Status:
COMPLETED
Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients
Lead Sponsor:
Digma Medical Ltd.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
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 exc...
Eligibility Criteria
Inclusion
- 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
- Diagnosed Type I diabetes
- Serum C peptide \<1ng/ml
Key Trial Info
Start Date :
July 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03390322
Start Date
July 28 2017
End Date
August 31 2024
Last Update
December 18 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
IKEM
Prague, Czechia
2
Soroka Medical Center
Beersheba, Israel
3
Shaarei Tzedek
Jerusalem, Israel