A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis

ISRCTN	ISRCTN71877586
DOI	https://doi.org/10.1186/ISRCTN71877586
Protocol serial number	SCH-05-015
Sponsor	Sheffield Children's NHS Foundation Trust (UK)
Funders	British Society of Paediatric Endocrinology and Diabetes (UK) - Initial funding of £10,000 in November 2004, Sheffield Children's Appeal Charity (UK) - £32,000 in early 2005, Novo Nordisk (UK) - the makers of Detemir; £72,000 (post MREC approval) in summer 2005

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Neil Wright
Scientific

Sheffield Children's NHS Foundation Trust
Academic Unit of Child Health
C Floor Stephenson Wing
Western Bank
Sheffield
S10 2TH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis
Study objectives	To establish a better methodology for identifying patients with Cystic Fibrosis Related Diabetes mellitus (CFRD) and to show that early treatment produces clinical benefits.
Ethics approval(s)	West Midlands Research Ethics Committee, 17/10/2005
Health condition(s) or problem(s) studied	Cystic Fibrosis Related Diabetes mellitus (CFRD)
Intervention	Children will be randomised to receive Insulin detemir 0.2 units per kg body weight by once daily subcutanous injection daily for one year. The control group will receive no intervention. There is no placebo or sham treatment (it was not felt appropriate given that it would require a daily injection).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Insulin detemir
Primary outcome measure(s)	Measurements of beta-cell function
Key secondary outcome measure(s)	1. Height, weight, Body Mass Index (BMI), triceps and biceps skin fold thickness 2. Respiratory function testing 3. Three monthly glycosylated haemoglobin 4. Adverse event monitoring
Completion date	01/11/2009

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Sex	All
Target sample size at registration	240
Key inclusion criteria	Any child over ten years of age with either fasting plasma glucose more than 6.1 mmol/l but less than 7.0 mmol/l and/or a two hour glucose of more than 7.8 mmol/l but less than 11.1 mmol/l.
Key exclusion criteria	1. Failure to provide informed consent 2. Pre-existing insulin or oral hypoglycaemic agent treatment
Date of first enrolment	01/10/2006
Date of final enrolment	01/11/2009

Sheffield Children's NHS Foundation Trust

Sheffield
S10 2TH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

15/03/2016: No publications found, verifying study status with principal investigator