Low vs High glycaemic index bedtime snacks for patients with type 1 diabetes - which should we be encouraging? - A cross-over trial.

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

Mrs L Sawyer
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Do low glycaemic index bedtime snacks improve fasting blood glucose levels, and reduce nocturnal hypoglycaemia compared to traditionally recommended snacks?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nutritional, Metabolic, Endocrine: Diabetes
Intervention	Block randomisation cross-over trial.
Intervention type	Other
Primary outcome measure(s)	Rates of nocturnal hypoglycaemia, fasting blood glucose values.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/05/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	44
Key inclusion criteria	44 subjects with type 1 diabetes.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	20/11/2002
Date of final enrolment	31/05/2003

c/o R&D Office

Bristol
BS16 1ND
United Kingdom

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