DENVER, CO – October 13, 2006 – A new study demonstrated the importance of reducing pain to minimize needle anxiety when introducing daily injections to children with diabetes. Using a simple injection port was shown to reduce pain and increase therapy compliance. The study, designed to investigate the reasons for poor glycemic control in children with type 1 diabetes, was conducted by the renowned Barbara Davis Center for Childhood Diabetes.

Two key findings emerged from this study. First, a link between needle anxiety and the pain associated with the daily injections was identified as one of the main reasons for the poor control of childhood diabetes. Second, use of the insuflon injection port reduced the needle pain associated with injections and increased therapy compliance in children with diabetes.

“Nearly 70 percent of children and adolescents with type 1 diabetes are poorly controlled”, said Peter Chase, MD, Professor of Pediatrics and Clinical Director Ameritus of the Barbara Davis Center for Childhood Diabetes . “The observation that needle fear, present in up to 25 percent of all people, can result in omission of insulin injections is very important in understanding childhood diabetes. Finding a simple solution to the problem can have a significant impact.”

In this study, patients were divided into three different groups: a control group (insulin, NovoPen insulin delivery device and FreeStyle glucose meter), an alarm group (control group plus an alarmable Flash FreeStyle meter) and the insuflon group (control group plus the insuflon.) At three months the insuflon group showed improved glycemic control andat six months the insuflon group had obtained even better glycemic control. The alarm group demonstrated a small improvement inglycemic control at three months, with no differences at six months. The control group did not show any improvements. In addition, the insuflon group reported a decrease in pain associated with injections at three and six months.

“The study demonstrated that by using a simple device as the insuflon injection port, the children accepted the daily injections. As a result, compliance increased and glycemic control was improved,” remarked Dr. Chase. “And whereas the insuflon port may not be the right option for everyone, the study demonstrates that it is clearly a viable alternative for people to lessen needle anxiety and for health care practitioners to set off a successful course of treatment.”

About the Study
The study, which was conducted by the Barbara Davis Center for Childhood Diabetes, included 66 children aged 5 to 17years. All patients had been diagnosed with type 1 diabetes for more than 1 year (mean duration 7.3 years) and all were poorly controlled. The patients were randomized equally by gender into one of three groups: control group, alarm group and insuflon group. The haemoglobin A1c levels in the blood were measured at baseline and then at three and six months as an indicator of the level of control achieved. At the same points, the participants were asked to rate the severity of pain of the shots on a scale from 0-10.

About insuflon
The insuflon injection port is a soft catheter usually inserted in the abdomen or buttocks. After removing the insertion needle, the port stays in the body and the insulin can be easily injected thereby reducing the number of pricks significantly. Compared to traditional insulin injections, use of the insuflon port is even considered rational pharmacotherapy as it increases compliance at the lowest possible expenses.

Facts About Childhood Diabetes

Each year 13,000 children are diagnosed with type 1 diabetes
in the United States (US).

It is estimated that there are more than one million Americans
with type 1 (insulin dependent) diabetes.

In the United States and worldwide, the number of cases of
type 1 diabetes is increasing by 3 percent each year.

Type 1 diabetes is a chronic metabolic disorder caused by the lack
of insulin resulting in the need for daily insulin injections.

Today, more and more people with poorly controlled diabetes develop
complications. The insuflon helps to improve control and reduce
HbA1c;thereby reducing the risk of diabetic complications.

About Unomedical
Unomedical a/s is a leading Medical Device manufacturer in Europe specialized in the development, manufacture and marketing of sterile medical single-use devices. With more than 4,000 employees worldwide, Unomedical has production facilities and sales offices in: Denmark, Norway, Finland, UK, Italy, Belarus, Slovakia, Russia, Malaysia, Singapore, Australia, Mexico and the United States of America. Unomedical a/s is owned by Nordic Capital.

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