Study: Insulin Pumps vs. Lantus
THIS IS GREAT INFORMATION FOR ANYONE INTERESTED IN THE INSULIN PUMP,
I FOUND THIS ARTICLE ONLINE. JENNIFER
First randomized, prospective study directly comparing insulin pumps
with Lantus® therapy in pediatric patients identifies pump therapy
as a more optimal treatment for blood sugar control
NORTHRIDGE, Calif., July 2, 2004 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® 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® 512 and
712 insulin pump systems, which utilize a Bolus Wizard 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.