Hybrid closed loop insulin delivery systems for the treatment of diabetes

Diabetes mellitus (DM) is a chronic metabolic disorder characterized by persistent elevated blood glucose due to insulin insufficiency, resistance, or both. It presents in two primary forms: Type 1 diabetes mellitus (T1DM), an autoimmune condition resulting in insulin deficiency, and Type 2 diabetes mellitus (T2DM), characterized by insulin resistance and a relative decrease in insulin production. Both types are associated with acute and long-term complications that can significantly impact health outcomes. Acute complications, such as hypoglycemia and diabetic ketoacidosis (DKA), can lead to severe, life-threatening conditions if not managed. Long-term complications, including cardiovascular disease, neuropathy, nephropathy, and retinopathy, develop over time due to poor glycemic control and can affect quality of life and increase mortality risk. Additionally, diabetes poses unique risks during pregnancy, requiring careful management to prevent adverse maternal and fetal outcomes. Uncontrolled diabetes can increase the risk of complications such as miscarriage, congenital anomalies, and stillbirth.

The epidemiology of diabetes shows a growing trend in its prevalence. In British Columbia, diagnosed T1DM and T2DM affected 11% of the population in 2023, and is predicted to increase to 14% by 2033.

Diabetes management includes blood glucose monitoring, insulin or other medications, and lifestyle modifications. T1DM requires lifelong insulin therapy to be delivered via different methods like multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Monitoring technologies have evolved, with continuous glucose monitoring (CGM) and metrics like time in range (TIR) offering improved glycemic control and reduced complications.

Hybrid closed loop (HCL) systems, which combine CGM, insulin pumps, and algorithms to automate insulin delivery, are an advancement in DM management. These technologies reduce hypoglycemia and improve glycemic control. To the date of this publication, some HCL systems, including Medtronic MiniMedTM 670G, 770G, and 780G, Tandem Control-IQ, and Insulet Omnipod® 5, have received approval from Health Canada.