Closed-loop control in insulin pumps for type-1 diabetes mellitus: safety and efficacy

ABSTRACT

Introduction

Type 1 diabetes is a lifelong disease with high management burden. The majority of people with type 1 diabetes fail to achieve glycemic targets. Algorithm-driven automated insulin delivery (closed-loop) systems aim to address these challenges. This review provides an overview of commercial and emerging closed-loop systems.

Areas covered

We review safety and efficacy of commercial and emerging hybrid closed-loop systems. A literature search was conducted and clinical trials using day-and-night closed-loop systems during free-living conditions were used to report on safety data. We comment on efficacy where robust randomized controlled trial data for a particular system are available. We highlight similarities and differences between commercial systems.

Expert opinion

Study data shows that hybrid closed-loop systems are safe and effective, consistently improving glycemic control when compared to standard therapy. While a fully closed-loop system with minimal burden remains the end-goal, these hybrid closed-loop systems have transformative potential in diabetes care.

KEYWORDS:

• Artificial pancreas
• automated insulin delivery
• closed-loop
• continuous glucose monitoring
• insulin pump
• type 1 diabetes

Article highlights

• Algorithm-directed automated insulin delivery is possible via hybrid closed-loop systems

• People with type 1 diabetes will soon have a choice of multiple hybrid closed-loop systems, tailored to individual needs and preferences

• Study data show that hybrid closed-loop systems are safe to use

• Hybrid closed-loop systems increase the time spent in the target glucose range while reducing hypoglycaemia and lowering HbA1c compared to gold-standard insulin therapy

• Funding restrictions and lack of health-economic data, as well as insufficient healthcare provider education and knowledge, are the main barriers to making hybrid closed-loop systems widely available

Declaration of interest

R Hovorka reports having received speaker honoraria from Eli Lilly and Novo Nordisk, serving on advisory panel for Eli Lilly and Novo Nordisk; receiving license fees from BBraun and Medtronic; having served as a consultant to BBraun, patents and patent applications related to closed-loop insulin delivery, shareholder and director at CamDiab Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was supported by the National Institute of Health Research Cambridge Biomedical Research Centre, Efficacy and Mechanism Evaluation National Institute for Health Research, The Leona M. & Harry B. Helmsley Charitable Trust, JDRF, National Institute of Diabetes and Digestive and Kidney Diseases and Diabetes UK.