Clinical Care/Education/Nutrition

O R I G I N A L A R T I C L E

A Randomized Controlled Trial of Insulin

Pump Therapy in Young Children With
Type 1 Diabetes
LARRY A. FOX, MD1 TIM WYSOCKI, PHD2 cemia because of their refusal to eat or
LISA M. BUCKLOH, PHD2 NELLY MAURAS, MD1 drink. These problems can lead to widely
SHIELA D. SMITH, RN1 fluctuating blood glucose levels or fre-
quent hypoglycemia, which could have
adverse developmental effects (7,8).
Thus, a better way to provide insulin ther-
apy to toddlers and young children with

Downloaded from http://diabetesjournals.org/care/article-pdf/28/6/1277/659968/zdc00605001277.pdf by guest on 09 March 2023

OBJECTIVE — This study assesses the effects of insulin pump therapy on diabetes control diabetes is desirable.
and family life in children 1– 6 years old with type 1 diabetes. Insulin pump therapy (continuous
RESEARCH DESIGN AND METHODS — Twenty-six children with type 1 diabetes for
subcutaneous insulin infusion [CSII]) is
ⱖ6 months were randomly assigned to current therapy (two or three shots per day using NPH an attractive way of treating patients with
insulin and rapid-acting analog) or continuous subcutaneous insulin infusion (CSII) for 6 diabetes (9), but there are limited data
months. After 6 months, current therapy subjects were offered CSII. Changes in HbA1c, mean comparing insulin injection therapy with
blood glucose (MBG), hypoglycemia frequency, diabetes-related quality of life (QOL), and CSII in toddlers and preschool-aged chil-
parental adjustment were recorded. dren with type 1 diabetes (10 –12). Fur-
thermore, although there is an extensive
RESULTS — Eleven subjects from each group completed the trial (age 46.3 ⫾ 3.2 months body of literature concerning the complex
[means ⫾ SE]). At baseline, there were no differences between groups in HbA1c, MBG, age, sex, psychological factors and family manage-
diabetes duration, or parental QOL. Mean HbA1c, MBG, and parental QOL were similar between ment of diabetes (13,14), there are few
groups at 6 months. Mean HbA1c and MBG did not change from baseline to 6 months in either
group. The frequency of severe hypoglycemia, ketoacidosis, or hospitalization was similar be-
data assessing these quality of life (QOL)
tween groups at any time period. Subjects on CSII had more fasting and predinner mild/ issues in this young population. We
moderate hypoglycemia at 1 and 6 months. Diabetes-related QOL improved in CSII fathers from therefore designed this study to deter-
baseline to 6 months. Psychological distress increased in current therapy mothers from baseline mine whether the use of CSII in young
to 6 months. All subjects continued CSII after study completion. children improves diabetes control, de-
creases the frequency of hypoglycemia,
CONCLUSIONS — CSII is safe and well tolerated in young children with diabetes and may and improves the family’s QOL.
have positive effects on QOL. CSII did not improve diabetes control when compared with
injections, despite more mild/moderate hypoglycemia. The benefits and realistic expectations of RESEARCH DESIGN AND
CSII should be thoroughly examined before starting this therapy in very young children.
METHODS — After institutional re-
Diabetes Care 28:1277–1281, 2005 view board approval, children between
the ages of 12 and 72 months with type 1
diabetes for at least 6 months were re-
cruited for the study between January

T
he Diabetes Control and Complica- contribute to the difficulty in managing 2001 and September 2003. Parental in-
tions Trial clearly demonstrated the diabetes in these young children, includ- formed consent was obtained, and en-
benefits of good blood glucose con- ing unpredictable insulin absorption rolled subjects were randomly assigned to
trol (1,2). However, achieving the neces- (3,4), variable eating patterns and activ- either continue their current insulin regi-
sary good control is not easy and is ity, increased sensitivity to small amounts men (current therapy group) (consisting
especially challenging in infants and tod- of insulin, parental fear of hypoglycemia of two or three injections per day of NPH
dlers with type 1 diabetes. Several factors (5,6), and difficulty in treating hypogly- insulin and a rapid-acting analog) or re-
● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ceive CSII (using the Medtronic MiniMed
From the 1Division of Endocrinology, Nemours Children’s Clinic, Jacksonville, Florida; and the 2Division of 508; Medtronic, Northridge, CA). Insulin
Psychology and Psychiatry, Nemours Children’s Clinic, Jacksonville, Florida. pumps and supplies were provided at no
Address correspondence and reprint requests to Larry A. Fox, MD, Nemours Children’s Clinic, NE Florida charge to all study participants for the du-
Pediatric Diabetes Center, 807 Children’s Way, Jacksonville, FL 32207. E-mail: lfox@lwpes.org. ration of the trial. Families randomly as-
Received for publication 8 December 2004 and accepted in revised form 3 March 2005.
N.M. has received grant support from Medtronic MiniMed. signed to CSII underwent proper pump
Abbreviations: CSII, continuous subcutaneous insulin infusion; MBG, mean blood glucose; QOL, quality education over the next 2– 4 weeks before
of life. starting CSII.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion Blood glucose levels were monitored
factors for many substances.
© 2005 by the American Diabetes Association.
at home at least four times per day in both
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby treatment groups. Blood glucose records
marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. were analyzed to assess frequency of mild,

DIABETES CARE, VOLUME 28, NUMBER 6, JUNE 2005 1277

Insulin pump therapy in young children
Table 1—Baseline characteristics of the two treatment groups
n (enrolled/completed)
Sex (male/female)
Age (months)
Duration of diabetes (months)
Injections/day
Total daily dose (units 䡠 kg⫺1 䡠 day⫺1)
HbA1c (%)
MBG (mg/dl)
Data are means ⫾ SE. Baseline data analyses do not include subjects who dropped out immediately after
randomization (two CSII and one current therapy).
moderate, and severe hypoglycemia and
to obtain mean blood glucose (MBG) (av-
erages of all blood sugar levels for 1
month before baseline, before 1-, 3-, and
6-month visits in both groups, and before
9- and 12-month visits in CT). In addition
to the endocrine physicians, a dedicated
diabetes educator was available for all
education and follow-up needs of the
study subjects. HbA1c was measured at
3-month intervals using a Bayer DCA
2000⫹ (Tarrytown, NY), which is certi-
fied by the National Glycohemoglobin
Standardization Program and displays Di-
abetes Control and Complications Trial
equivalent results. Patients randomly as-
signed to current therapy were offered
CSII 6 months after randomization.
Family dynamics and QOL were as-
sessed at baseline before randomization
and at 6 months using several validated
questionnaires: the Impact on Family
Scale, a measure of perceived effects of the
disease and its treatment on family func-
tion (15); the Brief Symptom Inventory, a
measure of parental psychological adjust-
ment and psychopathology (16); the Par-
enting Stress Index, a measure of the
degree of stress experienced by parents
regarding the child with diabetes (17);
and the Pediatric Diabetes Quality of Life
Scale, designed for this study to retrieve
parental perceptions of the degree to
which the child’s current diabetes regi-
men has positive or negative effects on
certain specific dimensions of child be-
havior and parent-child interactions sur-
rounding diabetes.
Statistical analysis
Statistical evaluation was performed us-
ing the Statistical Package for the Social
Sciences (SPSS, Chicago, IL). Data are ex-
pressed as means ⫾ SE. A 2 ⫻ 4 factorial
1278
Paired-sample t tests were used to com-
pare maternal and paternal scores on all
CSII Current therapy P value measures at baseline and at 6 months and
to compare psychological functioning
11/11 12/11 from baseline to 6 months in CSII and
7/4 6/5 current therapy. P ⬍ 0.05 was considered
47.5 ⫾ 4.8 45.3 ⫾ 4.3 0.29 significant.
15.3 ⫾ 3.4 19.7 ⫾ 4.1 0.31
2.5 ⫾ 0.3 2.3 ⫾ 0.1 0.54 RESULTS — Thirteen children were
0.6 ⫾ 0.1 0.6 ⫾ 0.1 0.65 randomly assigned to each group (Table
7.4 ⫾ 0.5 7.6 ⫾ 0.3 0.62 1). Two patients dropped out of the CSII
175 ⫾ 20 182 ⫾ 8 0.96 group before starting pump therapy be-
cause the children refused to wear the
pump. One subject dropped out of the
current therapy group immediately after
Downloaded from http://diabetesjournals.org/care/article-pdf/28/6/1277/659968/zdc00605001277.pdf by guest on 09 March 2023
randomly assigned because the family did
ANOVA with repeated measures on one not want to wait for pump therapy. One
factor (two groups of subjects and four current therapy subject was lost to fol-
time periods of baseline, 1, 3, and 6 low-up before the 6-month visit. There-
months) was used to test for differences in fore, 11 subjects completed 6 months in
HbA1c and MBG. Paired Student’s t tests each treatment group. Eight of the 11 sub-
were used to test for differences between jects who completed current therapy also
baseline and 3- and 6-month HbA1c. ␹2 completed 6 months of pump therapy.
analyses were used to compare the fre- At baseline (Table 1), there were no
quency of hypoglycemia between groups. differences between CSII and current
Unpaired t tests were used for between- therapy groups in HbA1c, MBG, age, race,
group analyses of other baseline charac- duration of diabetes, number of injections
teristics. The psychological measures per day, total daily insulin dose, or socio-
were analyzed using separate indepen- economic status.
dent sample t tests to compare current Mean HbA1c values were similar be-
therapy with CSII. ANOVA with baseline tween CSII and current therapy groups at
as a covariate was used to analyze the dif- baseline (7.43 ⫾ 0.48 vs. 7.57 ⫾ 0.27,
ferences between the two groups at 6 CSII vs. current therapy), 3 months
months to control for differences in base- (7.20 ⫾ 0.29 vs. 7.46 ⫾ 0.22), and 6
line values between the two groups. months (7.24 ⫾ 0.31 vs. 7.46 ⫾ 0.18)
Figure 1—HbA1c (means ⫾ SE) results for the 6-month study period in current therapy (CT)
(– – –) and CSII (——) groups. Number of subjects are indicated for each group. Repeated-
measures ANOVA revealed no significant differences for baseline, 3 months, and 6 months between
groups (P ⫽ 0.537). There was no group effect (P ⫽ 0.592) nor time period effect (P ⫽ 0.935).
DIABETES CARE, VOLUME 28, NUMBER 6, JUNE 2005

Figure 2—Frequency of hypoglycemia. The number of episodes of mild/moderate hypoglycemia for each treatment group at the different meals or
at bedtime, depending on how hypoglycemia was defined, is shown. CSII/current therapy pairs with significant differences using ␹2 analysis are
highlighted, and P values are provided.
(Fig. 1). There was no group effect (P ⫽
0.59) or interaction effect for group and
time period (P ⫽ 0.94). There was no sig-
nificant change in HbA1c in either group
from baseline to 3 months (P ⫽ 0.475 for
CSII; P ⫽ 0.509 for current therapy) or 6
months (P ⫽ 0.58 for CSII; P ⫽ 0.60 for
current therapy). HbA1c did not change in
the current therapy subjects after starting
CSII (P ⫽ 0.848 comparing current ther-
apy at 12 and 6 months).
MBG analysis (repeated-measures
ANOVA) revealed no significant differ-
ences between time periods (baseline, 1
month, 3 months, and 6 months; P ⫽
0.964) or between groups (P ⫽ 0.308),
nor was there a time period by group in-
teraction (P ⫽ 0.533). Comparison of
MBG from the current therapy subjects
after starting pump therapy with the CSII
group revealed no significant differences
for mean glucose by time (P ⫽ 0.578),
between groups (P ⫽ 0.406), or for a time
by group interaction (P ⫽ 0.230). Com-
parison of MBG values in the current ther-
apy group while receiving pump therapy
with the current therapy group while re-
ceiving injections revealed no signifi-
cant differences in MBG by time (P ⫽
0.135), by type of therapy (P ⫽ 0.576),
or for a time by therapy type interaction
(P ⫽ 0.682).
The frequency of mild/moderate hy-
poglycemia (defined as blood glucose
⬍80 for this age-group) was similar at
baseline between the two treatment
DIABETES CARE, VOLUME 28, NUMBER 6, JUNE 2005
groups before meals and at bedtime (Fig.
2). However, CSII subjects experienced
more hypoglycemia before breakfast at 1
month but not afterward and more hypo-
glycemia before dinner at 3 months and 6
months (Fig. 2). These differences were
present at 1 month even if mild/moderate
hypoglycemia was defined as blood glu-
cose level ⬍70, ⬍60, or ⬍50. As shown
in Fig. 2, CSII subjects also experienced
more mild/moderate hypoglycemia at
breakfast at 6 months if low blood glucose
was defined as ⬍70 or ⬍60. Further-
more, after adjusting for multiple com-
parisons with a significance level set at
P ⬍ 0.004, the amount of hypoglycemia
was still significantly more in the CSII
group at these time periods (P ⬍ 0.001).
There were no differences between cur-
rent therapy and CSII groups at any time
period throughout the study when hypo-
glycemia was defined as blood glucose
level ⬍40.
We also compared the frequency of
hypoglycemia in current therapy subjects
after starting pump therapy (6 –12
months) with when they were receiving
injections (0 – 6 months). Subjects had
more frequent mild/moderate hypoglyce-
mia while receiving pump therapy than
with injections at breakfast, whether the
definition of hypoglycemia was defined as
blood glucose level ⬍80 (number of re-
corded episodes ⫽ 50 CSII vs. 16 current
therapy; P ⬍ 0.01), ⬍70 (36 vs. 11; P ⬍
0.01), ⬍60 (24 vs. 3; P ⫽ 0.001), or ⬍50
Fox and Associates
Downloaded from http://diabetesjournals.org/care/article-pdf/28/6/1277/659968/zdc00605001277.pdf by guest on 09 March 2023
(7 vs. 0; P ⬍ 0.03). There were no differ-
ences between current therapy subjects
receiving injections versus pump therapy
at any time period throughout the study
when hypoglycemia was defined as blood
glucose level ⬍40.
One current therapy patient had a se-
verely low blood glucose level within 1
month after randomization. There were
no severe hypoglycemic events for pa-
tients enrolled in the CSII group, al-
though one patient initially enrolled in
the current therapy group had two severe
low blood glucose readings after starting
pump therapy. One subject in the CSII
group was admitted for diabetic ketoaci-
dosis ⬃2 months after starting pump
therapy. One current therapy subject had
three hospitalizations for diabetic ketoac-
idosis within 2 months after starting
pump therapy because of a failure to fol-
low sick-day management protocol while
using the pump.
Mothers in the current therapy group
reported a greater impact of diabetes on
the family than did mothers in the CSII
group at baseline (P ⫽ 0.04), but there
were no differences between the mothers
in the two groups at 6 months when con-
trolling for the baseline differences. Fa-
thers in the CT group reported more
psychological distress than did fathers in
the CSII group at baseline (P ⫽ 0.05), but
there were no significant differences be-
tween the two groups at 6 months when
correcting for these baseline differences.
1279
Insulin pump therapy in young children
There were no differences between
groups for mothers or fathers on the Pe-
diatric Diabetes QOL scale at any time pe-
riod. However, fathers in the CSII group
reported significantly more positive QOL
changes for themselves from baseline to 6
months (P ⫽ 0.03). Mothers in the CT
group reported more parenting stress
than did mothers in the CSII group at
baseline (P ⫽ 0.05). The differences in
maternal parenting stress did not remain
significant at 6 months. No differences
were found between mothers and fathers
for any of the psychological measures at
baseline or 6 months.
There were no significant problems
with the placement and care of infusion
sites in these young children, and no sub-
jects experienced site infections. All sub-
jects who completed 6 months of current
therapy (n ⫽ 11) began CSII after the
6-month study period, including two
who started CSII outside of the study. All
subjects treated with CSII have continued
this therapy after study completion.
CONCLUSIONS — Our data indi-
cate that CSII is safe and well tolerated in
this population, consistent with three re-
cent reports in this age-group (10 –12). In
our study, however, CSII did not result in
improved diabetes control when com-
pared with insulin injections, similar to
the study by DiMeglio et al. (11) and the
more recent paper by Wilson et al. (12)
but in contrast to two other studies
(10,18). In the study by Litton et al. (10)
comparing CSII with multiple daily injec-
tions in toddlers between 20 and 58
months of age, HbA1c levels decreased
after using CSII for an average of 13
months. There are several reasons for the
difference in results; one is difference in
study design. Their study was not a ran-
domized trial; each patient served as his
or her own control, and it included only
nine subjects. A second potential reason is
difference in patient selection. It is possi-
ble that insulin pump therapy did not
lower the average HbA1c in our subjects
because it was already low at baseline
(7.5 ⫾ 0.3% for all subjects); the subjects
reported by Litton et al. (10) had a higher
HbA1c at baseline (9.5 ⫾ 0.4%). Safely
lowering an already low HbA1c may not
be better achieved with insulin pump
therapy and may certainly be accompa-
nied by increased hypoglycemia. The low
HbA1c in our subjects indicates that some
1280
of them may have been in the remission
phase, also suggested by the low total in-
sulin daily dose (0.6 ⫾ 0.1 units 䡠 kg⫺1 䡠
day⫺1 in both groups) at the start of the
study. Lastly, although we studied more
subjects than those reported by Litton et
al. (10), using the effect size of our popu-
lation, 40 – 60 subjects per group would
have been needed to demonstrate a signif-
icance difference in HbA1c or MBG. This
population size would be best evaluated
in a large, multicenter trial.
In another recent study (18), children
with type 1 diabetes using insulin pumps
were compared with children receiving
multiple daily injections (using insulin
glargine and insulin aspart), a more in-
tensive regimen than that used in our
subjects receiving injections. In that ran-
domized trial, patients receiving CSII had
significantly lower HbA1c levels at 16
weeks compared with multiple daily in-
jections. However, subjects were older
(⬎8 years) than in our study, and the du-
ration of CSII therapy was shorter, mak-
ing direct comparisons difficult.
Fear of hypoglycemia is often a deter-
rent to good diabetes control (5,6). Our
data do not indicate that the frequency of
severe hypoglycemia is affected when us-
ing CSII, similar to the results reported by
Maniatis et al. (19) and more recently by
Wilson et al. (12). However, CSII subjects
in our study experienced more mild/
moderate hypoglycemia at certain time
periods (most often fasting or before din-
ner) than subjects receiving injections;
that difference persisted even when a
lower definition of hypoglycemia was
used. It is interesting to note that even
though subjects receiving CSII in our
study had more frequent fasting hypogly-
cemia, they did not have frequent hypo-
glycemia at bedtime. This suggests that
CSII may predispose subjects to late-night
or early-morning hypoglycemia.
The frequency of hypoglycemia seen
in pump subjects is highly variable in
published reports. Litton et al. (10) had
results similar to ours (i.e., an increase in
mild/moderate hypoglycemia with the
use of pumps), whereas two other studies
(19,20) showed that the frequency of hy-
poglycemia decreased with the use of CSII
in children and adolescents. Our results
may reflect the tighter diabetes control as
reflected in the lower HbA1c levels in our
subjects, indicating that they are more
likely to have hypoglycemia. Although
the number of children in our study was
relatively small, other investigators have
studied a comparable number of chil-
dren, or even less as in the report by Lit-
ton et al. (10). Additionally, only one
other study (18) analyzed the data with
respect to time of day. Nonetheless, al-
though care should still be taken when
interpreting these data, our results are im-
portant as they demonstrate that CSII is
at least as good as insulin injection ther-
apy in toddlers and preschoolers, and
our experimental design using a ran-
domized control arm makes our obser-
vations strong. A large-scale random-
ized trial would best be suited to further
Downloaded from http://diabetesjournals.org/care/article-pdf/28/6/1277/659968/zdc00605001277.pdf by guest on 09 March 2023
assess whether mild/moderate hypogly-
cemia is more likely with pump therapy
in toddlers.
As with injection therapy, the family
must adjust to a variety of new tasks with
CSII, which can have a psychosocial im-
pact. Wilson et al. (12) reported that dia-
betes QOL slightly improved in those
receiving either treatment (injections or
pumps), although only the improvement
in the CSII group was significant. They
found no difference between the two
treatment groups. Our findings are con-
gruent with this report and suggest that
CSII does not adversely affect diabetes-
related QOL and parental stress/distress
when compared with current therapy. On
the contrary, fathers in the CSII group re-
ported improved diabetes-related QOL
from baseline to 6 months, even though
comparisons of those changes over time
in the current therapy and CSII groups
were not significant. Mothers and fathers
reported similar levels of distress and im-
pact on QOL, suggesting that for these
families CSII and current therapy did
not have differential effects within the
family. Caution should be taken when
interpreting these analyses given the
large number of statistical tests that
were performed relative to the small
sample size. Lastly, the fact that all sub-
jects continued CSII after study comple-
tion is itself an excellent indicator of
parent satisfaction. Other studies had also
suggested high levels of parental satisfac-
tion with CSII (10,11), although QOL is-
sues were not formally tested in young
children in those studies.
This randomized controlled trial
showed that CSII is safe and well tolerated
in toddlers and young children with dia-
betes and is as good as current therapy
with two or three daily insulin injections
in maintaining good diabetes control.
DIABETES CARE, VOLUME 28, NUMBER 6, JUNE 2005

However, CSII did not result in improved
diabetes control when compared with in-
jection therapy in that age-group, despite
a trend toward increased frequency of
mild/moderate hypoglycemia with CSII
use. CSII may have some positive effects
on QOL. The possible benefits and realis-
tic expectations for diabetes control of
CSII need to be thoroughly examined and
reviewed with the family before starting
this form of therapy in young children.
Even though pump therapy may in-
crease the costs associated with diabetes
management, other potential benefits
must be taken into account when con-
sidering this regimen in young children.
A description of CSII to parents of chil-
dren with type 1 diabetes in this age-
group must emphasize that this pump
therapy may not necessarily improve di-
abetes control, although it may provide
a more precise tool for insulin therapy,
avoiding frequent injections in very
young children.
Acknowledgments — This study was funded
by the Nemours Research Programs (Jackson-
ville, FL) and an unrestricted grant from
Medtronic MiniMed (Northridge, CA).
Parts of this study were presented in ab-
stract form at the annual meetings of the Pedi-
atric Academic Society, San Francisco, CA,
1– 4 May 2004 and the American Diabetes As-
sociation, San Francisco, California, 14 –18
June 2002.
References
1. DCCT Research Group: The effect of in-
tensive treatment of diabetes on the devel-
opment and progression of long-term
complications in insulin-dependent dia-
betes mellitus. N Engl J Med 329:977–986,
1993
2. DCCT Research Group: Effect of intensive
DIABETES CARE, VOLUME 28, NUMBER 6, JUNE 2005
diabetes treatment on the development
and progression of long-term complica-
tions in adolescents with insulin-depen-
dent diabetes mellitus: Diabetes Control
and Complications Trial. J Pediatr 125:
177–188, 1994
3. Hildebrandt P, Birch K, Sestoft L, Volund
A: Dose-dependent subcutaneous ab-
sorption of porcine, bovine and human
NPH insulins. Acta Med Scand 215:69 –
73, 1984
4. Galloway JA, Spradlin CT, Howey DC,
Dupre J: Intrasubject differences in phar-
macokinetic and pharmacodynamic re-
sponses: immutable problem of present-
day treatment? In Diabetes 1985:
Proceedings of the International Diabetes
Federation. Serrano-Rios M, Lefebvre P,
Eds. New York, Elsevier Science, 1986,
p. 877– 886
5. Marrero DG, Guare JC, Vandagriff JL,
Fineberg NS: Fear of hypoglycemia in the
parents of children and adolescents with
diabetes: maladaptive or healthy re-
sponse? Diabetes Educ 23:281–286, 1997
6. Cryer PE: Hypoglycemia is the limiting
factor in management of diabetes. Diabe-
tes Metab Res Rev 15:42– 46, 1999
7. Rovet JF, Ehrlich RM, Hoppe M: Intellec-
tual deficits associated with early-onset of
insulin-dependent diabetes mellitus in
children. Diabetes Care 10:510 –515, 1987
8. Soltesz G, Acsadi G: Association between
diabetes, severe hypoglycemia, and elec-
troencephalographic abnormalities. Arch
Dis Child 64:992–996, 1989
9. Ahern JA, Boland EA, Doane R: Insulin
pump therapy in pediatrics: a therapeutic
alternative to safely lower HbA1c levels
across all age groups. Pediatr Diabetes 3:
10 –15, 2002
10. Litton J, Rice A, Friedman N, Oden J, Lee
MM, Freemark M: Insulin pump therapy
in toddlers and preschool children with
type 1 diabetes mellitus. J Pediatr 141:
490 – 495, 2002
11. DiMeglio LA, Pottorff TM, Boyd SR,
France L, Fineberg N, Eugster EA: A
randomized, controlled study of insulin
Fox and Associates
pump therapy in diabetic preschoolers.
J Pediatr 145:380 –384, 2004
12. Wilson DW, Buckingham BA, Kunselman
EL: A two-center randomized controlled
feasibility trial of insulin pump therapy in
young children with diabetes. Diabetes
Care 28:15–19, 2005
13. Anderson BJ, Laffel L: Behavioral and
family aspects of the treatment of children
and adolescents with IDDM. In Ellenberg
and Rifkin’s Diabetes Mellitus. 5th ed. Porte
R, Sherwin R, Rifkin H, Eds. Stamford,
CT, Appleton & Lange, 1996, p. 811–825
14. Wysocki T, Greco P: Self management of
childhood diabetes in family context. In
Handbook of Health Behavior Research. Vol.
Downloaded from http://diabetesjournals.org/care/article-pdf/28/6/1277/659968/zdc00605001277.pdf by guest on 09 March 2023
II. Gochman DS, Ed. New York, Plenum
Press, 1997, p. 169 –187
15. Stein REK, Reissman CK: The develop-
ment of an impact on family scale: Prelim-
inary findings. Medical Care 18:465– 472,
1980
16. DeRogatis A: Brief Symptom Inventory:
Scoring and Procedures Manual. Baltimore,
Clinical Psychometrics Research, 1977
17. Abidin RR: Parenting Stress Index Manual:
Manual and Administration Booklet. Char-
lottesville, VA, Pediatric Psychology Press,
1983
18. Doyle EA, Weinzimer SA, Steffen AT,
Ahern JAH, Vincent M, Tamborlane WV:
A randomized, prospective trial compar-
ing the efficacy of continuous subcutane-
ous insulin infusion with multiple daily
injections using insulin glargine. Diabetes
Care 27:1554 –1558, 2004
19. Maniatis AK, Klingensmith GJ, Slover RH,
Mowry CJ, Chase HP: Continuous sub-
cutaneous insulin infusion therapy for
children and adolescents: an option for
routine diabetes care. Pediatrics 107:351–
356, 2001
20. Sulli N, Shashaj B: Continuous subcuta-
neous insulin infusion in children and ad-
olescents with diabetes mellitus:
decreased HbA1c with low risk of hypo-
glycemia. J Pediatr Endocrinol Metab 16:
393–399, 2003
1281