The Use of Insulin Pumps With Meal Bolus
Alarms in Children With Type 1 Diabetes to
Improve Glycemic Control
H. PETER CHASE, MD
BRIAN HORNER, MS
KIM MCFANN, PHD
HANNAH YETZER, MS
JANA GASTON, RD
CAROLYN BANION, PNP
ROSANNA FIALLO-SCHARER, MD
ROBERT SLOVER, MD
GEORGEANNA KLINGENSMITH, MD
OBJECTIVE — The aim of this study was to determine whether the use of meal bolus alarms
would result in fewer missed meal boluses per week in youth with type 1 diabetes using
continuous subcutaneous insulin infusion (CSII) therapy.
RESEARCH DESIGN AND METHODS — This was a randomized trial of 48 youth
four subjects were randomized to use a Deltec Cozmo insulin pump with meal bolus alarms
(experimental group), while the other 24 subjects continued use of their current insulin pumps
(control group) without meal bolus alarms.
RESULTS — After 3 months of study, the number of missed meal boluses per week was
significantly lower in the experimental group (from 4.9 ? 3.7 to 2.5 ? 2.5; P ? 0.0005) but not
significantly lower in the control group (from 4.3 ? 2.7 to 4.2 ? 3.9; P ? 0.7610). Also after 3
to 8.86 ? 1.10; P ? 0.0430). No significant decline in A1C was present for the control group
(from 8.93 ? 1.04 to 8.67 ? 1.17; P ? 0.1940). After 6 months of study, the significant decline
in A1C from baseline in the experimental group was no longer present. Pooling of all available
data from the control and experimental groups showed that at baseline and 3 and 6 months, the
number of missed meal boluses per week was significantly correlated with A1C values.
CONCLUSIONS — While meal bolus alarms may have the potential to improve suboptimal
glycemic control in youth using CSII, our results demonstrated that these alarms had only a
transient, modest effect in doing so.
Diabetes Care 29:1012–1015, 2006
tiple daily injections of insulin or contin-
uous subcutaneous insulin infusion
(CSII; insulin pump) therapy. Unfortu-
nately, even with CSII, ?30% of subjects
remain in suboptimal glycemic control
(2). The primary reason for suboptimal
glycemic control in children using CSII
was recently shown to be missed insulin
meal boluses (3). The purpose of the cur-
ntensive diabetes management is now
being advised for children with type 1
rent study was to determine whether the
use of a pump with meal bolus alerts
would result in reduced missed meal bo-
luses and improved glycemic control.
RESEARCH DESIGN AND
METHODS— The first 48 subjects
between the ages of 8 and 20 years, inclu-
sive, who were using insulin pumps for at
values ?8.0% were invited to participate.
All subjects were patients who were rou-
of 23 male and 25 female subjects were
enrolled in the study. Mean age of sub-
jects was 15.2 ? 2.9 years. All subjects
and parents signed consents approved by
the Colorado Multiple Institutions Re-
view Board and in compliance with the
Health Insurance Portability and Ac-
This was an investigator-initiated
prospective, randomized, parallel-group
pilot study following subjects during
three clinic visits over 6 months. The vis-
months. Randomization to the control or
experimental group for each subject
Upon enrollment, each subject opened a
sealed envelope that contained the next
sequential subject number and corre-
youth were randomized to use the Deltec
alarms (experimental group). The alarms
was not delivered within the time range
subject. Alarms were also set to remind
participants to check blood glucose levels
2 h after correction boluses were taken
and to alert the need to do a set change
every 3 days. The subjects randomized to
use the Deltec pump underwent a 1- to
2-h training session.
The 24 subjects randomized to be
rent insulin pump) underwent an ad-
vanced pump training session of similar
length. Both groups were told about the
importance of not missing food boluses
and that they could phone us if they had
questions. They were asked to return to
the clinic for their routine appointments
after 3 and 6 months. They did not have
other required visits or contacts with the
health care team. All 48 subjects were
bott Diabetes Care, Chicago, IL) and suf-
ficient blood glucose strips to do four or
more self-monitored blood glucose
(SMBG) tests per day.
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From the Department of Pediatrics, University of Colorado Health Sciences Center, Barbara Davis Center,
Diabetes, Mail Stop A140, P.O. Box 6511, Aurora, CO 80045-6511. E-mail: email@example.com.
Received for publication 18 October 2005 and accepted in revised form 24 January 2006.
Abbreviations: CSII, continuous subcutaneous insulin infusion; SMBG, self-monitored blood glucose.
A table elsewhere in this issue shows conventional and Syste `me International (SI) units and conversion
factors for many substances.
© 2006 by the American Diabetes Association.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby
marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
E m e r g i n g T r e a t m e n t s a n d T e c h n o l o g i e s
O R I G I N A L A R T I C L E
DIABETES CARE, VOLUME 29, NUMBER 5, MAY 2006