Positive Implications of Initiating
Insulin Pump Therapy at Diagnosis of Type 1 Diabetes
Ramchandani, Neesha1; Ten, Svetlana1; Anhalt, Henry2; Sinha, Sunil1; Finkelstein, Audrey3; Maclaren, Noel4,5
1Maimonides Medical Center, Pediatric Endocrinology, Brooklyn, NY, United States; 2St. Barnabas Health Care System,
Pediatric Endocrinology, Livingston, NJ, United States; 3Animas Corporation, West Chester, PA, United States; 4BioSeek Endocrine
Clinics, Endocrinology, New York, NY, United States; 5Weill Cornell Medical Center, Pediatric Endocrinology, New York, NY, United States
Ramchandani, Neesha1; Ten, Svetlana1; Anhalt, Henry2; Sinha, Sunil1; Finkelstein, Audrey3; Maclaren, Noel4,5
1Maimonides Medical Center, Pediatric Endocrinology, Brooklyn, NY, United States; 2St. Barnabas Health Care System,
Pediatric Endocrinology, Livingston, NJ, United States; 3Animas Corporation, West Chester, PA, United States; 4BioSeek Endocrine
Clinics, Endocrinology, New York, NY, United States; 5Weill Cornell Medical Center, Pediatric Endocrinology, New York, NY, United States
Methods
Abstract
Objectives
Results
Conclusions
1.To demonstrate that initiation of continuous subcutaneous
insulin infusion (CSII) using an insulin pump as an initial therapy at
time of diagnosis of T1DM is feasible, will lead to enhanced
educational efficiency, and will produce better metabolic control
with fewer episodes of hypoglycemia than will standard multi-dose SQ
insulin replacement injections (MDI), over a 1-2 year follow-up
period.
2.To demonstrate that the use of CSII immediately after the
onset of T1DM will result in the improved preservation of pancreatic b
cell function compared to conventional multi-dose insulin therapy,
over a 1-2 year follow-up period.
Growing
experience indicates that continuous subcutaneous insulin infusion (CSII) is the best available means
of insulin replacement therapy for patients with type 1 diabetes (T1DM). Recent findings also
indicate that if one
is able to achieve good metabolic control earlier in the course of the disease, there is a decreased
incidence of diabetes-related complications later on. CSII allows for an improved quality of
life compared to
that obtainable using multiple daily injections (MDI) with less risk of hypoglycemia. We hypothesized that
initiation of CSII from time of diagnosis of T1DM would be well-accepted by patients, would
simplify patient
diabetes education over time, and could prolong the honeymoon period by preserving residual pancreatic
beta cell function. Twenty-six patients were enrolled in the study and started on CSII within
the first month of
diagnosis (average age at diagnosis = 12.1 + 6.2 yrs,
80.8% male,
average duration of MDI before starting pump = 2.2 + 1.6 weeks). Mixed Meal Tolerance Tests (MMTT) were done on these patients at baseline and at 6 and 12 months after
diagnosis. C-peptide (C-pep) area under the curve did not decrease over the 12 months of study (C-pep0months =
267, C-pep6months = 110, C-pep12months = 311; p>0.05), suggesting that β-cell function did not
deteriorate during this time. Mean HbA1c was 10.6% at diagnosis, decreased to 6.6% at 3 months after
diagnosis (p<0.001),
and reached a peak of 7.4% by 12 months after diagnosis (p<0.001 vs baseline, p=NS vs.
3, 6, and 9 months). Mean total insulin dose hovered just under 0.5 units/kg/day (honeymoon
range) during the
initial 12 months after diagnosis. Patients in the CSII group exhibited no attrition from the study, and
no significant hypoglycemia was reported. Our data are encouraging that CSII is both a feasible
and beneficial
form of initial therapy for T1DM which allows for greater prolongation of the clinical honeymoon
period during the first 12 months after diagnosis. Further studies are required to determine the
longitudinal metabolic
and psychosocial benefits of this approach.
ØAll patients
self-sufficient on CSII within 3 months of dx.
ØNo subject wanted to d/c
CSII at any time during the study.
ØOnly one subject had
difficulty obtaining approval for a pump from their insurance company; approval was given within 6
months.
Ø2 subjects lost to
follow-up because they lived a significant distance away from the study center.
CSII is both a feasible
and beneficial form of initial therapy for T1DM which allows for greater prolongation of the clinical
honeymoon period during the first 12
months after diagnosis. Further
studies are required to determine the longitudinal metabolic and psychosocial benefits of this approach.
•Subjects/families approached, study explained, and consent
obtained.
•Baseline 3-hour Mixed Meal Tolerance Test (MMTT) done on
most.
•Subjects started on CSII (loaner pump) within 1st month of dx
of T1DM. CSII taught by Diabetes NP;
CHO counting taught by Nutritionist and reviewed by Diabetes
Team.
•Inpatients (n=4) started straight on insulin; outpatients
(n=24) started on saline and returned within 1 week for switchover to Humalog
insulin.
•Initially intensive follow-up, involving NP and Fellow On
Call/MD on-call coverage during first 24 hours and daily phone calls from pt to
NP for first 2 days, then spaced to every few days to weekly to prn with increased patient/family
comfort and documented stability of BG’s.
•Patient switched over from loaner pump to their own pump upon
receipt of own pump and returned loaner pump to Diabetes Team.
•Clinical follow-up: 1
month after initiation of CSII, then every 3 months thereafter.
•Study follow-up: 3-hour
MMTT q6 months. Pump d/c’d at 5 am for scheduled 9 am MMTT; nothing
to eat or drink after midnight the night before, last bolus no later
than 5 am.
•Statistical analysis of data done using unpaired t-tests and
mean and standard deviation calculations on Microsoft Excel 2000.
Figure 1. HbA1c improved significantly
within 3 months of dx and remained relatively stable over the next
15 months
(* p<0.001 vs baseline. All other comparisons
p=NS).
Baseline Demographics
Figure 2. 57% of subjects were able to maintain good
glycemic control at honeymoon doses of insulin (<0.5 units/kg/day)
throughout the first year after diagnosis. (*p=0.001 vs baseline. All other comparisons p=NS.)
Figure 3. BMI
remained stable over time
(p=NS between all time points).
Figure 4. Endogenous insulin secretion did
not deteriorate over the first 12 months after dx, as measured by
C-peptide area under the curve (AUC) during MMTT (p=NS between
all data points).
N
28
Age at diagnosis (years)
12.1 + 6.2 (26 mos – 32
yrs)
% Male
82%
HbA1c at diagnosis (%)
10.5 + 2.4
u/kg at diagnosis
0.56 + 0.26
% on MDI
89.2%
Duration of MDI (weeks)
2.2 + 1.6
HbA1c over time
Units/kg over time
BMI over time
C-peptide AUC over time
Months
Months
Months
Months
10.5
6.6*
6.5*
7.0*
7.4*
7.0*
0.57
0.33*
0.46
0.52
0.49
0.56
20.7
21.6
19.7
20.7
22.1
20.2
267
110
312