Contact information
Type
Scientific
Primary contact
Dr Mark Daly
ORCID ID
Contact details
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
+44 (0)1392 403086
M.E.Daly@exeter.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0203125673
Study information
Scientific title
Improving insulin treatment
Acronym
Study hypothesis
Is post-prandial targeting of glucose better than pre-prandial targeting when using insulin glargine and novorapid in combination?
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
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Nutritional, Metabolic, Endocrine: Diabetes
Intervention
Randomised Controlled Trial
1. Glargine/novorapid/fasting and post-prandial titration of insulin doses
2. Glargine/novorapid/fasting and pre-prandial titration of insulin doses
30 patients with Type I diabetes will be recruited via clinicians (medical and nursing staff) within the Exeter Diabetes Centre, fully informed and having given written consent. Prior to randomisation, each patient will wear a continuous glucose monitor for 72 hours and have blood samples taken for HbAlc. Each patient will then be randomised to receive one of two treatments. One group will be transferred to the intervention (glargine/novorapid/fasting and post-prandial titration of insulin doses) and followed up for three months. The second group will be randomised to the same insulin regimen but insulin doses will be titrated against pre-prandial and fasting measurements. Both groups will undergo a similar protocol of specialist nurse contact and intensification of their glycaemic control. 72 hours of continuous glucose monitoring system (CGMS) will take place before treatment and at the end of the three month period. Food and exercise diaries will be kept for these periods and patients will be asked to replicate the initial pattern of food and exercise for the second period.
Intervention type
Drug
Phase
Not Applicable
Drug names
Insulin
Primary outcome measures
To see if adjusting pre-prandial insulin on the basis of post-prandial measurements is feasible as a clinical approach in the routine clinical situation and to explore the possibility that it might improve overall diabetes control.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
22/04/2003
Overall trial end date
22/11/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type 1 diabetes
2. >2 years duration
3. Clinical decision for glargine/novorapid therapy independently of the study
4. Fully informed and consented
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
30
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
22/04/2003
Recruitment end date
22/11/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Devon and Exeter 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