Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association

Abstract

A technological solution for the management of diabetes in people who require intensive insulin therapy has been sought for decades. The last 10 years have seen substantial growth in devices that can be integrated into clinical care. Driven by the availability of reliable systems for continuous glucose monitoring, we have entered an era in which insulin delivery through insulin pumps can be modulated based on sensor glucose data. Over the past few years, regulatory approval of the first automated insulin delivery (AID) systems has been granted, and these systems have been adopted into clinical care. Additionally, a community of people living with type 1 diabetes has created its own systems using a do-it-yourself approach by using products commercialised for independent use. With several AID systems in development, some of which are anticipated to be granted regulatory approval in the near future, the joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association has created this consensus report. We provide a review of the current landscape of AID systems, with a particular focus on their safety. We conclude with a series of recommended targeted actions. This is the fourth in a series of reports issued by this working group. The working group was jointly commissioned by the executives of both organisations to write the first statement on insulin pumps, which was published in 2015. The original authoring group was comprised by three nominated members of the American Diabetes Association and three nominated members of the European Association for the Study of Diabetes. Additional authors have been added to the group to increase diversity and range of expertise. Each organisation has provided a similar internal review process for each manuscript prior to submission for editorial review by the two journals. Harmonisation of editorial and substantial modifications has occurred at both levels. The members of the group have selected the subject of each statement and submitted the selection to both organisations for confirmation.

Therapie des Typ-2-Diabetes

“…Obgleich CGM-Systeme und AID-Applikationen (AID: „automated insulin delivery“) bei der Therapie des Typ-1-Diabetes einen immer größeren Stellenwert einnehmen, zeigen sich auch bei Menschen mit Typ-2-Diabetes, insbesondere mit einer Insulintherapie, in ersten Studien vergleichbare Vorteile: größere Stoffwechselstabilität, mehr Patienten im vereinbarten TIR-Bereich, weniger Hypoglykämien und größere Therapiezufriedenheit. Aber auch kurzfristige Anwendungen von CGM-Systemen können in Zukunft für den Menschen mit einem Typ-2-Diabetes wichtige Erkenntnisse für die weiteren Therapiestrategien geben 31 32 33 34 .…”

In vitro retardation and modulation of human insulin amyloid fibrillation by Fe3+ and Cu2+ ions

“…15 In the case of continuous delivery of insulin via insulin pumps, this kind of fibrillation may lead to inconsistent supply and further complications. 16,17…”

“…15 In the case of continuous delivery of insulin via insulin pumps, this kind of fibrillation may lead to inconsistent supply and further complications. 16,17 Prevention of the above unwanted and harmful aggregate formation requires knowledge on the particular structural transformation of the protein from its native state and also tracing out the mechanism of disruption of the preformed aggregates with the probable interacting molecules. Insulin is a 51-residue peptide hormone having two interchain disulfide bonds (A and B) that controls the blood glucose level in the human body.…”

UK's Association of British Clinical Diabetologist's Diabetes Technology Network (ABCD‐DTN): Best practice guide for hybrid closed‐loop therapy

“…Suggested indications for HCL are displayed in Table 1. HCL systems may not suitable for all people with diabetes 17 (Table 2). HCL use will vary from country to country.…”