The largest prospective observational study to date to compare hard clinical end points among patients with type 1 diabetes using insulin pumps vs those using multiple daily insulin pen injections has shown a large reduction, an almost halving, of fatal cardiovascular events among those using the pump.

Lead author of the study, Soffia Gudbjörnsdottir, MD, of the University of Gothenburg, Sweden, told Medscape Medical News: ”This is by far the largest study [to date] on end points. We saw that the main effect was on fatal cardiovascular disease.”

Dr. Gudbjörnsdottir presented her findings during a press conference here at the European Association for the Study of Diabetes (EASD) 2014 Meeting

Dr. Soffia Gudbjörnsdottir

”The results are quite dramatic,” she said. ”For fatal cardiovascular disease, the hazard ratio is 0.56 and for total mortality 0.71, so 30% less risk [of any death] if you are treated with the pump.”

However, she cautioned that the patients using pen injections were different from those using pumps: the former had a slightly lower educational level, were slightly older, had a longer duration of diabetes, higher blood pressure, and more previous cardiovascular disease, although the same HbA_1c. Although they used propensity-scoring to balance the 2 groups and compare them fairly, they may not have eliminated all confounding, she noted.

Asked if she thought the pump itself saves lives, she said: ”I don’t think it’s the pump per se; it’s everything that comes with the pump. In our country, pump users are invited to diabetic school when they start the pump, and it’s easier to contact a doctor or nurse on weekends, so you have better care.”

EASD president Andrew Boulton, MD, of the University of Manchester, United Kingdom, who chaired the press conference, said: ”This is an observational study, it isn’t a randomized controlled trial, so it’s difficult to draw true conclusions. But I think that pump-delivered insulin is the best form of therapy we have today. Nevertheless there are still safety concerns — there are problems occurring with pumps, but these can be picked up by the patient if they have been educated.”

Dr. Gudbjörnsdottir presented her findings during a press conference in which the safety of new devices, such as insulin pumps, in diabetes was discussed, with a focus on the lack of regulation regarding approval of these in the European Union. Even in the United States, although the Food and Drug Administration has the MAUDE database for reporting of adverse events with devices, it’s still difficult to drill down into the reasons these occur, doctors at the briefing said. Indeed, the EASD and American Diabetes Association intend to issue a joint statement on insulin pumps here at the meeting, and the American Association of Clinical Endocrinologists has called for better training of both patients and providers in the use of insulin pumps.