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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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