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Trial registered on ANZCTR


Registration number
ACTRN12611000068965
Ethics application status
Approved
Date submitted
31/03/2010
Date registered
19/01/2011
Date last updated
5/11/2019
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
CF-IDEA (Cystic Fibrosis - Insulin Deficiency, Early Action): Randomised controlled trial of once-daily insulin detemir in patients with cystic fibrosis and early insulin deficiency
Scientific title
Randomised controlled trial to determine whether once-daily insulin detemir slows decline in weight and lung function in patients with cystic fibrosis and early insulin deficiency
Secondary ID [1] 253444 0
ClinicalTrials.gov NCT01100892
Universal Trial Number (UTN)
Trial acronym
CF-IDEA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 257055 0
Insulin Deficiency 257056 0
Condition category
Condition code
Respiratory 257214 257214 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once-daily insulin detemir (Levemir) administered by subcutaneous injection for 12 months. Commencing dose 0.1 units/kg/day, titrated in 0.5 unit increments according to the results of home blood glucose monitoring.
Intervention code [1] 256228 0
Treatment: Drugs
Comparator / control treatment
No insulin (Observation only)
Control group
Active

Outcomes
Primary outcome [1] 258107 0
Prevention of decline in weight and lung function assessed by Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC).
Timepoint [1] 258107 0
0, 6, 12 months
Secondary outcome [1] 263715 0
Reduced frequency of hospitalisation for acute respiratory illness (assessed from medical records data)
Timepoint [1] 263715 0
Over 12 months from baseline
Secondary outcome [2] 263716 0
Reduced rate of decline in glycaemic category
Timepoint [2] 263716 0
Comparing Oral Glucose Tolerance Test (OGTT) at 0 and 12 months
Secondary outcome [3] 263717 0
Change in glycaemic status assessed by glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM)
Timepoint [3] 263717 0
HbA1c at 0, 6, 12 months
CGM at 0 and 6 months
Secondary outcome [4] 263718 0
Improved quality of life, assessed by validated Cystic Fibrosis Quality of Life (CFQOL) questionnaire (Quittner A.L. et al 2000)
Timepoint [4] 263718 0
0 and 12 months
Secondary outcome [5] 263719 0
Change in additional lung function tests to assess effort-dependent lung function: MIP (Mouth Inspiratory Pressure), MEP (Mouth Expiratory Pressure) and SnIP (Sniff Nasal Inspiratory Pressure)
Timepoint [5] 263719 0
0, 6, 12 months
Secondary outcome [6] 263720 0
Change in maximal isometric Grip-strength of the non-dominant hand, using a handgrip dynamometer
Timepoint [6] 263720 0
0, 6, 12 months
Secondary outcome [7] 263721 0
Body composition by DEXA (Dual Energy X-ray Absorptiometry). Patients at Children's Hospital Westmead (CHW) will also have pQCT (peripheral Quantitative Computed Tomography
Timepoint [7] 263721 0
0 and 12 months
Secondary outcome [8] 263722 0
Bacterial colonisation of sputum
Timepoint [8] 263722 0
0 and 12 months

Eligibility
Key inclusion criteria
(1) Patients with Cystic Fibrosis aged >5 yrs attending Sydney Children’s Hospital (SCH), Children’s Hospital Westmead (CHW), John Hunter Children’s Hospital (JHCH), Lady Cilento Children's Hospital Brisbane (LCCB), or Women's and Children's Hospital Adelaide (WCHA).

(2) Cystic Fibrosis Insulin Deficiency Stage 1 or 2 (defined as peak blood glucose >=8.2 and 120-minute blood glucose <11.1mmol/l on OGTT performed within the last 6 months, when respiratory function stable, as judged by the treating respiratory team.
Minimum age
5 Years
Maximum age
19 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Diabetes, defined as 120-minute blood glucose on OGTT >=11.1mmol/L or fasting blood glucose >= 7mmol/L. Such patients will be offered insulin treatment as standard clinical care.

(2) Unstable respiratory disease (hospital admission for treatment of respiratory exacerbation within the last month)

(3) Current treatment with systemic glucocorticoids or treatment with systemic glucocorticoids of more than 1 month duration, within the last 12 months.

(4) Current treatment with fluoroquinolone antibiotics.

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 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 256729 0
Charities/Societies/Foundations
Name [1] 256729 0
Australian Cystic Fibrosis Research Trust
Address [1] 256729 0
P.O. Box 149, North Ryde NSW, 1670
Country [1] 256729 0
Australia
Funding source category [2] 258353 0
Government body
Name [2] 258353 0
National Health and Medical Research Council (NHMRC)
Address [2] 258353 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [2] 258353 0
Australia
Primary sponsor type
Hospital
Name
Sydney Children's Hospital
Address
High Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 256013 0
None
Name [1] 256013 0
Address [1] 256013 0
Country [1] 256013 0
Other collaborator category [1] 1173 0
Hospital
Name [1] 1173 0
Children's Hospital at Westmead
Address [1] 1173 0
Locked Bag 4001
Westmead NSW 2145
Country [1] 1173 0
Australia
Other collaborator category [2] 1174 0
Hospital
Name [2] 1174 0
John Hunter Children's Hospital
Address [2] 1174 0
Locked Bag 1
Hunter Regional Mail Centre
NSW 2310
Country [2] 1174 0
Australia
Other collaborator category [3] 278246 0
Hospital
Name [3] 278246 0
Lady Cilento Children's Hospital
Address [3] 278246 0
Raymond Terrace
South Brisbane
QLD 4101
Country [3] 278246 0
Australia
Other collaborator category [4] 278247 0
Hospital
Name [4] 278247 0
Women's and Children's Hospital
Address [4] 278247 0
72 King William Road
North Adelaide
SA 5006
Country [4] 278247 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258741 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 258741 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 258741 0
Australia
Date submitted for ethics approval [1] 258741 0
Approval date [1] 258741 0
07/12/2009
Ethics approval number [1] 258741 0
Approval Reference No. 09/10/21/5.01 - HREC/09/HNE/339

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
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 33, 221-226. 2010

Hameed, S., Morton, J. R., Field, P. I., Belessis, Y., Yoong, T., Katz, T., Woodhead, H. J., Walker, J. L., Neville, K. A., Campbell, T. A., Jaffe, A., Verge, C. F. Once daily insulin detemir in cystic fibrosis.
Archives of Disease in Childhood 97(5), 464-467. 2012

Hameed, S., Jaffe, A., and Verge, C. F. Cystic Fibrosis Related Diabetes - the end stage of progressive insulin deficiency. Pediatric Pulmonology 46(8), 747-760. 2011.

Public notes

Contacts
Principal investigator
Name 30994 0
Dr Charles Verge
Address 30994 0
Endocrinology
Room P4036, Level 4, Emergency Wing
Sydney Children’s Hospital
High Street, Randwick NSW 2031
Country 30994 0
Australia
Phone 30994 0
+61293821456
Fax 30994 0
Email 30994 0
c.verge@UNSW.edu.au
Contact person for public queries
Name 14241 0
Dr Charles Verge
Address 14241 0
Endocrinology
Sydney Children's Hospital
High Street
Randwick NSW 2031
Country 14241 0
Australia
Phone 14241 0
+61 2 93821456
Fax 14241 0
Email 14241 0
c.verge@UNSW.edu.au
Contact person for scientific queries
Name 5169 0
Dr Charles Verge
Address 5169 0
Endocrinology
Sydney Children's Hospital
High Street
Randwick NSW 2031
Country 5169 0
Australia
Phone 5169 0
+61 2 93821456
Fax 5169 0
Email 5169 0
c.verge@UNSW.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided
What supporting documents are/will be available?
No other documents available
Summary results
No Results