DIY Automated Insulin Delivery Systems Bring Unique Challenges to HCPs

Researchers in Canada are highlighting the uncertainties and challenges posed by automated insulin delivery (AID) systems designed by patients, as the approach continues to gain steam among patients who have type 1 diabetes (T1D).

Spearheaded and facilitated by people living with T1D, do-it-yourself (DIY) AID systems have gained rapid uptake, yielding self-reported improvements in glycemic control and quality of life for patients, but creating unique challenges for providers, as they have not been assessed in randomized controlled trials and are unregulated.

“Widespread use of unlicensed and unregulated insulin delivery systems presents challenges for health care systems and HCPs [health care providers]. A lack of legal, ethical, and regulatory guidance in the use of DIY AID systems creates uncertainty for HCPs with respect to their ethical and professional obligations in providing prescriptions for the technology and associated required supplies,” detailed the researchers. “From a clinician’s perspective, each component of the DIY AID system that a doctor is responsible for prescribing is an approved medical treatment or device; insulin pump, insulin, glucose sensor, and pump supplies. However, individuals using DIY AID systems combine these approved technologies in an unregulated and off-label way.”

Their findings published in Canadian Journal of Diabetes.

Recently, the OPEN International Healthcare Professional Network and Open Legal Advisory Group, comprising over 40 providers and legal experts globally, published a consensus statement on use of DIY AID. In their statement, the groups acknowledged the potential of DIY AID systems, along with commercial AID systems, to benefit people with diabetes while noting that they do not support universal uptake of DIY AID systems over commercial systems. The statement also underscored the need for providers to account for local law and organizational governance within their practice.

In a survey of 317 providers in the United Kingdom, the majority reported that they do not proactively discuss DIY AID with their patients and only discuss the approach if their patient brings it up.

“Collecting HCP views on DIY AID across Canada will be beneficial to target education and inform coherent and appropriate guidance on best practice,” explained the researchers. “If commercial AID system capabilities continue to advance in line with user need, this may result in a reduction in future DIY system use. However, currently the ethical and professional obligations for clinicians caring for patients using these systems need to be clarified urgently, to ensure optimal, consistent, and safe patient care.”

The researchers also highlighted challenges facing DIY AID users due to a lack of guidance, including a potential disconnect between patients and their providers. For example, the researchers note that if providers are not actively discussing DIY AID, patients may hesitate in bringing up the topic, feeling uncertain about the provider’s knowledge or opinion about the systems.

The group also cited concerns over potential harm from inappropriate or misprogrammed use of the systems, as they are individually set up and designed by patients.

Reference

Morrison A, Senior P, Bubela T, Farnsworth K, Witteman H, Lam A. Do it yourself and commercial automated insulin delivery systems in type 1 diabetes- an uncertain area for Canadian healthcare providers. Can J Diabetes. Published online June 22, 2022. doi:10.1016/j.jcjd.2022.06.003