#Israel type 1 diabetes pilot trial#

In this context, we designed a prospective, single-center study. Although, as mentioned above, glycemic control with long-term CSII use has been extensively studied in the literature ( 1– 9), only one pediatric study has retrospectively assessed insulin needs at CSII initiation without reporting in detail rates of hypoglycemia and hyperglycemia ( 18). While most of them propose a reduction in the TDI dose while transitioning to CSII, the insulin dose of our protocol is relatively lower. When comparing the above protocols, we observe large variability in the method of calculation. 3 However, to our knowledge, none of these protocols has been validated for safety in children in a prospective study. We identified several adult and pediatric protocols in the literature ( 12– 21), with additional guidelines published by the American Diabetes Association, 1 in textbooks ( 22, 23), by tertiary centers, 2 and by pharmaceutical manufacturers. To date, there is no consensus on the initial insulin doses recommended when starting CSII this practice varies between centers and depends on the local experience ( 12).

#Israel type 1 diabetes pilot trial#

Our protocol provides a safe model to avoid hypoglycemia at CSII initiation in children.Ĭlinical Trial Registration: identifier NCT01840358. We observed only a trend toward prolonged episodes of hyperglycemia after pump initiation (RR = 1.52, p = 0.06, 95% CI 0.97–2.35).Ĭonclusion: Our study is the first to assess, through CGM and in a prospective way, the impact of a CSII initiation protocol on glycemic values. Results: After CSII initiation, there was no difference in the rates of hypoglycemic events expressed as relative rates (RRs) per person-reading (RR = 0.85, p = 0.52, 95% CI 0.52–1.39), as well as in the number of prolonged hypoglycemic events (>1 h) per day (RR = 1.12, p = 0.56, 95% CI 0.75–1.68). Methods: We assessed 22 pediatric patients with type 1 diabetes, using continuous glucose monitoring (CGM) before and after CSII initiation (☓ days).

The aim of this prospective study was to demonstrate that the protocol applied in our diabetes clinic is safe at CSII initiation in children. 2Department of Pediatrics, University of Montreal, Montreal, QC, Canadaīackground: The occurrence of hypoglycemia and hyperglycemia during the first days after transition to continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes has not been systematically studied in children.1Endocrinology Service and Diabetes Unit, CHU Sainte-Justine, Montreal, QC, Canada.