Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients

Digma Medical

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: DiaGone™

Study type: Interventional

Funder types: Industry

Identifiers

NCT03390322

CLD-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Duodenal Glycemic Control™

Experimental group

Treatment:

Device: DiaGone™