Abstract
Over the past several decades, insulin treatment has changed drastically, not only with the development of further insulin analogs but also with the introduction of novel insulin delivery devices such as pumps and pens. In addition, adjunct devices such as continuous glucose monitors and sensor-augmented pumps have become increasingly used in clinical care, increasing the volume of information available to patients and providers. However, with the development of new devices it has become clear that along with the many benefits of these advances, the use of these devices can also present a burden to people with diabetes. For example, some patients report being overwhelmed by too much data when using continuous glucose monitors. Furthermore, there are concerns regarding the accuracy of some of these new devices, particularly for glucose monitoring. As a result, some patients may choose not to use available devices, despite the recognized benefits. Therefore, it is critical to understand how the various insulin delivery devices available currently and in the future affect patients in terms of their diabetes management and perceived burdens and to understand which patient characteristics may predict a lack of satisfaction with these devices. This critical gap in our knowledge is addressed in an article in this issue of the journal through the development of a questionnaire that allows for a better understanding of the impact of insulin delivery devices on quality of life and diabetes management among both type 1 diabetes and insulin-dependent type 2 diabetes patients. The novelty, as well as limitations, of this new instrument for the assessment of insulin delivery device satisfaction are discussed.
T
The use of SAPs, a step toward an integrated system, has been demonstrated to improve glycemic control as well as quality of life measures. 1 –8 Current work developing closed-loop systems and moving toward an artificial pancreas (AP) promises even more devices will become available. However, with the development of new devices it has become clear that along with the many benefits of these devices, their use can also present a burden to people with diabetes. For example, some patients report being overwhelmed by alarms and sleep interruptions when using CGMs. 9 Others are bothered by the attention that can be attracted to their disease by having a visible pump or other device. A recent report from Tang et al. 9 demonstrated higher treatment satisfaction for adults with type 2 diabetes (T2D) who were treated with standard blood glucose monitoring with an Internet-based system when compared with those using real-time continuous glucose monitoring, with the CGM rated as less convenient and less flexible. Furthermore, there are concerns regarding the accuracy of some of these new devices, particularly for CGMs, 10 –12 which companies are working to improve. 13 In a focus group study of adults with T1D who were current pump users, concerns about using an personalized glucose advisory system included fear of relinquishing control to the system, as well as the personalization of the device algorithm to their individual dietary, activity, and other factors. 14
As a result, some patients may choose not to use available devices, despite the recognized benefits. This may be particularly important when developing systems such as the AP, which has long been viewed as the ultimate goal to make treatment as physiologic as possible and to reduce many of the burdens of managing diabetes. 15 –17 Even in light of these promised benefits, not all insulin-dependent patients with diabetes are good candidates for the AP system due to several patient characteristics and perceived detrimental aspects of using such a system. 14 –19 Currently, groups are working on ideas to assess the ways in which AP systems can improve diabetes management and reduce burdens, while carefully considering the psychological and other factors that will determine the satisfaction with these devices of individual patients. 20
Therefore, it is critical to understand how the various insulin delivery devices available currently and in the future affect patients in terms of their diabetes management and perceived burdens and to understand which patient characteristics may predict a lack of satisfaction with these devices.
A novel report from Polonsky et al. 21 is this issue of Diabetes Technology & Therapeutics addresses this critical gap in our knowledge through the development of a questionnaire that allows for a better understanding of the impact of insulin delivery devices on quality of life and diabetes management among both T1D and insulin-dependent T2D patients.
As noted by Polonsky et al., 21 there are limited other instruments available to assess patient satisfaction with insulin delivery devices. Some of these previous instruments focused on the insulin rather than the delivery method, 22 and others were published several decades ago and likely do not reflect the many changes that have occurred in device features. 23 A more comprehensive scale, the Insulin Delivery System Rating Questionnaire (IDSRQ), 24 has been used in several studies assessing the effects of treatments in T2D. 25 –28 However, this is a 67-item instrument and so is fairly long and may present a burden to complete. Therefore, the development of this novel instrument to assess insulin delivery devices may allow for a comprehensive yet convenient method to quickly make this assessment.
Although the current study adds an important tool in the effort to better understand factors influencing insulin delivery device satisfaction, there are several limitations to the current study that should be recognized. The patients who participated were selected from the Taking Control of Your Diabetes (TCOYD) Research Registry, recruited from among participants in 1-day diabetes education events. As a result, these particular patients are likely to be highly motivated and are perhaps more likely to use new technologies than the larger population of patients with T1D. This is supported by the high rate of pump and pen use in this cohort of adults with diabetes. Furthermore, only adults were included in the current study, and so the resulting instrument may not be generalizable to children and adolescents with either T1D or T2D. The authors developed separate questions for patients with T1D versus T2D, as there were different factors that entered into the model for each group. However, given the significant differences in age, diabetes duration, and pump use between the T1D and T2D groups, it is possible that the differences in factors relating to device satisfaction could be related to treatment and demographic differences, rather than specifically to the type of diabetes. Therefore, more research with this instrument in a sample with a larger age range and sample size may allow for an examination of this question.
Assessing the satisfaction with insulin delivery devices and the factors associated with satisfaction and other metrics such as health-related quality of life (HRQOL) in children and adolescents is more complicated than in adults 29 because the responsibility for care is usually shared between children and their parents or caregivers, and this shared responsibility often transitions during either childhood or adolescence but varies based on family and patient characteristics. 30 –35 Parents of younger children and adolescents and the patients themselves may face different burdens and issues than adults, for example, often reporting more fear of hypoglycemia, 36 concerns about accurate dosing, and desire to avoid pain with insulin delivery 37 than adult patients, and so this may influence their satisfaction with insulin delivery devices. 29,36,38 –41 However, most studies examining the use of newer technologies have demonstrated better glycemic control, HRQOL, and satisfaction with CSII than with multiple daily injections in children and adolescents. 42 –44 In 2014, Cherubini et al. 44 reported on HRQOL as assessed by the IDSRQ in adolescents with T1D and were able to discern differences in HRQOL between CSII and multiple daily injections users. Similarly, Bayrakdar et al. 43 found that adolescents and young adults using CSII had better HRQOL than multiple daily injections users. In contrast, Skogsberg et al. 45 showed improved satisfaction but no corresponding improvement in glycemic control with CSII use in adolescents with T1D.
It is therefore possible that this new instrument will be applicable in children and adolescents with T1D, but it should be tested in these age groups to determine if there are differences in factors influencing device satisfaction between children and adolescents and their caregivers versus adults. In addition, there are increasing numbers of younger patients with T2D. Adolescents and young adults with T2D tend to more rapidly transition to insulin treatment than those patients who develop T2D in middle age. The average age of the T2D sample included in this validation study was 59 ± 11.6 years, and a marked difference in device satisfaction was already observed between younger and older T2D patients included in this analysis. 21 Therefore, it is likely that the factors related to device satisfaction differ substantially between young versus older patients with T2D.
The novelty of this new instrument is that it promises a comprehensive assessment of insulin delivery device satisfaction in both adults with T1D and T2D, allowing for specific factors among each group. However, there are several limitations to this instrument that may limit its applicability to other age groups, in particular, children and adolescents with T1D, as well as young people with T2D. Further studies in these additional age groups and in samples more representative of the population of people with T1D and T2D will be needed to demonstrate the generalizability of this instrument.