Open source automated insulin delivery: addressing the challenge

Oliver, Nick; Reddy, Monika; Marriott, Claire; Walker, Tomas C.; Heinemann, Lutz

doi:10.1038/s41746-019-0202-1

Cited by 23 publications

(26 citation statements)

References 20 publications

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“…Further, it could be claimed that ''real-life'' facts are stronger than those congregated and monitored in a controlled environment [49]. Moreover, the lack of evidence base for clinical-and cost-effectiveness hinders the establishment of supportive policies and funding on the DIYAPS approach [13].…”

Section: Safety Concernsmentioning

confidence: 99%

“…But it explicitly recommended that the users and HCP identify the potential risks associated with the improper and off-label use devices. The loopers and HCPs were cautioned to be aware that the transfer of selfbuild DIY systems or training people on DIYAPS use will subject them to legal liability consequences [13].…”

Section: Regulatory and Ethical Concernsmentioning

confidence: 99%

“…But there is a dearth of high-quality evidence exploring DIYAPS outcomes in a real-world context. As of now, the clinical governance, regulatory, and medicolegal status of DIYAPS are undefined [13]. Most essentially, we should identify the potential risks to users, as well as the ethical viewpoint of healthcare professionals (HCP) on the use of licensed devices in an off-label fashion.…”

Section: Introductionmentioning

confidence: 99%

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The Do-It-Yourself Artificial Pancreas: A Comprehensive Review

Kesavadev

Srinivasan

Saboo³

et al. 2020

Diabetes Ther

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Diabetes technology (DT) has accomplished tremendous progress in the past decades, aiming to convert these technologies as viable treatment options for the benefit of patients with diabetes (PWD). Despite the advances, PWD face multiple challenges with the efficient management of type 1 diabetes. Most of the promising and innovative technological developments are not accessible to a larger proportion of PWD. The slow pace of development and commercialization, overpricing, and lack of peer support are few such factors leading to inequitable access to the innovations in DT. Highly motivated and tech-savvy members of the diabetes community have therefore come up with the #WeAreNotWaiting movement and started developing their own do-it-yourself artificial pancreas systems (DIYAPS) integrating continuous glucose monitoring (CGM), insulin pumps, and smartphone technology to run openly shared algorithms to achieve appreciable glycemic control and quality of life (QoL). These systems use tailor-made interventions to achieve automated insulin delivery (AID) and are not commercialized or regulated. Online social network megatrends such as GitHub, CGM in the Cloud, and Twitter have been providing platforms to share these open source technologies and user experiences. Observational studies, anecdotal evidence, and realworld patient stories revealed significant improvements in time in range (TIR), time in hypoglycemia (TIHypo), HbA1c levels, and QoL after the initiation of DIYAPS. But this unregulated do-it-yourself (DIY) approach is perceived with great circumspection by healthcare professionals (HCP), regulatory bodies, and device manufacturers, making users the ultimate riskbearers. The use of the regularized CGM and insulin pump with unauthorized algorithms makes them off-label and has been a matter of great concern. Besides these, lack of safety data, funding or insurance coverage, ethical, and legal issues are roadblocks to the unanimous acceptance of these systems among patients with type 1 diabetes (T1D). A multi-agency approach is necessary to evaluate the risks, and to delineate the incumbency and liability of Digital Features To view digital features for this article go to

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Section: Safety Concernsmentioning

confidence: 99%

Section: Regulatory and Ethical Concernsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The Do-It-Yourself Artificial Pancreas: A Comprehensive Review

Kesavadev

Srinivasan

Saboo³

et al. 2020

Diabetes Ther

View full text Add to dashboard Cite

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“…Although there are no proper laws against biohacking insulin devices in the United States, the German model serves as an example of the current regulations: "Healthcare professionals must point out the dangers that may arise when using a DIY AID system and should clearly distance themselves from the use of an open system and not encourage patients to use the system." [8] Of course, healthcare professionals are worried about their patients, but they also benefit from higher medications and treatment costs. Healthcare professionals fail to advocate for cheaper alternatives, leaving patients with no one to fight for them.…”

Section: Applications Of Autonomymentioning

confidence: 99%

“…The person who builds and transfers the system is responsible under the Product Liability Act." [8] When biohacking for their children, parents take on additional ethical responsibility that, not being healthcare professionals, they may not be able to uphold. These parents likely never wanted this responsibility, but healthcare conditions forced them to act.…”

Section: Applications Of Autonomymentioning

confidence: 99%

Ethical Implications of Biohacking as Activism: Democratized Health Care, Danger, or What?

Zheng¹

2021

ArestyRURJ

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Biohacking refers to optimizing one’s body through modifying biology. In the 20th century, do-it-yourself (DIY) biology emerged as a type of biohacking involving biotechnology. Current high- healthcare costs promote DIY -biology insulin and EpiPens as ways to challenge norms in healthcare, thus serving as forms of activism. Biohacked insulin is part of the #WeAreNotWaiting movement to support improved treatment of Type 1 diabetes, whereas biohacked EpiPens allow people to make lifesaving autoinjectors at low costs. Social media acts as a catalyst and aids in the spread of insulin and EpiPen biohacking as activism. In 1979, Principles of Biomedical Ethics by Beauchamp and Childress proposed four principles that continue to guide decision-making in clinical medicine: beneficence, nonmaleficence, autonomy, and justice. This paper applies these principles to explore whether the benefits of performing DIY biology outweigh the potential health risks. Examining biohacking with a biomedical ethics frame, as outlined by Beauchamp and Childress, reveals that biohacking acts as a response to current issues but cannot serve as a solution in its current form. However, biohacking can grant patients more power in their relationship with the healthcare system, therefore lessening the dominance of formal institutions. Out of the four principles, autonomy applies most differently when regarding biohacking than traditional medicine. Accordingly, a model of ethics for biohacking, such as of Beauchamp and Childress’ with the autonomy altered to acknowledge the additional implications of biohacking, should be developed in the future.

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