BALTIMORE – With proper supervision, toddlers and preschool
children with Type I diabetes can safely and successfully use
an external insulin pump rather than multiple daily injections
to treat their disease, according to a study by Duke University
Medical Center researchers. However, the scientists emphasized
that further research is necessary before treatment guidelines
recommend widespread use of pumps by young children.

Insulin pumps are small beeper-sized machines that infuse
programmed amounts of insulin into the body via a catheter
placed through the skin. These pumps are sometimes used in
adolescents and adults as an alternative to the traditional
injection-based treatment of diabetes, but they are rarely used
in young children. Typically, diabetes in infants and toddlers
is treated with two to four injections of insulin daily.
However, multiple insulin injections cannot always stabilize
blood glucose, and young children are at high risk for episodes
of severe hypoglycemia (low glucose levels). Severe
hypoglycemia can, in some cases, result in coma, seizures,
learning disabilities and behavioral disorders.

"In young children, food intake and physical activity levels
are unpredictable, and it is difficult to administer very low
doses of insulin precisely," said Michael Freemark, M.D., chief
of the division of pediatric endocrinology and diabetes at
Duke. "Moreover, the child is often unable to convey symptoms
of low blood glucose to parents and caretakers. These factors
make diabetic control exceedingly difficult in this age group
and increase the risk of severe hypoglycemia."

Freemark is senior author of the study, which was presented
today (May 6) at the 2002 Pediatric Academic Societies'
Annual Meeting.

There has been considerable controversy concerning the use
of insulin pumps by young children, Freemark said.

"Some suggest that the insulin pump is inappropriate for
preschool children because they lack the knowledge, skill and
maturity to enable them to manage the essentials of pump
therapy," he said.

Freemark and his colleagues, however, reasoned that
conscientious parents and caretakers could provide the
supervision necessary to use the insulin pump effectively and
safely.

The study involved nine children between the ages of 20 and
58 months who had developed Type I diabetes between the ages of
10 and 40 months. After diagnosis, the children were treated
with insulin injections for six months to establish baseline
levels of their disease before being placed on insulin pumps.
Families also received extensive diabetes education, dietary
counseling, and training in the use of insulin pumps before the
start of the trial.

The children were treated with insulin pumps for seven to 19
months. Throughout the study, parents monitored their
children's blood glucose levels at least four times each
day.

The effect of pump therapy on diabetic control was assessed
through measurements of hemoglobin A1c, frequency and severity
of diabetic complications and parental satisfaction. Hemoglobin
A1c is a blood test that reflects average blood glucose levels
during the previous 60 to 90 days. The normal value for
non-diabetic children and adults is 4.3 percent to 6 percent.
Before initiating insulin pump therapy, the children in the
study averaged 9.5 percent.

"During pump therapy, hemoglobin A1c levels declined in all
nine patients. The mean value at the time of the last clinic
visit was 7.9 percent," Freemark said. "Importantly, the
decrease in HbA1c was achieved with a fivefold decline in the
number of episodes of severe hypoglycemia. While on insulin
injections, the children averaged 0.52 episodes per month of
severe hypoglycemia. After initiation of pump therapy, the
frequency of these episodes declined to 0.09 per month."

The frequency of physician or emergency room visits remained
the same before and during the use of the insulin pump. The
frequency of parental contacts with medical staff, however,
declined precipitously after pump therapy began, dropping from
one contact every 5.9 days to one contact every 46.3 days by
six months into the study.

"In conversations, parents stressed their increasing level
of comfort with diabetes management, their sense of improvement
in quality of life for all family members and their high levels
of satisfaction with pump therapy," Freemark said.

Freemark also noted that during the study there were no
changes in growth rates or weight gain, no pump site infections
and no episodes of pump failure.

"The improvement in blood glucose concentrations,
accompanied by a reduction in the number of episodes of severe
hypoglycemia in these children, indicates that diabetic control
could be established safely without increasing the risk of
seizures or coma," Freemark said. "This is particularly
important in young children, as they are at highest risk for
cognitive and behavioral deficits following episodes of severe
low glucose levels. Our pilot study suggests that insulin pump
therapy may provide an effective alternative for selected
infants, toddlers and younger children with Type I
diabetes."

Freemark cautioned, however, that insulin pump therapy is
not suited for all children.

"Continuous insulin administration should not be employed in
all toddlers and young children. It requires strong parental
motivation, a capacity to understand the technology and to use
the pump properly, continuous oversight of the child and pump
and frequent blood glucose monitoring," he said.

Joining Freemark in the study, which was funded by Duke,
were Duke colleagues Jean Litton, R.N., Alan Rice, M.D., Nancy
Friedman, M.D., Jon Oden, M.D., and Mary Lee, M.D.