The Science of Diabetes Self-Management and Care2023, Vol. 49(1) 46 –54© The Author(s) 2022Article reuse guidelines:sagepub.com/journals-permissionsDOI: 10.1177/26350106221144957journals.sagepub.com/home/tde
Abstract
Purpose: The purpose of the study was to explore the perspectives and experiences of adults with type 1 diabetes (T1DM) who are currently using the closed-loop insulin delivery system (CLIDS).
Methods: Eleven adults with T1DM who used closed-loop insulin pumps for at least 6 months participated in this qualitative descriptive study.
Results: Four themes emerged from the rich descriptions: (1) striving for improvement, (2) missing a magic wand effect, (3) seeking support, and (4) barriers to adaptation. These themes represent both process-based and psychosocial implications for nursing practice and patient education.
Conclusions: To optimize CLIDS use and outcome, the antecedent conditions that contribute to patients’ decision to adopt it must be understood. Then, interventions that focus on setting realistic expectations must be created. Patients need support as they incorporate CLIDS into their T1DM self-management. Training health care providers on the idiosyncrasies of adapting to CLIDS is critical. Patients must learn to relinquish control and trust the machine and manage the anxiety the system’s intrusive alarms cause them so they can be better supported cognitively and psychosocially.
Type 1 diabetes (TIDM) places considerable physical and psychological stress on individuals as they aim to achieve normoglycemia.1 Many T1DM technological advancements have emerged, most notably the closed-loop insulin delivery system (CLIDS),2 which mitigates the daily tasks and constant decision-making demands of T1DM.1 With great promise, this technology has been adopted by adults with T1DM; however, health care providers (HCPs) have not been attentive to the stress of adjusting to it.1,3 Understanding patients’ experiences from the decision to adopt CLIDS through the process of adapting to it must be expanded. Developing comprehensive cognitive and psychosocial interventions to support patients depends on it.
The CLIDS automates diabetes management for which previous insulin pump models required human input. CLIDS uses data from continuous glucose management systems and continuous subcutaneous insulin infusion to create an algorithm specific to the user.4 The algorithm uses insulin delivery and blood glucose data automatically to achieve blood glucose targets of either 120 mg/dL or 150 mg/dL.3 The first CLIDS, Medtronic 670 g, was approved by the Food and Drug Administration in June 2017 and came to market soon thereafter.3 A pivotal trial demonstrated its safety, feasibility, and effectiveness and acknowledged its ability to improve time in target blood glucose range, to decrease episodes of hypoglycemia, and to improve A1C.3 Despite these positive outcomes, meaningful information is missing from the literature about which patient characteristics promote adaptation or who should use a CLIDS.4 Furthermore, no data exist that explains the patient experience from motivation through adaptation to CLIDS and/or reaching self-management mastery. The purpose of this qualitative descriptive study was to describe the self-management experiences of adults using CLIDS. Specific aims were to (1) identify the antecedent conditions leading adults to choose the technology, (2) describe the progression of self-management learning that led to adopting new technology including facilitators and barriers, and (3) identify educational and support interventions.
A qualitative descriptive approach was employed to describe the self-management experiences of adults with T1DM who were learning to adjust to a CLIDS.5
Participants were included if they (1) had been using a CLIDS for 6 to 36 months, (2) were age 18 to 55, (3) spoke English, and (4) had a device with Internet access to the Zoom platform used for data collection. Responding to the call for participants were 25 people; 12 met the inclusion criteria, and 11 completed the informed consent and interview. Of the 11 participants, 4 were male, and 7 were female; 9 were White, 1 was Asian, and 1 defined their race as Hispanic. Their mean age was 41, and average time using CLIDS was 20.4 months (see Table 1).
All procedures were reviewed and approved by the study site’s Institutional Review Board. Purposive sampling was used to recruit participants from May 15 to August 5, 2020, from an online social media platform where patients with T1DM communicate with peers across the world about daily life with T1DM (N = approximately 3000 members). Permission to recruit was obtained from the Facebook group administrator, and an invitation to participate was posted. Interviews were conducted via Zoom. Each interview was audio-recorded, and transcripts were professionally transcribed verbatim.
Interviews lasted 45 to 72 minutes; open-ended questions were asked per a semistructured interview guide (see Table 2), undergirded by the theory of self-management mastery.6 Field notes were kept during the interviews. Participants received a $25 gift card as a thank you. Once information redundancy was reached, the interviews ceased. Member checks were conducted with all participants, with no changes recommended.
The interview transcripts were reviewed and cross-checked with recordings and field notes. Coding was done manually. Initial coding was undergirded by concepts of the theory of diabetes self-management mastery.6 This theory acknowledges that to manage stress and integrate diabetes into daily life, behavioral modifications are required. This process can be understood through the lens of the theory’s 2 components: the theory of mastery and the organismic integration theory.6-8 The researcher/author reviewed all transcripts, identified codes, reviewed notes and findings, refined the codes, reviewed again, and allowed the themes to emerge from the coded data. Trustworthiness principles are described in Table 3.
Participants described a journey in chronological sequence, representing evolution of self-management mastery. They offered rich descriptions of learning to live with CLIDS and incorporating it into their T1DM management. First expressed was the goal for self-improvement, including improved disease burden and glycemic control. Then, once they began using CLIDS, participants identified a need for support. They described a realization that their disease did not magically resolve with the adoption of CLIDS. Finally, they identified barriers to adjusting to CLIDS. These findings are represented by 4 themes: (1) striving for improvement, (2) missing a magic wand, (3) seeking support, and (4) barriers to adaptation. Ultimately, as one participant said, they all persevered despite their challenges: “Because I have seen such great results from it, I am not going to give up on it. And it really works for me. The system works for me. I like how it works.â€
All participants described a belief that CLIDS would improve their life with T1DM. They acknowledged that room for improvement existed within their current T1DM self-management. Glycemic control was central to the decision to adopt novel technology. Five participants explained that improvement implied preventing complications: “I had pretty much decided that I thought it was going to add 20 years to my life.â€
For adults with T1DM, the balance between glycemic control and disease burden is a constant struggle.5,6,9,10 Participants described the need to find ways to improve glycemic control without increasing their disease burden. They identified a goal of a lower A1C with less stress in their daily lives. For all participants, this implied an improved A1C, even if their current control was acceptable: “I just wanted to try and get below 7 on my A1C. You know, high 6s I would be totally cool with.†Four participants cited a goal to decrease episodes of hypoglycemia and the stress it brings to their family as a motivation to switch to CLIDS. The automaticity of CLIDS was identified as a motivation, particularly in the setting of decreased disease burden. Ten participants mentioned specific ways they anticipated their daily lives to become more manageable with CLIDS (eg, how CLIDS meant fewer insulin injections and less frequent finger pokes). One participant identified repeated hospital admissions for ketoacidosis as a burden and perceived CLIDS as able to improve this. Once the participants moved beyond the decision to adopt CLIDS, they faced the need to adapt to the new tool, which was an evolution for all. Experiences varied, but some very clear adaptation themes emerged: missing a magic wand, seeking support, and barriers to adaptation.
This relates to expectations of a miraculous T1DM resolution as they adapted to CLIDS. Participants described being informed about the positive aspects of CLIDS use but not the struggles they might face.
They [HCPs and CLIDS manufacturers] claim it’s an artificial pancreas, but I wouldn’t go that far. . . . It’s just a closed-loop system, but the sensors are still a pain in the butt. . . . People get frustrated with getting up at 2:30 in the morning.
Although most participants described satisfaction with the CLIDS device, they also identified that the product was not a cure for the disease, not a pancreas transplant, and not a replacement for blood sugar testing; rather, it was a mere tool for disease management. One participant wished they had been advised to “temper their expectations.†Another revealed this:
I thought that it would do a lot more without me interfering. So I was surprised by how often it would alert me, or tell me Enter your blood sugar! Oh? Calibrate again!? I thought this was supposed to be all on its own and I don’t have to do anything.
Participants realized they were still responsible for their own T1DM self-management despite the novel technology. In fact, the device’s intrusive demands to take action to manage a glycemic event often made them feel more accountable. Because of the challenges during this adaptation phase, participants described needing support, and in most cases, they struggled to access formal health care support. Thus, the next theme that emerged was the need to seek support.
Overwhelmingly, participants described needing support during the adaptation process. Most identified a lack of sufficient training and preparation and said they were significantly missing support of their HCP during their adaptation. Thus, they sought support via social media.
Participants identified that they were missing HCP support specifically related to the HCPs’ lack of understanding of the equipment. All participants verbalized dissatisfaction with the support the HCP offered: “So, I was basically left to learn how to use the 670 g on my own†and “I was kind of doing it on my own, and my nurse was kind of in the sidelines.†Another participant highlighted these feelings of loneliness and self-reliance:
You think you’re getting what they say in these long trainings, and then you go home, and you’ve got this thing! It’s almost like . . . bringing home a puppy, like, oh [expletive!], now what do I do with it? You know it beeps, like a dog whines.
Most felt they were “on their own†when they left the HCP’s office on Day 1 of using CLIDS. Participants described reaching out to strangers on social media and Medtronic’s customer service rather than to their own HCP. One participant tried to defend their HCP:
It’s kind of tough for the endocrinologist because there’s so many different pumps and different things that everyone has. They can get the gist of each one, but it’s not like wearing it 24/7 where you find little kinks and everything.
All participants used social media during their CLIDS adaptation. They unequivocally relied on the support of social media, namely, a Facebook group started specifically for the Medtronic 670 g, rather than calling their HCP. Most participants recognized the benefit of a medical provider, but they identified a need for a real-life experience rather than a “textbook answer.â€
The social media use extended beyond participants feeling their HCP was ill equipped to manage the day-to-day CLIDS struggles. Most identified convenience as the reason:
And then sometimes, if it’s 2:00 in the morning and I’m having an issue, I don’t want to bother her [diabetes educator] because it’s not right. I’ll get on the support group and there’s always somebody who’s up and willing to answer.
Participants verbalized that they were very satisfied with social media advice as a means of adapting to their CLIDS. Some also appreciated the anonymity of social media. One used the word “faceless†as a means of describing anonymity and mentioned, “I would rather be faceless and go on Facebook†than call their HCP.
Although social media offered functional, technical assistance, it also filled an unmet need for emotional support:
I know these groups, they’re not doctors, I understand that, but when somebody’s sharing the same experience as you, you’re like, Oooooh I’m not crazy!
Participants clearly identified their struggles adapting to CLIDS, their unmet needs, and the emotions involved. Themes pertaining to the many barriers to adaptation emerged. Richly described were the intrusiveness due to the frequency of alarms, the anxiety caused by the unknown functionality of CLIDS, the balance of trusting CLIDS while maintaining control of their disease management, experimenting and figuring out workarounds, and the slow movement toward realizing less of a struggle.
Much like the balancing act of glycemic control and disease burden, a similar struggle was uncovered pertaining to living with the frequent alarms. CLIDS uses alarms to notify the wearer of hyper- or hypoglycemia and to alert the wearer that user input is needed to continue to achieve automaticity. For some, these alarms enhanced the user’s ability to self-manage their disease, yet simultaneously, most described the alarms as intrusive:
I have a disease that’s going to kill me. I’m lucky, I’ve lived with it for 36 years. But the anxiety of knowing anything can go wrong . . . the alarms are there for a purpose and they’re doing their thing, but it is a constant reminder of this nasty disease.
Every participant cited the alarms as a barrier to integrating CLIDS into their daily life. Four had been warned about these alarms during the preadoption phase, yet they had not realized how frequent they would be or how much they would interfere with their daily life—especially sleep:
There were times when I had to call in to Medtronic and go “Okay, what is this alarm and how do I shut it off?†because the alarms are obnoxious.
Along with distress over the alarms, most participants described feelings of anxiety, sadness, and depression during adaptation:
My husband says this is the most he’s ever seen me cry about this disease. And I am, like, this is the worst experience I’ve ever had with this disease—being on this CGM [continuous glucose monitor] with this pump.
Participants verbalized that they were required to learn or relearn disease management and then trust these new management strategies. Trusting is required for adaptation. Alarms and finicky sensors contributed to the process of trusting and adjusting. Participants spoke about their experience of adjustment in terms of their general feelings and in context of the theme of trust:
Occasionally, I get frustrated, and I complain, but it’s a lot. Diabetes is a ton, and for people learning or switching to this pump, it adds even more stress until, you know, they get the hang of it. There’s a learning curve to it.
The journey participants endured to gain trust in the CLIDS was discussed explicitly. They recounted checking and double-checking the CGM via testing the blood sugar and comparing it to the automatic readouts on the CLIDS:
I don’t trust 100% of the readings from my Medtronic CGM. And I have reason not to, because I’ve tested my sugar manually when I don’t think the reading is correct. And sometimes it’s not even close.
The automatic nature of the CLIDS is not accurate until the system has created an individual algorithm for the user, which takes from several days to a week.11 One participant said, “I had to learn it, and it had to learn me, and now it is just a part of me.â€
Nine of the 11 participants described the struggle of being a person with T1DM managing their own disease with their own understanding of the disease’s idiosyncrasies to suddenly handing that trust over to a machine. One participant said this:
Now I’m trusting a machine to handle my diabetes. It definitely was nerve-wracking . . . I was just, like, Okay, okay, I’m trusting this machine.
Participants described finding harmony between control and trust as something that arrived with time, but none were able to articulate a process for this or identify a particular time frame for their complete adaptation. They reported that the sense of trust came once they were able to predict that the pump would keep them safe. This process took time and was anxiety-provoking for most. Notions of feeling overwhelmed, lacking support, giving up control, and the associated vulnerability contributed to the anxiety.
A lot of experimentation contributed to the process of relinquishing control and attaining a sense of trust in the CLIDS. This experimentation was comprised of trial and error and workarounds. Participants described it as a means to determine how glycemic control could be maximized while using CLIDS. One reported spending time experimenting with how they could get their blood sugar to be perfectly stable using CLIDS. Another reported the realization that although CLIDS is not an actual pancreas, it functions more like one than previous T1DM management tools. Although some participants realized increased improvement in glycemic control, others realized the constraints of the CLIDS and the need to experiment with workarounds to close the gap between the automaticity of the pump and their own expertise.
These workarounds, overrides, and experimentations represented an evolving adaptation process. Although adapting to CLIDS represented a struggle for most participants, once they moved toward adaptation, they cited more food flexibility, that is, they were able to make more spontaneous changes to their diet. Although the CLIDS is not perfect and creates a certain degree of burden and distress, in the end, it is associated with less struggle. One participant summed up this notion:
Because I have seen such great results from it, I am really not gonna give up on it. And it really works for me. The system works for me. I like how it works.
As participants settled into the adaptation phase of their life with technology, they described features of adaptation, including managing their unmet expectations, unmet needs, and the support they found in unexpected places along the way. Ultimately, they realized that CLIDS was not a cure for their chronic disease. Constant vigilance and attention to diabetes management continue to be required. This reality sometimes led to emotional distress and disappointment, but the resiliency of these participants was revealed, and the intention to continue their process of adaptation was evident. The emotional and physical learning curve was detailed during this evolution to adaptation:
It’s definitely a love/hate relationship. Because I did want to quit. I wanted to throw in the towel. And I went sensor-less for 3 weeks. And I thought it’s just not worth the headache. But, you know, when it works as it’s supposed to, it works so good.
This study illustrates important information that must be incorporated into patient care and help serve as groundwork for the creation of interventions supporting this patient population. Understanding the antecedent conditions that contribute to patients’ decision to adopt CLIDS is vital. Setting realistic expectations during the adoption process and arranging formal and informal support for patients as they incorporate CLIDS into their T1DM selfmanagement are necessary steps, especially as CLIDS becomes more widely used. Training HCPs on the idiosyncrasies involved with adapting to CLIDS is critical. Lastly, better grasp of the process of relinquishing control and learning to trust the machine and understanding the role of anxiety caused by the intrusiveness of alarms is needed so that patients can be better supported from a cognitive and psychosocial perspective.
Gaining insight into individual patient goals may help to initiate a conversation regarding realistic expectations before adopting CLIDS. This may serve to counterbalance the magic wand effect and help keep the patient’s decision to adopt technology their own rather than an idealistic magical illusion of what CLIDS may be.
Control is a tenet of self-management.6,12-14 This sense of control juxtaposes the sense of turning over trust to a machine that is required of CLIDS users. Although some evidence exists of the concepts of trust and control related to novel diabetes technology, the experience of learning to trust a machine is not described. Adults with T1DM who have not used technology to manage their disease in the past were less trusting and more skeptical of the automaticity of CLIDS technology.2,15
The participants in this current study reported being trained on the machine, or the technology that they would be adopting. They reported attending technology training before they were approved to adopt the technology. It was not exclusively the functionality of the pump itself that patients expressed concern about once they went home, but rather the psychological distress caused by adjusting to the idiosyncrasies of the CLIDS. Further research should surround the efficacy of psychosocial training (ie, training sessions that prepare the user for the shift in disease burden at the expense of treatment burden, the stressors of frequent alarms, and the potential isolation that one might feel as they are seeking support). This may assist in establishing realistic expectations and teaching strategies for resilience during this time. CLIDS holds great promise for improving lives of patients with T1DM in both the short and the long term. Generating new knowledge around holistic support interventions is vital to CLIDS longevity.
Psychosocial training interventions may also provide ongoing patient support. Per the seeking support theme, patients require ongoing support during adaptation. If small psychosocial training interventions were held frequently during the adaptation process, patients’ needs may be better met. This type of intervention might be especially helpful in mitigating risk-taking behaviors by avoiding the development of workarounds and utilization of social media for medical advice. Informal groups led by a HCP could help close the gap between a formal medical provider visit and social media support by offering interventions in a virtual, interactive, nonthreatening environmental of peers. Of course, research on this approach is needed.
Future studies should be aimed at understanding the process of relinquishing control and gaining trust, which constitutes a separate and unique adaptation process; interventional studies that seek to understand both positive and negative experiences as one adopts and adapts to new technology are also needed. Understanding how to better assist adults with T1DM as they work through the delicate dance that is the continuum of trust and control in a structured manner may help direct this process. Ensuring, for example, that the patient is exposed to experiences where they can trust the machine in a controlled setting may prevent erosion of trust. Focused attention on such situations may yield improved confidence and ease frustration.
The fact that participants were recruited via a Facebook group for adults with T1DM who were using Medtronic 670G poses a limitation. Participants who use Facebook can be assumed to have a basic comfort level with technology. Therefore, those adults with T1DM who do not use social media may have more technological limitations than were represented in the sample. Also, because of the constant evolution of advancing technology, generalizability may not be possible. Racial diversity is limited in this sample of adults with T1DM. The interview guide and research paradigm did not consider the previous health care technology experiences of CLIDS users or comfort levels with technology that may have impacted adoption and adaptation.
In summary, the 4 themes uncovered in this study represent both experience-based and psychosocial implications for practice and research. Further work is needed to standardize the support that each patient is given during the adoption and adaptation processes while being mindful of the patient’s individual cognitive and psychosocial needs. Additionally, further research should be focused on exploring how HCPs can become more aware of individual patient needs and the unique processes that a patient experiences during their adoption and adaptation phases. This is especially relevant because the role of technology in both T1DM and other chronic diseases is expected to outpace the ability to research individual novel innovations each time one comes to market.
Chrystina Manero https://orcid.org/0000-0001-6746-6890
From Tan Chingfen Graduate School of Nursing, UMass Chan Medical School, Worcester, Massachusetts (Dr Manero).
Corresponding Author:Chrystina Manero, Tan Chingfen Graduate School of Nursing, UMass Chan Medical School, 55 Lake Ave North, Worcester, Massachusetts 01655, USA.Email: Chrystina.Manero@Umassmed.edu
