Successful Test of Artificial Pancreas System, Hypoglycemia Hyperglycemia Minimizer (HHM) System For Type 1 Diabetes

In response to high levels of glucose in the blood, the insulin-producing cells in the pancreas secrete the hormone insulin. Type I diabetes occurs when these cells are destroyed by the body’s own immune system.

Diabetes is a life long disease in which the body has difficulty in maintaining the high levels of glucose (sugar) in the blood. Insulin is needed by the body to regulate glucose levels. In diabetes, there is too little insulin or the body is resisting the insulin, or both.

There are two types of diabetes, Type 1 and Type 2 diabetes. In type 1 diabetes, the cells that produce the insulin (beta cells) produce little or no insulin. With type 2 diabetes, the insulin produced is rejected by the body.

In type 1 diabetes, the body mistakenly identifies the beta cells located in the pancreas as harmful and start attacking it. Because of this, type 1 is identified as an autoimmune disorder. This kind of disorder is hereditary and can be passed down through families.

Positive results from first human clinical trials of a first-generation artificial pancreas system

Results from the first feasibility study of an advanced first-generation artificial pancreas system were presented today at the 72nd Annual American Diabetes Association Meeting in Philadelphia. Findings from the study indicated that the Hypoglycemia-Hyperglycemia Minimizer (HHM) System was able to automatically predict a rise and fall in blood glucose and correspondingly increase and/or decrease insulin delivery safely. The HHM System included a continuous, subcutaneous insulin pump, a continuous glucose monitor (CGM) and special software used to predict changes in blood glucose. The study was conducted by Animas Corporation in collaboration with JDRF as part of an ongoing partnership to advance the development of a closed-loop artificial pancreas system for patients with Type 1 diabetes.

"The successful completion of this study using the HHM System in a human clinical trial setting is a significant step forward in the development of an advanced first-generation artificial pancreas system," said Dr. Henry Anhalt, Animas Chief Medical Officer and Medical Director of the Artificial Pancreas Program. "It lays the foundation for subsequent clinical trials, bringing us one step closer to making the dream of an artificial pancreas a reality for millions of people living with Type 1 diabetes."

Video: Type 1 Diabetes

In June 2011, Animas received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to proceed with human clinical feasibility studies for the development of a closed-loop artificial pancreas system. The company partnered with the JDRF in January 2010 to begin developing such an automated system to help people living with Type 1 diabetes better control their disease.

"We are encouraged by the results of the first human trials in this partnership with Animas," said Aaron Kowalski, Ph.D., Assistant Vice President of Research at JDRF. "An artificial pancreas system that can not only detect, but can predict high and low blood sugar levels and make automatic adjustments to insulin delivery would be a major advance for people with Type 1 diabetes. Such a system could alleviate a huge burden of managing this disease."

About the Studies

The trial was a non-randomized, uncontrolled feasibility study of 13 participants with Type 1 diabetes at one trial site in the United States. The investigational Hypoglycemia-Hyperglycemia Minimizer (HHM) system was studied for approximately 24 hours for each study participant during periods of open and closed loop control via a model predictive control algorithm with a safety module run from a laptop platform. Insulin and food variables were manipulated throughout the study time period to challenge and assess the system.

The primary endpoint was to evaluate the ability of the algorithm to predict a rise and fall in glucose above or below set thresholds and to command the pump to increase, decrease, suspend and/or resume insulin infusion accordingly. The secondary endpoint was to understand the HHM system's ability to safely keep glucose levels within a target range and to provide guidance for future system development. The study also examined the relationship between CGM trends and the control model's algorithm for insulin delivery.

Quantum Day

11 June 2012

Successful Test of Artificial Pancreas System, Hypoglycemia Hyperglycemia Minimizer (HHM) System For Type 1 Diabetes