Results of a study published recently 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 insulin, a release from Medtronic said.

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 paediatric patients using Medtronic insulin pumps experienced a statistically significant reduction in HbA1c levels (from 8.1 per cent to 7.2 per cent), whereas no significant change was reported in patients using multiple daily injections with Lantus (from 8.2 per cent to 8.1 per cent). 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 per cent or below. At the end of the study, 50 per cent of pump patients and only 13 per cent of patients using multiple daily injections with Lantus met this goal. Studies have found that for every one per cent drop in HbA1c, the risk of developing eye, kidney and nerve disease is reduced by up to 40 per cent. 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 per cent, 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 paediatric patients. Furthermore, the lifestyle flexibility pumps provide makes it easier for patients living with diabetes," Elizabeth added.

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 paediatric 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 (totalling 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 per cent of patients using the Lantus treatment switched to insulin pumps and 88 per cent 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 per cent fewer hypoglycemic events in patients using insulin pumps. Other studies have shown similar benefits, with pump therapy reducing severe hypoglycemia as much as 85 per cent, and mild-to-moderate hypoglycemia as much as 60 per cent 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. He added, "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."