Automated insulin delivery (AID) has been a boon to individuals with diabetes, satisfactorily alleviating the disease burden. However, the challenge of using AID lies in suggesting AID to a patient who is not aware of the proper usage of the system which in turn leads to safety issues. On this background, experts from scientific organizations such as the ADA and EASD put forth a series of consensus recommendations for all concerned parties to further enhance and refine the safe use of these systems.

Some of the major points of the consensus recommendations include:

• Recommendations to the regulatory agencies to specifically mention the trials conducted for the validation of AIDs precisely
• Recommendations to the manufacturers to assess the applicability of the device in an easy manner,incorporation of academic and health care professionals to provide balanced and adequate information both to providers and patients with diabetes and a high degree of data security and patient confidentiality
• Recommendations to the international and national professional societies and advocacy organizations to engage all stakeholders including people with diabetes,HCPs, manufacturing companies,and regulatory authorities together to facilitate discussion on how to advance AID while prioritizing the safety and privacy of people with diabetes, encourage academicians to do extensive research on AID advancements,provide evidence-based guidelines on the effectiveness of AID systems,recommend appropriate forms of structured education required for HCPs to support patients with diabetes to ensure benefit from the chosen AID system etc
• Recommendations to the international and national research funding bodies regarding the provision of funding for the well-designed acquisition of independent clinical evidence on safety,effectiveness,outcomes, and use of AID systems in real-world settings, provision of a harmonized/standardized approach to reporting results obtained with AID systems
• Recommendations to the researchers/academicians regarding data sharing in accordance with local law, developing and validating specific and appropriate patient-related outcome measures
• Recommendations to the healthcare professionals to widen their perspectives of AID systems, nuances of different systems,strengths and weaknesses of different systems, informing patients with diabetes about AID systems,including review of currently available systems,and create realistic expectations for device use,involve patients with diabetes in shared decision-making,and sharing information about general standards set by national and international guidelines on AID systems
• Recommendations to the consumers of AID systems (people with diabetes, family members, and caregivers) to have realistic expectations of AID systems,discuss available AID systems with their healthcare professionals,submit data for HCPs to review and report issues with device components to their HCPs,manufacturers,and/or regulatory authorities
• Recommendations that evidence-based access policies for AID should be set by policymakers and ideally reflect the evidence base, including acknowledgment of the challenge in diabetes technology research as the evidence base and the product cycle move so rapidly that dynamic review is required but is almost never undertaken,be frequently and regularly reviewed, embed structured consideration of health inequalities in the access policy and include patient-reported outcomes when forming policy

Read More