Consensus Statement by the American Association of Clinical Endocrinologists/American College of Endocrinology Insulin Pump Management Task Force

Grunberger, George; Abelseth, Jill M.; Bailey, Timothy S.; Bode, Bruce W.; Handelsman, Yehuda; Hellman, Richard; Jovanovič, Lois; Lane, Wendy; Raskin, Philip; Tamborlane, William V.; Rothermel, Caitlin

doi:10.4158/ep14145.ps

Cited by 152 publications

(146 citation statements)

References 82 publications

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“…41 In adults, pump users endorse wanting pump treatment to improve glycemic control, to gain a more flexible lifestyle, and to reduce fluctuations in blood glucose.…”

Section: Behaviors and Attitudes Associated With Technology Usementioning

confidence: 99%

Diabetes Technology

Naranjo

Tanenbaum

Iturralde

et al. 2016

J Diabetes Sci Technol

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Patients managing type 1 diabetes have access to new technologies to assist in management. This manuscript has two aims: 1) to briefly review the literature on diabetes technology use and how this relates to psychological factors and 2) to present an example of human factors research using our data to examine psychological factors associated with technology use. Device/technology uptake and use has increased over the years and at present day is a common clinical practice. There are mixed results in terms of health and psychosocial outcomes, with specific subgroups doing better than others with technology. Our data demonstrated that patients have moderately elevated diabetes distress across differing types of technology used, from low-tech to high-tech options, possibly meaning that technology does not add or take away distress. In addition, users on multiple daily injections compared to all other technology groups have less positive attitudes about technology. Finally, we discuss implications for clinical practice and future research.

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“…41 In adults, pump users endorse wanting pump treatment to improve glycemic control, to gain a more flexible lifestyle, and to reduce fluctuations in blood glucose.…”

Section: Behaviors and Attitudes Associated With Technology Usementioning

confidence: 99%

Diabetes Technology

Naranjo

Tanenbaum

Iturralde

et al. 2016

J Diabetes Sci Technol

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“…Aunque inicialmente se recomendaba de forma más limitada, las guías actuales [19][20][21] plantean que aquéllos sujetos que tienen problemas de variabilidad glicémica, hipoglicemia severa o no logran el control metabólico óptimo, entre otras indicaciones, son candidatos a usar tecnología en diabetes (Tabla 5). Así mismo, se plantean que todo sujeto que quiera usar ICSI puede hacerlo si tiene compromiso con su tratamiento y reúne las características descritas en la Tabla 4.…”

Section: Inicio E Indicaciones De Terapia Con Icsiunclassified

De la bomba de insulina y el monitoreo continuo de glucosa al páncreas artificial

2017

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, época en que se utilizó por primera vez un infusor continuo subcutáneo de insulina (ICSI), también conocido como bomba de insulina. En la siguiente década surgió el monitoreo continuo de glucosa (MCG), que permite medir glicemia intersticial en forma continua. Inicialmente el MCG era usado sólo como examen solicitado por el médico y analizado en forma retrospectiva; posteriormente fueron desarrollados equipos que informan niveles de glicemia en tiempo real (MCG-TR).Hace una década que ICSI y MCG fueron unidos en un sólo dispositivo que tiene la capacidad de infundir insulina y también medir glicemia intersticial, dando paso a lo que se conoce como Sensor-Augmented Pump Therapy (SAPT). Estos equipos inicialmente no tenían un programa que permitiera suspender el aporte de insulina ante hipoglicemia, pero actualmente existen modelos de SAPT que interrumpen automáticamente la infusión de insulina frente a la predicción de hipoglicemia, tecnología conocida como integrada.Durante la última década las investigaciones en nuevas tecnologías se han centrado en el desarrollo del páncreas artificial, en que existe un programa computacional que permite aumentar o disminuir el aporte de insulina según los valores de glicemia obtenidos en el MCG.Este artículo tiene como objetivo describir el estado actual de las tecnologías disponibles y en desarrollo para los pacientes con diabetes, así como aquéllas en vías de comercialización, como es el caso del primer sistema híbrido aprobado para uso clínico.

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“…The situation is broadly similar in children, although in some countries CSII is routinely started at the time of diagnosis. Guidelines are available recommending either broad [5] or narrow [6] indications (see 3a in the text box of recommendations below). Although there is no overall consensus, it is widely accepted that those with frequent, severe hypoglycaemia and/or hypoglycaemia unawareness may derive particular benefit.…”

Section: Current Use Of Csii Therapymentioning

confidence: 99%

“…In this context, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have joined forces to review the systems in place for evaluating safety from a clinical perspective. The aim was not to replicate overviews of CSII therapy available elsewhere [5], but instead to consider how healthcare professionals, pump manufacturers, regulatory authorities and policymakers can best ensure the safety of new and longstanding users of insulin pumps as the technology continues to develop. We gathered evidence from clinical experience, the published literature, regulatory authorities and pump manufacturers.…”

Section: Introductionmentioning

confidence: 99%

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

Fleming²,

et al. 2015

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Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycaemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycaemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilised due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices, EUDAMED) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to 'predicate' products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real-world setting; such data could provide vital information Diabetologia (2015) 58:862-870 DOI 10.1007 to help healthcare teams to educate and support users, and thereby prevent AEs. As well as requiring more from the manufacturing companies, we call for public funding of more research addressing clinically important questions in relation to pump therapy: both observational studies and clinical trials. At present there are significant differences in the regulatory systems between the USA and European Union at both preand post-marketing stages; improvements in the European system are more urgently required. This statement concludes with a series of recommended specific actions for 'meknovigilance' (i.e. a standardised safety approach to technology) which could be implemented to address the shortcomings we highlight.

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Consensus Statement by the American Association of Clinical Endocrinologists/American College of Endocrinology Insulin Pump Management Task Force

Cited by 152 publications

References 82 publications

Diabetes Technology

Diabetes Technology

De la bomba de insulina y el monitoreo continuo de glucosa al páncreas artificial

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

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