3854 - onset® 5 insulin pump study
Research type
Research Study
Full title
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes
IRAS ID
200989
Contact name
Mark Evans
Contact email
Sponsor organisation
Novo Nordisk Limited
Eudract number
2010-024054-11
Duration of Study in the UK
0 years, 10 months, 19 days
Research summary
The aim of this study is to confirm that continuous subcutaneous insulin infusion (CSII – insulin pump) treatment with faster-acting insulin aspart is as effective at controlling blood sugar levels in adults with type 1 diabetes mellitus (T1DM) as a currently-marketed and available insulin (NovoRapid®). This will be measured by looking at the change in HbA1c (glycosylated haemoglobin - a long term marker of blood sugar) after 16 weeks of treatment.
The study will also look to confirm that CSII treatment with faster-acting insulin aspart is better than CSII treatment with NovoRapid® in adults with T1DM in terms of regulation of blood sugar after a meal, overall glycaemic control (HbA1c) and time spent in low interstital glucose as measured using a continuous glucose monitoring (CGM) device .
The study will consist of a 4-week run in period, a 16-week randomised, double blind treatment period and a 30 day follow up period.
To be eligible, participants must have been diagnosed with T1DM for at least 1 year and have been using the same type of insulin pump for at least 6 months before entering the study. Participants will also need to be willing to stay on the same type of insulin pump during the study.
It is understood that some participants may be using their own CGM device. The study has been set up to ensure that up to 50% of the participants who enter the study will be allowed to wear their own CGM devices. On three occasions during the study, all participants will be asked to wear a CGM device for 11-13 consecutive days. Participants will not be able to see the CGM measurements during this time to ensure that their diabetes management is not affected. This means that some participants will wear two CGM devices during this time.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0130
Date of REC Opinion
26 Apr 2016
REC opinion
Further Information Favourable Opinion