criteria
* 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).
Minimum age
5 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2023
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 0 0
Lady Cilento Children's Hospital - Brisbane
Recruitment hospital [5] 0 0
Women's and Children's Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2310 - New Lambton
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
5006 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado

Funding & Sponsors
Primary sponsor type
Other
Name
Sydney Children's Hospitals Network
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
John Hunter Children's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Lady Cilento Children's Hospital, Brisbane
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Women's and Children's Hospital, Adelaide
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Children's Hospital Colorado
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01100892
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Charles Verge, MBBS PhD
Address 0 0
Endocrinology, Sydney Children's Hospital Randwick; School of Women's and Children's Health, University of NSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01100892