Does oral terbutaline prevent asymptomatic nocturnal hypoglycaemia in children with insulin dependent diabetes mellitus in a clinical setting?

ISRCTN	ISRCTN22414310
DOI	https://doi.org/10.1186/ISRCTN22414310
Secondary identifying numbers	N0220093140

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 13/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

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

Contact information

Dr NP Wright
Scientific

Division of Child Health
Sheffield Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom

Phone	+44 (0)114 222 2000
Email	N.P.Wright@sheffield.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Does oral terbutaline prevent asymptomatic nocturnal hypoglycaemia in children with insulin dependent diabetes mellitus in a clinical setting?
Study objectives	Does oral terbutaline prevent asymptomatic nocturnal hypoglycaemia in children with diabetes?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Diabetes
Intervention	Twenty-five diabetic children will be recruited from the population attending the diabetes clinic in Sheffield. They will be visited at home on three separate occasions by a diabetes research nurse. Following either placebo or one of two doses of terbutaline at bedtime, their blood sugar will be measured every half hour overnight whilst they sleep. Blood samples will be taken from a cannula sited in a vein on the back of the hand after application of an anaesthetic cream. The day before and the day after the overnight study, each child will be asked to do several finger prick glucose measurements using both their usual glucose meter and dried blood spots on to paper. The child's routine should be only minimally disrupted.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Terbutaline
Primary outcome measure	The main outcome measures are: 1. Differences in the number of nights when hypoglycaemia occurs between placebo and terbutaline treatment 2. The effect on blood sugar assessed by comparing the children's home blood glucose measurements before/after the bedtime dose
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/11/2002
Completion date	28/02/2004

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	25
Key inclusion criteria	Twenty-five diabetic children will be recruited from the population attending the diabetes clinic in Sheffield
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/11/2002
Date of final enrolment	28/02/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Sheffield Children's Hospital

Sheffield
S10 2TH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Sheffield Childrens Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/04/2018: No publications found, verifying study status with principal investigator.
31/03/2016: No publications found, verifying study status with principal investigator.