posted 12/02/02
Quality of life and glycemic control improved after only 16
weeks of insulin pump therapy.
Among patients with long-standing poor glycemic
control who self-monitored their blood glucose regularly during a pre-study
qualification period, 16 weeks of insulin pump therapy improved glycemic control
and quality of life.
Poorly regulated patients "are the most obvious
candidates for treatment intensification" but "to our knowledge," have never
been enrolled in a study of insulin pump therapy, Dr. J. Hans DeVries, of Vrije
University in Amsterdam, and colleagues write in the November issue of Diabetes
Care. At 11 centers, they recruited such patients to enter a crossover trial of
insulin pump treatment followed by multiple daily injections, or vice versa.
For injections, patients were to use NPH insulin
as the basal insulin and insulin as part as the meal-coverage insulin. While on
pump therapy, they were to use insulin as part as both basal and meal-coverage
insulin.
Altogether, 89 patients entered a 14-week
qualification phase during which they were required to measure their blood
glucose at least twice a day. "This is the third study reported, and largest so
far, comparing [insulin pump therapy with injection therapy] using the modern
rapid-acting insulin analogs in both study arms
Due to a high drop out rate because some of the
patients did not want to start pumping, the researchers analyzed the results as
if the trial had a parallel design, using only data from the first half of the
crossover phase. They calculated that the change in HbA1c was 0.84% greater in
the insulin pump group than in the injection group.
This is "the largest difference in HbA1c for
insulin pump therapy since the modern era of intensive insulin therapy and
self-monitoring of blood glucose started, said Dr. DeVries. He and his
associates suggest in the journal that this large effect might outweigh the fact
that mild hypoglycemic episodes were more common in the pump group than in the
injection group, 0.99 versus (0.02 per patient-week (p = 0.028).
"Improved stability was reflected in the study by
a significantly lower standard deviation in 24-h glucose profiles in the insulin
pump group. There was no difference between groups in treatment satisfaction,
but health-related quality of life, as scored on the SF-36, improved more in the
pump group.
In an editorial, Dr. David S. Schade and a colleague, from the University of New Mexico in Albuquerque, speculate that the ability to vary basal insulin delivery with pump therapy "may be important in a subset of diabetic individuals with variable lifestyles or an exaggerated dawn phenomenon." But noting the high dropout rate in this study, they suggest that for many patients, "the increase in cost and 'hassle' do not offset this feature."
Source: Diabetes In Control Dot Com: Diabetes
Care 2002;25:2074-2080,2100-2102.
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