New York – April 16 2015 – A three-year study lead by Professor Harold E. Lebovitz of the State University of New York Health Science Center in Brooklyn, New York, concluded that the meal-mediated gastric electrical stimulation delivered by the DIAMOND device improves glycemic control and reduces body weight in patients with type 2 diabetes inadequately controlled by oral medication.
The international study recruited 75 patients across eleven centers in six countries, including the USA and Germany. Professor Lebovitz explained – “This study is the first to observe the long-term impact of meal-mediated gastric electrical stimulation delivered by the DIAMOND device on type 2 diabetes. We found that the reduction in HbA1c was durable throughout the period. These are promising results which give new hope in addressing the global diabetes pandemic.”
The study reported that the mean decrease in HbA1c in type 2 diabetes patients, with normal fasting plasma triglycerides, was 1.1% and lasted through the three years of observation. Dr. Mateusz Zelewski, CEO of MetaCure, explained the importance of the findings – “According to Stratton et al., each 1% reduction in HbA1c lowers the risk of diabetes related death by 21% and decreases microvascular complications by 37%.”
Marked weight loss of 10% or more was also observed in a significant proportion of patients with normal fasting plasma triglycerides and this persisted throughout the study period.
Professor Shlomo Ben-Haim, founder of the Hobart Group and MetaCure, said: “This is major step forward for the care of hundreds of millions of sufferers of type 2 diabetes worldwide. Research to date has demonstrated that the DIAMOND device has a significant and durable impact on obese type 2 diabetes sufferers and allows us to press forward with bringing our device to the many who need it.”
Some of the three-year study results are shown below. The full study results as published are available here.
Some key figures are provided below.
Sustained Decrease in HbA1c
Change in HbA1c in patients with type 2 diabetes with low triglyceride level managed with the DIAMOND device over three years (cross-sectional data). The decrease in HbA1c in these patients was durable over the three years and averaged at 1.1% (ANCOVA p=0.001). Reproduced from Lebovitz HE, Ludvik B, Yaniv I, et al. Treatment of Patients with Obese Type 2 Diabetes with Tantalus-DIAMOND® Gastric Electrical Stimulation: Normal Triglycerides Predict Durable Effects for at Least 3 Years. Horm Metab Res. 2015;47(6):456-62.
Sustained Weight Loss
Changes in body weight as percentage from baseline in obese type 2 diabetes patients with low triglyceride level over 12, 24 and 36 months under DIAMOND therapy. Produced from data published in Lebovitz HE, Ludvik B, Yaniv I, et al. Treatment of Patients with Obese Type 2 Diabetes with Tantalus-DIAMOND® Gastric Electrical Stimulation: Normal Triglycerides Predict Durable Effects for at Least 3 Years. Horm Metab Res. 2015;47(6):456-62.
Learn about clinical evidence of DIAMOND therapy for Type 2 Diabetes here
About type 2 diabetes
Type 2 diabetes is a metabolic disorder characterized by hyperglycemia resulting from inadequate insulin secretion or insulin resistance. The most common form of diabetes, it represents 90% of all cases. Often referred to as a pandemic, it is estimated that over 400 million people worldwide are affected by diabetes, with management costs exceeding $800 billion annually.
About DIAMOND therapy
DIAMOND therapy is delivered via an implantable medical device which has the potential to be used as an alternative to insulin. The safety and efficacy of DIAMOND therapy have been validated in clinical trials involving over 300 patients, including a pilot study which demonstrated a comparable effectiveness to insulin treatment, but avoiding many side-effects and the inconvenience of frequent blood tests and injections. Designed to treat type 2 diabetes in obese patients who are refractory to oral medication, DIAMOND therapy is delivered via a small pacemaker-like device implanted in the abdomen, which delivers electrical signals to the stomach when eating, improving glycemic control and promoting weight loss. DIAMOND has received CE mark and is approved for sale in Europe, Australia and other international markets; it is currently not approved for use in the USA. For more information, visit www.MetaCure.com/DIAMOND.
MetaCure, a member of the Hobart Group companies, aims to provide a better way to manage type 2 diabetes, focusing on the impact on the day-to-day lives of patients. It develops, produces and markets the DIAMOND therapy, an alternative to insulin delivered via a proprietary implantable device. For more information, visit MetaCure.com.
About Hobart Group
The Hobart Group develops and commercializes medical technologies which target top healthcare markets with significant unmet needs. Its growing portfolio of companies covers the areas of cardiology, diabetes, oncology, neurology and rehabilitation. Together, Hobart Group companies have over 200 scientists, engineers, regulatory and business experts across four continents, benefitting from clinical expertise and extensive regulatory and international market knowledge across Europe, the USA and Asia. For more information, visit www.Hobart-Group.com.