Patients with Type 2 diabetes achieve better glycaemic control with insulin pumps than multiple insulin injections, show the findings of the OpT2mise randomised trial.
Lead study investigator Yves Reznik (University of Caen Côte de Nacre Regional Hospital Center, Caen, France) said in a press statement: “Our findings open up a valuable new treatment option for those individuals failing on current injection regimens and may also provide improved convenience, reducing the burden of dose tracking and scheduling, and decreasing insulin injection omissions.”
For the multicentre study, which appears in The Lancet, 331 insulin-dependent patients with poor glycaemic control completed a 2-month run-in phase designed to achieve optimum glycaemic controls with insulin injections and were then randomly assigned to continue with multiple injections or to use an insulin pump.
A total of 308 patients completed the 6-month study. At baseline the average glycated haemoglobin level in both groups was 9.0%, which fell to 7.9% in the insulin pump group but to just 8.6% in the injections group. The 0.7% difference in favour of pump treatment was statistically significant.
At this point, 55% of patients in the pump group had achieved a glycated haemoglobin level of 8% or less, compared with 28% in the injections group. Patients did better with pumps than injections regardless of their glycated haemoglobin level at baseline.
Also, patients in the pump group had a reduction in average 24-hour glucose levels, from 10.4 mmol/L at baseline to 9.3 mmol/L at 6 months. This was significantly larger than the reduction in the injections group, from 10.1 to 9.6 mmol/L.
Furthermore, the improved glycaemic profile among patients using pumps was achieved with less insulin; the average total daily dose at 6 months was 97 units versus 122 units in the injections group.
Two patients in the pump group and one in the injections group developed hyperglycaemia or ketosis without acidosis that required hospital admission. No patient developed ketoacidosis and one patient in the injections group was hospitalised for severe hypoglycaemia.
In a commentary accompanying the study, Pratik Choudhary (King’s College London, UK) says that “OpT2mise provides a compelling case for the clinical effectiveness of insulin pump treatment in type 2 diabetes, suggesting that it can help improve glycaemic control in this difficult to treat group of patients who are unable to achieve glucose control despite increasing doses of insulin.”
He notes that the study investigators “used a simple approach with few basal rates and fixed boluses, without the use of carbohydrate counting, and it remains to be seen whether addition of these measures would yield greater benefits.”
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