Managing type 1 insulin dependent diabetes in children less than 6 years of age is a major challenge; low insulin needs along with variable activity levels and food intake can make glycaemic control difficult. Closed loop systems (‘the artificial pancreas’) have been shown to be effective and safe in older children and adults. This system is made up of an insulin pump, a glucose monitoring device which links with a control algorithm. This algorithm adjusts insulin volumes responding to the glucose levels. Closed loop systems have been shown to improve glycaemic control with lower glycated haemoglobin and improved percentage of time within an acceptable target range. Wadwa RP et al. N Engl J Med 2023;388:991-1001 DOI: 10.1056/NEJMoa2210834 have completed a 13-week, randomised, multicentre controlled study in 102 children who were at least 2 years of age but younger than 6 years of age with type one diabetes. There were 68 children randomised to the closed-loop group and 34 children recruited into the standard-care group. Standard care was either an insulin pump or standard daily subcutaneous injections and a continuous glucose monitor. Time-in-range (TIR) was the primary outcome expressed as a percentage; the normal range was 70mg/dL (3.9 mmol/L) to 180 mg/dL (10 mmol/L). Glycated haemoglobin levels at baseline ranged from 5.2 to 11.5. The mean (±SD) percentage of time that the glucose level was within the target range increased from 56.7±18.0 at baseline to 69.3±11.1 during the 13 week follow-up period in the closed-loop group and from 54.9±14.7to 55.9±12.6 in the standard-care group (mean adjusted difference, 12.4 percentage points equivalent to approximately 3 hours per day; 95 CI, 9.5 to 15.3; p<0.001). What about hypoglycaemia? The incidence was low in both groups (two in the closed loop and one in the standard management group. Diabetic keto-acidosis (DKA) occurred in only one patient who was using the closed loop system and it was due to pump failure. There were no cases of DKA in the standard group. It is interesting that over all, 60 of the closed loop group had an adverse event whereas 32 of the standard management group which was significant (p<0.001): the devil is always in the detail. Those subjects who had the poorest control at the onset of the study, improved their glycated haemoglobin to a greater extent and in the closed loop group. Clearly there are benefits for the closed loop system in these younger children. A useful editorial from Bruttomesso D N Engl J Med 2023;388:1052-1054 DOI: 10.1056/NEJMe2301252 accompanies the article. The most fascinating element of this study is that it was conducted during the COVID-19 epidemic. Many studies were put on hold, cancelled, or seriously challenged by the epidemic; this study carried on recruiting and managed to train and follow-up the subjects recruited in the study... virtually. They were able to train over 80 of subjects with the closed loop arm over the internet and over 90 of all visits were conduced virtually. Quite remarkable.
展开▼
