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

December 15, 2024 updated by: Digma Medical Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia
        • IKEM
  • Israel
      • Beer Sheva, Israel
        • Soroka Medical Center
      • Jerusalem, Israel
        • Shaarei Tzedek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duodenal Glycemic Control™
Device: DiaGone™
Duodenal Glycemic Control™ using the DiaGone™ system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of procedure related SAEs.
Time Frame: 7 days
7 days
Incidence of procedure related SAEs.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change to Fasting Glucose levels
Time Frame: 12 months
12 months
Change to Post Prandial Glucose levels
Time Frame: 12 months
12 months
Change to HbA1c levels
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Digma Medical Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2017

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLD-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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