Low vs High glycaemic index bedtime snacks for patients with type 1 diabetes - which should we be encouraging? - A cross-over trial.
| ISRCTN | ISRCTN59477791 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59477791 | 
| Secondary identifying numbers | N0234135754 | 
- Submission date
 - 30/09/2005
 - Registration date
 - 30/09/2005
 - Last edited
 - 25/04/2014
 
- 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
                                            Mrs L Sawyer
Scientific
                                        Scientific
                                                c/o R&D Office
North Bristol NHS Trust
Bristol
BS16 1ND
United Kingdom
                                                
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Not specified | 
| Study type | Not Specified | 
| 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 | Rates of nocturnal hypoglycaemia, fasting blood glucose values. | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 20/11/2002 | 
| Completion date | 31/05/2003 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Not Specified | 
| Sex | Not Specified | 
| Target number of participants | 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 | 
Locations
Countries of recruitment
- England
 - United Kingdom
 
Study participating centre
                                            c/o R&D Office
                                        
                                        
                                            
                                            Bristol
BS16 1ND
United Kingdom
                                    BS16 1ND
United Kingdom
Sponsor information
                                            Department of Health
Government
                                        Government
                                                Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
                                                
| Phone | +44 (0)20 7307 2622 | 
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en | 
Funders
Funder type
Government
                                                North Bristol NHS Trust (UK)
                                            
                                            No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No | 
| IPD sharing plan summary | Not provided at time of registration | 
| Publication and dissemination plan | Not provided at time of registration | 
| IPD sharing plan |