Researchers at Cambridge University have conducted a successful clinical trial studying the effectiveness of an artificial pancreas in patients with Type 2 diabetes. They published their findings in the journal ‘Nature’ in January 2023.
Diabetes Test
How many people in the US have Type 2 diabetes?
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Type 2 diabetes affects 415 million people around the globe. In the US alone, 37 million have diabetes, and 90-95% of these Americans have Type 2 diabetes. Type 2 diabetes requires lifestyle changes, medications, and regular measurements of blood insulin levels. In its later stages, it can involve other body organs such as the eye, kidney, and nerves, and many life-changing complications can manifest.
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What is Type 2 diabetes?
In a typical individual, insulin, secreted from the pancreas, regulates blood glucose levels. The insulin levels change in response to glucose levels and maintain them to an optimum range for normal functioning. In Type 2 diabetes, insulin secretion is impaired from the pancreas, and the glucose levels in the blood can increase significantly. It gives rise to various symptoms and puts patients at risk for multiple complications including death.
What kind of insulin system did the scientists evaluate in this study?
Scientists from the Wellcome-MRC Institute of Metabolic Science evaluated a fully-closed insulin delivery system. This system consists of an insulin delivery apparatus, a continuous glucose monitor, and an algorithm that detects glucose levels in the blood and automatically delivers insulin subcutaneously.
Are there similar systems currently in use?
Hybrid-closed loop systems are available in the market and used for type 1 diabetes. The newly developed system improves on the previous closed-loop insulin delivery systems as it does not require user input at meal times.
The fully-closed systems (the one assessed in this study) have been evaluated on an outpatient basis for patients with Type 2 diabetes and for patients who require dialysis. The results of those studies are favorable as they show improved glucose control for those patients. However, long-term studies have not been done to assess these outcomes, so it is currently unclear if these systems improve glycemic control in the long run.
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How was the clinical trial conducted?
In this clinical trial, scientists studied the effectiveness of a fully-closed loop insulin system in achieving the optimum blood glucose levels in patients with type 2 diabetes compared to standard insulin therapy.
Initially, researchers recruited 28 patients in this study and divided the participants into two groups. The control group received standard insulin therapy. The other group of fourteen participants received closed-loop systems. After eight weeks, both groups switched their insulin therapies.
What were the results?
The team of scientists assessed the outcomes of this study using different measurements. Firstly, they studied the time spent by patients with their blood glucose levels in the range of 3.9-10.0mmol/L. The study participants who were using an artificial pancreas (fully closed-loop insulin delivery system) spent almost double (66%) the amount of time in the required range as compared to control group participants (32%).
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Secondly, they assessed the percentage of time the glucose levels remained above 10.0mmol/L in study participants of both groups. In the patients who were using an artificial pancreas, the blood glucose levels were higher than 10.0mmol/L 33 percent of the time while in the control group, this was around 67 percent of the total time.
Furthermore, the average glucose level was 9.2mmol/L in patients using the artificial pancreas compared to 12.6 mmol/L in the control group. Similarly, the HbA1c levels also showed a positive picture. The average HbA1c level in patients who used closed-loop therapy was 57 mmol/L. However, it was 72 mmol/L in patients using control therapy. In addition to these favorable results, researchers noted that none of the patients suffered dangerously low glucose levels while using this system.
Conclusion
The scientists conclude that their study provides evidence for the effectiveness and safety of this automatic insulin delivery system and builds on the previous scientific evidence. They also mention some favorable results of feedback from patients regarding the usage of this system.
Future direction
The team of researchers now plans to study the effectiveness and safety of the developed system on a wider scale. They plan to strengthen the evidence base by conducting multicentre studies. Researchers have submitted the device seeking regulatory approval and plan to make it commercially available.
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Significance
The insulin delivery system developed by this team provides many advantages for patients. It can alleviate the need to think about insulin regulation constantly and help tackle the worrying thoughts about low glucose levels (hypoglycemia). It also provides a convenient way to regulate blood sugar levels. It would be interesting to see further research on this issue as it may provide more in-depth insights about a wide range of patients and the system’s ability to regulate glucose levels in different types of patients with Type 2 diabetes.
The below-provided link provides further information about authors, funding agencies, and detailed study results.
References
Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial (Accessed on March 23, 2023)
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