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Insulin PumpsInsulin pump therapy accuracy -
In total, 13 insulin pump systems were tested: eight durable pumps with different infusion sets and one patch pump. Bolus accuracy was determined by individually weighing 25 consecutive 0. Regarding different systems, average 0. During 0.
In general, delivery was more accurate when using larger doses. Considerable differences in insulin delivery accuracy were observed between the tested pumps.
In general, when using very low doses, accuracy of insulin delivery is limited in most insulin pumps. This should be considered for CSII therapy in children. Funding Source Roche Diabetes Care GmbH, Deutschland. About this region Search Form Enter search terms. Select query limiter Anywhere Article Title Keywords Abstract Author Journal Title Journal Title Exact ISSN DOI ORCID iD Load Date.
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On the basis of our investigations, we believe that a more standardised and transparent approach to identifying, reporting and cataloguing AEs would help both patients and healthcare providers understand the risks associated with insulin pump therapy see 1a—c. This could be achieved in large part by improvements to the MAUDE and EUDAMED systems.
Manufacturers have to document such changes in both the USA and the EU, but these data are not publicly accessible. More transparency would be of help to quantify and understand the impact of such changes on the rates of AE reports and their contents see 2f. The FDA has now approved two sensor-augmented pump systems and one threshold suspend system, which are Class III systems.
After approval of the threshold suspend system, the FDA also required the company to undertake a significantly enhanced post-marketing surveillance study, which will require active follow-up of all users with periodic phone survey or, in some cases, office visit follow-up.
This higher level of reporting related to actual real-world user experience may provide an opportunity for assessing the value of enhanced post-marketing surveillance of pump use.
For instance, it may determine how many button and infusion set errors, blank screens and actual pump failures occur during use of this device.
If informative, it could serve as a model for increased surveillance of Class II pumps see 1b, c, 2c, 4b. When a user returns a pump to the manufacturer, its performance status following real-life use can be evaluated.
The FDA informed us that all publicly available data from such analyses are listed in MAUDE. However, as with AEs, although some information is available in individual reports, it is not currently possible to extract a summary of the problems most frequently found and categorise them as mechanical, electronic or related to the IIS see 1b.
In our view, an opportunity is therefore missed to glean relevant information about safety. To supplement information available from MAUDE, we asked companies for summarised information on how many calls they receive, how they assess the incoming information e.
malfunction vs user error , how many pumps are returned and how they select what they report to the regulatory agencies.
We sent a formal request seeking such information signed by the ADA and EASD to the manufacturers Animas, Cellnovo, Medtronic MiniMed, OmniPod, Roche and Tandem on 20 June All replied promptly stating they would provide the requested information within a few weeks.
By the time this statement went to press, we had received information from three companies in the form of an in-person meeting with Tandem, a conference call with OmniPod and a PowerPoint presentation from Roche Diagnostics.
From the two meetings it was clear that no primary data on pump approval or safety data would be available, although companies were in general willing to share information on the process by which they tested their pumps, their perception of the regulatory process, and their systems for AE reporting.
We also sought information on pump and pump-related device recalls. cfm , accessed February entries were found for the past 12 years. However, many of these entries were duplicates, and the actual number of discrete recalls was Interestingly, most of the issues related to IISs and cartridges rather than pumps themselves see below.
Many pumps offer a variety of programmable boluses according to the type of meal ingested. However, these boluses are named differently by each manufacturer, posing a challenge for education and training. Furthermore, the speed with which a given insulin bolus e. From a clinical point of view we consider it important to have information on whether these enhanced features are considered helpful by either users or healthcare professionals as an aid to achieving good glycaemic control see 2b, 4b.
Most but not all pumps have the facility to receive blood glucose values directly from an SMBG meter. When used correctly, an insulin dose calculator can help to prevent errors by decreasing both overtreatment and undertreatment; such features claiming increased safety by thus preventing both hypoglycaemia and hyperglycaemia are highlighted in marketing materials.
Many pump users might benefit from these, but almost no good evidence exists in support of this assumption [ 18 ]. We are aware of users who appear to derive benefit from pump therapy without being able to make full use of these features, and providers who are reluctant to advocate them in the absence of more definitive supporting evidence.
An important aspect of medical device design and development is human factors engineering, which is the study and optimisation of how people use and interact with technology.
Over the last decade, the FDA has established clear requirements for the design and evaluation of new medical devices with respect to human factors [ 19 ].
Manufacturers of insulin pumps are required to evaluate the handling of new devices by regular users rather than just engineers and highly trained laboratory personnel.
These measures are intended to verify that the devices will work safely, accurately and reliably before they reach the market. However, studies of actual everyday use are not required. Human factors studies and analyses occur in a number of settings, including evaluation in the clinic of user performance in adjusting pump functions or inserting IISs.
There will usually be a focus on a specific aspect, e. understanding written instructions or being able to read a display. These evaluations complement typical clinical trials, which are not sensitive to identifying or quantifying many aspects of human performance.
It is to be welcomed, but we believe that more studies are required to guide efforts to optimise the design of pumps according to the needs of different groups of users see 2b, 3c, 4a. This insulin is fully absorbed within hours, so hyperglycaemia or ketoacidosis can rapidly develop following catheter occlusion if the glucose level is already elevated or rising quickly.
Depending on the technology used by the pump and the infusion rate required by the user, it can be many hours before an occlusion alarm is signalled, leaving the user at risk of serious harm.
Inappropriate handling while changing the insulin cartridge or technical errors with the IIS represent additional sources of risk e. priming the infusion set while it is connected to the user or connecting the infusion set without due attention see 2b, c.
The number of publications focusing on IISs is small. However, many AEs on the MAUDE database relate to IIS difficulties. The mechanisms underlying blockage are not well understood; it is speculated that a complex interaction can occur between the plastic material used in the IIS, the insulin formulation used, the way the insulin is pumped and the infusion site.
This might be due to differences in the physico-chemical stability of insulin related to the properties of the IIS. It is noteworthy that in the USA, labels for the duration of insulin cartridge usage vary between products: e.
Apidra insulin glulisine; B3Lys,B29Glu human insulin —new cartridge recommended every 2 days; Novolog insulin aspart; B28Asp human insulin —new cartridge every 5 days.
Insertion of IISs at the same skin site over and over again raises the risk of local skin reactions, including lipohypertrophy [ 20 ]. From clinical experience, only a limited area of skin may remain available for catheter insertion in those who have used pump therapy for many years.
However, there are very few systematic data on the epidemiology of lipohypertrophy in patients on CSII, including the extent to which insulin absorption from such skin areas is impaired see 4b.
We were unable to find guidelines on use of IISs specifically with insulin pumps, or on assessing difficulties associated with the long-term use of pump infusion sites over long periods of time. However, IIS issues have led to the greatest number of recalls by the FDA in the USA see above. The pump and the IIS should be considered as parts of a system, rather than as individual components [ 21 ].
However, this is not currently the case, as some IISs are cleared as part of the pump system under different product codes and some are cleared as a separate device product code. AE reporting is typically coded under the assigned product code when cleared. Therefore, IIS issues might be listed on different FDA websites see 2c.
Rational strategies for reducing AEs caused by user error include:. ensuring that healthcare professionals supporting pump users are themselves well-trained and supported;. ensuring that teams supporting pump users contain a critical mass of members with the necessary skill mix medical, nursing, dietetics, diabetes educators see 5b.
It is likely that these proportions are lower with modern pumps, but the available information is insufficient for this to be concluded with certainty. In the USA, the T1D Exchange Clinic Registry includes over 26, individuals with type 1 diabetes from over 70 centres across the USA on MDI or CSII [ 23 , 24 ].
It represents a variety of demographic settings and approaches to diabetes management, but covers the more skilled and experienced centres with a relatively large volume of pump usage. In a report from this registry, individuals with the best HbA 1c levels were more likely to be using CSII.
Of 6, pump users who provided baseline and 1 year follow-up data, 4. Reported rates of ketoacidosis were similar between MDI and CSII users [ 24 ]. The T1D Exchange Clinic Registry is closely allied to Glu, a US patient networking site that collects data on insulin pump use: this could also be a useful source of safety information if the data were made available for these purposes [ 25 ].
In the EU, diabetes registries containing data from all or at least most of the total users in the population are established in Sweden, Scotland, Austria and Germany. Information from these registries on real-life use of pumps has been published [ 26 ]; more could be extracted with greater support, e.
on user outcomes, HbA 1c levels, frequency of SMBG, bolus administration, frequency of IIS changes, type of IIS used, type of insulin. Results from unselected cases from these cohorts might differ from those of clinical trials. To date, registries have focused on collecting data on metabolic control, but they should be encouraged to include a wider range of items in their databases, covering—among other aspects—AEs with insulin pumps.
Classical large multicentre clinical trials of sufficient duration to derive outcome data with insulin pumps are of limited feasibility as a result of rapid innovation and the introduction of new models during the period of study.
However, there are already examples of large publicly funded clinical trials addressing clinically relevant issues e. Relative Effectiveness of Pumps Over MDI and Structured Education [REPOSE], NCT More funding should be made available for such trials.
Care should be taken to ensure that trials financed or supported by manufacturing companies are conducted by independent investigators to minimise bias and ensure credibility see 4b. By harnessing innovative technology, modern insulin pumps appear to provide clinically important and increasing benefits for people with diabetes.
On the basis of the evidence summarised above, we recommend the specific actions listed in the text box. a harmonise standards to be met by pump manufacturing companies at both pre- and post-marketing stages. b provide, publicise and maintain a single publicly accessible international database expanded from the current MAUDE system for AE reporting.
This should be searchable according to clinically relevant keywords such as demographics, user errors, components involved hardware, software, IIS , consequences of event diabetic ketoacidosis, hypoglycaemia, etc.
Pump manufacturing companies should be required to provide with transparency to the regulators:. a annual estimates of the number of individuals who use their insulin pumps including basic demographic data.
b the results of clinical research conducted into the human factors associated with newly introduced features of pump design.
c updated data on the compatibility of their pumps with specific insulin formulations and infusion sets. d systematic data on the durability and precision of insulin pumping over years of real-world clinical usage.
f open listings of changes in device function, features and specifications reported to authorities. b recommend appropriate forms of structured education required for new and established pump users. c set standards for levels of staffing and skills required by teams of healthcare professionals providing initial and ongoing education and support for pump users supporting reimbursement of these activities by payers.
a provide or facilitate funding for well-designed independent clinical trials of safety, efficacy, outcomes and adherence under real-world conditions. b provide or facilitate significant financial support for long-term data collection within new and existing registries.
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We would like to thank Viktor Jörgens Executive Director, EASD , Monika Grüsser Vice Director, EASD and Robert Ratner Chief Scientific and Medical Officer, ADA for their support in bringing this statement forward, and numerous other colleagues for helpful comments and discussion, especially Philip Home University of Newcastle, UK and Eric Renard Montpellier University, France.
We are also grateful for critical review of the manuscript by the FDA. No honoraria were received by members of the ADA—EASD Diabetes Technology Committee AEDTC for writing this manuscript or associated meetings, although travel costs were covered by the EASD and ADA.
Most of the members of the AEDTC work with industry, as listed below; however, the industry is considered to have had no impact on the manuscript or its content by reviewers from the ADA and EASD. LH is partner of Profil Institut für Stoffwechselforschung in Neuss, Germany, and of Profil Institute for Clinical Research in San Diego, CA, USA.
He is a member of a number of advisory boards for companies developing novel diagnostic and therapeutic options for diabetes therapy, including Roche Diagnostics, Sanofi, Abbott, and Medtronic. GAF is President and CEO of Kinexum, which advises multiple health product companies in the fields of metabolism, cardiology, oncology and dermatology.
He was formerly Group leader, Division of Metabolism and Endocrine Drug Products, US Food and Drug Administration.
JRP has served on an advisory board for one company manufacturing medical diagnostic devices Alere and for a number of companies manufacturing pharmaceuticals used in the treatment of diabetes. RWH has not received any personal honoraria. All authors made substantial contributions to the conception and development of the Position Statement.
ALP led on acquisition of data and LH produced the early drafts.
Background: Continuous subcutaneous Lycopene and skin rejuvenation infusion CSII theeapy commonly used in patients with diabetes. Accurate and reliable delivery accurady Insulin pump therapy accuracy pumps is essential for a safe and Inshlin therapy, Insulin pump therapy accuracy puump using small doses. In this study, accuracy of bolus and basal rate delivery of various available insulin pumps was evaluated. Methods: In total, 13 insulin pump systems were tested: eight durable pumps with different infusion sets and one patch pump. Based on IECinsulin delivery was measured by recording weight gain of a beaker into which insulin was infused by the pumps. Jill Recovery for menJeanne Antisdel-LomaglioInsulon Seshadri; Accuuracy Pump Therapy : A meta-analysis. Diabetes Care Pjmp April ; tjerapy 4 : — OBJECTIVE —To conduct a meta-analysis of the metabolic and psychosocial impact of continuous subcutaneous insulin infusion CSII therapy on adults, adolescents, and children. Means and SDs for glycohemoglobin, blood glucose, insulin dosages, and body weight for CSII and comparison conditions were subjected to meta - analytic procedures. Data regarding pump complications and psychosocial functioning were reviewed descriptively.
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