Improving insulin treatment

ISRCTN	ISRCTN79558333
DOI	https://doi.org/10.1186/ISRCTN79558333
Secondary identifying numbers	N0203125673

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 26/07/2016

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

Dr Mark Daly
Scientific

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom

Phone	+44 (0)1392 403086
Email	M.E.Daly@exeter.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Improving insulin treatment
Study objectives	Is post-prandial targeting of glucose better than pre-prandial targeting when using insulin glargine and novorapid in combination?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Insulin
Primary outcome measure	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 study start date	22/04/2003
Completion date	22/11/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	30
Key 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
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	22/04/2003
Date of final enrolment	22/11/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Devon & Exeter Hospital (Wonford)

Exeter
EX2 5DW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

Royal Devon and Exeter 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

Editorial Notes

26/07/2016: No publications found, verifying study status with principal investigator.