NCT03390322Completed
Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients
DiaGone™ First in Human (FIH) Study - Safety and Performance of the DiaGone™ Device for the Treatment of Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 18 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 26 Dec 2017
- Start date
- 28 Jul 2017
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Digma Medical Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT03390322
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 28 Jul 2017 to the primary completion date, 31 Aug 2024
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosed Type I diabetes
Lab values
- Serum C peptide \<1ng/ml
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IKEM Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Shaarei Tzedek Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.