CamAPS HX (artificial pancreas)

2023: Product Announcement

In mid-January 2023, scientists from the Institute of Metabolic Sciences at the University of Cambridge developed a fully automated closed-loop insulin delivery system that improved glucose control in adults with type 2 diabetes. The system does not increase attacks of low blood sugar compared to standard insulin therapy and does not require user involvement during meals. The results of an open-label, single-center, randomized crossover trial were published in the journal Nature Medicine.

Study co-author Charlotte Boughton of the Institute of Metabolic Sciences at the University of Cambridge reported that many people with type 2 diabetes are trying to control their blood sugar levels with treatments available for January 2023, such as insulin injections. The artificial pancreas can provide a safe and effective approach to help them, and the technology is easy to use and can be safely applied at home.

CamAPS HX (artificial pancreas)

Earlier studies successfully tried hybrid closed-loop insulin delivery systems, but they required user intervention in the form of meal-time announcements that regulated insulin release boluses. Such systems are available for patients with type 1 diabetes. A new artificial pancreas called CamAPS HX responds to a patient's blood glucose levels. It includes a continuous glucose monitor, an insulin pump and an algorithm that predicts the amount of insulin needed to maintain glucose levels in the target range, which modulates the delivery of insulin under the skin.

In the current study, the CamAPS HX system was tested on 28 patients from Addenbrooke's Hospital Diabetes and Endocrinology Clinic, and a local group of GPs. The recruited patients were randomly assigned to two groups: the first group used the CamAPS HX system for eight weeks and then switched to standard therapy in the form of multiple daily insulin injections; the second group first took standard therapy and then switched to the CamAPS HX system after eight weeks.

The researchers estimated the proportion of time patients spent with glucose levels between 3.9 and 10.0 mmol/L. On average, patients using the CamAPS HX system spent two-thirds of the time (66%) in the target range, double that of standard therapy (32%). Next, the scientists measured the proportion of time patients spent with glucose levels above 10.0 mmol/L and found that patients on standard therapy spent two-thirds (67%) of their time at high glucose levels. While patients using the CamAPS HX system spent half that time (33%) at levels above 10.0 mmol/L. Moreover, mean glucose decreased from 12.6 mmol/L on standard therapy to 9.2 mmol/L using the CamAPS HX system, and glycated hemoglobin (HbA1c) decreased from 8.7% on standard therapy to 7.3% using the CamAPS HX system.

Hypoglycemia was not observed in patients in both groups during the study. Co-author of the study, Aidin Daly, MBBS, also from the Institute of Metabolic Sciences, reported that one of the barriers to the widespread use of insulin therapy was concern about the risk of severe "hypo" - dangerously low blood sugar. But the scientists found that no patient in the study experienced this, and patients spent very little time with blood sugar levels below target levels. " According to Daly, the only serious adverse event during the study was the hospitalization of one patient using the CamAPS HX system due to an abscess at the site of the pump cannula.

Scientists intend to conduct a larger multicenter study to confirm the safety and effectiveness of the system and have submitted the device for regulatory approval.^[1]

Notes