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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01100892