Navigation Links
Animas Makes Progress in Development of a First-Generation Closed-Loop Insulin Delivery System With Study Participants Maintaining Safe Glucose Levels for Over 90 Percent of the Overnight Period
Date:6/21/2013

WEST CHESTER, Pa., June 21, 2013 /PRNewswire/ -- Animas Corporation announced today further promising results from the second phase of human clinical trials of a first-generation closed-loop insulin delivery system in development. Data investigating the predictive Hypoglycemia-Hyperglycemia Minimizer (HHM) System* demonstrated that the system is capable of maintaining safe glucose levels overnight. The data was presented at the 73rd Scientific Sessions of the American Diabetes Association (ADA) in Chicago, Illinois.

The feasibility study of the predictive glucose control system in development was conducted in 20 adults with type 1 diabetes and designed to investigate the System's automatic control algorithm, with emphasis on the overnight period from 9 PM to 7 AM. The System showed encouraging performance with the participants, on average, spending over 90 percent of the overnight period with blood glucose values in the range between 70-180 mg/dl.  Additionally, fewer than half of the study participants had blood glucose values less than 70 mg/dL during the overnight period.  

These results build on the data Animas presented from the same feasibility study earlier this year at the annual Advanced Technologies and Treatments for Diabetes (ATTD) conference, which demonstrated that the System shows promising ability to minimize the number, duration and severity of hypoglycemic events with no safety concerns.  The study was conducted in partnership with leading academic research institutions, including the University of California, Santa Barbara; Sansum Diabetes Research Institute; and the Center for Diabetes Technology at the University of Virginia.

"Avoiding hypoglycemia during the overnight period is a primary concern for people with diabetes, so maintaining safe glucose levels during this time frame is crucial in helping to not only achieve better control, but also helps ease worry throughout the night," said Ramakrishna Venugopalan, Director, Research & Development at Animas Corporation. "We are encouraged by the results of this overnight study, and we are excited to be one step closer to bringing this technology to patients."

Animas began collaborating with industry, academia and advocacy organizations, including the JDRF (formerly the Juvenile Diabetes Research Foundation), in 2010. After receiving Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in 2011, researchers began the first human clinical feasibility studies for the development of a closed-loop insulin delivery system. Together with these key partners, Animas continues to work toward developing such an automated system to help people living with type 1 diabetes better control their disease. 

"We are encouraged by Animas' latest findings that indicate the System is able to control overnight blood glucose levels safely," said Aaron Kowalski, Ph.D., Vice President of Treatment Therapies Research at JDRF. "For children and their families living with diabetes, the fear of hypoglycemia during the night is very real, so any peace of mind we can provide, particularly in the overnight period, would be a tremendous benefit.

* The HHM System includes a continuous subcutaneous insulin infusion pump, a continuous glucose monitor (CGM) and a control algorithm used to predict changes in blood glucose.

About the Clinical Study
The study investigated an automatic control algorithm of a predictive glucose control system in development during the overnight period of 9 PM – 7 AM.  Glucose-related metrics calculated specifically for this overnight period were based on both continuous glucose monitor (CGM) readings and readings obtained from the YSI 2300 STAT Plus.  The results demonstrated that the System was capable of maintaining safe glucose levels overnight, and indicate feasibility for continuing development.

During the study, the System dosed insulin automatically based on CGM values.  The mean overnight glucose value based on CGM was 135 mg/dl (129 mg/dl by YSI) for the entire cohort.  The median  percentage of overnight time spent at glucose values between 70-180 mg/dl was 93.8% (90.9% by YSI). The median percentage of overnight time spent at glucose values less than 70 mg/dl was 0% by both CGM and YSI.

About Animas Corporation
With a shared vision of "creating a world without limits" for people with diabetes, Animas is a part of Johnson & Johnson Diabetes Solutions Companies, a cross-company collaboration that reflects an ongoing commitment to better serve the diabetes community with integrated solutions that meet the needs of people with diabetes across the continuum of care.  Animas provides a wide range of insulin delivery products for people living with diabetes, including the OneTouch® Ping® Glucose Management System, Animas® Vibe™ insulin pump and CGM system and the Animas® 2020 insulin pump.  Animas, from the Latin word meaning "true inner self or soul," has been committed since 1996 to meeting individual patient needs through the development of life-performance technology and customer service 24 hours a day, 7 days a week, 365 days a year. To learn more about Animas, visit http://www.animas.com/.  


'/>"/>
SOURCE Animas Corporation
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Animas Development of a First-Generation Closed Loop Insulin Delivery System Progresses With Data Presented at the Advanced Technologies & Treatments for Diabetes (ATTD) Conference
2. Microsofts Surface Pro Tablet Makes its Debut and Sells Out Fast; the Company was One of the Few to Defy the Dows Loss Yesterday
3. West Health Institute licenses Kinect-based physical therapy technology to Reflexion Health; West Health Investment Fund makes $4.25 million investment
4. Dr. Milton Owens, Well Known Bariatric Surgeon, Introduces Innovative "Inverted Corner Gastric Sleeve technique," An advanced technique that makes weight loss surgery even safer
5. PatientPay from Zepherella Makes Patient Registration and Payment Pre-Authorization Faster, Easier for Physician Groups
6. Chronic Kidney Disease: Reducing Risks of Progression-- Prismic Pharmaceuticals Secures Exclusive Licensing Rights
7. Ameritox Joins with Progressive Medical in Urine Drug Monitoring Network to Help Improve Care of Injured Workers
8. BioElectronics and Pulsed Shortwave Therapy Make Progress
9. Inhibikase Therapeutics to present at Industry Conference on Drug-Induced Progressive Multifocal Leukoencephalopathy (PML)
10. OncoGenex Announces Multiple Trials in Progress Presentations at the 2013 ASCO Annual Meeting
11. Boehringer Ingelheim Presents Progression-Free Survival Data for Investigational Afatinib and Nintedanib in Advanced NSCLC
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... -- The Senior Care Pharmacy Coalition (SCPC) today commended ... Jason Chaffetz (R-UT) and Ranking Member Elijah ... "Developments in the Prescription Drug Market," to examine ... abusive pharmacy benefit manager (PBM) pricing practices. ... Elijah Cummings (D-MD) are diligent, serious lawmakers committed ...
(Date:2/4/2016)... , Feb. 4, 2016   Bernstein Liebhard LLP ... filed in the United States District Court for the District ... class (the "Class") consisting of all persons or entities who ... "Company") (NASDAQ: INSY ) from March 3, 2015 through ... and certain of its officers with violations of the Securities ...
(Date:2/4/2016)... 2016 Wegener Polyangiitis - Pipeline Review, ... ,Wegener Polyangiitis - Pipeline Review, H2 2015, provides ... This report provides comprehensive information on the ... analysis at various stages, therapeutics assessment by drug ... (RoA) and molecule type, along with latest updates, ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... 2016 , ... Boar’s Head Brand®, one of the nation’s leading providers of ... Take the stress out of your party preparation – follow these easy, yet delicious ... of the game. , “The key to hosting a successful game-day party is creating ...
(Date:2/5/2016)... Atlanta, Georgia (PRWEB) , ... February 05, 2016 , ... ... pleased to announce their 2nd Annual No Cost Dental Day to individuals in need. ... 4pm. The purpose of this No Cost Dental Day is to provide dental care ...
(Date:2/5/2016)... ... 05, 2016 , ... Colorize is a web theme package created ... next using Colorize's dynamic moving camera. Colorize is perfect for personal and web related ... environment with 1 to 5 focus points per scene, stage floor scene presets that ...
(Date:2/5/2016)... ... 2016 , ... California Mobile Kitchens , a company ... latest mobile kitchen model, featuring customizable stainless steel interiors and a new, 26-foot ... use anywhere in the U.S. Many of their units can be seen at ...
(Date:2/5/2016)... ... February 05, 2016 , ... ... Men’s Soccer Career Development event in New York City on Thursday, January 21, ... and CEO of Mediacom, (both alumnus of the varsity Columbia soccer program) spoke ...
Breaking Medicine News(10 mins):