Recommendations for Insulin Dose Calculator Risk Management.

Area of Science:

• Medical device regulation
• Diabetes technology
• Glycemic control

Background:

• Automated insulin dose advisors (BAs) show promise for improving glycemic control in diabetes patients.
• Current BAs lack standardized dosage calculations and may pose risks.
• Increasingly stringent regulations complicate the approval process for medical device software.

Purpose of the Study:

• To review the use, benefits, and safety of automated insulin dose advisors.
• To identify regulatory challenges and risk management needs for BAs.
• To recommend risk management activities for BA development and regulatory submissions.

Main Methods:

• Comprehensive literature search on diabetes BAs, infusion pump safety, and medical device regulations.
• Inclusion of country-specific and international guidance documents.
• Analysis of risk management requirements for BAs.

Main Results:

• No specific worldwide guidance exists for BA risk management.
• Existing medical device, infusion pump, and software regulations offer applicable guidance.
• Algorithm-specific risk management exercises can aid regulatory submissions.

Conclusions:

• Manufacturers can leverage existing regulatory frameworks for BA development.
• Algorithm-specific risk management is essential for navigating regulatory pathways.
• Standardized guidance for BAs would enhance patient safety and device adoption.