Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
25/04/2014
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

Mrs L Sawyer

ORCID ID

Contact details

c/o R&D Office
North Bristol NHS Trust
Bristol
BS16 1ND
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234135754

Study information

Scientific title

Acronym

Study hypothesis

Do low glycaemic index bedtime snacks improve fasting blood glucose levels, and reduce nocturnal hypoglycaemia compared to traditionally recommended snacks?

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetes

Intervention

Block randomisation cross-over trial.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Rates of nocturnal hypoglycaemia, fasting blood glucose values.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

20/11/2002

Overall trial end date

31/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

44 subjects with type 1 diabetes.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

44

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

20/11/2002

Recruitment end date

31/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o R&D Office
Bristol
BS16 1ND
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

North Bristol 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