Safety and efficacy, adaptive control algorithm to be tested in U.S. and Europe.
As one of the most common chronic disease states, diabetes mellitus is increasing worldwide. People with diabetes need to vigilantly monitor their blood glucose levels, and administer insulin when necessary via needles or insulin pumps. The non-adherence rates of insulin administration and the risks of life-threatening hyper- and hypoglycemia are gradually increasing. A device that automatically monitors blood glucose levels, and administers insulin accordingly, in people with diabetes is an ideal tool to treat the disease state.
The artificial pancreas is an automated insulin delivery system that replicates the actual organ by mimicking a healthy person’s glucose regulating system. The device consists of 3 parts — an insulin pump, a continuous blood glucose monitor that is placed under the patient’s skin, and an advanced control algorithm software embedded into the patient’s smartphone that detects how much insulin to provide based on the individual’s physical activity, stress, sleep, and metabolism.
The device supplies the appropriate amount of insulin not by reacting to the individual’s body, but by predicting the blood glucose levels in advance. As described by principle investigator Boris Kovatchev, director of the UVA Center for Diabetes Technology, “Our foremost goal is to establish a new diabetes treatment paradigm: the artificial pancreas is not a single-function device; it is an adaptable, wearable network surrounding the patient in a digital treatment ecosystem.”
In a previous study conducted by Taylor MJ et al., an artificial pancreas was implanted in a domestic pig. The device consisted of a small glucose-sensitive gel that forms a gateway to an insulin reservoir that was designed to sense glucose levels and deliver insulin into the peritoneal cavity. The reservoir could be refilled with insulin via subcutaneous route. The diabetes-induced pig was observed for several weeks during which time the blood glucose went down from >25 mg/dL to <10 mg/dL in about five days. The reservoir was removed in 10 days after good glycemic control, upon which the blood glucose returned to diabetic levels (>20 mg/dL). The device controlled the basal and bolus insulin needs for more than 4 weeks without manual administration of insulin.
To be successful in the treatment of diabetes, the device will need to prove its safety and efficacy in long-term pivotal trials in the patient’s natural environment. UVA’s goal is to acquire necessary data to satisfy requirements in order to get FDA and other international agencies’ approval. With over $12 million in support from the National Institute of Health (NIH), a team of researchers from University of Virginia (UVA) School of Medicine and the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) will conduct two trials to determine the safety and efficacy of the artificial pancreas. The two trials will take place in early 2016 at nine different sites in the U.S. and Europe.
In the first trial, 240 type 1 patients will test the safety and efficacy of the device for 6 months. The device will be compared to a control — a standard insulin pump that was developed by UVA. The device’s effectiveness in controlling the blood glucose and its tendencies to induce hypoglycemia will be compared to the control.
In a second trial, 180 of the patients from trial 1 will test the adaptive control algorithm of the device for 6 additional months. The algorithm controls the patient’s glucose levels within an acceptable zone by controlling any variables that might cause it to fluctuate. According to co-principal investigator and engineering lead on the project Francis J. Doyle III, dean and John A. & Elizabeth S. Armstrong Professor of Engineering & Applied Sciences at Harvard SEAS, “The biggest challenge in the design of the artificial pancreas is the inherent uncertainty in the human body. Day to day, hour to hour, the various stresses that impact the human body change the way it responds to insulin-controlling glucose. Physical stresses, anxiety, hormonal swings will all change that balance.”
Although the clinical trials are yet to be conducted, an approval of the artificial pancreas will be a game changer in the treatment of diabetes. Not only will it ease the burden on the patients of administering daily insulin, but it will take medical informatics to greater heights. (See this issue’s New Product – The artificial pancreas)
- The artificial pancreas is a device that mimics the healthy human pancreas and automatically administers accurate insulin depending on the individual’s daily activity.
- Two new artificial pancreas trials, with 240 patients, will be conducted in the U.S. and Europe to determine its safety and efficacy.
- The first trial will compare the device to a control insulin pump. The second will test the adaptive control algorithm that monitors and controls the patient’s glucose levels.
Taylor MJ, Gregory R, Tomlins P, Jacob D, Hubble J, Sahota TS. “Closed-loop glycaemic control using an implantable artificial pancreas in diabetic domestic pig (Sus scrofa domesticus).” Int J Pharm. 2015;
Researched and prepared by Sabair Pradhan, Doctor of Pharmacy Candidate from University Of South Florida College of Pharmacy, reviewed by Dave Joffe, BSPharm, CDE