Type 1 diabetes occurs when the pancreas does not properly synthesize insulin, which is the hormone that controls blood glucose levels. It is also called insulin-dependent diabetes, since people who suffer from it need a daily supply of this hormone. For this reason, the traditional treatment of type I diabetes consists of the continuous control of glucose levels, through a series of annoying daily pricks, together with the injection of insulin and strict control of the diet.
In recent years, alternatives have emerged to minimize the discomfort of treatments and allow people with diabetes to lead a more comfortable life. The artificial pancreas is one of these systems: it is based on continuously monitoring the level of glucose in the plasma and automatically injecting the adjusted insulin dose that the patient needs at all times. The artificial pancreas is made up of three elements: an insulin pump, a sugar measurement system, and an algorithm that performs the necessary calculations to adjust the dose.
Pre-marketing clinical trials
As Beatriz Ricarte Benedito, a researcher at the Polytechnic University of Valencia, explains in this article published in The Conversation , currently only one artificial pancreas system is marketed, called Medtronic Minimed 670G, but there are many more prototypes that are in various phases of the pre-marketing trials.
As the researcher explains in this article, “for the validation of a system, controlled tests must be carried out in the hospital, tests outside the hospital in a controlled environment (such as a hotel or a camp) and outpatient tests with the patient leading a normal life with or without supervision by the team responsible for development. Once all the tests have been passed, the process for its commercialization can be started ”.
Well, the New England Journal of Medicine has just published the results of a study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases (USA), which has included five clinical protocols of artificial pancreas in the third phase of the trials, that is, evaluating its effectiveness with the participants in their daily activities.
The article in question refers to the results obtained by one of the prototypes, which uses a technology called Control-IQ , which was originally developed at the University of Virginia. In this system, the insulin pump is programmed with advanced control algorithms based on a mathematical model that uses the person’s glucose monitoring information to automatically adjust the insulin dose.
The results have shown that this prototype artificial pancreas is more effective than those existing to date in controlling blood glucose levels. In addition, the system is not only effective during the day, but also at night, a particularly delicate time since blood glucose levels can drop sharply while the patient sleeps.
A large-scale trial
The study, called The International Diabetes Closed-Loop (iDCL) Study , separately tested five different types of artificial pancreas developed by ten research centers in the US and Europe. For six months, the 168 participants, diagnosed with type 1 diabetes and over 14 years of age, tested the prototypes in the ‘real world’ , that is, while leading their normal lives, and only went to the research center every few weeks to download the data. There was no type of remote monitoring, so the test was carried out in totally real conditions.
The results revealed that users of this artificial pancreas, compared to the control group – sensor augmented pump therapy with a continuous glucose meter and a pump that did not adjust insulin automatically throughout the day – spent longer throughout the day. of the day with their blood glucose levels in the range that is considered normal, in addition to showing improvements in the time they spent in high and low blood glucose, in hemoglobin A1c and in other variables related to the control of diabetes.
“This artificial pancreas system has several unique characteristics that improve glucose control beyond what can be achieved with traditional methods,” explained Boris Kovatchev, director of the research group at the University of Virginia. “In particular , there is a special safety module dedicated to the prevention of hypoglycemia, and monitoring is gradually intensified during the night to reach almost normal blood sugar levels every morning. “
As we have already mentioned, the results refer to the third phase of the clinical trials to test the prototype, prior to the commercialization phase, which will still take some time to arrive.
