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: 

  • Over 500 million world-wide are obese (with Body Mass Index of 30 or higher)
  • Over 250 million people have type 2 diabetes 
  • Roughly 60 million people are afflicted with both obesity and type 2 diabetes

In the United States, 1 in 3 people will have type 2 diabetes by 2050, if current trends continue:

  • In 2012, 1.7 million new cases of type 2 diabetes were diagnosed 
  • Currently, 86 million people — more than 1 out of 3 adults — have pre-diabetes 
    • 15–30% of those will develop type 2 diabetes within 5 years

The costs to the healthcare system in the US are staggering and continue to climb:     

  • More than 1 in 5 health care dollars in the U.S. go to the care of people with diagnosed diabetes.
  • Total estimated costs of treating diabetes have increased 41%, from $174 billion in 2007 to $245 billion in 2012 .
  • Diabetics incur average medical expenses of $13,700 per year, some 2.3 times higher than those of a comparable age but without diabetes.

Treatment Options

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. 

L Sjostrom et al - N Engl J Med 2007; 357:741-752, G Mingrone et al. N Engl J Med 2012;366:1577-1585, 
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.

References: 

1: Parikh M, Chung M, Sheth S, McMacken M, Zahra T, Saunders JK, Ude-Welcome A, Dunn V, Ogedegbe G, Schmidt AM, Pachter HL. Randomized pilot trial of bariatric surgery versus intensive medical weight management on diabetes remission in type 2 diabetic patients who do NOT meet NIH criteria for surgery and the role of soluble RAGE as a novel biomarker of success. Ann Surg. 2014 Oct;260(4):617-22; discussion 622-4.

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.