DiaGone™ First in Human (FIH) Study - Safety and Performance of the DiaGone™ Device for the Treatment of Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 3
- Primary Endpoint
- Incidence of procedure related SAEs.
Study Overview
Brief Summary
This is a multi-center, prospective, open label study of the Duodenal Glycemic Control™ procedure on type 2 diabetes patients sub-optimally controlled, to examine the safety and initial performance of the DiaGone™ system.
Detailed Description
This study is a multi-center, prospective, open label trial of type 2 diabetes patients sub-optimally controlled on at least one oral anti-diabetic medication.
Subjects who meet all inclusion and exclusion criteria after screening are hospitalized and go through the Duodenal Glycemic Control™ treatment.
Duodenal Glycemic Control™ treatment is conducted by a gastroenterologist, in an endoscopic suite, with an off-the-shelf endoscope, using the DiaGone™ system.
Patients are followed for 6 months for AE and SAE. Patients are followed for 12 months for glycemic control parameters.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects who are ≥ 18 years and ≤ 75 years of age.
- •HbA1c at 7.5%-12%
- •On oral glucose lowering drugs in a stable medication regimen
- •Fasting plasma glucose level at ≥125mg/dL
- •BMI 25-40 Kg/m2
Exclusion Criteria
- •Diagnosed Type I diabetes
- •Serum C peptide <1ng/ml
Arms & Interventions
Duodenal Glycemic Control™
Intervention: DiaGone™ (Device)
Outcomes
Primary Outcomes
Incidence of procedure related SAEs.
Time Frame: 6 months
Incidence of procedure related SAEs.
Time Frame: 7 days
Secondary Outcomes
- Change to HbA1c levels(12 months)
- Change to Fasting Glucose levels(12 months)
- Change to Post Prandial Glucose levels(12 months)