Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
31/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr NP Wright

ORCID ID

Contact details

Division of Child Health
Sheffield Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom
+44 (0)114 222 2000
N.P.Wright@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0220093140

Study information

Scientific title

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

Acronym

Study hypothesis

Does oral terbutaline prevent asymptomatic nocturnal hypoglycaemia in children with diabetes?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Terbutaline

Primary outcome measures

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 trial start date

01/11/2002

Overall trial end date

28/02/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Twenty-five diabetic children will be recruited from the population attending the diabetes clinic in Sheffield.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

25

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/11/2002

Recruitment end date

28/02/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Children's Hospital
Sheffield
S10 2TH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Sheffield Childrens Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/03/2016: No publications found, verifying study status with principal investigator