GI Dynamics, Inc. Announces Positive Results on One-Year Data from the Association of British Clinical Diabetologists Endobarrier Obstructive Sleep Apnea Study
March 28, 2019 at 05:25 pm EDT
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GI Dynamics, Inc. announced positive results on one-year data from the Association of British Clinical Diabetologists (ABCD) EndoBarrier Obstructive Sleep Apnea Study (End-OSA Study). Principal and chief investigator, Robert Ryder, MD of Sandwell and West Birmingham Hospitals presented the results at the Diabetes UK Professional Conference 2019. The data show a significant reduction in weight and body mass index (BMI), as well as reduction in obstructive sleep apnea (OSA) events and HbA1c. The aim of this study, titled "One-year Results of the Association of British Clinical Diabetologists (ABCD) Sponsored EndoBarrier in Type 2 Diabetes/Pre-Diabetes with Obstructive Sleep Apnoea (OSA) Study," was to investigate whether weight loss associated with EndoBarrier would reduce OSA events for patients with type 2 diabetes or pre-diabetes who are treated with continuous positive airway pressure (CPAP). The study consists of data collected from 12 patients who each received 12 months of EndoBarrier treatment. All patients were recruited and studied at Birmingham's City Hospital (UK). Baseline criteria included patients diagnosed with moderate OSA (apnea hypopnea index [AHI] 15 - 29 events/hour) treated with CPAP, type 2 diabetes or pre- diabetes, and obesity (BMI 30 and 45 kg/m2). Of the 12 patients, eight had type 2 diabetes and four had pre-diabetes. Following a 12-month EndoBarrier treatment, 10 out of 12 (83 percent) patients saw their AHI events fall below the moderate OSA threshold of 15 AHI events/hour, allowing them to discontinue the use of CPAP, according to NICE guidelines. Of the remaining two patients, one discontinued CPAP usage at 18 months (six months post-explant); the second patient partially discontinued CPAP usage at nine months.
GI Dynamics, Inc. is a medical device company. The Company designs and applies device and disease management solutions for the treatment of metabolic disease. The Company designs, develops, manufactures and markets medical devices for non-surgical approaches to treat type II diabetes and obesity. The Company's product, EndoBarrier, is an endoscopically-delivered device therapy, which is approved for the treatment of obese type II diabetes with body mass index (BMI) greater than or equal to 30 kilogram/square meter (kg/m2), or obese patients with BMI greater than or equal to 30 kg/m2 with greater than or equal to one comorbidities, or obese patients with BMI over 35 kg/m2. EndoBarrier is an incision-free, non-anatomy altering solution designed to specifically mimic the duodenal-jejunal exclusion created by gastric bypass surgery.
GI Dynamics, Inc. Announces Positive Results on One-Year Data from the Association of British Clinical Diabetologists Endobarrier Obstructive Sleep Apnea Study