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Positive Implications of Initiating Insulin Pump Therapy at Diagnosis of Type 1 Diabetes Ramchandani, Neesha 1 ; Ten, Svetlana 1 ; Anhalt, Henry 2 ; Sinha, Sunil 1 ; Finkelstein, Audrey 3 ; Maclaren, Noel 4,5 1 Maimonides Medical Center, Pediatric Endocrinology, Brooklyn, NY, United States; 2 St. Barnabas Health Care System, Pediatric Endocrinology, Livingston, NJ, United States; 3 Animas Corporation, West Chester, PA, United States; 4 BioSeek Endocrine Clinics, Endocrinology, New York, NY, United States; 5 Weill 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- pep 0months = 267, C-pep 6months = 110, C-pep 12months = 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. All patients self-sufficient on CSII within 3 months of dx. No subject wanted to d/c CSII at any time during the study. Only one subject had difficulty obtaining approval for a pump from their insurance company; approval was given within 6 months. 2 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 BGs. 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/cd 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). N28 Age at diagnosis (years)12.1 + 6.2 (26 mos – 32 yrs) % Male82% HbA1c at diagnosis (%)10.5 + 2.4 u/kg at diagnosis0.56 + 0.26 % on MDI89.2% Duration of MDI (weeks)2.2 + 1.6 HbA1c over timeUnits/kg over time BMI over time C-peptide AUC over time Months HbA1c (%) Months units/kg Months BMI (kg/m 2 ) C-peptide AUC 10.5 6.6*6.5* 7.0* 7.4* 7.0* 0.57 0.33* 0.46 0.52 0.49 0.56 20.721.6 19.7 20.7 22.1 20.2 267 110 312