Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
26/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes

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