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. Author manuscript; available in PMC: 2020 Jan 1.
Published in final edited form as: Diabetes Metab. 2018 Apr 25;45(1):1–10. doi: 10.1016/j.diabet.2018.04.003

Table 1.

Summary table of potential ethically problematic situations that could arise through AP use.

Domains of ethical issues Issues Ethically problematic situations Recommendations
Confidentiality and safety Information-transmission features The AP’s information-transmission features makes it vulnerable to cybersecurity breaches, such as unauthorized data access or modification, threatening privacy and confidentiality, as well as physical integrity [36,37,31]. Regulatory agencies could require more systematic testing for data interception and modification in the research and development stages [36].
Data access The person with T1D may feel surveilled if he did not personally authorize the healthcare professional and/or his relatives to have access to his data [32,40]. Data sharing should be established in partnership with the patient and with his consent.
Complexity Complex systems have an increased number of vulnerabilities, which amplifies security concerns [45]. Additional features and functionalities should only be added to the AP if their benefits outweigh their risks.
Coverage Coverage decisions Without coverage, the AP’s costs will involve additional out-of-pocket expenditures for people with T1D, which already face tangible socio-economic burdens [48]. AP coverage could be of interest to public and private insurers due to its potential cost-effectiveness (i.e., limiting expenditures by reducing the incidence of T1D complications [51,52]). Further studies are needed to validate cost-effectiveness.
Insurability and care AP coverage could be discontinued through a change in insurability, forcing the patient to resort to a simpler and less effective treatment modality. When acquiring an AP, patients could be sensitized to the risk of discontinued or terminated coverage.
Patient selection Clinical needs Some people with T1D experience poor glycemic control despite rigorous adherence to insulin therapy, which results in a high likelihood of developing long-term complications. AP allocation could prioritize people with T1D with complex clinical needs, so that maximum clinical benefits are attained. People with T2D could benefit from simpler and less costly interventions than the AP [56].
Patient attitudes and traits While positive patient attitudes favour clinical benefits, some patient traits (e.g., age, technological ability) are not predictive of success with T1D management technologies [60]. Patients with positive attitudes and realistic expectations are good AP candidates. The AP should not be allocated simply according to age and technological ability. More studies are needed to establish which traits are predictive of clinical benefits.
Social environment While a patient with good social support and a flexible schedule may be more likely to benefit from AP use, patients without this socio-economic advantage may equally benefit from the AP. Social support and flexibility of schedule should not be used as selection criteria, since it could further enhance inequity in T1D care that already exists for people with lower socio-economic status [6264].
Adherence to therapy and follow-up Eligibility to some insulin pump public coverage programs is determined by specific criteria [65]. Some of these criteria could be used for AP attribution, but others may be irrelevant given the AP’s functionalities (e.g., being able to adjust insulin doses to prevent hypo- and hyperglycemic events). Eligibility criteria for a public coverage program for the AP would favour clinical benefits, safety, and optimal resource use. While these criteria could mirror those of the insulin pump, they should be coherent with the AP’s functionalities and patients’ needs.
Patient coaching and support Realistic expectations With unrealistic expectations on the AP’s capabilities, patients could be deceived by the technology despite positive outcomes. Healthcare professionals could portray the AP as a partner in T1D care by explaining the AP’s capabilities and limits and insisting on the patient’s responsibilities. Providing the patient with a balanced account of the advantages, drawbacks, and capabilities of the AP will also foster realistic expectations [24].
Troubleshooting Healthcare professionals may not have extensive knowledge and time to assist patients in AP troubleshooting, who may feel overwhelmed when starting to use the technology. To empower their patients in their T1D management, healthcare professionals could direct patients to written and online troubleshooting resources. AP companies should deliver technical support to patients.
Experiential knowledge Patients develop experiential knowledge (e.g., personal tricks and habits) to aid them in the management of T1D through trial-and-error [68]. Such manipulations may result in sub-optimal raw glycaemic data. Healthcare professionals may need to interpret raw glycaemic data by acknowledging contextual factors, such as new AP use to allow patients to develop experiential knowledge.
Lifestyle habits Healthy nutrition and physical activity are an essential part of T1D management, but may add to the burden of the illness (i.e., through carbohydrate counting and fear of hypoglycemic events during exercise [5]). An AP that would not require strict carbohydrate counting [19] could help improving diet quality and allow patients to eat and exercise more mindfully. In contrast, patients should not expect the AP to account for high sugar intake through increases in insulin infusions. All upcoming AP versions will require meal notifications.
Personal identity and agency Agency Patients who trust the AP are comfortable with surrendering part of their control of T1D to the technology, gaining agency in their daily lives. Yet, trust in the AP could be limited by unfamiliarity, technical limitations, and patient values and preferences. To ensure that trust toward the AP is built over time, healthcare professionals could be sensitive to values, preferences, and technical abilities in directing patients towards the AP. They could remind patients that the need for sustained oversight will resolve itself over time.
Burden of control Patients often experience frustration when unable to control their T1D despite rigorous self-care [73]. Shared responsibility with the AP alleviates the burden of successful T1D control. Positive feedback provided by the AP when target glycaemic readings are attained may improve patients’ confidence.
Visibility of T1D management or devices T1D is visible punctually (i.e., through self-injections or glucose monitoring) or continuously (i.e. by wearing an insulin pump, a continuous glucose monitoring device or an AP). This visibility may limit adherence, elicit stigmatization, or negatively impact relationships (e.g., professional encounters, intimacy)[1,7577]. Healthcare professionals should acknowledge patient preferences regarding visibility (i.e., punctual or continuous) in directing the patient towards an appropriate treatment modality.
Dependence and vulnerability Patients may become dependent on the AP and forget how to resort to conventional management strategies if a technical problem arises. Healthcare professionals should ensure that patients remain knowledgeable of conventional management strategies (e.g., calculating insulin doses according to blood glucose readings) to avoid jeopardizing their health in the event of a technical failure. The AP could include a feature that suspends insulin infusions in the case of technical issues or hypoglycemic events.