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Hospital Healthcare Europe

CE Mark for JuniorSTAR®


27 September, 2013  
Sanofi has announced at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD), Barcelona, the CE Mark of JuniorSTAR®, a new half unit insulin reusable pen that can be used with Lantus® (insulin glargine), Apidra® (insulin glulisine) or Insuman® (recombinant human insulin).
Delivering from 1 to 30 units per injection, JuniorSTAR® is an easy-to-use lightweight pen with a large dose display and a single-step dial back that does not leak insulin. JuniorSTAR® has been developed and is manufactured by Sanofi’s partner Haselmeier GmbH, Stuttgart, Germany.
“Everyone deserves high-quality care while learning to manage their diabetes, for the best chances in life,” said Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. “With JuniorSTAR®, we aim to meet the needs of type 1 patients worldwide, specifically the younger ones, who need an easy-to-use pen device. This is a welcome addition to our comprehensive portfolio of established insulins, which leads the way in personalised diabetes care.”
Half-unit dose increment pens provide flexibility to achieve target insulin doses especially in young patients with diabetes. JuniorSTAR® has been tested by people with type 1 diabetes (6 to 18 years old), parents and nurses in a non-comparative survey with 167 insulin pen users from five European countries(1):
  • 81% of patients/parents and 86% of nurses agreed it is easy to carry on a daily basis, due to its light weight (approximately 34 grams)
  • 98% of patients/parents and 94% of nurses agreed it is easy to read due to its large dose display and legible numbers
  • Additionally, 91% of patients/parents and 89% of nurses agreed that dialling back was easy due to its single-step dial back, a feature that avoids insulin leakage
  • Overall, 93% of survey participants agreed on its ease of use.
A rising number of people with type 1 diabetes are being diagnosed worldwide at an increasingly younger age.(2) People with diabetes deserve the best support to meet their needs and Sanofi is committed to providing efficient and simplified care to lighten the lives of young people living with type 1 diabetes with a comprehensive treatment portfolio, which includes established insulins, optimised insulin pens, innovative blood glucose monitoring systems and tailored patient support.
JuniorSTAR® meets the new ISO 11608-1 2012 standard, passed all requirements for robustness and dose accuracy, and is in three different colors (blue, red and silver) for flexibility and insulin differentiation.
JuniorSTAR® is expected to become available in Europe during 2014.
References:
  1. Klonoff D et al., Evaluation of the JuniorSTAR® half-unit insulin pen in young people with type 1 diabetes – user perspectives. European Endocrinology. 2013; 9(2):82-5.
  2. International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: 2012 update. Brussels, Belgium, 2011. http://www.idf.org/diabetesatlas (accessed: June, 2013)