Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

A Trial for a Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.

Randomized, Single-Center, Parallel-group, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Magnet Anastomosis System (MAS) When Used to Create a Dual-path Enteral Diversion Compared with Medical Therapy Alone To Effect Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus (T2DM)

Inclusion Criteria:

• Body mass index (BMI) 30 to 50.

• Subject Type 2 Diabetes Criteria:

  1. T2DM diagnosis ≥6 months but < 10 years
  2. On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose)
  3. 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)
  4. 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

Exclusion Criteria:

• Known or suspected allergy to nickel or titanium or Nitinol
• Type 1 Diabetes
• Use of injectable insulin
• 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)
• Any documented conditions for which endoscopy/colonoscopy would be contraindicated.
• Contraindication to general anesthesia
• Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation.
• 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
• If on metformin, history of polycystic ovarian syndrome (PCOS)
• Unable or unwilling to perform home blood glucose monitoring
• 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
• Previous surgical or endoscopic treatment for obesity including but not restricted to intragastric balloons, endoscopic suturing or stapling procedures, malabsorptive sleeves.
• Specific genetic or hormonal cause of obesity (e.g. Prader-Willi syndrome)