insulin pump case study in software engineering

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Insulin pump case study retrieved from Ian Sommerville's Software Engineering, Tenth Edition https://software-engineering-book.com/case-studies/

opendesigncasestudies/InsulinPump-IanSommerville

Folders and files, repository files navigation, insulin pump case study - cited from ian sommerville software engineering, tenth edition.

https://software-engineering-book.com/case-studies/ This case study is part of the Open Design Case Study project. This work is licensed under the Creative Commons Attribution-NonCommercial 3.0 ( CC BY-NC 3.0 ) United States License.

Sommerville, I. (2016) Software Engineering. 10th Edition, Pearson Education Limited, Boston.

A personal software controlled insulin pump

This case study discusses the control software for a personal insulin pump, which is used by diabetics to mimic the function of the pancreas and hence control the level of glucose (sugar) in their blood. The level of blood sugar depends on what the system user has eaten, the speed of their digestive processes and the effectiveness of their body in metabolising blood sugar. Therefore, their is not a simple relationship between a blood sugar measurement and the amount of insulin to be injected. Rather, the control system has to make several measurements and assess the rate of change of blood sugar. Based on the current level and the rate and direction of change, the incremental amount of insulin to be injected is computed and injected using the micro-pump in the system. This is a safety-critical system as failure to inject the correct amount of insulin can have serious health consequences.

Stakeholder

• User (diabetic patient)
• Doctors (indirect user)
• Caregiver (indirect user)
• Nurses (indirect user)

Requirements

Description.

• Using readings from an embedded sensor, the system automatically measures the level of glucose in the users' body
• Consecutive readings are compared and, if they indicate that the level of glucose is rising, then insulin is injected to conteract this rise
• The ideal situation is a consistent level of sugar that is within some "safe" band
• Sugar levels can be categorized as "unsafe", "safe", and "undeseriable" where different amount of insulin will be injected (or not injected) to the users.

Detailed requirements can be found here

Constraints

• The system shall be available to deliver insulin when required
• The system shall perform reliably and deliver the correct amount of insulin to counteract the current level of sugar.
• If error condition occurs, alarm will be shown to the users based on the constraints stated in the detailed requirement specification

Quality Attributes

Reliability - (a) can inject the correct amount of dosage all the time (safety-critical) (b) must monitor blood sugar level at fixed intervals (c) if error occurs, must notify the users with the designated alarm condition (d) intermittent demand for service are made on the system

Availability - the pump should have a high level of availability but the nature of the diabetes is such that continous availability is unnecessary

Safety - The key safety requirements are that the operation of the system should never result in a very low level of blood sugar.

Environment

Entities and assumptions, design solution.

Architecture Model (hardware)

Activity Diagram of the insulin pump

Teaching Materials

Suggested usage.

The author use this case study to discuss general issues of safety and safety-critical systems. It is used in discussing issues of dependability specification and the use of formal specification techniques in dependable system engineering. Formal specification is especially valuable for this system as the computation to calculate the amount of insulin required is detailed and complex and quite difficult to specify using natural language. The formal specification in the Z notation is provided.

In lectures on dependability assurance, the author use examples from the insulin pump system to illustrate safety arguments and safety cases. Users of this case study can use the example more generally in lectures on requirements engineering, system modeling and embedded systems.

Other notes and resources

• Overview of a software controller insulin pump
• System overview slides
• Insulin Pump Requirements Specification
• Insulin Pump Z Schema

Help Center Help Center

• Help Center
• Trial Software
• Product Updates
• Documentation

Design Insulin Infusion Pump Using Model-Based Systems Engineering

This example uses:

• System Composer System Composer
• Requirements Toolbox Requirements Toolbox
• Simulink Simulink
• Simulink Test Simulink Test
• Stateflow Stateflow

This example shows you how to use a model-based systems engineering (MBSE) workflow to investigate optimal insulin infusion pump design. Insulin pumps are medical devices used by people with diabetes that mimic the human pancreas by delivering insulin continuously and delivering variable amounts of insulin with food intake.

The purpose of an insulin pump wearable device is to keep the blood glucose level of the wearer near a healthy set point by infusing insulin as needed and in response to food intake. This example shows a proposed insulin infusion pump system with two sensor and three pump variants that represent alternate design choices.

Begin by determining system requirements, then create detailed design models with code generation and verification tests. Finally, simulate the system architecture model that meets the evolving requirements.

Insulin Pump System Architecture Model

This figure shows the System Composer™ architecture model for the insulin pump system. This example uses Stateflow® blocks. If you do not have a Stateflow license, you can open and simulate the model but can only make basic changes, such as modifying block parameters.

The BGSensor component measures the blood glucose level. The Controller component makes a decision about the insulin rate. The Pump component provides insulin to the body using the InfusionSet . The Patient receives the treatment. The BGMeter calibrates the BGSensor . Finally, the HID (human interface device) component may be a mobile app on the phone for the patient to communicate with the system. The HID provides information to the PatientDataServer component, which sends analyses to the Clinician , Regulator , and Reimburser components.

System Requirements and Links

Use Requirements Toolbox™ to analyze the system requirements, further break them down into subsystem requirements, and link derived requirements to architectural components that satisfy them. A Requirements Toolbox license is required to link, trace, and manage requirements in System Composer.

Manage requirements and architecture together in the Requirements Perspective from Requirements Toolbox. Select Apps > Requirements Manager . To edit requirements, select Requirements > Requirements Editor or enter these commands to open the Requirements Editor (Requirements Toolbox) .

The requirements decomposition and analysis at this point represent these concerns:

Accuracy of delivery

Mitigations against over-infusion, which leads to dangerously low blood glucose levels

Fault analysis to prevent negative outcomes, for example, when the battery is depleted or the device runs out of medication

On the architecture model, select the requirements icon to see the requirements that are associated with the component. For example, below are the requirements linked to the Pump component.

Conversely, select a requirement to see the highlighted component by which the requirement is implemented. For example, the BGSensor component implements the Sense blood glucose requirement.

Outcome Analysis for Optimal Design Choice

Outcome analysis consists of a trade study where the goal is to maximize the business value of the design options based on calculations that sum up different component properties with weighting factors. Many are directly entered properties, such as non-recurring engineering (NRE) costs to develop the component. Compliance score, however, is a derived property that is based on different data for each type of component. These properties model the burden to an end user of the system. The compliance score includes these considerations:

Energy consumption

Size and weight

Mean time between failures (MTBF)

Sound level produced during operation

Ease of use

Navigate to Modeling > Profiles > Profile Editor , or enter this command.

A System Composer profile, defined in the Profile Editor , is composed of stereotypes with properties defined. You can apply stereotypes to components in the model to assign specific property values to each component.

The pump and sensor trade study includes these steps:

Collect all variant combinations.

Activate variants one by one to represent all the combinations.

Iterate over the model to calculate compliance and compute the outcome using the stored and calculated parameters.

Collect outcomes and weight them using the same units.

Provide the optimized option.

A Variant Component block named BGSensor contains two different sensor variants representing example sensors from different manufacturers.

The Variant Component block named Pump contains three different pumps in this example called PeristalticPump , SyringePump , and PatchPump .

To programmatically cycle between the different variant choice combinations, calculate compliance, and monitor the outcome to determine the optimal design choice, run OutcomeAnalysis.m . For more information on variant analysis, see Analysis Function Constructs .

The normalized outcome score is at a maximum for the SensorA + SyringePump combination. This design choice is optimal for the insulin pump.

Controller Implementation Model

Implement the insulin infusion pump controller in Simulink®. To access the Controller model, navigate to the InsulinInfusionPumpSystem architecture model and double-click the Controller component. The input ports in this implementation include User input , with user metrics that the insulin pump reads, and Hardware status , with information about the insulin pump. The block named ModeControl deteremines in which mode the insulin pump must operate.

The block named ModeControl contains a Stateflow chart with details on how to select the mode.

The three modes include:

Alarm mode, where the system is be suspended, repaired, and restarted once clear

Bolus delivery mode to deliver insulin quickly with food intake

Basal delivery mode to deliver insulin over a longer period of time to keep glucose levels steady throughout the day

After the mode is selected, this component behavior determines the insulin rate for the outport.

Verification and Validation Using Test Manager

You can use model-based design to verify architectural designs and system requirements. The abstract architecture model and the detailed Simulink design model are connected with traceable requirement links. This section requires a Simulink® Test™ license.

The Controller implementation model in Simulink demonstrates requirements traceability for the Alarm handling requirement.

Load and view the Simulink Test Manager (Simulink Test) using these commands.

The Alarm_Detection functional test verifies the Alarm handling requirement.

Double-click the Test Sequence block to view the steps in the test sequence. The steps define a scenario to verify the functioning of the alarm system.

To run this test, go back into the Simulink Test Manager (Simulink Test) .

Right-click the test Alarm_Detection in the Test Browser and select Run . In the Results and Artifacts section, view your test results. A passing test indicates that the system requirement Alarm handling is verified by the conditions defined in the Test Assessment Block:

Whether the alarm disables insulin delivery when there is low battery, occlusion (line blockage), or low medication (insulin)

Whether the system restarts after the issue has passed

• Profile Editor | Simulink Test Manager (Simulink Test) | Requirements Editor (Requirements Toolbox)

Related Topics

• Allocate and Trace Requirements from Design to Verification
• Compose Architectures Visually
• Analysis Function Constructs
• Simulate Mobile Robot with System Composer Workflow
• Calculate Endurance Using Quadcopter Architectural Design
• Model-Based Systems Engineering for Space-Based Applications

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INSULIN PUMP DEVELOPMENT

Insulin pump development experience for patch style and traditional pumps.

NOVO has contributed to the mechanical, electrical, and software design of several insulin pump product families including pumps, controllers, consumables, and accessories. The image above shows the Medtronic 670G (a component of the first FDA approved artificial pancreas system) , the Tandem Diabetes t:slim, and the Unilife Imperium pumps. NOVO contributed to each of these designs, and to several others still under development. Our experience extends to every subsystem in either a belt-worn or wearable pump (patch pump), including core systems like the pump drive, automatic cannula insertion/retraction, primary container, occlusion sensing, electronics, and embedded software.

In addition to product development, NOVO has developed automated test equipment and process control automation for insulin pump manufacturing and quality control purposes.

NOVO has integrated peripheral devices such as wireless continuous glucose monitors (CGM devices) and blood glucose meters, in addition to developing pump control electronics and Bluetooth low energy (BLE) communications. The breadth of our experience in diabetes care device development made NOVO an obvious choice as a development partner for an automated insulin delivery system development program currently underway. Our strong understanding of the design and manufacturing of diabetes care devices for both hospital and ambulatory applications makes us a unique resource to product companies bringing new insulin pumps, pen-injectors, and CGM devices to market.

INSULIN PUMPS: TECHNICAL CHALLENGES

Insulin pumps present a unique combination of technical challenges related to usability, performance, and reliability requirements. For example, usability requirements drive a goal of minimizing the size of the device, which in turn complicates the achievement of performance and reliability goals. Miniature, precision drive trains, occlusion sensing, environmental hardening for shock and water ingress, electrostatic discharge (ESD) hardening, wireless communications, system integration, manufacturability, and most importantly, patient safety combine to increase the technical challenges in these designs. Regulatory requirements and manufacturing considerations for both high-volume consumables and lower-volume durable assemblies add further challenges to insulin pump development.

THE ENGINEERING BEHIND GREAT PRODUCTS

NOVO has a history of helping our clients solve the most challenging aspects of the durable and consumable designs on several insulin pump projects. We have worked closely with our clients’ operations departments to create automated test equipment and assembly automation. NOVO continues to build our expertise in this important medical device product category, and in the related category of on-body drug delivery devices , as we provide product, process, and manufacturing development support to our clients developing the next generation of diabetes care products.

Related case studies include:

• Insulin Pump Embedded Design
• Insulin Pump Controller Development

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Software Design Specification and Analysis of Insulin Dose to Adaptive Carbohydrate Algorithm for Type 1 Diabetic Patients

• First Online: 31 January 2021

Cite this chapter

• Ishaya Gambo 5 , 6 ,
• Rhodes Massenon 6 ,
• Terungwa Simon Yange 7 ,
• Rhoda Ikono 6 ,
• Theresa Omodunbi 6 &
• Kolawole Babatope 8  

Part of the book series: Studies in Computational Intelligence ((SCI,volume 932))

1145 Accesses

1 Citations

Crucial in the development of a technological solution for managing insulin-dependent patients is an appropriate method of software engineering (SE) process. The SE process aims at providing supports for the design and implementation of a high-quality system by engaging patients and other healthcare professionals in knowing the exact specification for development. Primarily, insulin-dependent patients have a big challenge in determining the right dose of insulin to be injected according to measurements of glucose level and estimated carbohydrate from food intake. The result of this is often hypoglycaemia and hyperglycaemia, which may lead to coma and cause unfortunate death. The objective of this research work is to develop an adaptive model dedicated to the adjustment of insulin dose requirements in patients with type 1 diabetes. A mathematical model is formulated based on insulin sensitivity, basal insulin, bolus insulin, correction factor, carbohydrate counts, bolus on board equations and continuous blood glucose levels. We have evaluated the model by using root-mean-square error (RMSE) and mean absolute error (MAE) as parameters. The results showed the correct insulin dose values within the range of 4.76–0.18 IU for the fifty-two (52) patients with T1DM. Consequently, the developed model suggests a reduction in the incidence of hypoglycaemia, which can be used to predict the next insulin dose.

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Ishaya Gambo

Department of Computer Science and Engineering, Obafemi Awolowo University, Ile-Ife, Nigeria

Ishaya Gambo, Rhodes Massenon, Rhoda Ikono & Theresa Omodunbi

Department of Mathematics, Statistics and Computer Science, Federal University of Agriculture, Makurdi, Nigeria

Terungwa Simon Yange

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Gambo, I., Massenon, R., Yange, T.S., Ikono, R., Omodunbi, T., Babatope, K. (2021). Software Design Specification and Analysis of Insulin Dose to Adaptive Carbohydrate Algorithm for Type 1 Diabetic Patients. In: Patgiri, R., Biswas, A., Roy, P. (eds) Health Informatics: A Computational Perspective in Healthcare. Studies in Computational Intelligence, vol 932. Springer, Singapore. https://doi.org/10.1007/978-981-15-9735-0_7

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Published : 31 January 2021

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Chapter 6 the insulin pump therapy case study.

• Introduction

This case study focuses on IPT, used in the treatment of type 1 diabetes. Type 1 diabetes is a long-term condition that affects around 250,000 people in the UK and requires lifelong treatment with insulin. 187 Rates of type 1 diabetes have been increasing over time, with the greatest increase in children younger than 5 years of age. People with type 1 diabetes are unable to produce the natural hormone insulin, which is needed to control and use glucose. Most people with the condition control their diabetes through multiple daily injections (MDIs) of insulin. IPT, also known as continuous subcutaneous insulin infusion (CSII), is an alternative method of treatment to insulin injections by syringes or insulin pens. The pump provides a CSII, thus replacing the need for MDIs and typically producing better control of blood glucose levels.

Insulin pump therapy was first introduced in the UK in the 1970s, initially within the context of research studies on type 1 diabetes. However, mainstream adoption of the technology was limited, linked to concerns about efficacy and safety and the potential financial burden on the NHS. 188 , 189 In the past decade, technological advances have resulted in a new generation of smaller, more portable, more efficient and user-friendly pumps with additional safety features. 189 – 191 Several studies in recent years have demonstrated the benefits of IPT in type 1 diabetes compared with MDIs. 190 , 192 – 199 In particular, it is suggested that the continuous infusion of insulin provides not only improvement in metabolic control, but also increased physiological and psychological well-being. 189 , 200 Other benefits include improved patient outcomes [e.g. lower glycated haemoglobin (HbA 1c ); HbA 1c is a measure of the average plasma glucose concentration over a period of time, in people with diabetes, a higher plasma glucose concentration indicates poorer control of blood glucose levels], reduction in all grades of hypoglycaemia (hypoglycaemia is a low blood glucose level, which is too low to provide sufficient energy for the normal body functions), a reduction in blood glucose concentrations, fewer blood glucose swings, and a lower daily insulin dosage compared with insulin injection therapy. 201 It is also suggested that quality of life for patients and their family and treatment satisfaction are likely to be better on pump treatment than on MDIs, 145 particularly for people who have experienced significant and continued control problems on MDIs. 201 However, comprehensive patient education, such as carbohydrate counting, and frequent self-monitoring of blood glucose or continuous glucose monitoring are necessary components of successful IPT. 190

The IPT case is the only one of the three technologies studied that had been the subject of a national technology appraisal process; however, this did not guarantee that the evidence base for the technology was universally accepted, as the findings illustrate. NICE issued technology appraisal guidance on IPT in 2003, which was further updated in 2008, and recommended it as a clinically effective and cost-effective treatment option for people with type 1 diabetes, whether adult or child, for whom MDIs have failed, and for children aged < 12 years if MDIs are not deemed practical or appropriate. 202 Alongside the technology appraisal, NICE produced a commissioning guide to help health service commissioners plan and deliver services in line with the guidance. This suggests that the standard benchmark rate for the uptake of IPT should be 12% of people with type 1 diabetes, and 33% for children younger than 12 years old.

A national working group on insulin pump services 203 used a variety of sources, including national registers, manufacturers’ records and published reports of pump practice in various countries, to estimate the uptake of IPT at an international level. These data suggested that some countries (USA, Israel and Germany) were using pumps for about 15–20% of people with type 1 diabetes. A typical figure for Europe (e.g. France, Sweden and the Netherlands) was around 10% of people with type 1 diabetes using insulin pumps for routine management. In contrast, overall UK pump usage was estimated at around 1% of people with type 1 diabetes using insulin pumps for routine management.

A subsequent review of IPT in England was undertaken by the Medical Technology Group in 2010. 204 They carried out a survey of all PCTs ( n  = 152) in England to ascertain levels of insulin pump provision. Of these, 87.5% responded to the survey and the data indicated that the average rate of pump use was 3.7%, with rates across the country ranging from 0.25% to 13%. 204 Thus, although the rates were higher than those estimated by the Department of Health Working Group in 2007, they were still some way from the NICE recommended benchmark of 12% and considerably lower than in most other countries of comparable economic standing and level of health-care provision.

• The NHS Technology Adoption Centre project on insulin pump therapy

NHS Technology Adoption Centre selected IPT to go forward as a technology implementation project so that it could identify the challenges associated with implementing IPT and suggest ways to overcome them. Three NHS trusts were selected to work as implementation sites; these were organisations that responded to the NTAC call for implementation sites and were selected because they wanted to develop their IPT service in line with NICE guidance (see Chapter 4 for a more detailed description of the NTAC selection process). Three MSs were identified to work with the implementation sites, these were organisations that were already using insulin pumps with many of their patients and could provide clinical mentorship to the teams in the implementation sites. The experiences of the sites involved in the IPT project were collated into a HTWT guide. 205 This was intended as an online resource that could be used to help the adoption of IPT throughout the NHS.

• The case study

The main data collection took place in four NHS organisations: two NTAC implementation sites for IPT; one MS; and one organisation that had initially applied to be an implementation site, but was not selected by NTAC. This latter organisation was keen to increase the use of pump therapy and, as such, would be typical of the organisations that NTAC was aiming to target with the HTWT guide. In all sites, interviews were conducted with a range of individuals involved in implementing IPT, including commissioners, clinicians, diabetes nurse specialists and business/procurement managers. A total of 23 interviews were conducted across the four sites; details of the interview sample by site are provided in Table 3 .

Interviewees for the IPT case study

Alongside these qualitative interview data from the case study sites, supplementary sources of data included a survey of clinicians about IPT use in the NHS in England and documentary analysis of e-mail correspondence received by the patient support group INPUT between September and November 2011.

Before presenting the main findings relating to the IPT case, some brief background information on each of the four NHS organisations studies is outlined, along with a summary of the results of the survey we conducted on IPT uptake in England.

Implementation site 1

The first site that worked on IPT with NTAC was an NHS trust providing acute services that had been formed from the merger of two trusts some 8 years earlier. Diabetic services were provided at two separate sites and the acute trust had two main commissioners. The trust was in the process of applying for foundation trust status. One of the two main acute hospital sites had a history of interest in using IPT and was very receptive to the adoption of the technology; the second site was less enthusiastic about the technology. However, prior to their involvement with NTAC, there were no formalised processes or systems for managing the introduction of IPT at an individual patient or service level.

Implementation site 2

The second implementation site was an NHS foundation trust providing specialist children’s services, commissioned from a wide range of primary care organisations (around 17 in total). The pressure to provide IPT had particularly been driven from the patient population (children and parents); as a consequence, the diabetic team was keen to become more skilled and up to date in terms of providing pump services.

Mentor site

The MS was an NHS foundation trust, providing an integrated hospital, community and primary care diabetic service. The trust had originally applied to be part of the NTAC implementation project, but had been seen to be relatively well advanced in terms of the adoption of IPT and, therefore, did not meet the early adopter criteria. As a consequence, it was invited to act as a MS for IPT (although in reality they received limited requests for advice or information from the implementation sites). The trust had an internal manager with responsibility for commissioning, who acted as an interface with the PCT to develop and negotiate contracts, an arrangement that had worked particularly well in the introduction of IPT.

Non-implementation site

The fourth site was a specialist diabetes centre, hosted by an NHS foundation trust. The centre had only recently moved from a primary to secondary care setting, as a result of the changes to commissioning in the NHS. On account of its specialist status, the trust dealt with a large number of commissioners, across a wide geographical area. The introduction of IPT had been led by a clinical academic, who had submitted an application to become an NTAC implementation site for IPT. This application was unsuccessful; however, the consultant and some of his colleagues had continued to try to develop their pump service without NTAC's input.

• Uptake of insulin pump therapy: survey findings

As outlined in Chapter 3 , Research methods and Data analysis and Appendix 3 , we conducted an online survey of a network of UK clinicians actively engaged in trying to increase IPT uptake to assess the current level of uptake of IPT. Table 4 summarises the key findings from this survey, comparing estimated uptake of IPT in May 2012 with uptake levels 3 years previously.

Percentage of patients with diabetes estimated by respondents to be using IPT

These data suggest an increased use of IPT, in line with the findings of the Medical Technology Group survey of 2010. However, they also indicate that, in summer 2012, 65% of respondents reported that pump use was lower than 10% in their NHS trust (in other words, below the 12% target recommended in the NICE guidance). Moreover, of the 62 respondents working in trusts where the uptake rate of IPT was < 5% 3 years previously, only 29 (47%) had managed to raise this level to > 5%.

Our qualitative data collection attempted to explore in more depth the reasons for the lower than recommended uptake of IPT in the NHS in England, and the difficulties encountered in attempting to increase the uptake rate. Analysis of the findings reveals a number of key themes in terms of factors that appear to facilitate or hinder the adoption of IPT, ranging from those on the individual level, including patient- and clinician-focused factors, through to more organisational- and system-level issues relating to past history and experience of IPT including resourcing, financing and commissioning issues. Each of the key themes is discussed in more detail in the following sections.

• The patient pull for insulin pump therapy

A number of patient level factors appear to be important in terms of the adoption (or otherwise) of IPT. These include patient-driven demand for the service, acceptability of the technology and the importance of patient self-management of the technology. In relation to the first issue, views differed in terms of the extent to which patient demand was important in driving the introduction of the technology. In some cases, patient requests for IPT were seen to be a major driver:

We are very good at being ahead of our patients in what they know about either their condition or their treatment plan or their medications. But with insulin pumps, there was a feeling that we were only just one step ahead of our patients because they came in so suddenly really that the patients were asking for them and we were saying, ‘Oh, hang on a minute. We’re not so sure that we have the skills and knowledge to facilitate this for you.’ So there was a definite perceived, you know, we weren’t skilled enough to run these kind of programmes. Diabetic specialist nurse, IS2

By contrast, other interviewees did not perceive a significant patient demand for pumps; rather they felt that it tended to be the clinicians who raised the possibility of using a pump as an alternative to MDIs.

One of the things that I have noticed when I’ve been to meetings and so on elsewhere that some of the people say patients ask for pump therapy. It doesn’t happen in my experience very much . . . Yes it tends to be us that says, well actually I think you might benefit, would you consider a pump? There is also a significant turning down of going on pump therapy. Diabetic consultant, IS1

Linked to the above point, there was a fairly consistent view among many of the clinical staff interviewed that there were issues relating to patient acceptability of pumps that accounted for some of the lack of uptake of IPT. For some patients, this was about how the pump would fit in with their lifestyle or how they felt about having to be attached to a pump at all times; for others it was the requirements that went hand in hand with using a pump, for example the need for active self-management and regular blood glucose monitoring.

There are a significant number who think about it and then just don’t want even to take anything any further. They’re clear in their own minds that they don’t want a pump. And I think the minority are the ones who would be prepared to consider a pump and they then go on to have an assessment, a formal assessment. And of those who go forward, not everyone in the end decides that they want a pump. Having seen one, talked about it in more detail, quite a number of them have come to the conclusion that it’s not for them . . . Diabetic consultant 3, NIS

However, for others the pump was seen to provide them with a greater freedom to manage their diabetes, despite some initial concerns about the pump itself:

Well there’s the body image, which probably is more of a concern for females, understandably . . . There’s a classic quote where the partner calls them the Bionic Man or Bionic Woman because they are linked up to the machine. Certainly in my study . . . I think the patient experience is honestly amazingly positive. Even people who have apprehensions about going on the pump, but still probably want to do it because their control is not where they want to be or they’ve got severe hypos, generally speaking a few months into pump they would not go back to injections. Specialist medical trainee, NIS

The comments above represent a rather divergent set of opinions on patients’ views of IPT from the perspective of professionals delivering the service. It also appears that professionals’ views do not always correspond with the views of patients themselves. This is illustrated by some of the e-mail correspondence received by the patient support group, INPUT.

[My] consultant said: ‘If you use a pump you will be a failure to yourself.’ ‘It’s not suitable for you because you work.’ ‘If you have to miss a meal you’ll be in trouble because the insulin is going in all the time.’ Patient A with type 1 diabetes

My daughter has had diabetes for 4 years. The clinic team are saying it’s not the right time for a pump. She is aged 9, will be 10 in April. [Her] control is very poor. The diabetes clinic said ‘how would we work out her pump ratios when she’s so up and down?’ Parent of child B with diabetes

Achieving effective self-management of pumps

Despite some differences of opinion on the level of acceptability of pumps to patients, there was more consensus on the need for effective self-management by patients using pumps, including educational preparation and support to use the pump. This included regular monitoring of blood glucose and a level of understanding to interpret the results and adjust the pump settings accordingly.

When a patient goes on a pump, initially, it is . . . very time-consuming, the patient needs lots of education . . . the thing about the pump it, whether it works or not, depends on patients’ self management. Now, for a patient to be able to self manage the pump, they need to be, learn a lot about the pump. They need to learn all the pump functions, they need to know what to do if they hypo, if their blood sugars are high . . . Diabetic specialist nurse, IS1

In the case of children, the second implementation site had identified a number of additional criteria to determine which children were eligible to be started on pump therapy.

As long as they’ve got at least one English speaking parent because, as you can imagine, it’s quite tricky to train somebody who doesn’t read and speak English to use that level of technology. If you’ve got one parent that speaks and reads English, we can go for it. And we’ve had ten children in the last two years go straight onto insulin pumps from diagnosis. So there is no [lower age limit] – and they actually work really, really well for tiny babies. Diabetic specialist nurse, IS2

• The influence of clinicians on the implementation of insulin pump therapy

Clinician-related factors appeared particularly influential in the adoption of IPT; this was particularly the case at a consultant level. Where consultants providing a diabetic service were motivated and enthusiastic about IPT, they played an important role in leading the introduction of the technology.

. . . we have always been a forward looking trust I think, although we are only a district general hospital I do think that we have a philosophy of, the philosophy that we have in this department is that our patients should not miss out on any treatment that could be of benefit to them and that is available in the UK and that’s how it has always been. Diabetic consultant, IS1

Equally, where consultants were sceptical or wary of the technology, they represented a significant barrier to its implementation. For some clinicians, this appeared to relate to bad experiences of using pump in the earlier stages of developing the technology, alongside some more recent negative incidents.

And you have to remember that I did actually use pumps in 1982, so I’ve been using pumps for a very long time . . . So I’m not sceptical because I’ve had nothing to do with them. I’m sceptical because I’ve seen the good things and I’ve also seen the bad things about pumps. Like the girl we admitted last weekend, in very severe diabetic ketoacidosis [ketoacidosis is a dangerous complication of diabetes caused by a lack of insulin in the body], with a pH of 6.8, who nearly died, and I’m not egging this up because she’d . . . we hadn’t put her on a pump, she was put on a pump elsewhere and she didn’t self-manage properly. When she felt sick, she took her pump off and she was that close to dying. Diabetic consultant 3, NIS

In other cases, resistance appeared to be tied up with local politics and personalities:

And that’s one of the sort of barriers . . . internal barriers to implementation and it just kind of reflects the bigger picture I think and problems within the sort of structure of the team that was highlighted by this project. So I think some of the barriers to this project aren’t really barriers to this project, they’re more to do with identifying barriers that are within . . . our Diabetes Team . . . one individual in particular who was asked to be involved but because of other work commitments he wasn’t, couldn’t get involved but if it isn’t his project he doesn’t want to know and he has done quite a few things to try and sabotage the . . . and he’s still trying to do things to sabotage it. It’s not just in this, it’s in other things as well. And those are the sort of kind of things that actually aren’t necessarily surmountable. Project manager, IS1

• The strength of evidence for insulin pump therapy

One particular issue that emerged, and may partly account for the differences of opinion at a clinical level, was the strength of the evidence supporting the introduction of IPT. Some clinicians perceived the evidence supporting the use of IPT as rather ‘shaky’.

I don’t think we have the evidence yet and that is a really important question. I think it was an assumption when we started our journey with pumps really so hopefully if you can get people good at this then their needs for support get less. I don’t know if that’s born true and I think this comes back to your patient selection that you need to be very careful about the reasons that the patient is selecting a pump. The one thing that it does not do is take away your diabetes it makes it even more in the front and you know whether they are able to manage it themselves and again I think we haven’t to my knowledge got very good data on long-term outcomes from our pump clinic. Diabetic consultant 4, NIS

I’m not even a hundred per cent sure about the proven clinical benefits. If you have . . . do the proper randomised controlled trial, pump versus intensive therapy with an equivalent amount of input from health care professionals, you don’t get a great difference in Hb 1c or in anything else. You might get a difference in patient satisfaction in favour of pump, but that’s in folk who want to go onto the pump. So I think sometimes the benefits of pumps are a bit overstated. Diabetic consultant 3, NIS

This second quote raised an issue that a number of interviewees at site NIS referred to: whether it was the additional educational input and support that pump patients received that made the most difference, as opposed to the technology itself. However, at other sites, the evidence for pumps was much less disputed, with IPT being described as a ‘proven technology’. With the endorsement from the NICE technology appraisal that IPT was a clinically effective and cost-effective treatment, this has enabled organisations to develop a case for their commissioners for increased funding of IPT.

I suppose, on the surface, it looks expensive but there’s then the evidence to show that . . . that’s why NTAC have taken it on . . . because the improvement of the blood result, HbA 1c  , in preventing complications . . . is a proven technology for improving progress with [diabetic] complications. Diabetic specialist nurse 2, IS1

PCTs have to follow NICE, have to be seen to be following NICE guidance, so I know it’s a time of austerity and the PCTs have other priorities, but a trust should always play the NICE guidance card and say, look you know, that’s why we’ve got NICE guidance because it’s the best outcomes for this group of patients. Diabetic specialist nurse, MS

However, there were some who were critical of the wording of the NICE guidance, which indicates that IPT should be used where MDIs have not been effective in controlling blood glucose levels. This led some interviewees to suggest that IPT was perceived as a ‘treatment of failure’:

And at the moment, very much NICE guidance is geared to pump use being used as a treatment of failure. So if you fail with your multiple daily injections, i.e. you’ve still got poor control, or you’ve still got low blood glucose. It’s a negative process . . . it’s sort of like a downward staircase on diabetes. Start on maybe twice daily injections or your control is not very good – let’s put you onto the next treatment, which might be structured education and basal bolus regime [a basal-bolus regimen, which includes an injection at each meal, attempts to roughly emulate how a non-diabetic person’s body delivers insulin]. Oh you’ve not done well with that, you’ve failed with that. Right, let’s go onto something else. And eventually you get to pump therapy. By that time, the question is, is the patient demoralised, is the clinician demoralised? Why is pump therapy used as the treatment of failure, if it’s supposedly the best treatment? Compared to cancer treatment, you wouldn’t . . . We’ll start with something but if you don’t get better then we’ll use the next one. Whereas in diabetes, it is like that. Specialist medical trainee, NIS

This could lead to a dilemma as to how to proceed with patients who might benefit from a pump, but did not meet the NICE criteria.

But there are definitely people whose diabetes control is okay but actually they probably would do better if they were on a pump, but that’s not covered by NICE guidance, so they’re currently excluded and you can’t really encourage them to let their HbA 1c s go up, which you know some of the conversations that not just us have had but we’ve you know . . . well do you let them increase their [blood glucose] . . . so they meet the criteria? Project manager, IS1

• The initial investment costs of insulin pump therapy

A key issue relating to the introduction of IPT was the service investment required, including the availability of specialist pump trained nurses, educational preparation of patients to use a pump, and the cost of purchasing pumps and related consumables. The upfront investment costs in terms of staff and patient education were seen to be significant. Furthermore, several interviewees raised questions about the extent to which investing in service development for the introduction of IPT took services away from non-pump users and could result in inequity.

And I think the other barrier is the fact that, certainly in [this organisation], we expend a great deal of health care time with the small number of people who are on pumps and that is to the detriment of people who are not on pumps. We have a limited number of physicians, nurses, dieticians and if they’re working with pumps, it means that they’re not working with our other non-pump population. And I think we have a tension there; that the more resources we devote to pumps, the less we’ve got for somebody else. So it’s not just the cost of the pump and the pump consumables, it’s the health care professional time as well. Diabetic consultant 3, NIS

Others raised concerns about the costs of the technology itself, suggesting that the cost was kept unnecessarily high by the producers, which, in turn, acted to limit the wider scale uptake of IPT.

So there’s been a lot of input from the pump manufacturers, but then there ought to be because prices of the pumps is ridiculous. And if you want to ask about the constraints, I’ve said it to everybody so I may as well say it to you, if an iPad can be 600 quid, why is an insulin pump £3,500? . . . And if – it strikes me that it’s not any technical – I don’t know anything about technology, but I think they’re milking it. And if you could even – that’s your – that’s your biggest constraint. Diabetic consultant 2, NIS

• Funding and commissioning insulin pump therapy

Each of the four sites had different arrangements in terms of the commissioning of IPT services. In the first implementation site (IS1), the trust had a close working relationship with commissioners. The PCT had been instrumental in driving the adoption of IPT and agreed to provide funding for the service without a formal business case.

So that’s when I got involved, I suppose that’s why they’re saying it’s been driven primarily by the PCT because once I became involved, I did actually start trying to structure it and say, you know, let’s look at it in a more comprehensive way; rather than just clinicians thinking this is a great thing to do, without any thought about how we’re going to pay for it. Commissioner, IS1

. . . unlike other places we don’t actually have anything signed between the PCTs and us, we didn’t have to do a business case or anything. We sat around the table. . .. Diabetic consultant, IS1

The second implementation site worked with a large number of commissioners, which could cause difficulties as different commissioning bodies had different ways of working.

I think what’s difficult is they all have a different way of working. For example, the main PCT that we work with . . . are quite happy to be invoiced directly by the insulin pump companies. I order a pump and the consumables from the pump company; they invoice the PCT; the PCT pay the bill. The patient then starts ordering consumables from the company and the PCT get the bill. That’s brilliant. I don’t have to have a cupboard full of stock. I don’t have to sign off invoices. I don’t have to get involved. So that works really well. Then you have another PCT, who shall remain nameless – there are two or three of them – where they insist on recharging back to the children’s hospital, who then have to pay the company, and then the company will supply. And then the bill will come back to the children’s hospital, we pay the bill, then we recharge the PCT . . . So you add another step. An unnecessary step in some respects, but it’s in there . . . And the other problem that that then causes is the PCTs do not get any bulk buying discount and they are missing a trick . . . Diabetic specialist nurse 1, IS2

In the MS, the acute trust had a commissioning manager who acted as a point of liaison and negotiation with the PCTs, which was seen to have played an important supporting role in the introduction of IPT.

. . . not every trust has got like my post and my team that can be the conduit so sometimes the individual departments struggle with, who do they speak to within the PCT or we can help with that. We facilitate it, we package it in a way we know the PCTs would be amenable and so I think that’s quite important . . . We call it commissioning, which is a bit of a daft name, . . . so we agree the contracts, we agree the quality in the case of the PCT, we’re always mindful of whatever we agree is, I’ve got an inward looking role and an outward looking role and we’ve got to keep that, that communication going both ways from my department basically. Commissioning manager, MS

In the fourth (non-implementation site; NIS), the organisation had been used to working on a block contract arrangement and had discretion over the use of their resources, which meant they could decide the level of investment they made in pumps. This was initiated when a clinical academic consultant came to work in the service and was interested in establishing a pump service. However, the consequence was that the service had largely grown around the practice of this particular clinician without being more widely adopted by or embedded in the rest of the organisation.

[The consultant] . . . was told in no uncertain terms that he could not develop a service bigger than that because he was an academic . . . It was not clear what his long-term shelf life would be . . . so he could then leave me with a huge number of people on pumps . . . We have to be quite careful that if he did move we’re then not left with a service and nobody and no budget to cover it. Clinical manager, NIS

In summary, the implementation and MSs were able to get the PCTs to fund IPT because of the NICE guidance and, as a consequence, they were not particularly worried about the lack of a national tariff for IPT. Indeed, having the PCT pay directly for the costs was seen to be an advantage, as a tariff only provides the average national cost, which may be less than the actual cost.

I guess the danger with having a specific HRG [for the pump service] is making sure it reflects the cost and responds to changes in cost. Whereas the advantage to us at the moment is we don’t have to worry about it. If someone’s having a pump, the PCT pays for it direct. Diabetic consultant, IS2

However, a persistent concern raised related to the infrastructure required to establish an IPT service, in terms of nurse specialist provision and patient education (as discussed in the previous section); this was a cost that the organisation typically had to absorb as part of setting up the IPT service.

• The role of NHS Technology Adoption Centre in supporting implementation

NHS Technology Adoption Centre clearly played a key role in supporting the implementation of IPT for the two implementation sites. This included acting as an initial catalyst to ‘do something’ about IPT, introducing a formal project management structure, providing a map of how to get started and implement IPT and developing the systems that were needed to support the use of the technology (see Chapter 4 for a description of the NTAC process of working with implementation sites).

I mean I think it was if you like the catalyst, participating in this project was the catalyst that we needed to get us to focus on this. Diabetic consultant, IS1

They [NTAC] were phenomenally helpful. We knew where we wanted to be, but weren’t sure of the map to use to get us there . . . NTAC were really good in helping us to get the people in the room who needed to be in the room, to have the right conversations. Project management – I think that’s what we really lack and what they did really well. Diabetic specialist nurse, IS2

That’s the difference with NTAC. It’s a project. One of the things that’s come out of it, I would say, is that there’s been joint working with commissioners and PCTs and a recognised procurement process . . . The whole problem in the past is that you had patients waiting for pumps but it was either applying for funding individually, . . . or finding an ad hoc way of doing it. Diabetic specialist nurse, IS1

The NTAC method of supporting technology adoption seemed particularly suited to the sites attempting to introduce IPT, providing a co-ordinating structure and project management that had been lacking, despite prior enthusiasm or intent to support IPT. The lack of a co-ordinated approach to IPT provision is equally apparent in some of the patient feedback received by the support group INPUT:

My consultant supports my belief that an insulin pump should now be tried as soon as possible and referred me to a Dr X at the X Diabetes Centre. Dr X has agreed that a pump should be tried soon, however he has warned me that there may be a delay of possibly 5 months before the local PCT gets around to agreeing to this proposal. Patient C with type 1 diabetes

I would like some guidance if possible on how much choice I have on the insulin pump that is provided for my 5 year old. We have had funding approved for a pump, although the pump of our choice – we are told is too expensive by the PCT. Our hospital have said they will support us in whatever pump we choose if we can obtain funding, but have also said that if we don’t make up our minds soon the funding will be retracted. Parent of child D with type 1 diabetes

Although acknowledging the important input that NTAC provided in structuring and signposting the implementation of IPT, there was also a view from some interviewees that the hard work only started once the NTAC project was coming to an end and they had to actually implement all the things they had planned on paper. In one of the two implementation sites, this responsibility sat with an internal project manager for IPT.

Well, it’s like anything; the pump project is in some way a theory. It was setting a structure, having guidelines, having a structure to every stage of pump therapy, but then, whatever we’ve decided now as part of this pump project – you’ve got to put it into practice! . . . That’s when the real hard work starts, doesn’t it? Up to now it’s been on paper. Diabetic specialist nurse 2, IS1

How to Why to guides

Overall, the case study sites had limited involvement with the HTWT guides. Although the two implementation sites had been involved in the development of the guides, the first site had received almost no contact from other organisations asking for information or advice since the publication of the guide. This was the same situation in the MS studied and there was a view among the interviewees that the guide could not substitute for the hands-on project management support provided through working with NTAC.

I’d like to be able to show you some examples of where the How to Why to guide has been used and someone’s done what we have done, but my worry is that it’s quite hard without that push from NTAC centrally. Diabetic specialist nurse, IS2

The exception to this was IS2, where one of the diabetic nurse specialists reported using the HTWT guide to direct people who contacted the trust for advice and guidance on setting up a pump service.

I’ve [directed] an awful lot of people to the How To Why To guide . . . I used to get a lot of calls saying, you know, ‘How do I get my pump service up and running? How do I get more kids on pumps? What do I do?’ and you’d spend, you know, forty minutes on the phone. The How To Why To guide has saved us loads of time because you can say, ‘Go on and track it through,’ and all those questions you’re likely to ask are answered. And there are templates on there for doing a business case.’ Diabetic specialist nurse 2, IS2

• Discussion and summary

Overall, the NTAC process seemed relatively well matched to the needs of IPT implementation sites; these were sites that were generally receptive to IPT and were already working with the technology, but often in an ad hoc way. NTAC brought a structured project management approach that enabled them to formalise the implementation of IPT. From an ANT perspective, the network of human and non-human actors was less complex in the IPT case, compared with the other two technologies studied in the research. Certainly, in the implementation sites, work had already been undertaken to address issues related to problematisation and interessement. However, the sites were lacking the guidance and ‘know-how’ to move further along the translation path in a systematic and structured way; the input from NTAC provided the support that these organisations needed. Through applying a project management approach and enlisting the involvement of key stakeholders, the NTAC model enabled and supported implementation sites to move through the translation path from problematisation/interessement to enrolment and mobilisation. Introducing IPT requires changes to the patient pathway and the design and delivery of diabetes services, for example in relation to patient and staff education and dedicated specialist nursing support. In turn, this requires a different set of networks and relationships to be developed. However, the fact that the evidence base for the technology was relatively well established and accepted (at least in the implementation sites) meant that the NTAC model of working had a good fit with the organisation’s needs in terms of developing this new network of actors, agreeing and co-ordinating roles, and embedding new structures and processes required to sustain the innovation.

The data reveal a marked contrast between the experiences and views of the two implementation sites and the NIS, where the receptivity to the technology appeared more mixed, particularly in relation to the benefits of IPT, the evidence supporting its adoption and the feasibility of establishing a wider adoption programme. From an ANT perspective, it could be hypothesised that the NIS was still at the problematisation stage, with human actors (particularly the clinicians) not agreeing on the nature of the problem and whether or how it needed to be addressed. This site did not receive the type of external input and support that NTAC provided to address the translational stages from problematisation through to interessement and beyond. The existence of an online resource in the form of a HTWT guide did not appear to provide a comparable substitute to the more ‘hands-on’ role provided by NTAC to actively facilitate the translational process. However, the question remains as to whether or not the NTAC process would be sufficient to address the barriers in the NIS. The issues at this site appeared to be more to do with differences of professional opinion over the value and benefit of the technology, rather than more practical problems of how to ensure implementation.

Included under terms of UK Non-commercial Government License .

• Cite this Page Llewellyn S, Procter R, Harvey G, et al. Facilitating technology adoption in the NHS: negotiating the organisational and policy context – a qualitative study. Southampton (UK): NIHR Journals Library; 2014 Jul. (Health Services and Delivery Research, No. 2.23.) Chapter 6, The insulin pump therapy case study.
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Recall notice after more than 200 insulin pump users injured due to app malfunction

by Ernie Mundell

The U.S. Food and Drug Administration has issued a Class 1 recall—its most urgent kind—for an IOS app linked to a specific kind of insulin pump used by people with diabetes.

The recall notice , which the FDA says is a "correction" rather than a product removal, involves version 2.7 of the Apple iOS t:connect mobile app. It's used in conjunction with t:slim X2 insulin pump with Control-IQ technology.

The problem: The app can repeatedly crash and then restart. Over time, this drains the battery of the insulin pump, which must function in order for patients to stay healthy. Already, nearly 86,000 of the apps have been recalled due to this issue.

"Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis , which can be a life-threatening condition due to high blood sugars and lack of insulin," the FDA explained in a statement released Thursday.

So far, the agency knows of 224 reported injuries from this malfunction as of April 15. No deaths have been reported.

Anyone who uses the t:slim X2 Insulin Pump Mobile App version 2.7 on the Apple iOS platform could be affected.

According to the FDA notice, Tandem Diabetes Care, Inc. has recalled version 2.7 of the t:connect mobile app, which was first released on the Apple iOS platform on Feb. 12, 2024. It works in conjunction with the t:slim X2 insulin pump, which delivers insulin under the skin at specific but varying rates.

Tandem is urging users to update the software to version 2.7.1 or later. It is available in the Apple App Store.

After that:

• Identify the software version of the t:connect mobile app by opening the app, clicking the "Setting" icon on an iPhone's screen, and then clicking "About."
• Complete the online form External Link Disclaimer to acknowledge receipt of this notice.
• Keep using the pump as described in the user guide, paying heed to all system alerts and alarms.
• Monitor pump battery level closely to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown.
• Begin charging device after the first low battery alert.
• Always carry backup supplies for insulin delivery in the case of insulin pump failure.

2024 HealthDay. All rights reserved.

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Hundreds injured after insulin pump software issue, FDA says

(CNN) - The Food and Drug Administration reports hundreds of people were injured by a malfunctioning insulin pump.

The problem was with T-Connect, the software that connects the T-Slim insulin pump to iPhones.

A glitch in the code caused the app to crash and relaunch, which can also drain the pump’s battery sooner than expected.

On March 26, Tandem Diabetics Care told affected owners to update their mobile phone apps to an updated version that corrects the issue.

About 85,000 people were running the problematic software at that time.

The FDA is now reporting the technical issue left to 224 injuries.

No deaths have been attributed to the problem.

Copyright 2024 CNN Newsource. All rights reserved.

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