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

  • End date
    Mar 22, 2022
  • participants needed
  • sponsor
    Digma Medical Ltd.
Updated on 22 February 2021
Chen Botvin Moshe
Primary Contact
IKEM (1.2 mi away) Contact
+4 other location
plasma glucose


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.


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.

Condition NIDDM, Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment DiaGone™
Clinical Study IdentifierNCT03390322
SponsorDigma Medical Ltd.
Last Modified on22 February 2021


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note