A new study shows that an artificial pancreas could replace insulin trackers in treating type 1 diabetes.
Studies on how to control type 1 diabetes have long been conducted: artificial pancreas developments can be traced back 50 years. Science has come a long way since then, and researchers have continued to look for new and innovative ways to treat type 1 diabetes.
The most recent development came after researchers successfully completed a trial of the latest artificial pancreas treatment on 29 patients. The results indicate that the innovative artificial pancreas treatment being trialed could soon replace insulin trackers as the prominent method for treating type 1 diabetes.
A Brief History
According to a report published by the National Center for Biotechnology Information, artificial pancreas developments were introduced at the turn of the century, in 1999, by the continuous glucose monitoring (CGM) system.
Initially, CGM was introduced as a method for retrospective review profiles, but the rise in prominence of real-time devices allowed them to provide online glucose readings. Since that time CGM has significantly improved, becoming a more reliable and versatile tool for use in artificial pancreas treatment.
The artificial pancreas treatment also incorporates the use of the insulin pump, a vital component for continuously treating type 1 diabetes. According to the report, the insulin pump became an accepted method of treatment in the late 1990s, but had been decades in the making.
Researchers of the study added that landmark studies in 1979 proved that subcutaneous insulin infusion was the most feasible route to achieve continuous insulin delivery.
A key component of the artificial pancreas is the use of algorithms, which have been historically explored to efficiently monitor glucose levels and accurately deliver the needed amount of insulin.
The adaptive control algorithm used on the latest artificial pancreas prototype is based on model-predictive control (MPC), a strategy developed in 1996 by Frank Doyle, Dean and Professor at Harvard John A. Paulson School of Engineering and Applied Sciences, and colleagues.
This new method determines an acceptable range of an individual’s glucose levels and works to ensure the patient stays in that range. Doyle is also a part of the Harvard team that ran the most recent trial.
How it Works
“It [the artificial pancreas] is designed to learn what an individual’s insulin needs are and to take action to minimize both high and low glucose levels,” said Hooman Hakami, Executive Vice President and President of Medtronic Diabetes, when describing their newest version of the artificial pancreas.
According to the FDA, the way the newest artificial pancreas treatment works can be best described by breaking it down into four parts that work together: the CGM, the controlled algorithm, the insulin pump, and the patient.
The CGM is the first part, continuously providing information about the patient’s blood levels through a sensor placed just under the patient’s skin. This sensor measures the glucose in the fluid around the cells. A small transmitter then communicates the information to a receiver, which allows the CGM to display an estimate of blood glucose levels, their direction, and the rate of change of said estimates.
In order to get precise estimates of blood glucose from a CGM, the use of a blood glucose device (BGD) is required. The BGD is used to periodically calibrate the CGM by measuring blood glucose levels.
However, as the CGM performance improves over time, the FDA expects the use of a BGD to become obsolete.
The second component is the control algorithm, which is not a part of the subcutaneous sensor. It’s a software placed in an external controller with which the CGM communicates. The algorithm learns from the patient’s repeated daily cycles and customizes treatment for them.
The dosing instructions are then sent to either the insulin pump, a smartphone, or a computer. The recent trial employed the use of a bluetooth-enabled smartphone.
The third component is the insulin pump, which receives the dosing instructions and adjusts insulin delivery accordingly. The insulin delivery is based on food intake, physical activity, stress, metabolism, and sleep.
The fourth component is the patient, who is an important part of the artificial pancreas treatment in that the concentration of glucose circulating in their blood always changes.
The trial, published by Diabetes Care, consisted of 30 adults with type 1 diabetes. The patients used the artificial pancreas for more than 60,000 hours over 12 weeks, and periodically checked in at multiple stages throughout the trial.
Researchers Doyle and Eyal Dassau, also of Harvard John A. Paulson School of Engineering and Applied Sciences, led the day-to-day supervision in Cambridge, Massachusetts.
“This is by far the longest-duration trial we have conducted, and it is a testament to the robustness of the algorithm that our key performance indices were maintained from our earlier, shorter trials,” said Doyle. “Moreover, we took a disciplined group that had very good overall HbA1c levels before the trial, and we brought the group level even lower,” he added.
Harvard researchers reported that the test had positive effects on the patients. The artificial pancreas treatment decreased hemoglobin and reduced the amount of time spent in a hypoglycemic state.
The Demand and Challenges
Approximately 1.25 million American children and adults have type 1 diabetes in the U.S. alone, and from 2011-2012 an estimated 17,900 American youth had type 1 diabetes. Additionally, the American Diabetes Association reported that diabetes was the seventh leading cause of death in the U.S.
Such staggering numbers not only indicate that there are plenty of patients in need of the artificial pancreas treatment, but that it could save tens of thousands of lives in the U.S. alone.
The challenge of the mainstream use of the artificial pancreas at this point, according to Diabetes Care, is that the researchers had to override 10 percent of adaptation recommendations for dosages.
The Hindustan Times reported that the wrong dose can lead to hypoglycemia, which can cause drowsiness, dizziness, depressed mood, headache, hunger, fatigue, and an inability to concentrate. More serious consequences include disorientation, comas, and seizures.
These risks are obviously a concern to the FDA and as of September 2016, it still required further study to better understand how the device performed in real-world settings. The organization especially wants further studies done if artificial pancreas treatment is to be used on children, who, according to the American Diabetes Association, accounted for an estimated 17,900 cases of type 1 diabetes in the U.S. from 2011-2012.
“We expect improvements … as it becomes more mainstream and more data comes back; then we can extend it to the younger population,” said Dr. Robert Courgi, Endocrinologist at Northwell Health’s Southside Hospital.
A Life-Altering Advancement
People with type 1 diabetes have to vigilantly monitor blood glucose levels and administer doses of insulin either with an infusion pump or through a needle. These requirements have become so routine that it becomes a huge part of a patient’s life.
For people with type 1 diabetes, having an artificial pancreas would be life-altering. Studies like these indicate that every day we continue making advances on how to treat type 1 diabetes in ways that can markedly improve the lives patients.
Artificial pancreas treatment now holds the potential to improve the quality of life of a person with type 1 diabetes by curtailing it’s negative side effects while taking on the task of monitoring and maintaining glucose levels. Simply put, the artificial pancreas could be a game changer.