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
Protocol serial number	N0220093140
Sponsor	Department of Health (UK)
Funder	Sheffield Childrens Hospital NHS Trust (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Terbutaline
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	28/02/2004

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Sheffield Children's Hospital

Sheffield
S10 2TH
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.