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

  • STATUS
    Recruiting
  • End date
    Mar 22, 2022
  • participants needed
    16
  • sponsor
    Digma Medical Ltd.
Updated on 22 February 2021
fasting
plasma glucose

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.

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.

Details
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

Eligibility

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
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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.

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

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