To view this page ensure that Adobe Flash Player version 11.1.0 or greater is installed.

Diabetes The Hypoglycaemia-Hyperglycaemia Minimizer System in the Management of Type 1 Diabetes Brian L Levy, Thomas W McCann, Jr and Daniel A Finan Animas Corporation, Wayne, USA Abstract Living with type 1 diabetes (T1D) presents many challenges in terms of daily living. Insulin users need to frequently monitor their blood glucose levels and take multiple injections per day and/or multiple boluses through an insulin infusion pump, with the consequences of failing to match the insulin dose to the body’s needs resulting in hypoglycaemia and hyperglycaemia. The former can result in seizures, coma and even death; the latter can have both acute and long-term health implications. Many patients with T1D also fail to meet their treatment goals. In order to reduce the burdens of self-administering insulin, and improve efficacy and safety, there is a need to at least partially remove the patient from the loop via a closed-loop ‘artificial pancreas’ system. The Hypoglycaemia-Hyperglycaemia Minimizer (HHM) System, comprising a continuous, subcutaneous insulin infusion pump, continuous glucose monitor (CGM) and closed-loop insulin dosing algorithm, is able to predict changes in blood glucose and adjust insulin delivery accordingly to help keep the patient at normal glucose levels. Early clinical data indicate that this system is feasible, effective and safe, and has the potential to dramatically improve the therapeutic outcomes and quality of life for people with T1D. Keywords Hypoglycaemia-Hyperglycaemia Minimizer System, type 1 diabetes, artificial pancreas Disclosure: Brian L Levy, Thomas W McCann, Jr and Daniel A Finan are employees of Animas Corporation. Acknowledgments: Medical writing support was provided by Katrina Mountfort at Touch Medical Media, funded by Animas Corporation. Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit. Received: 16 December 2015 Accepted: 25 January 2016 Citation: European Endocrinology, 2016;12(1):18–23 Correspondence: Daniel A Finan, Animas Corporation, 965 Chesterbrook Blvd, Wayne, PA 19087, US E: DFinan@its.jnj.com Support: The publication of this article was supported by the Animas Corporation. The views and opinions expressed in the article are those of the authors and not necessarily those of the Animas Corporation. Type 1 diabetes (T1D) is a lifelong condition that results from autoimmune destruction of insulin-secreting beta cells, resulting in an absence of insulin production. In the US, it is estimated that 29.1 million people have diabetes, 1 with T1D accounting for 5–10% of all cases. Furthermore, its incidence is increasing, particularly among children under the age of 15. 2 A doubling of new cases of T1D in European children younger than five years has been predicted between 2005 and 2020, with a 70% rise in children younger than 15 years. 3 Optimal glycaemic control is essential in people living with T1D; intensive treatment of T1D has been associated with delayed onset and slowed progression of numerous complications, including diabetic retinopathy, nephropathy and neuropathy. 4 Management of T1D involves multiple daily injections of insulin or use of an insulin pump, both of which require the user to actively track glucose and calculate the needed insulin dose. There is also a significant time lag between when a dose is administered and when it takes effect. Other therapies, including immunotherapy and islet cell transplantation, have been investigated, but with limited success. 5,6 There is therefore a need for an automated system that removes the patient from the loop: a closed-loop system. 7 This article discusses the potential clinical benefits of closed-loop systems, with a focus on the Hypoglycaemia-Hyperglycaemia Minimizer System (HHM System; Animas Corporation, West Chester, PA, US). 18 The Treatment Burden of Living with Type 1 Diabetes Exogenous insulin therapy is not subject to the usual physiological feedback mechanisms so may induce hypoglycaemia. 8 The risk of hypoglycaemia limits the efficacy of insulin therapy; the average patient suffers two episodes of symptomatic hypoglycaemia per week and one severe episode per year. 4,8–10 Severe hypoglycaemic episodes often occur during sleep. 11 These episodes, termed nocturnal hypoglycaemia, can cause convulsions and coma, 12 and can be a rare cause of death in individuals with T1D. 13 The fear of hypoglycaemia has been associated with decreased quality of life in children with T1D 14 and their parents. 15 Fear of hypoglycaemia can also result in avoidance of activities beneficial to health, such as exercise. 16 In addition, insulin therapy is associated with poor compliance. In the US, children with T1D often do not meet their treatment goals in terms of glycated haemoglobin (HbA 1c ) values. 17 Several factors contribute to this failure, including difficulty in correctly estimating the amount of carbohydrates in a meal, missed meal boluses and anxiety about hypoglycaemia resulting in under-treatment. Poor glycaemic control may affect cognitive development in children with T1D. 18 In addition, short-term variation in glucose levels can have an effect on complications of T1D. 19 It is well-known that compliance is difficult to achieve with complicated treatment regimens. TOU C H ME D ICA L ME D IA