Paradigm Veo (Medtronic, U.K.)
3 July 2014. An international clinical trial shows insulin pumps worn by people with type 2 diabetes do a better job of controlling blood glucose levels than multiple daily injections of insulin, the usual control treatment. Results from the post-marketing study funded by Medtronic Inc., a medical device developer in Minneapolis that makes insulin pumps, appear today online in the journal The Lancet (paid subscription required).
Type 2 diabetes is a chronic condition where the body fails to produce enough insulin that regulates the flow of glucose or sugar into cells, or resists the effects of insulin. For advanced cases of the disease where diet and exercise are not enough to control blood glucose, patients need medications or insulin therapy.
The usual method for providing insulin in these cases is with multiple daily injections, but insulin pumps — originally developed for people with inherited or type 1 diabetes — are being considered as an alternative. Insulin pumps are small, wearable computer-controlled devices that feed insulin in a continuous flow or short-term busts at meal time through a catheter into the body to emulate a normal body’s release of insulin. Controlled comparative effectiveness studies of insulin pumps versus injections, however, have so far not produced conclusive results.
This clinical trial, conducted after regulatory approval of Medtronic’s insulin pump, aimed to provide more solid evidence. The study enrolled 331 patients with type 2 diabetes and not able to adequately control their blood glucose levels despite receiving multiple daily injections of insulin.
Patients were recruited at 36 medical centers in the U.S., Canada, Europe, Israel, and South Africa, and selected at random to either wear a Medtronic insulin pump or continue with injections. The researchers looked primarily at patients’ ability to reduce blood glucose levels over 6 months in a standard test known as A1c, but also measured variability in glucose levels and weight loss, as well as safety issues such as episodes of severe hypoglycemia, where glucose levels fall too low.
The findings show on the main measure, patients with insulin pumps reduced their blood glucose levels an average of 1.1 percent after 6 months, compared to 0.4 percent for the injection patients, a statistically reliable difference. More than half (55%) of participants wearing insulin pumps were able to reduce their blood glucose levels to the target range, under 8 percent, compared to 28 percent of the participants receiving injections. In addition, patients wearing insulin pumps were able after 6 months to receive a daily amount of insulin 20 percent lower than patients receiving injections.
The amount of weight loss was about the same for both groups of patients. On safety issues, the number of adverse events during the trial were few and about the same between the two groups: 2 cases of blood sugar levels rising too high, requiring hospitalization, occurred in the insulin pump group, while 1 case of hypoglycemia occurred in the injection group.
“This patient population is sizable and difficult to manage, which frequently results in costly complications,” says study leader Yves Reznik of University Hospital in Caen, France in a Medtronic statement, “These trial results are important in showing that insulin pump therapy can safely reduce A1c without causing hypoglycemic episodes.”
Read more:
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- Blood Glucose Control Drug Approved for Type 2 Diabetes
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- Trial Shows Glucose-Lowering Drug Effective with Elderly
- Arthritis Drug Shown to Reduce Glucose in Type 2 Diabetes
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