[July 02, 2004] Medtronic Insulin Pumps Help Pediatric Patients with Type 1 Diabetes Achieve Significantly Better Blood Sugar Control Compared to Lantus NORTHRIDGE, Calif. --(Business Wire)-- July 2, 2004 -- First randomized, prospective study directly comparing insulin pumps with Lantus(R) therapy in pediatric patients identifies pump therapy as a more optimal treatment for blood sugar control Results of a study published in the July 2004 peer-reviewed issue of Diabetes Care confirm that insulin pump therapy is a more optimal treatment in improving blood sugar (glucose) levels in children and adolescents with type 1 diabetes than multiple daily injection therapy using long-acting Lantus(R) insulin. This first-ever randomized, 16-week prospective trial included 32 patients, and was conducted by investigators from Yale School of Medicine. The study confirmed that pediatric patients using Medtronic insulin pumps experienced a statistically significant reduction in HbA1c levels (from 8.1 percent to 7.2 percent), whereas no significant change was reported in patients using multiple daily injections with Lantus (from 8.2 percent to 8.1 percent). All participants were using multiple daily injections prior to the study. Baseline HbA1c measurements were established upon commencement of the trial. At randomization, two patients from the pump group and one patient from the Lantus group met the American Diabetes Association's "target" HbA1c goal of 7.0 percent or below. At the end of the study, 50 percent of pump patients and only 13 percent of patients using multiple daily injections with Lantus met this goal. Studies have found that for every one percent drop in HbA1c, the risk of developing eye, kidney and nerve disease is reduced by up to 40 percent. In addition, lowering HbA1c levels and maintaining near-normal glucose control has been shown to reduce the risk of overall diabetes-related complications as much as 76 percent, thereby improving health and extending life for people with diabetes. "We have long known that insulin pumps improve glycemic control in both adults and children. Now a definitive study indicates that insulin pumps more effectively control blood sugar than multiple daily injections with Lantus in young patients," said Elizabeth (Boland) Doyle, MSN, APRN, CDE, Yale School of Medicine. "Pump therapy allows for more immediate and precise fine tuning of insulin dosages that is not possible with injection therapy. We believe this is one of the main reasons why pump therapy has been so successful in pediatric patients. Furthermore, the lifestyle flexibility pumps provide makes it easier for patients living with diabetes." The study also highlighted several advantages of pump therapy, noting that basal rate settings (background insulin delivered to the patient around the clock), which are easily adjusted by the patient, may have contributed to better blood sugar control in the pump group. In addition, the pump's "bolus history" feature allowed investigators to review insulin increments previously delivered to patients and reinforce the need for pre-meal insulin to improve blood sugar control. The investigators noted that objective data of this kind are not available with multiple daily injection therapy. It was also noted that Lantus treatment still required a large number of daily insulin injections and adherence problems may explain, in part, why pediatric trials have failed to show lower HbA1c levels in patients using multiple daily injections with Lantus. To deliver insulin, four or more injections per day are typically associated with Lantus treatment (totaling more than 12 shots over a 3-day period); no injections are required to deliver insulin using a pump. In fact, after the study, 75 percent of patients using the Lantus treatment switched to insulin pumps and 88 percent of pump patients remained on the therapy. Pump therapy participants also had a significant reduction in their total daily dose of insulin, whereas no significant reduction was found in the Lantus group. Excess insulin in the body can induce hypoglycemia (low blood sugar), which is a concern for many diabetes patients and their families. If blood sugar drops to low levels, patients can become confused and disoriented, lose consciousness or have a seizure. In this study, investigators observed 75 percent fewer hypoglycemic events in patients using insulin pumps. Other studies have shown similar benefits, with pump therapy reducing severe hypoglycemia as much as 85 percent, and mild-to-moderate hypoglycemia as much as 60 percent compared to type 1 patients using multiple daily injections. "This study confirms what we and many leading clinicians have known for years - that the exclusive use of predictable, rapid-acting insulin, delivered precisely and on command as only a pump can do, is better than multiple daily injection therapy with Lantus," said Jeffery A. McCaulley, vice president and general manager of Medtronic's Diabetes business. "Moreover, today's 'smart' pumps, which were not available for use in this trial, add even more value by considering the amount of insulin still active in the body before recommending an insulin dosage to help patients achieve HbA1c target levels and live fuller, more healthy lives. These features represent just a few of the many new advances to come from Medtronic Diabetes." Pathway Program and Medtronic Insulin Pumps Paradigm insulin pumps are part of a product continuum in which new features are added as they become available. As a result, pump customers can purchase upgrades through the company's Pathway Program to stay current with the latest technology advancements. Today's clinically advanced features are found in Paradigm(R) 512 and 712 insulin pump systems, which utilize a Bolus Wizard(TM) calculator to perform complex "diabetes math" and recommend an insulin dosage after considering the amount of insulin still active in the body. Future innovation is expected to include sensor-augmented pump therapy (FDA approval required), in which an integrated pump, meter and sensor system are designed to display real-time glucose readings and 24-hour trend graphs. A feasibility study using a prototype system was recently completed and a larger, multi-center study is planned for later this year. Hemoglobin A1c Diabetes patients typically assess their blood sugar control via a hemoglobin A1c (HbA1c) test, which discloses the average amount of sugar in the blood, generally over a two-to-three month period. People without diabetes naturally maintain an HbA1c below 6.0 percent, while diabetes patients strive to keep their HbA1c at 7.0 percent or below. Unfortunately, roughly one-third of Americans with diabetes have an HbA1c above 9.5 percent. Elevated HbA1c levels can lead to serious short- and long-term complications of diabetes, including blindness, kidney failure, amputation, impotence and heart disease. Medtronic Diabetes (www.minimed.com) is the world leader in insulin pump therapy and continuous glucose monitoring systems. The company's products include external insulin pumps, related disposable products, and continuous glucose monitoring systems. Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. EDITOR'S NOTE: Detailed information about diabetes and insulin pump therapy is available by accessing Medtronic's online newsroom at www.medtronic.com/newsroom. Any statements made about the company's anticipated regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results. Lantus(R) insulin is a registered trademark of Aventis Pharmaceuticals Inc. Paradigm(R) insulin pumps are a registered trademark of Medtronic MiniMed [ Back To TMCnet.com's Homepage ]