The process of incorporating insulin pumps into the everyday lives of people with Type 1 diabetes: A critical interpretive synthesis

Abstract Background Insulin pump therapy (IPT) is a technological advancement that has been developed to help people manage Type 1 diabetes (T1D). However, ways of managing diabetes requiring the implementation of health technologies bring new complexities and a need to understand the factors which enable people with T1D to incorporate a novel device. This new comprehension could provide an exemplar for people with long‐term conditions to incorporate new technologies more generally. Objective To determine what influences the incorporation, adaptation and use of IPT into the everyday lives of people living with diabetes. Design Critical interpretive synthesis (CIS) using systematic searches undertaken in 7 electronic databases of literature, published 2008 onwards. Results A total of 4998 titles were identified, 274 abstracts reviewed, 39 full articles retrieved and 22 papers selected for analysis. Three themes emerged which were of relevance to the introduction and use of IPT; Tensions between expectations and experiences in adoption and early adaptation; Negotiation of responsibility and accessing support; Reflexivity, active experimentation and feedback. Conclusions This CIS builds on earlier reviews on lived experiences of IPT. Novel insights are offered through examination of the experiences of pump users from children through to adults, their families and health‐care professionals. Expectations of what the device can do to improve self‐management impacts on the early stages of adoption as the reality of the technology requires substantial thought and action. Areas for intervention to improve IPT incorporation include establishing who is responsible for management tasks of the device and enabling navigation to further means of support and resources.


| INTRODUCTION
Over 4 million people live with diabetes in the UK, and Type 1 diabetes (T1D) accounts for about 10% of that population. 1 Continuous subcutaneous insulin infusion (CSII), insulin pump therapy, is a technological advancement used to support people with T1D manage their diabetes optimally. It is associated with psychosocial benefits (quality of life-QoL) [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16] and improved biomedical outcomes. 2,4,8,10,12,14, Historically, new ways of managing diabetes through implementing new health innovations have brought new complexities and are of particular relevance to CSII, which is more technologically advanced than previous modes of insulin delivery. Understanding the impact of these advance- Optimal self-care practices of people living with T1D constitutes a demanding and multifaceted regimen 42 including monitoring and controlling blood glucose levels, which are subject to extreme fluctuations, and risk of complications (Box 2). [43][44][45] While multiple daily insulin injections (MDI) remain the main delivery method of insulin therapy globally, 46 both MDI and CSII are recommended. 38,47,48 However, the focus of insulin delivery is shifting towards the latter as a method considered more physiologically representative of a fully functioning pancreas. 49,50 CSII has been shown to yield particular benefits over MDI, 16,29,38,51,52 for example, lower cardiovascular mortality, 53 higher treatment satisfaction 54 and improved glucose control. 47 In 2008, the National Institute for Health and Clinical Excellence (NICE) recommended CSII for people with T1D whose glucose levels were not well controlled by MDI. 38 This has been estimated to apply to 15%-20% of adults living with T1D in the UK, 55 compared to 6% currently utilizing CSII. 56 Two reviews of CSII in 2003 and 2009 found that while CSII improves glycaemic control, few studies have robustly assessed psychosocial aspects of using insulin pumps. 22,27 The latter is likely to be pertinent to assess given that CSII requirements are likely to constitute an added burden for people, particularly in the initial stages of adoption. 22 A review by   57 established that studies, which do measure psychosocial aspects of CSII, were characterized by; variable methodology and psychosocial constructs, small sample sizes, a focus on one particular patient group, or were dated (the devices have since become smaller, more accurate and more widespread). While understanding psychosocial outcomes is relevant to assessing the impact of CSII on well-being, 22,27 it is important to explore the factors that may promote or inhibit its adoption and embedding as a self-management strategy for T1D. Thus, exploration of existing evidence is needed to illuminate the processes and outcomes by which CSII becomes part of the management of diabetes.
This review is designed to build on earlier reviews by providing a current and in-depth exploration of user experience, and those integrally involved in or impacting on this experience (i.e parents/caregivers/health-care professionals [HCPs]). The aim is to offer enhanced understanding of mechanisms that shape the incorporation, adaptation and use of CSII into the everyday lives of people living with diabetes, and establish what support and resources are needed to enable this.

| Study design
Critical interpretative synthesis (CIS) was used to identify domains from the literature that are key to successfully incorporating CSII. CIS is an exploratory method of reviewing literature, focused on prioritizing generation of theory in synthesizing findings. CIS allowed us to pragmatically explore the range of data and understand factors which may enable someone to incorporate an insulin pump into their everyday lives. The review had 3 stages: (i) Systematic search, (ii) Critical appraisal and (iii) Synthesis.

| Identifying relevant studies
A search strategy was developed incorporating the 3 main research aims: T1D (population); CSII (intervention); and terms relating to the psychosocial outcomes of the studies searched, using the PICOS

Box 1
Insulin pumps are electronic devices, about the size of a pager, which drip feed rapid-acting insulin via a fine cannula implanted into subcutaneous tissue continually throughout the day (called a basal dose). 47 This device must therefore be worn constantly. The user then selfadministers, as required, extra shots of insulin (called bolus doses) to match their intake of glucose (carbohydrates) throughout the day. These extra doses of insulin can be much more specific (and minute) at delivering insulin than traditional insulin injections. This apparatus also integrates what is called a "bolus calculator/advisor/wizard," which recommend an appropriate (and usually personalised) insulin dose to the user.

| Study selection and appraisal
Inclusion/exclusion (Table 2) and eligibility criteria (Table 3) were established using the PICOS approach. Initially, search criteria did not exclude studies based on publication date; however, early searches indicated that the (most recent) changes to NICE guidelines (2008) 38 considerably widened pump uptake, and consequently technological advancement and research of this device. We therefore restricted our inclusion criteria to studies published 2008 onwards. However, some of the included papers were retrospective, and involved interviewing people who had been using CSII for 5+ years. These papers were included on the basis that they provided useful background and contextual information, and some of the barriers and facilitators to adoption and embedding of CSII remain relevant. Although quantitative evidence was also reviewed, these papers were not included in the final analysis because they did not sufficiently explore lived experiences of CSII.
Duplicate papers were removed before screening (Figure 1).
Titles and abstracts were screened by CR and a second reviewer from the team (split between MB, AR, AK and IV). Disagreements about inclusion were resolved at the title screen stage by third review (IV) and through discussion between CR, AK and AR at the abstract stage. Thirty-nine full-text articles were reviewed by both CR and AR, and one further article was identified through screening the reference lists of the full-text articles. After exclusions, quality appraisal was performed by CR and AR using guidance from Dixon-Woods et al. 101 Included papers were deemed as mostly good quality based on this guidance, except for 2 which were included because of theoretical relevance. 59 The final literature search was run in March 2017.

| Data extraction and synthesis
Key information was extracted from papers using a data extraction form including (i) background information about each paper, (ii) key findings and themes identified by authors, (iii) references how/whether social support was defined/discussed. The data in the review constituted the main themes reported in each of the individual studies. 60 Each paper was analysed in consideration of themes identified, after which the papers were systematically compared. CR reviewed full papers, and review findings were then discussed and refined with AR and IV in an iterative process. Where more than one paper contributed to a single theme, identifying numbers from the studies were noted at the end of each theme. This enabled relationships across the studies to be identified and provided the basis for a broader explanatory framework.

| RESULTS
Twenty-two studies were identified which described the experi-  Table 4.
From the data analysis, 3 themes of relevance emerged: "Tensions between expectations and experiences in adoption and early adaptation; Negotiating responsibility and accessing support from health-care professionals and wider networks; and Reflexivity, active experimentation and feedback".

| Tensions between expectations and experiences in adoption and early adaptation
Polarization between expectations and experiences of users in learning to live with the technology was reported as common in the early stages of adoption. Prominent in the narratives was the device allowing for "increased flexibility" but accompanied by descriptions of on-going disruption in daily activities, and needs for adjustment when initiating this type of insulin therapy. [61][62][63] There were differences in people's initial expectations. Where some saw the pump as a panacea for insulin delivery, others simply saw the device as a tool, which incrementally improved existing efforts at diabetes-related daily management by making subtle but useful adjustments. However, improved self-management and "flexibility" sat in tension with increased expectations to learn new "work"; new skills and adopt new practices associated with a more complex piece of technology. 11 Acquiring new skills relating to use and monitoring of the device was seen as tedious, challenging 11,52,63 and burdensome with respect to the complexity and frequency of some tasks. 63,74 Considering where and how to wear this contraption on the body also illuminated constraints to "flexibility," while a potential dissonance seemed to occur between expectations that insulin management is automatic and simplified with the reality of the new machine requiring substantial thought and action. Feelings of vulnerability were also described when there was an overwhelming need to prepare for potential failures in this new apparatus. 61 In addition to new work, the device also introduced new inflexibilities.
Typical daily experiences of CSII were described in dichotomized terms as representing both a shackle and lifeline. 61 For many, the pump was experienced as constraining because it interfered with day-to-day life, due to the increased visibility necessitating further work to discretely attach this piece of equipment to the body, and/or the status attributed to a permanent appendage to be worn 24/7. 52,61,62,64,65,69,70,74,76 Physical restrictions were also imposed, which were caused by the bulky nature of the tool and its connecting tubes and alarms.
As a woman, I like tight skirts and dresses, I can't wear that anymore. I have to choose clothes based on the pump.
(Female 43 years) 69 Women expressed more concern than men about body image and social acceptance in terms of the visibility and concealment of the pump. 64,69,76 Parents were less concerned about practicalities of wearing the device, and more with the reliance and safety of the technology. 11,52,65,73,75 These disadvantages illuminate discrepancies between expectations and realities of introducing a new health contraption, and a variety of experiences and perspectives on its adoption. Different demands in daily activities, and in user's preferences and priorities, mean that everyday contexts in which the device may be accommodated is variable, and that there are a range of "trade-offs" between the limitations and advantages of CSII.
There were descriptions of persistent aloneness in trying to be "normal," and trying to hide the equipment from others to achieve this.
Many users of CSII expressed feelings of being different from peers, yet wanting to be and feel "normal". 61 76 Living with diabetes was described as a constant struggle, and the process of self-management as isolating and lonely, 70 especially when there was a potential for prying or judgement from others. 62,66,69,70,72,73,[76][77][78] Intimate relations were also discussed with reference to the inevitable awkwardness in explaining the device to a sexual partner, or the contraption getting in the way. 61

| Negotiating responsibility and accessing support from health-care professionals and wider networks
This second theme highlights the ensuing need for emotional and practical assistance, and understanding of who is responsible for the management tasks relating to the pump, during the initial phase of adoption.
How individuals incorporate the device and undertake activities relies, to an extent, on external influences, encompassing a range of social and health-care support-related relationships. Users of CSII articulated how social support provided additional assistance, and how a network of support enabled the work of self-management to be shared out. 62,63,67,71 HCPs also echoed the importance of on-going multifaceted, holistic and tailored expertise in facilitating CSII use. 66,79 However, not all social interactions were viewed as beneficial to self-management.
In the main, facilitation and encouragement from family members and HCPs in adapting to and understanding the mechanisms of the device were considered helpful by those living with this tool. 72,78 Mastering CSII, from the user's point of view, was described as easier when there was trust and assistance from HCPs, which was tailored and holistic. 61 The complexity of the equipment could make users feel vulnerable in terms of needing backing to programme and manage its more advanced features. 61,69 Complex tasks included understanding how insulin is administered, and sharing practical tips for discrete/un-invasive placement on the body (from other users or HCPs). Advocated assistance included provision of psychological support in clinics and play therapy for younger children. Aids to assist with subcutaneous cannula insertion, simplifying the process and easing pain, or testing a saline pump to experience how it feels to be attached to the device before implementation were also advised, 73 as well as more information and interaction to set up the machine. 69,71,79 However, too much information at initiation could be unhelpful. Not seeking or having any on-going support or information about the equipment proved to be detrimental to incorporation. 64,71,79 Assistance and information from others in a non-clinical setting was identified as relevant. Insulin pump users described wanting to learn about the device and find ways to fit it into their lives through learning from peers (i.e people who actually have experience of living with T1D). 70 Interactions with peers offered the prospect of support, shared learnings and practical solutions for day-to-day problems. 11,62,68,70,72 Connecting with others through face-to-face contact or through blogs was considered valuable. 70 Similarly, meeting other families was valued, 73 where parents with some shared responsibility for managing this machine also reported on the initial burden. 11,52,65  The level of responsibility is also seen to vary between age groups, from younger children needing more intensive parental assistance to adults wanting to feel a full sense of control over their diabetes, and incremental changes in desired responsibility in between. 61,62,64,65,67,70,72,77,78 There are also times when the need for support varies (e.g in times of sickness A hindrance to this transfer of responsibility could be parental fear of the ability of the child to self-manage and so the parent may be reluctant to surrender responsibility. Parents were quoted as desiring education and assistance themselves. 65,67

| Reflexivity, active experimentation and feedback
This theme focuses on challenges faced by new pump users, and the process of the integration and normalization of the device. The term "reflexivity" here refers to how experiences that interrupt what is normalized and/or habitual for individuals are encountered and understood consciously (i.e reflexively), and the implications that this has for how people then act and incorporate the new apparatus into their everyday lives.
Normalization of this piece of equipment as a new practice is a process of gradual acceptance and assimilation. Some respondents described how the device felt like a tattoo, an appendage, or an extension of self after the initial period of getting to grips with the new contraption, requiring a journey of reflection, active experimentation and feedback. 62 Adoption was predicted on a demand that the user trust the machine to perform its functions safely. 62,64,75,78 In addition to ad- is not all that is required, as people living with T1D may, for example, feel fatigued. Sharing responsibility for the work of managing the condition can enable better self-management and improved health outcomes through sharing the illness and CSII-related burden associated with the complexity, frequency and relentless nature of some selfmanagement tasks. 98,99 This is where a link to support and resources could prove crucial.

| Implications
These findings identify the types of beliefs that influence the adoption and diffusion of technologies. In terms of CSII, barriers to incorporation for the person with diabetes include the tension between the expectations of the device and the actual experience.
For improved integration, early conversations are needed from HCPs about the likely period of disruption. Potential pump users have not been familiarized with the work that is going to be carried out, and they need time, resources and information to overcome this. HCPs and manufacturers of CSII need to be realistic with potential users so that they can anticipate this work. Frank conversations about the limitations of the apparatus are necessary. People with diabetes need to be given the opportunity to build confidence about using this new appliance, and negotiations between children/ adolescents and their parents must be undertaken. Being prepared for the time required to work the contraption into their lives, as well as sensitivity to the inevitable variability between users could set realistic expectations. Harrison 100 described how perceived assistance from HCPs or peers formed an important aspect of patient satisfaction and should be considered for future interventions. In examining the social network that pump users have access to, and enabling them to tap into further (and on-going) means of support and resources, users of CSII could incorporate the apparatus more successfully.

| Limitations
A number of limitations must be acknowledged with respect to the present review. Firstly, the findings of the synthesis reflect the background and experiences of the reviewers, and as such are subjective.
We acknowledge that the findings could have been different if conducted by a different set of researchers, however, steps have been taken in line with guidance 101 to ensure transparency in reporting on analytic processes which informed our analyses. Secondly, the papers included in the review incorporated a variety of methods, meaning that data quality was variable. The authors were sensitive to the quality of the methodology and did bear this in mind throughout the data analysis, and no concerns were raised with respect to the veracity of reporting or integrity of findings.
Thirdly, while men and women were, roughly, equally represented as participants in the papers reviewed (where these were reported; 44% vs 56%), it appears that men were relatively underrepresented in the quotes given in the papers (15% vs 45%-with the remaining 40% of quotes being non-gender specific). Therefore, quotes offered in this synthesis of papers could potentially offer a pump adoption experience that is skewed towards female users. One possible contributor to this gender imbalance could be that more women expressed fears and concerns relating to body image and social acceptance than male participants.
Fourthly, reporting on demographic composition of study samples was not consistent across the papers reviewed. For example, not all studies disclosed the mean/median age 21,62,[64][65][66]68,76,78,79 or range 64,72,74 of their participants. For those that did, the range was from 5 to 80, and of HCPs, the range of years in practice was 2.5-45. The papers included a range of ages (children, adolescents, young adults, adults) and perspective (users of CSII, parents, HCPs), which offered an array of insights. However, saturation was not reached for any demographic group or perspective. Future studies may therefore look to explore comparatively the experiences of subgroups within the population of CSII adoptees and their families/ significant others.

| CONCLUSION
This review makes several original contributions to the knowledge base relating to experiences of pump users adoption and use; (i) investigation of recent studies not included in previous reviews of CSII device adoption; (ii) synthesis of lived experiences of users of various ages, in greater depth; (iii) synthesis of perspectives from parents and HCPs. To our knowledge, this review also represents the first to explore, qualitatively and pragmatically, the process of incorporating a new technology, worn 24/7, in a long-term condition.