Endoscopy 2019; 51(04): S159
DOI: 10.1055/s-0039-1681640
ESGE Days 2019 ePoster podium presentations
Friday, April 5, 2019 16:30 – 17:00: Bariatric ePoster Podium 1
Georg Thieme Verlag KG Stuttgart · New York

ENDOSCOPIC SUBMUCOSAL LASER ABLATION FOR THE TREATMENT OF TYPE 2 DIABETES – PRELIMINARY FIRST IN HUMAN STUDY RESULTS

M Benes
1   Gastroenterology and Hepatology, IKEM, Prague, Czech Republic
,
I Marcovitch
2   Clinical Department, Digma Medical Ltd., Petah Tikva, Israel
,
M Mraz
3   Diabetology, IKEM, Prague, Czech Republic
,
A Herschkovitz
2   Clinical Department, Digma Medical Ltd., Petah Tikva, Israel
,
M Haluzik
3   Diabetology, IKEM, Prague, Czech Republic
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Publikationsverlauf

Publikationsdatum:
18. März 2019 (online)

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Aims:

Duodenal exclusion by surgery or an artificial liner has been found very effective in treating T2DM.

Duodenal Glycemic Control (DGC) is an endoscopic procedure under direct vision which uses a disposable catheter (DiaGone) without an Implant. DiaGone utilizes precisely controlled laser technology to target the duodenal submucosa in order to modulate the GI neurohormonal axis, hence improving glucose metabolism.

Following encouraging data from an insulin-resistant porcine animal-model study, the DiaGone catheter was tested in a first-in-human study for the evaluation of safety and performance. The DGC procedure was performed under direct vision by interventional gastroenterologists on Subjects with T2DM uncontrolled on oral medication (metformin).

Methods:

Six patients (All men; baseline HbA1c 9.0% & mean BMI 30.0 kg/m2) were treated with sub-optimal energy dosage and analyzed for tolerability and safety.

Results:

All procedures completed successfully. Median procedure time was 50 minutes. 1-month follow-up endoscopies were without any clinical findings in all patients; there were no reported adverse events related to the device or the procedure. None of the patients reported changes in GI symptoms or behavior.

Conclusions:

DGC is an easy to use endoscopic treatment of T2DM, demonstrating safe and highly tolerable results. Currently, DiaGone catheter and DGC procedure are being tested in T2DM patients using therapeutic dosage in an on-going study.