ArticlesInsulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial
Introduction
Type 2 diabetes is characterised by insulin resistance and progressive β-cell failure, which results in increasing hyperglycaemia.1 Many patients with advanced disease require treatment with insulin, and in most cases the addition of basal insulin is sufficient to achieve glycated haemoglobin targets.2, 3 If these targets are not met after active dose titration of basal insulin, a multiple daily injection regimen combining a long-acting and a rapid-acting insulin in a basal-bolus fashion can be offered to patients; however, such intensified regimens do not meet glycated haemoglobin targets in about 30% of patients, and are associated with increased risks of hypoglycaemia and weight gain.4 These limitations of multiple daily injection treatment show the need for new treatments for this group of patients.
Only four randomised controlled studies have compared pump treatment and multiple daily injection treatment for lowering glycated haemoglobin in patients with type 2 diabetes. Two parallel-group studies5, 6 included 132 and 107 moderately obese, insulin-using patients with a baseline glycated haemoglobin of 8·0–8·4%. The studies lasted 6 months and 12 months respectively and reported similar benefit from treatment intensification. By contrast, two randomised crossover studies7, 8 showed that pump treatment was superior to multiple daily injections. Uncontrolled longitudinal studies9, 10 have also shown that pump treatment can help to achieve and maintain good metabolic control.
To further assess the potential benefits of pump treatment for type 2 diabetes, we did a randomised, controlled trial (OpT2mise) to compare the efficacy and safety of pump treatment and multiple daily injection treatment for patients with type 2 diabetes who had not responded to a basal-bolus regimen after active insulin titration.
Section snippets
Study design and participants
OpT2mise was a randomised, parallel-group study consisting of a run-in period, a 6-month randomised phase, and a 6-month continuation phase. 36 hospitals, tertiary care centres, and referal centres participated: eight in Canada, 23 in Europe and Israel, two in South Africa, and three in the USA. The study started in December 2010, and the final data collection date for the primary outcome measure was in February 2014. The study methods have been reported in full elsewhere.11 Only the results of
Results
Between Dec 26, 2010 to May 17, 2013, 590 patients were assessed for eligibility, of whom 495 entered the 2-month run-in phase. Of these, 164 were excluded (figure 1) and 331 entered the study phase and were randomly assigned to either the pump treatment group (n=168) or the multiple daily injection group (n=163). This small imbalance is a result of the random block sizes for each centre and also by the different number of patients recruited at each centre. Centres stopped recruitment when the
Discussion
In this large multinational study, we report that treatment with an insulin pump is better at reducing glycated haemoglobin than multiple daily injections in patients with type 2 diabetes. Previous studies5, 6, 7, 8, 9, 10, 16 of the efficacy of pump treatment for patients with type 2 diabetes enrolled few participants and yielded inconclusive results (panel). Only four randomised controlled studies comparing the ability of pump treatment and multiple daily injection treatment to lower blood
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