Skip to main content
OpenTrials
Completed

NCT Number: NCT03390322

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IKEM, Prague, Czechia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DiaGone™

Device

Duodenal Glycemic Control™ using the DiaGone™ system

Primary outcomes

  1. Incidence of procedure related SAEs.

    Time frame: 7 days

  2. Incidence of procedure related SAEs.

    Time frame: 6 months

Secondary outcomes

  1. Change to Fasting Glucose levels

    Time frame: 12 months

  2. Change to Post Prandial Glucose levels

    Time frame: 12 months

  3. Change to HbA1c levels

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Digma Medical Ltd.

Industry

Registry information

Official study title

DiaGone™ First in Human (FIH) Study - Safety and Performance of the DiaGone™ Device for the Treatment of Type 2 Diabetes

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jan 4, 2018
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.