Medtronic, Inc. (MDT) reported positive results of the OpT2mise trial, validating the efficacy of the MiniMed insulin pump in achieving better glucose control. The study results were published online in the July 3, 2014 issue of the medical journal, The Lancet.
Per the study, Medtronic's MiniMed insulin pumps are more effective in lowering the glucose level in insulin-administered type 2 diabetes patients, compared with multiple daily injections (MDIs).
The OpT2mise Trial
Hyperglycemia or type 2 diabetes refers to the medical condition in which high levels of glucose exist in a patient's blood. In such situations, one's body cells do not get the required insulin from the body and thus need to be dosed with insulin artificially from outside.
The purpose of the randomized controlled OpT2mise trail was to prove the comparative effectiveness of insulin pump treatment versus MDIs in controlling the glucose level of a insulin-receiving type 2 diabetes patient.
This global study, funded by Medtronic, enrolled 331 type 2 diabetes patients who complained of poor glycemic control despite being treated with MDIs. The age group of the trial patients ranged between 30 and 75 years. These patients with insulin analogues were enrolled into a 2-month dose-optimization run-in period.
This multi center trial was conducted at 36 hospitals, tertiary care centers, and referral centers in Canada, Europe, Israel, South Africa, and the U.S. Notably, it is the largest global study to have estimated the comparative efficacy of insulin pump therapy over MDIs in type 2 diabetes people with poor glycemic control.
Results of the Study
In the OpT2mise trial, type 2 diabetes patients using insulin pumps achieved a mean A1C (average blood glucose) reduction of 1.1% compared to only a 0.4 % reduction in those using MDIs. It is noteworthy to mention that this improvement in glucose control was achieved without any episodes of severe hypoglycemia (incidence of abnormally low glucose level in the blood).
Moreover, the daily dose of insulin was 20.4% lower for patients administered with insulin pump therapy compared to those who were provided injection therapy. In addition, no difference in weight gain was observed between the two sets of patients.
Approximately 20 million people around the world with type 2 diabetes require insulin replacement therapy. However, many of them still fail to achieve glycemic control despite being administered insulin via MDIs. For such patients, insulin pump therapy should prove to be a life-saving boon that can safely reduce A1C without causing hypoglycemic episodes.
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