Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

Prior treatment

• Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas or right colon.
• Previous technically difficult or failed colonoscopy or endoscopy
• Previous surgical or endoscopic treatment for obesity including but not restricted to intragastric balloons, endoscopic suturing or stapling procedures, malabsorptive sleeves.

Other illness

• Known or suspected allergy to nickel or titanium or Nitinol
• Type 1 Diabetes
• Any documented conditions for which endoscopy/colonoscopy would be contraindicated.
• If on metformin, history of polycystic ovarian syndrome (PCOS)
• History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease)
• Diagnosis of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin
• Specific genetic or hormonal cause of obesity (e.g. Prader-Willi syndrome)

Lab values

• Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L)
• Probable insulin production failure, defined as fasting serum C Peptide \<1 ng/mL (0.3 nmol/l)
• Unable or unwilling to perform home blood glucose monitoring

Other

• Use of injectable insulin
• Contraindication to general anesthesia
• Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation.

• Body mass index (BMI) 30 to 50.
• Subject Type 2 Diabetes Criteria:
  • T2DM diagnosis ≥6 months but \< 10 years
  • On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose)
  • Hemoglobin A1C (HbA1c) between and including 6.5 and 10.0% (58 mmol/mol to 86 mmol/mol) at time of enrollment and has had a stable HbA1c over a 3-month period (i.e., \<0.3% reduction)
  • Stable medication regimen (i.e., no change in diabetes medications) for at least 3 months prior to Screening Visit.
• If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
• Able to understand and sign informed consent document
• Has primary care physician and/or endocrinologist who follows patient for all comorbid conditions