Creating value for diabetes patients
through a disruptive innovation.
By
Boudewijn Oude Wesselink
S2964813
E-mail: b.c.w.oude.wesselink@student.rug.nl
Master Thesis
MSc. Business Administration
Health Faculty of Economics and Business
University of Groningen
Date: 1 February 2021
Supervisor
dr. O.P. Roemeling
Co-assessor
dr. M.L. Hage
Word count: 11.316
Abstract
Purpose: The diabetes healthcare landscape is associated with increasing healthcare costs and variations in care quality. VBHC incentivizes providers to help patients improve their health by achieving the best outcomes at lower costs. Innovations in healthcare already showed potential to improve patient value. Therefore, this research aims to investigate how value can be created for diabetes patients through a disruptive innovation.
Methods: In this qualitative research, a single case study consisting of 8 medical- product- and patient experts was conducted to retrieve the supporting elements of patient value regarding a novel innovation in the diabetic industry, the Artificial Pancreas.
Findings: This research showed the supporting elements of patient value in 4 categories. Notably, clinical outcomes, and Quality of Life are the most important outcome measures for diabetic patients highlighted by experts in the field. Furthermore, costs related to long-term complications can be saved through the use of novel treatment methods which support a more value-based healthcare approach. Conclusion: This research provides a useful overview of the supporting elements of patient value for diabetes patients. Ultimately showing how the economic burden related to diabetes care can decrease through a novel treatment method.
Table of Content
Introduction ...5
Theoretical background ...7
Disruptive innovation ...7
Value-based health care ...8
Outcome measures for T1D patients ...9
Research framework ... 10 Methodology... 11 Research design ... 11 Case description ... 11 Data collection ... 12 Data analysis ... 13 Results ... 14
Theme 1: Medical Disruptive innovation ... 14
History of diabetic innovations ... 14
AP development ... 15
Theme 2: Clinical outcomes ... 17
Time in range ... 17
Glycemic control ... 18
HbA1c ... 19
Theme 3: Quality of Life ... 20
Psychological burden diabetes patient ... 20
Burden release by AP ... 21
PROMs and PREMs ... 22
Theme 4: Value-based healthcare costs ... 24
AP costs compared to SAP ... 24
AP and long-term complications cost saving... 26
Discussion ... 27
Main findings ... 27
Medical disruptive innovations ... 28
Clinical Outcomes ... 28
Quality of Life (QoL) ... 29
Value-based healthcare ... 30
Theoretical and managerial implications ... 31
Conclusion ... 32
References ... 33
Appendix A: List of terms related to Diabetes Mellitus... 37
Appendix B: Clinical outcome measures regarding T1D ... 38
Appendix C: visualization of the bi-hormonal AP ... 39
Appendix D: Health Technology Assesment ... 40
Introduction
Diabetes mellitus (DM) is one of the most common chronic diseases in the Netherlands (RIVM, 2016). In 2014 there were an estimated 1,078,400 diagnosed DM patients in the Netherlands. From 2000 to 2007, the DM prevalence rose by 55% from 480,000 patients in 2000 to 740,000 patients in 2007, and will reach 1,320,000 patients in 2025 according to Baan et al, (2009). Diabetes is a serious and demanding disease. Complications can be severe (e.g. stroke, heart disease, visual impairment, kidney disease). These complications have a significant impact on patients‘ perceived Quality of Life (QoL) (Da Rocha et al, 2015). Furthermore, DM is a source of medical costs and lost productivity for society (Peters et al, 2017).
The management of type 1 diabetes (T1D) is complex, and people living with the condition need to make numerous daily choices related to their medical treatment (American Diabetes Association, 2018). Patients need to monitor their blood glucose and administer insulin several times a day. The burden of living with T1D remains a challenge, despite new insulin types and innovative treatment technologies such as the development of Continuous Glucose Monitoring (CGM) and an Artificial Pancreas (AP) (Jones et al, 2015). Peyrot et al (2005), states that the psychological and emotional impact of living with diabetes is often unrecognized or underreported in diabetes care. Chronic diseases like diabetes may affect a person‘s QoL in many ways according to Rubin et al. (1999). One of the indicators of perceived QoL for diabetes patients are psychological and emotional effects that are created by not reaching medical outcomes to measure the management of T1D such as; HbA1c level, time in target glucose range, and time in hypo-and hyperglycemia, according to Maahs et al. (2016).
Next to the psychological and emotional effects T1D patients struggle with every day, DM is associated with a substantial economic burden. This total economic burden includes the costs of treating the illness, but also the costs of treating DM complications, the costs of productivity losses, and the costs of welfare payments due to DM-related disability (Muka et al, 2015). Insight into the total economic burden of DM and its complications is essential for decision-makers and payers, especially nowadays with the rising health expenditures. In 2016, the total economic burden of DM in the Netherlands was estimated to be €6.8 billion. For T1DM the burden was to be €873 million. For T1DM, the direct costs of complications made up 20.8% (€162 million) of the total costs (€873 million) (Peters et al, 2017).
The healthcare landscape is associated with increased healthcare costs, increasing complexity of care, and variations in the care quality. Value-based healthcare (VBHC) incentivizes providers to help patients improve their health by achieving the best outcomes at lower costs (Porter & Lee, 2013). Aiming for society to become healthier while reducing overall healthcare spending, VBHC has the promise to significantly reduce overall costs spent on healthcare. According to Teisberg et al, (2020), VBHC incentivizes to create more value for patients. So what is value? Porter and Lee (2013) determine that value is measured in terms of outcomes divided by costs. The assessment of value is
not a novelty, yet it has gained interest since the formal assessments of value are increasingly used in the decision-making regarding pricing, reimbursement, and funding new medicines or technologies. However, in reality, the relationship between outcome improvements and costs is complex and requires further investigation (Gupta & Rettiganti, 2017). Since VBHC might be the driver for quality improvements, it is necessary to further elaborate on, and research on its‘ role in the diabetic industry. Innovations in healthcare can possibly contribute to the demand for high-quality, cost-efficient, accessible, patient-focused and clinically integrated healthcare (Block, 2013). Within innovations, disruptive innovations are of particular interest for their potential in extending access to health care and improving the health of a population. According to Kostoff et al, (2004), Disruptive innovations offer a revolutionary change in the conduct of processes or operations. Furthermore, a disruptive innovation is an innovation that creates a new market and value network, to eventually disrupt an existing market and value network, displacing established market-leading firms or products (Rahman et al, 2017).
This research aims to discover how value can be created for diabetic patients, focusing on a disruptive innovation to show which elements are supporting value creation for T1D patients. Current research state that many would argue that the market view of value for pharmaceutical products remains focused on who controls the pharmaceutical. A value-based healthcare approach takes the conventional approach into a proactive scenario to increase the ability to manage a population and engage the patient in both their own health status and use of healthcare services (Vogenberg, 2008). By applying the principles of value-based healthcare, more insight is given for value for pharmaceutical products. Such an approach would disrupt the current interrelationships and functioning of the healthcare system around pharmaceutical products. The objective of this study is to answer the following research question: ―How can a disruptive innovation create value for patients in the diabetic industry? In order to answer the research question, this paper entails a qualitative research approach. In the theory section, the existing research on disruptive innovations and underlying elements that support value creation for T1D patients are examined. Thereafter, the method section describes the research design and methods that were conducted in this research. Afterwards, the findings based on the semi-structured interviews are provided in the results section. Followed by the discussion section, where is reflected on the results with regards to the relevant literature to answer the research question. The last section of this paper consists of the conclusion of this research.
Theoretical background
This chapter presents the theoretical background for this study. First, an explanation of disruptive innovations in the diabetic industry is given. Secondly, the underlying principles of a value-based healthcare approach are given. Thirdly an overview is given of the important outcome measures that define patient value. At last, the research model is introduced to give an overview of the important elements that support patient value.
Disruptive innovation
Innovations in healthcare are improving efficiency, effectiveness, quality, sustainability, safety and/or affordability, according to the World Health Organization (WHO, 2016). In the past years, several innovative technologies have been developed to help patients treat their diabetes (Maltoni et al, 2014). An example of one of these innovations is the development of the Continuous Subcutaneous Insulin Infusions (CSII) pump. This is a medical device that contains a cartridge with short-acting insulin. These insulin pumps release insulin with two modalities: continuous (basal infusion) and on request (insulin boluses). Another example of an innovation in the diabetic industry is the development of Continuous Glucose Monitoring (CGM) devices. CGM devices carry out the frequent measure of glycemic levels, allowing to quickly obtain the glycemic profile of a diabetic patient. The combination of both CSII and CGM technology leads to a Sensor Augmented insulin Pump (SAP), which delivers insulin through the CSII based on glucose levels measured by the CGM sensor. For an overview of diabetes-related terms see Appendix A
Taking a closer look at innovative technologies to further support the treatment of T1D, brings to light the development of ―disruptive‖ innovations in the diabetic industry. Disruption means causing or tending to cause disruption in an innovative or groundbreaking way (Christensen, 2015). A disruptive innovation creates a new market and value network and eventually disrupts established market-leading firms, products, or alliances (Christensen, 2015). Where companies active in the diabetic industry generally work with sustaining technologies, which rely on incremental improvements to previously established products, disruptive innovations can offer a revolutionary change in the conduct of processes or operations according to Utkarsj et al, (2018). An example of such a disruptive innovation is the development of an Artificial Pancreas (AP). As Klein (2009) stated: ―a safe and effective artificial pancreas will revolutionize the management of diabetes when such a device is released to the general public‖. This novel AP system is a closed-loop system, which means that the system will not only monitor glucose levels in the body but also automatically adjusts the delivery of insulin with no input required from the patient.
Ultimately, disruptive innovations provide new and different perspectives that tend to reduce costs and complexity in favor of improved access and empowerment of the patient (European commission, 2016). However, if the cost of the innovation is too high for the benefits obtained, or if the quality and safety of the product are reduced while reducing costs, then these innovations are not valuable for the health care system (European Commission, 2016). Ultimately, according to Garfield (2012), technologies like the AP could pose significant short-term cost challenges, but overall increase the Quality of Life of patients living with T1D.
Value-based health care
The challenges of delivering health care are growing worldwide, as costs continue to rise and evidence of uneven quality accumulates (Porter, 2008). While the number of people with chronic diseases continues to increase, there is also the growing need for more patient-centered care. This is putting tremendous pressure on health care systems (Struijs, 2011). Health care systems today are challenged by quality issues, spiraling costs, and variations in outcomes at all levels of care. According to Lüdtke et al. (2016), payment systems that favor volume over value, as well as fragmented and disconnected care-delivery models are limiting patients‘ access to optimal care, particularly for patients with chronic conditions.
According to Porter (2009), the structure of health care delivery, or how the practice of medicine is organized, managed, measured, and paid for requires a transformation. This so-called value-based healthcare approach (VBHC) incentivizes care providers to help patients improve their health by achieving the best outcomes for patients at lower costs (Porter & Lee, 2013). Health outcomes can be described in terms of capability, comfort, and calm (Wallace, 2016). Capability is the ability of patients to do the things that define them as individuals and enable them to be themselves. Comfort is relief from physical and emotional suffering, and calm is the ability to live normally while getting care. Improving a patient‘s health outcomes relative to the cost of care is an aspiration embraced by stakeholders across the health care system, including patients, providers, health plans, employers, and government organizations (Teisberg et al, 2020).
The main objective of value-based care transformation is to enable the health care system to create more value for patients (Teisberg, 2020). This is in line with Abassi, (2007) who states that the VBHC aims to increase patient value that is derived from resources available to the population. Were value is the measured as the improvement in a person‘s health outcomes against the cost of achieving this improvement (Porter, 2010). By focusing on the outcomes that matter most to patients, value aligns care with how patients experience their health. According to Teisberg et al (2020), better patient-related outcomes can reduce spending for ongoing care. By improving patient‘s health outcomes, value-based healthcare helps to reduce the complexity and disease progression that drives the need for more care. For example, a patient whose diabetes does not progress to kidney failure,
blindness, and neuropathy is over time less expensive to care for than a patient whose conditions worsen (Lüdtke et al, 2016).
What healthcare needs desperately are therapies and care pathways for patients that deliver clinical and economic value and drive efficient, integrated care. This VBHC perspective emphasis on fee for- value instead of fee-for-service which help better manage a patient condition, control costs, and continue to drive and reward innovations. Part of this pathway to deliver clinical and economic value is to make payment for products and services contingent upon the ability to improve patient outcomes relative to the costs. Diabetes care products deliver clinical value. However, to contribute to VBHC, it is important to demonstrate economic value too. Although manufacturers create technologies and therapies for providers to deliver care, it is ultimately the insurer who pays for that process.
Outcome measures for T1D patients
Important outcome measures for T1D patients are clinical outcome measures and psychosocial outcome measures such as Quality of Life. For a more elaborate overview of clinical outcomes related to T1D please visit Appendix B. A well-known psychosocial outcome measure is Quality of Life (QoL), which is recognized as an important health outcome in diabetes, as the burden of self-management is demanding (Kalra, 2018). chronic disease such as diabetes impacts a patient‘s Quality of Life with the burden of symptoms and managing the condition and concerns of progression and disease complications (Borg et al, 2019). Aspects to indicate QoL are captured by Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs). Furthermore, collecting Patient-Reported Outcome Measures (PROMs) and patient reported experience measures (PREMs) have the potential to improve care for people with diabetes and other chronic conditions by screening for and identifying problems, monitoring progress over time, improving patient-clinician communication, and enabling people to become more involved in managing their own health (Snyder et al, 2012).
The psychological and emotional impact of living with diabetes is often unrecognized or underreported in diabetes care (Peyrot et al, 2005). According to Huang et al. (2007), patients with diabetes perceive significant differences in the Quality of Life effects of complications and treatments related to their condition. Improvements in QoL have already been shown by adopting new diabetes treatment technologies such as Sensor Augmented Pumps (SAP‘s). This treatment resulted in improved Quality of Life in five categories: Energy and mobility, diabetes control, anxiety and worry, social burden, and sexual functioning for 85% of the patients (Alfian et al, 2016). In addition, surveys results from Barnard et al. (2015), highlighted the importance of new treatment methods such as an Artificial Pancreas to further alleviate some of the burdens of living with T1D such as reassurance and
reduced anxiety, improved sleep, and confidence and ―time off‖ from diabetes demands. This ultimately influences the perceived QoL for T1D patients.
Research framework
Based on a review of the literature, a guiding framework (figure 1) was constructed to show how patient value is supported by the following elements: Value-based healthcare, outcome measures, and a disruptive innovation.
Figure 1. Research Framework: Elements supporting patient value
Methodology
This method section describes the research design and explains the steps which were taken to answer the research question. The main purpose of this chapter is to present the method used for this, to introduce the case, and to show the way data is retrieved and analyzed.
Research design
In this qualitative single case study, we aim to develop new insights regarding the value of a disruptive innovation for T1D patients. Considering the qualitative nature of this study, a theory development approach is a good fit for this research (Van Aken et al, 2012). Theory development is needed when the business phenomenon has not yet been addressed in academic literature. Furthermore, qualitative research provides tools for researchers to study complex phenomena within their context. When applied correctly, it becomes a valuable method for health science research to develop theory, evaluate programs and develop interventions (Baxter, 2008). According to Yin (2015), a qualitative method is used to increase the understanding of how people cope in real-world settings and several qualitative research strategies are possible. In this research, a single- case study research is chosen, because this research aimed to gather new insights on how value is added by the application of a disruptive innovation, the development of an AP. Currently, little information and research are available on the development of an AP, especially with regards to value-based healthcare. Case study research is suited to answer how and why questions (Yin, 1994). In addition, according to Creswell (2013), a case study method explores a real-life, contemporary bounded system (a case) or multiple bounded systems (cases) over time, through detailed, in-depth data collection involving multiple sources of information.
Case description
In this qualitative single case study, I selected the introduction of an Artificial Pancreas system (AP). This case study is conducted based on a Dutch manufacturing company that developed a closed-loop hormonal Artificial Pancreas (AP). This company focuses on the development of the bi-hormonal AP, which is the newest development in diabetes care. A bi-bi-hormonal control system achieves a target glucose level by using two algorithms to instruct and infusion pomp to deliver two different hormones, namely insulin to lower glucose levels and glucagon to increase blood glucose levels. This portable device regulates one‘s blood glucose level fully autonomously intending to improve both the quality of treatment and QoL. See Appendix C for a visualization of the bi-hormonal AP on a T1D patient.
This Dutch company developed the first bi-hormonal device in the world that works completely automatically and in which all components are integrated. This did not go unnoticed by the Dutch government, which featured this company as ―National Icon‖. National icons are supported by
the government based on their innovation, which will have an impact on the Dutch economy and the social challenges faced in the short- or long-term. The government helps the National Icon to realize their ambitions and give them an international stage, by assigning a minister or state secretary as ambassador. This offers for example access to a large network in tapping new opportunities both domestically and abroad. Recently, in 2020 the first bi-hormonal AP project has started with 100 adult T1D patients in 6 hospitals in the Netherlands.
Data collection
The data consists of primary, qualitative data (semi-structured interviews) and secondary data in the form of a Health Technology Assessment as seen in Appendix D. The qualitative data serves to answer the ―how‖ research question (Eisenhardt, 1989). The secondary data increases the construct validity by making use of data triangulation (Yin, 2015). The purpose of the research interviews is to explore the views, experiences, beliefs, and motivations of individuals on specific matters. Semi-structured interviews are believed to provide a deeper understanding of social phenomena. Therefore, semi-structured interviews are appropriate where little is already known about the study phenomenon or where detailed insights are required from individual participants (Silverman, 2000).
To keep a clear structure, semi-structured interviews will be used. All interviewees will be informed about the purpose of the interview and research in general, which is done through an informed consent that is signed by both the researcher and interviewee. In this qualitative study, I interviewed respondents in 3 categories as seen below in table 1.
Respondent fictive name
Code Gender Function Category Interview
duration
Robert* PE01 Male CEO Patient
expert*
01:22:19
Jay* PE02 Male R&D Patient
expert*
00:32:16
Alex PRE01 Male Commercial
director
Product expert 00:56:44
Ben PRE02 Male R&D Product expert 00:24:03
Marcel PRE03 Male R&D Product expert 00:43:40
Amelia ME01 Female Endocrinologist Medical
expert
00:33:02
Maria ME02 Female Endocrinologist Medical
expert
00:35:33
Whitney ME03 Female Endocrinologist Medical
expert
00:45:50 Table 1: An overview of the conducted interviews
*Respondents are originally product experts, but are T1D themselves and used the AP for a longer period of time which implies them as a patient expert
The participants were selected and chosen based on purposive sampling. This is accomplished by applying expert knowledge of the population to select in a nonrandom manner a sample of elements that represents a cross-section of the population (Lavrakas, 2008). For this research, purposive sampling implies the respondents are experts with specific knowledge or involvement in the development of the AP. The participants (product and patient experts) were recruited at the manufacturing company based in the Netherlands, and are closely involved in the development of the AP. The patient experts used the AP for a longer time, which implies they are one of the few patients in the Netherlands that can actually give their opinion about the long-term use of an AP. Medical experts were recruited from different hospitals throughout the Netherlands. 2 medical experts were familiar with the test studies of the AP, while 1 medical expert was more familiar with the current most high-end diabetes treatment methods such as SAP treatment. The interviews are guided by a protocol added in Appendix E, giving clear guidance through the interview. However, during the interviews, a flexible approach will be taken to probe emerging themes in the research field that could enrich new insights. The interviews are recorded and transcribed thoroughly. After the transcription process, the transcripts were sent to the respondents for approval. By doing this, the internal and external validity is increased, and the researcher‘s bias was reduced according to Voss et al, (2002).
Data analysis
After collecting and organizing the data, the interviews are coded with help of the software program Atlas.ti. Content analysis has been used by using inductive codes (Eisenhardt, 1989). Coding is used to reduce and converse raw data into usable data (Karlsson, 2016). First, open coding was used to label the phenomena that emerged from the data. Secondly, axial coding was used to put data together in new ways to link categories to each other, which are introduced inductively (Yin, 2018). This implies that open codes are clustered in a new category, the axial codes. The objective of these second-order categories is to link categories more rationally. The last step is selective coding, where a core category is related to other categories (Strauss & Corbin, 1990). These codes indicate the overall relationship between the second-order codes. The inductive codes were merged into second-order codes; these second-order codes were merged into second-order categories. The categories were arranged into selective themes. Ultimately; a coding scheme can be conducted where the qualitative data is given in a schematic outlay, see Appendix F.
Results
This chapter accommodates a description of the main outcomes of the results of the interviews. The presence of key elements was researched by doing within-case analyses, where the main elements of the value-creating process will be given. These main elements are categorized into 4 themes: Medical disruptive innovation, clinical outcomes, Quality of Life, and value-based healthcare costs.
Theme 1: Medical Disruptive innovation
Several innovations have been implemented in the diabetic industry. However, the diabetic industry is pretty saturated. Giving smaller biotech firms an opportunity to compete with larger companies and enter a competitive market through product differentiation. An overview is given from the most important diabetic innovations from the past, and the latest development of a disruptive innovation in the diabetic industry, namely the AP.
History of diabetic innovations
The first innovation in the diabetic industry was around 1982 when it became possible to test your glucose level with a test strip. Nowadays, this doesn‘t look that exciting anymore. However, for that period in time it was a big innovation, due to the insight it gained in the patient his blood glucose level instead of having to go to a doctor. Although, this technology has also come to an end, as test strips are measuring faster and blood volume was getting smaller. As one of the product experts illustrates:
―The possibility to self-control your blood glucose level came around 1982. A basic blood glucose
strip could determine glucose through a finger prick”.- Alex, PRE01
―funny to see when you look back in retrospect, you think it’s not that special. But at the time it was.
The finger prick was the first step into self-managing your diabetes, instead of going to a doctor to check your blood sugar. Nowadays that technology has also come to an end, as test strips measure faster and blood volume to test is smaller and smaller”.- Alex, PRE01
This leads to the next big innovation on measuring blood sugar levels. With the upcoming CGM, self-control and management of T1D patients were increased. This was noticed by several respondents, who state the CGM and later on SAP treatment was innovative. Medical experts see the CGM and SAP as a helpful tool to better regulate T1D patients. However, the treatment for a patient may be better regulated, problems still occur in a way that the control of your disease is still in the
hands of the patients‘ hands. Even the newest technology such as SAP‘s needs human interaction. As follows from the quotes from medical-, user-, and product experts:
―In the last 10 years, the technique of test strips came to an end. When the CGM technique became
available, it all got better and easier in the aspect of self-management and self-control.”- Alex, PRE01
―At a certain point in time the CGM and SAP came in, which I can remember. Before that there was
not really anything that changed for me.” – Jay, PE02
―The SAP keep getting better, the newest insulin pumps communicate with the sensor, so you get more
information to adjust the settings of the insulin pump. This leads to better regulation of the patient”.- Whitney,ME03
―These SAP’s have been on the market for about 2/3 years. As a patient you still have to think in
particular about the number of carbohydrates you eat, to inject insulin, because the SAP can’t measure that”.- Amelia, ME01
―The newest SAP’s are called semi-closed loop, that also means semi-open in my opinion. As a patient
you still need to inject the insulin manually”.- Marcel, PRE03
AP development
With the CGM and SAP innovation already improving the self-management of T1D patients, the real disruptive innovation is seen in the past years, with the development of an Artificial Pancreas. This Artificial Pancreas can be seen as disruptive, due to the bi-hormonal feature which uses insulin and glucagon hormones, this creates a complete closed-loop reactive system to the body. This allows patients to stay between 4-10 mmol/l, without the patient having to interfere with the device. There is no treatment device on the consumer market at the moment that does the same. For the AP, only minimal action is required from the patient, such as maintenance and replacing infusion set, 2 sensors, and glucagon, while previous thoughts about metabolism settings can be forgotten. The following quotes illustrated the development of the AP
“The development of the CGM and SAP are great, but I think we’re going 10 steps further here. With the development of an AP, this is a bi-hormonal system that is completely closed-loop.”- Marcel, PRE03
―Well the main difference between a SAP and the AP is the bi-hormonal aspect. It’s just like a real
pancreas, it consists of 2 hormones, glucagon and insulin, that influence each other. That continuously secretes insulin and glucagon based on what’s going on in your body. That makes our system unique and disruptive. There is no system at the moment for the consumer market that does the same” – Alex, PRE01
―A closed-loop system means that you as a patient no longer have to think about your metabolic
setting anymore. Minimal interaction is required from the patient. Only maintenance is needed, such as replacing infusion sets and glucagon.”- Robert, PE01
“The AP allows patients to stay between 4-10mmol/l without having to do anything to the system or check your blood glucose level. The sensors continuously measure the patients’ blood glucose level, and the AP reacts with insulin or glucagon if needed.”- Ben, PRE02
The development of the bi-hormonal AP didn‘t get unnoticed by medical experts, as they overall reacted positively to the development of the AP, due to the closed-loop that was created. The medical experts were able to describe the positive and potentially negative aspects of the AP compared to the currently most advanced SAP treatment. Were all medical experts again emphasizing the positive effect of the closed-loop system using glucagon and insulin, some medical experts were concerned about the size of the AP, especially for female patients. As illustrated below:
―Looking back at the treatment method, the SAP was already a useful tool for patients. But the
closed-loop AP with insulin and glucagon, so a bi-hormonal system, that’s the holy grail!”.-Amelia, ME01
―One of my patients just started in the test study. She has just started, and already thinks it is unreal
that she no longer has to think about the settings of the device. She used to have a SAP and continuously adapt the settings to what she is going to do. This is no longer necessary with the AP”.- Maria, ME02
―It’s still quite a large device, I have spoken with many patients, and especially female patients think
the AP is not fashionable.”-Maria, ME02
With high expectations from physicians, it is important to release the AP in a controlled way, since it is a completely new treatment technology for users, treating physicians in hospitals, and for the manufacturer. Product experts gave more insight into how the AP is developed and continuously
improved based on patient preferences, which are included in the design in for example the frequency of alarms. As illustrated by the product experts as follows:
“Let’s realize that this is really a disruptive innovation, but we have to launch it in a controlled way. It is completely new for the users, treatment teams in hospitals, for us as producer, so we don’t know that many things yet”.- Alex, PRE01
“We started with interviewing people before the use of the AP, to see people’s expectations. Because the switch to a close-loop system is big. People with a SAP are not used to a device that takes over control completely. People have to project to us what it is like to have such a device, so we can adapt to that” –Marcel, PRE03
“In the previous clinical study, people indicated that unnecessary alarms were quite common. We adapted to this by building a silent mode, to give more priority to important alarms. The patient can decide whether the less important alarms are turned on or off. This is giving them more freedom.”- Ben, PRE02
Theme 2: Clinical outcomes
Clinical outcomes are important outcome measurements for patient value. When asked, every interviewee mentioned that the clinical outcome measures such as time in range, glycemic control, and HbA1c are improved by using an AP compared to the currently most advanced available treatment methods such as SAP‘s. The rise of the AP has not gone unnoticed; health insurers and hospitals are interested in running test studies for patients with the AP. For example, one of the largest health insurers in the Netherlands started on 20 October 2020 with the artificial pancreas test studies for 100 adults with T1D. The following section focuses on the most important clinical outcome measures such as Time in range, glycemic control, and HbA1c.
Time in range
Time in range is the time per day that the blood sugar is within target values. For people with T1D, these target values are usually between 4 and 10 mmol/l. Those target values are in general to achieve 70% of the day a blood glucose level between 3.9 and 10 mmol/l. With spending 4% of the day having blood glucose levels less than 3.9 mmol/l and as little time as possible higher than 10 mmol/l. Moreover, medical experts were interviewed to get an insight into the actual achieved time in range values from T1D patients. All the medical experts stated that these target time in range values are hard to achieve with the current most high-end treatment method, the SAP.
Furthermore, patient experts stated that time in range are important outcome measures, due to the fact that it is ultimately reflected in HbA1c value which can in the end be related to long-term complications. The clinical test studies with the AP gave insight in the time in range value that belongs to the AP treatment. An improvement in time in range was seen for all patients that participated in the test study. In some cases, the time in range increased from 54% using a SAP to 90% by using an AP. As the respondents stated:
―Time in range we try to maintain with an older SAP is 70%. With the newest SAP we aim for 80%,
however most patients don’t achieve that time in range %, Patients try to do their best, but if they are lucky they achieve a 60% time in range.” – Whitney, ME03
“Time in range was almost 87% for the AP, compared to 54% for the SAP. So that makes a huge
difference. Some patients achieve a higher outcome some a lower. But the SAP will never get near 80% time in range.”- Amelia, ME01
“You can see from test studies that time in range values affect the HbA1c, not directly, but after a couple of months. This has effects on long-term complications in the end. That’s what happened to me as well.”-Robert, PE01
Glycemic control
Next to time in range, glycemic control is an important outcome measure. As the medical experts state that bad glycemic control can lead to hypoglycemia, which is dangerous for T1D patients. Hypoglycemia (hypo) is also known as low blood sugar, which is a fall in blood sugar levels to below 3.9 mmol/l. Hypoglycemia results in a variety of symptoms including: clumsiness, trouble talking, confusion, loss of consciousness, seizures, or death. Product experts in the field state that hypoglycemia is the most important factor for acute hospitalization, which is not only bad for your health, but also entails costs for the entire healthcare sector.
Medical experts said that there is an international consensus of hypoglycemia, which is 3%-4% and is never achieved with the current treatment methods. Treatment of hypoglycemia involves quickly getting your blood sugar back to normal, with high-sugar foods or with medication (glucagon). Patient experts noticed that it is hard to treat a hypo, due to the fast rise in blood sugar after eating high-sugar foods. This results in hyperglycemia, which is a rise in blood sugar level to 11.1 mmol/l, or even higher since symptoms of hyperglycemia may not start to become noticeable until values as 16.7 mmol/l. A high frequency of hyperglycemia is considered as the main indicator for a high HbA1c which results in long-term complications. Patient experts and medical experts gave insight into how
hypoglycemia and hyperglycemia can be prevented by using an AP due to the normalization of metabolism. As the following quotes state:
―There is a consensus that has been agreed on internationally, which states that hypoglycemia should
be between 3% and 4%. is hard to achieve, even with a SAP.” – Whitney, ME03
―Next to a time in range from above 90% in all studies, the glycemic control increases enormously,
which is also an important one. Some patients from our test studies had 0 hypos, which is the most important factor for acute hospitalization. So, based on our test studies you can just determine that you normalize the glucose metabolism, which has a huge positive impact in both the short- and long-term complications”. – Marcel, PRE01
“I used to eat 14kilograms of sugar, like dextrose and lemonade to get rid of hypos. As a T1D you think this is normal, but any healthy person cannot imagine this. Instead of eating 14kg sugar a year, the AP uses half a glass of glucagon a year.”- Robert, PE01
―I used to have hypos of 1.5mmol/l or 1.2 mmol/l which almost knocked me out. With the use of an AP
I went from 300 hypos a year to approximately 10 hypos a year. I don’t experience it as a hypo anymore, because they barely get under 3.5 mmo/l.”- Robert, PE01
“Due to the use of glucagon by the AP, my blood sugar does not rise to 20mmol/l or higher. I was reaching these high glucose values before when I used a SAP. The last time my blood sugar was around 20 mmol/l is before the use of the AP.”- Jay, PE02
HbA1c
Next to time in range and glycemic control, HbA1c is most often used as a clinical outcome measure to measure the overall performance of a T1D patient. The goal for adults with T1D is to have an HbA1c that‘s less than 7%. A high HbA1c means you have too much sugar in your blood, which indicates that you‘re more likely to develop diabetes complications such as serious eye and foot problems. Medical experts gave insight into the HbA1c level of patients with an SAP, where some of the medical experts state that the consensus of having an HbA1c below 7% is barely achievable with the current treatment methods. Next to that, patient experts gave insight into how the AP can normalize HbA1c values within a couple of months. This implies that the chance of getting long-term complications is minimalized, which ultimately results in spending less money on treating these
complications, as stated by product experts. This will be further analyzed in the VBHC section. As the following quotes regarding HbA1c were given by the respondents:
―I had patients who used just an insulin pump, with an HbA1c level around 7.8, 8.0, or 7.6. When they
switched to a SAP the HbA1c was below 7.5, and in a very few cases around 7 if lucky”- Whitney, ME03
“By using an AP, HbA1c level also decreases enormously. In some cases HbA1c normalizes, which makes sense because your time in range increases”.- Alex, PRE01
“By using the AP I achieved a time in range of 93%, and my HbA1c is between 6.7-6.9, Which is normalized. Just like a person without diabetes.”- Robert, PE01
“Before the use of the AP, my HbA1c was only once at 7.3 with a SAP. Before that, my HbA1c has always been between 8.0 and 10.0. I’m on the AP for 3 months now, and my HbA1c already decreased to 7.0, which I’ve never reached since 2003 when I got diagnosed with T1D.”- Jay, PE02
“So if your HbA1c normalizes there is a lower chance of long-term complications. What we already see, for example, is that vision has improved spectacularly. This means that your eyes no longer deteriorate, but return to normal strength. So those are beautiful things that you perceive”. – Alex, PRE01
Theme 3: Quality of Life
Quality of Life is an important measure for the well-being of a patient. However, measuring QoL is fairly difficult, since different measurement methods are used among medical experts. Chronic diseases such as T1D impact a patient‘s daily life, the psychological burden and managing the condition, and concerns of progression of the disease complications are part of the struggles in daily life. Such aspects are captured by Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs). In this section, the psychological burden of T1D patients is given, based on PROMS and PREMS. Furthermore, insight is given on how the AP can play a role in releasing patients from this burden.
Psychological burden diabetes patient
T1D impacts the physical, social, and mental well-being of a patient. The burdens that diabetes patients experience are mostly psychological burdens such as disturbed sleep, eating behavior, and
having problems practicing sports. These psychological burdens are often underestimated and can lead even to depression in some cases. Additionally, the psychological burden T1D patients face, often results in a serious negative impact on patients‘ QoL as the patient experts and medical experts illustrated. Next to the individual burden experienced by patients, medical experts underlined how for example entire families are burdened by having a child with T1D. The following burdens were explained by the medical experts, patient experts, and product experts with regards to the SAP treatment:
“The biggest disadvantage of having diabetes is that you spend all day being busy with it. Even if you do have a SAP, you still have to look at it continuously. You have to continuously watch what is happening, is my blood sugar level going up or down and react to that”.-Robert, PE01
―I hear a lot of patients telling me: “I am constantly in my head making decisions regarding my
disease. Like how many carbohydrates I eat, how much insulin I need to take and am I going to sport tonight? Because then I have to adjust the SAP to that.”-Maria, ME02
―Diabetic patients have a much higher chance of depression anyway. If nobody has to spend all day
being busy with their diabetes, I think that person will also clear his mind and be less hazy.”- Maria, ME02
“Even though you do your best, you are also busy next to your diabetes. You are a father or mother, you have hobbies and work. You cannot be your pancreas and be a proud father at the same time. If you want to do it right, you have to be yourself and your pancreas 24/7, but then you are no longer human in my opinion. That's too bad. People try their best to be both, but that is very difficult.”- Marcel, PRE03
“There are parents who check a few times a night whether their child’s glucose level is all right. That is very drastic and very stressful I can imagine”.- Amelia, ME01
Burden release by AP
After mapping the psychological burden of disease is for T1D patients, the possible release of the burden was described by the interviewees. By using an AP, patients experienced more freedom in their eating and moving behavior. Next to that, patients were able to practice hobbies and sports again without having to think about their diabetes. One of the patient experts explained when he realized that the burden he faced every holiday was completely released by the use of an AP. This so-called ―time
off diabetes‖ will definitely increase the perceived QoL. Furthermore, the chronic fatigue patients experienced before using the AP declined by using an AP. This ultimately results in an increased QoL for T1D patients, explained in terms of experiencing more calmness and being less hazy. As the following quotes explain:
―By using an AP I’m free in my movement and eating behavior. It doesn’t matter if I forget to eat or
inject insulin; it doesn’t matter because the AP does that automatically.”- Robert, PE01
―The biggest burden release is that you never have to count or even think about carbohydrates
anymore, as I understand the AP does this automatically, which results in creating an eating pattern that is comparable to a non-diabetic person.”- Whitney, ME03
“If I am practicing a hobby, and I am completely in something, then I used to have a hypo after 1.5 hours, and I was completely out of it. I got a headache and all the hassle. Now I can just pursue a hobby from 9:00 am to 2:00 pm without having to think about anything. Next to that, I ran 10km yesterday without having to think about anything. This was impossible before using the AP.”- Robert, PE01
―An expression that I often hear from test patients is: I'm on vacation from my diabetes. That in itself
is a fairly representative expression. Vacation radiates calmness and time in my experience” – Marcel, PRE03
―Chronic fatigue is something I experienced before using the AP. After 2/3 weeks I already felt much
fitter, I’ve lost the haze which was always on my mind. I can think more clearly now. I see this as an improved quality of life.”- Jay, PE02
PROMs and PREMs
Quality of Life is the general well-being of an individual, outlining negative and positive features of life. It consists of the expectations of an individual for a good life. PROMs and PREMs can be used to indicate to what extent the QoL of a patient is affected. By interviewing medical experts, it came to light that there is no general consistent use of PROM and PREM. In different hospitals, they use different measures, which indicate that the QoL of a T1D patient never gets mapped out properly. Next to using different measures, patient experts noticed how T1D is woven into their daily life, after being diagnosed for a longer period. This implies that it is hard for patients to give a true QoL rating
regarding their treatment because they simply don‘t know the difference in QoL compared to people without T1D.
―In hospital X, we use a click system. You will receive questionnaires by the computer that you have to
fill in before the clinic visit. Also for parents, we did this once a year with the quality of life scales. They want to implement another QoL measure right now, I know they are working on that, but it’s still under development”.-Whitney, ME03
―During the annual check-up for T1D patients, we use the PhQ9 survey. This is for patients from 18 to
30 years old, and all about well-being. Next to that we use the BITE questionnaire, which focuses more on depression”.- Maria, ME02
“Diabetes is woven into your daily life, and at some point you have accepted it. Especially for patients who got diagnosed at a young age, they don’t have reliable measurements on how their QoL was before the diagnosis.”- Robert, PE01
The product experts highlighted how they make use of PROMs and PREMs after the test studies were complete with the AP. Simply by sending patients questionnaires. In the new test study, the product experts make use of 24/7 monitoring, which implies that the AP is sending all the data directly to a server. Next to that, a survey is sent to patients in the test study every 2 to 3 months. An example of these two outcome measures sketches how patients from the test studies experience change regarding their QoL.
“In the new test studies we monitor patients 24/7. We also make use of surveys which we send every 2 to 3 months. In this way we try to measure the quality of life of a patient and his/her experiences with our AP system.”- Marcel, PRE03
―Patients did not immediately experience the difference between their previous treatment and life with
an AP. Until the patients didn’t have the AP anymore and returned to their previous treatment. Then they suddenly saw a lot of differences in quality of life and start missing the AP. “-Robert, PE01
Theme 4: Value-based healthcare costs
Patient value in VBHC is calculated by outcomes/costs (Porter, 2008). The following section is used to describe how innovative treatment methods such as the AP can contribute to value-based healthcare focusing on constantly measuring costs and outcomes for patients. First, the costs of an AP are compared to current treatment methods in the form of a Health Technology Assessment (HTA). Moreover, an insight is given in how innovative treatment methods such as the AP can play a role in a value-based healthcare system by offering high-quality care in such a way that diabetes complications can be prevented as much as possible. This ultimately leads to cost-saving for the healthcare sector as a whole, as long-term complication costs are the main cost drivers in diabetes care.
AP costs compared to SAP
Now we know the improvement in outcomes for patients, it is important to give an overview of the costs related to the AP. An estimation of the costs and health outcomes for T1D patients over a lifetime horizon can be made based on the HTA of Appendix D. The SAP treatment is compared with the AP treatment, which reduces the number of hypoglycemic events and lowers the level of HbA1c. First, the costs for SAP treatment are calculated. This results in costs of €203,911 per patient over a lifetime horizon. Included in these costs are yearly healthcare costs of diabetes, treatment costs, hypoglycemic events and complications. For hypoglycemic events and complications, also societal costs were included. For an overview of the specific treatment and societal costs see Appendix D. The number of QALY‘s in the SAP strategy was 15.9. Next, we assessed the difference in costs and QALYs when using the AP compared to SAP. Based on the price differences between SAP and AP treatment, the extra costs over lifetime of using the AP instead of SAP are €25.567. The AP is assumed to reduce the baseline number of glycemic events by 70%. This result in saving €9,795 on healthcare and societal costs and a gain of 0.945 QALYs compared to SAP treatment. Additionally, the AP accomplishes a level of HbA1c of 6.5% while SAP treatment reaches a level of 7.5%. This results in a saving of €12,627 healthcare and societal costs and a gain of 0,469 QALYs. Combining these differences in costs and effects, the AP results in a gain of 1.414 QALYs and an extra cost of €3,145 (see table 2). Based on the difference in costs and effects, one can assess the potential cost-effectiveness ratio. This results in costs of €2,223 per QALY, which implies that the intervention is deemed cost-effective from the perspective of health economics.
Table 2. overview of the cost outcomes comparing SAP and AP treatment. Assuming that SAP treatment leads to an HbA1c level of 7.5% and reduces the number of hypoglycemic events with 70%. Assumed for the AP is HbA1c level of 6.5% and reduced number of hypoglycemic events with 90%.
What was noticed from the product experts was how innovations in healthcare are generally more expensive than the current treatment methods. This applies to the AP as well, as initial costs are higher than for example the costs of a SAP. These differences in costs can be explained due to the manufacturing costs of the AP (€8487) compared to SAP (€3671) and the double amount of disposables (infusion sets, sensors, insulin, and glucagon) that is needed for the AP. Despite the initial costs of the AP being higher than SAP treatment, the outcomes shown in QALYs is outweighing the cost as seen in Appendix D. Next to that, product experts in the development of the AP showed how the costs of the device housing can be cut by up scaling the production. As the housing of an AP is still being milled at the moment which costs approximately €400, injection molding would result in lower costs per unit around €0.43 if produced in batches of 10.000. As quotes from product experts underline:
―Unfortunately, it is almost always the case that new innovations in the market are more expensive
than what is already there. It is rarely the case that you have an innovation that is also a lot cheaper, especially in healthcare”.- Alex, PRE01
―In the case of the AP, the initial costs of a year AP treatment are more expensive compared to the
standard of care. You can also imagine that, because it contains twice the number of disposables and we use glucagon.” – Alex, PRE01
“A bare AP housing is milled at the moment, this costs approximately €400. If we upscale to 10.000 pieces, we can use injection molding for the housing, which cut costs to €0.43 per case, a huge difference”.- Ben, PE02
AP and long-term complications cost saving
All people with T1D are at high risk for severe long-term complications such as cardiovascular disease, kidney disease, blindness, and amputation. These complications do not only have a huge impact on the patient, but it also has a big impact on the healthcare system, as they account for a large portion of diabetes expenditures. The conducted interviews with product experts gave insight in how the AP can contribute to a healthier society, resulting in reduced overall healthcare spending. By using the AP, less money is spent helping people manage their T1D. This results not only in less costly hospitalizations and medical emergencies but also in less spending on long-term complications such as blindness or cardiovascular disease.
Product experts underlined how the application of the AP can help endocrinologists to better regulate their patients, due to the possibility of the AP to collect more accurate measurements of patient data. By collecting more accurate patient data, endocrinologists can fine-tune the treatment goals regarding clinical outcomes for patients. Patient experts state that the use of an AP will normalize clinical outcomes such as HbA1c, and therefore long-term complications related to a too high HbA1c (such as deteriorated vision) will be overcome. This simply implies that costs associated with these long-term complications burdening the healthcare system also vanished. As underlined with the following quotes:
“Costs associated with T1D are often the costs of complications at later age. These can be remedied by being properly in control of your diabetes. That may be a bit more expensive now, but save costs on the long-term”- Whitney, ME03
―Long-term complications are really associated with the level of HbA1c. Due to the use of an AP,
HbA1c could be normalized, which is just compatible with people who don’t have diabetes. So you do not expect any complication with that anymore, which means you don’t expect any more costs”- Maria, ME02
―I had an approximate correction of -1.75 on both my eyes. My left eye had only 25% vision. After 2
years of using the AP my left eye vision increased to 65% and I only have -0.5 corrections on both eyes. This perfectly explains how the AP normalizes HbA1c and long-term complications and its costs”.- Robert, PE01
―You can see it this way, at the moment patients have to go to internists and diabetes nurses a lot.
Advice on how to control your disease is given on limited data that is available. The AP actually measures everything on a patient 24/7. We measure blood glucose twice every 1.2 seconds. We bring all this data together in the portal, and give this back to the patient and physicians. Based on this, the
treatment can be way better regulated or adjusted, resulting in the patient becoming the central position of the whole care process.”- Ben, PRE02
Discussion
The central question of this research is: ―How can a disruptive innovation create value for patients in the diabetic industry?‖ To answer this research question, theory on disruptive innovations and VBHC was conducted as well as clinical outcome measures and QoL aspects. Thereafter, interviews have been conducted with patient-, product-, and medical experts. In the next section, the main findings will be discussed, following the structure of figure 2 where the supporting elements of patient value are discussed based on the 4 themes from the semi-structured interviews. Furthermore, the theoretical and managerial implications are given. Afterwards, the limitations and avenues for further research are addressed.
Figure 2. Research model displaying the supporting elements of patient value for T1D patients
Main findings
The results of this study indicate that patient value is supported by different elements. According to Porter and Lee, (2013), value in value-based healthcare is measured in terms of outcomes and costs. The interviews give an insight that 2 important outcome measures matter to the patient, namely; clinical outcome measures and the outcome measures on perceived QoL. The findings are based on the introduction of the AP, which can be seen as disruptive by its possibility to create a new market for T1D patients with better care for lower costs to eventually disrupt the current diabetic device market.
Figure 2 illustrates how a medical disruptive innovation indirectly influences patient value through improving clinical outcomes, QoL and costs from a VBHC perspective. Ultimately, patient value is derived from clinical outcomes and QoL outcomes divided by the costs.
Medical disruptive innovations
The results indicate that certain medical innovations such as the AP in the diabetic industry can be seen as disruptive. The AP seen as disruptive innovation has a positive influence on Quality of Life and clinical outcomes according to the respondents. However, costs on the short-term increase as well. This indicates how patient value is influenced through the AP as innovative treatment method, as the increase in Quality of Life and Clinical outcomes outweigh the cost increase. Next to that, research showed that the AP has the possibility to disrupt the SAP market, through its closed-loop bi-hormonal product differentiation. This creates an opportunity to compete with larger companies active in the diabetic industry, and possibly disrupt this market. This is in line with previous literature from Klein (2009), who stated that a safe and effective AP will revolutionize the management of diabetes when released to the general public. Furthermore, medical experts noticed that the currently available treatment methods such as CGM and SAP are helpful innovative devices that better regulates T1D patients overall.
However, there are still pitfalls regarding these treatment options, as the control of the disease is still in hands of the patient, which means human interaction is needed to regulate your disease. While product experts state that with the development of the AP, this human interaction decreases through the self-management functions of the closed-loop AP system in terms of automatically insulin or glucagon infusion. This links with previous research from the European Commission (2016), which assumes that disruptive innovations provide new and different perspectives that tend to reduce complexity in favor of the empowerment of the patient. However, the disruptiveness of the AP as innovation could be questioned, as the AP is not yet available to the general consumer market. At the moment, only 6 hospitals in the Netherlands are affiliated with the use of the AP. Finally, when the AP is included in the basic insurance and is made available through all healthcare providers, it can certainly disrupt the current market.
Clinical Outcomes
This study shows that patient value is derived partially from clinical outcome measures such as time in range, glycemic control, and HbA1c. From the interviewed medical and product experts came to light how HbA1c is the most often used outcome measure. This is in line with previous literature from Bode et al. (2005), who already explained that HbA1c is the most common outcome
measure for T1D patients to evaluate the efficacy of diabetes treatment and technologies. Furthermore, Maahs et al. (2016) indicated that HbA1c does not capture short-term variations in blood glucose or exposure to hypoglycemia and hyperglycemia, so Hba1c on its own has limitations. The Medical experts in this study stated that time in range and glycemic control are important indicators to capture short-term variations in blood glucose or exposure to hypo- and hyperglycemia. Furthermore, an improved time in range and better glycemic control ultimately result in an improved HbA1c, which is decreasing not only the chance of developing long-term complications such as serious eye and foot problems but also short-term complications in the form of acute hospitalization.
That improvements in clinical outcome measures such as time in range, glycemic control, and HbA1c can be achieved by using the AP compared to a SAP, is explained by patient- and medical experts. Where time in range using the current most high-end treatment type, namely a SAP achieved only 54% time in range, the AP achieved significantly reaches a higher time in range up to 93%.In combination with better glycemic control, due to the normalization of metabolism by the use of an AP, improvements in HbA1c (from 8.0 to 7.0) followed already after 3 months. This indicates that the AP has a positive influence on all clinical outcome measures compared to the current treatment methods.
Quality of Life (QoL)
This qualitative research shows that Quality of Life is an important outcome measure next to clinical outcome measures such as HbA1c. Furthermore, this study shows that chronic diseases such as T1D impact patient‘s physical, social and mental well-being, which can finally be translated into perceived Quality of Life. Patient and medical experts discussed that the burden faced by T1D patients is mostly described as psychological burdens, such as; disturbed sleep, having to think about your eating behavior and not being able to practice sports. This is in line with previous research from The American Diabetes Association (2018), explaining how the management of T1D is complex and people living with T1D need to make numerous daily choices related to their medical treatment.
Furthermore, previous research from Alfian et al. (2016), indicated that improvements in QoL have already been seen by adopting new diabetes treatment technologies such as SAP‘s in the categories: Energy and mobility, diabetes control, anxiety and worry, social burden, and sexual functioning. Patient experts provided insights in how these categories could be expanded in terms of having more ―time off diabetes‖ and experiencing more calmness and being less hazy, due to the use of an AP. Moreover, findings indicate that QoL is hard to measure for T1D patients, especially when the patient is diagnosed at an early stage in life, indicating that T1D is woven into their daily life for several years already. Previous research from Snyder et al. (2012), suggested that PROMs and PREMs
