New artificial pancreas could be a life changer for type 1 diabetics

Recent trials of new system that continuously measures glucose levels and automatically delivers insulin when needed, known as an ‘artificial pancreas’ have shown promising results. 

Type 1 diabetes is a condition that affects insulin levels in the body. When someone has type 1 diabetes their immune system destroys cells in the pancreas called ‘beta cells’. These are the cells that produce the hormone insulin. This hormone is vital to help control blood glucose levels. Type 1 diabetes is often referred to as ‘insulin-dependent’ diabetes because those with this condition need a daily supply of this hormone to maintain sufficient glucose levels. Glucose is the body’s main source of energy. Without sufficient glucose levels the body becomes weak and unable to function. Most diabetics control their glucose levels through numerous glucose level checks throughout the day (a fingerstick or continuous glucose monitor), insulin injections and a strict diet. This process can be both complicated and time consuming.  

In recent years alternatives have emerged to minimise the discomfort of treatment and enable diabetics to lead more comfortable lives. While automatic glucose monitors are not entirely new, the artificial pancreas system is different because it is wirelessly paired linked to an insulin pump. The artificial pancreas continuously monitors the level of glucose the plasma and automatically injects the appropriate insulin dose, at any given time. The artificial pancreas is made up of three elements: an insulin pump, a sugar measuring system, and an algorithm that performs the necessary calculations to adjust the dose.

Pre-marketing clinical trials

Beatriz Ricarte Benedito, a researcher at the Polytechnic University of Valencia, explained in the journal The Conversation that there is only one artificial pancreas system, called Medtronic Minimed 670G that is currently on the market. There are however numerous prototypes currently being tested.

Benedito goes on to discuss the process of clinical trials: "to validate new methods of treatment, controlled tests must be carried out. This includes clinical trials in hospital, controlled environment tests and outpatient trials – where a patient integrates the methodology, medicine or equipment into their ‘normal life’ – without direct intervention from professionals during the testing period.

Prototype testing

The New England Journal of Medicine published the results of a study by the International Diabetes Closed-Loop (iDCL) reporting on a third phase of clinical trial of five artificial pancreas prototypes. This research was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (USA). The study aimed to evaluate the effectiveness of artificial pancreas by integrating them into participants’ daily lives.

The focus of this research phase was one prototype ‘Control IQ’ – an artificial pancreas, which includes an automatic insulin pump that is programmed with specific algorithms to monitor and automatically adjust insulin doses for patients throughout the day and night.

Over the course of six months 168 participants (over the age of 14), diagnosed with type 1 diabetes took part in the trial testing. Participants were randomly assigned to use either the Control-IQ artificial pancreas or sensor-augmented pump (SAP) therapy (control group). SAP uses a continuous glucose monitor and insulin pump, but still requires frequent input and decisions from the user about when and how much insulin is needed. The Control-IQ system uses advanced computer algorithms to automatically adjust insulin doses based on glucose levels in the body.

Participants tested the new technology and integrated it into their ‘normal’ daily routine, only visiting the research centre every few weeks to download data for analysis. No remote monitoring took place to ensure that results presented a true indication of how effective an artificial pancreas could be to diabetics in ‘the real world’. 

Results found the artificial pancreas to be more effective in regulating and maintaining normal range glucose levels throughout the day and during the night, compared to the control group. 

The study also found the the Control-IQ artificial pancreas prototype to be more effective than others in controlling blood glucose levels. In addition, the system is not only effective during the day, but also at night, a particularly delicate time as blood glucose levels can drop suddenly while sleeping.

Research director, Boris Kovatchev said: "The artificial pancreas system has several unique features that improve glucose control beyond what can be achieved with traditional methods.

 "In particular, there is a special safety module dedicated to the prevention of hypoglycaemia, and control is gradually intensified during the night to reach almost normal blood sugar levels every morning.

Now that several clinical trials have demonstrated that artificial pancreas systems can safely control glucose levels, hopefully trials on a larger scale can be initiated to push this technology closer to market.

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