Type 2 diabetes and obesity are present-day epidemics. Figures from the World Health Organization, Centers for Disease Controls and Prevention, and American Diabetes Association indicate the degree to which these conditions are prevalent in the world’s populations:
In the United States, 1 in 3 people will have type 2 diabetes by 2050, if current trends continue:
The costs to the healthcare system in the US are staggering and continue to climb:
Type 2 diabetes and obesity are chronic diseases that require a lifetime of treatment. Diet and exercise are the front-line therapies, but over 85% of diagnosed diabetics see a progression of the disease, requiring oral medications and ultimately insulin therapy. These diseases, if unchecked, can lead to a host of other serious medical conditions including heart disease, end-stage renal failure, and blindness.
Bariatric surgery has been proven, in randomized controlled studies, to be an effective and durable treatment for obesity and type 2 diabetes.
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L Sjostrom et al - JAMA. 2014;311(22):2297-2304
The American Diabetes Association and the International Diabetes Federation have made changes in their treatment recommendations to include surgery for obese patients with uncontrolled type 2 diabetes. Yet despite these changes, adoption of the surgical option is low. Less than 1% of the afflicted population elects surgery as a treatment path. This may be due to high costs, the threat of adverse events, and an aversion to surgery from patients and primary-care physicians.
To address a healthcare need of this magnitude, solutions must be scalable to address the millions of patients afflicted. A clear, unmet clinical need exists for a non-surgical, simple, and lasting therapy that can be delivered in an out-patient setting, and makes economic sense for patients, providers, and payers alike.
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2: Halperin F, Ding SA, Simonson DC, Panosian J, Goebel-Fabbri A, Wewalka M, Hamdy O, Abrahamson M, Clancy K, Foster K, Lautz D, Vernon A, Goldfine AB. Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial. JAMA Surg. 2014 Jul;149(7):716-26.
3: Courcoulas AP, Goodpaster BH, Eagleton JK, Belle SH, Kalarchian MA, Lang W, Toledo FG, Jakicic JM. Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. JAMA Surg. 2014 Jul;149(7):707-15.
4: Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Brethauer SA, Navaneethan SD, Aminian A, Pothier CE, Kim ES, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes. N Engl J Med. 2014 May 22;370(21):2002-13.