Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

DiaGone™

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

IKEM
Soroka Medical CenterRecruiting
Shaarei TzedekRecruiting
Barcelona Clinical Hospital
Ramón y Cajal Insitute of Health Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duodenal Glycemic Control™

Arm Description

Outcomes

Primary Outcome Measures

Incidence of procedure related SAEs.

Secondary Outcome Measures

Change to Fasting Glucose levels

Change to Post Prandial Glucose levels

Change to HbA1c levels

Full Information

NCT ID

NCT03390322

First Posted

December 26, 2017

Last Updated

February 14, 2023

Sponsor

Digma Medical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03390322

Brief Title

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

Official Title

DiaGone™ First in Human (FIH) Study - Safety and Performance of the DiaGone™ Device for the Treatment of Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 28, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Digma Medical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 the DiaGone™ system.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Duodenal Glycemic Control™

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

DiaGone™

Intervention Description

Duodenal Glycemic Control™ using the DiaGone™ system

Primary Outcome Measure Information:

Title

Incidence of procedure related SAEs.

Time Frame

7 days

Title

Incidence of procedure related SAEs.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change to Fasting Glucose levels

Time Frame

12 months

Title

Change to Post Prandial Glucose levels

Time Frame

12 months

Title

Change to HbA1c levels

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hila Dagan

Phone

0547936392

hilad@digmamedical.com

Facility Information:

Facility Name

IKEM

City

Prague

Country

Czechia

Individual Site Status

Completed

Facility Name

Soroka Medical Center

City

Beer Sheva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Reuma Arusi

Phone

+972-8-6245375

reumaar@clalit.org.il

Facility Name

Shaarei Tzedek

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yael Lagemi

yaelagemi@szmc.org.il

First Name & Middle Initial & Last Name & Degree

Eran Goldin, Prof, MD

Facility Name

Barcelona Clinical Hospital

City

Barcelona

Country

Spain

Individual Site Status

Withdrawn

Facility Name

Ramón y Cajal Insitute of Health Research

City

Madrid

Country

Spain

Individual Site Status

Withdrawn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23388352

Citation

Salinari S, Bertuzzi A, Guidone C, Previti E, Rubino F, Mingrone G. Insulin sensitivity and secretion changes after gastric bypass in normotolerant and diabetic obese subjects. Ann Surg. 2013 Mar;257(3):462-8. doi: 10.1097/SLA.0b013e318269cf5c.

Results Reference

background

PubMed Identifier

19246589

Citation

Ferrannini E, Mingrone G. Impact of different bariatric surgical procedures on insulin action and beta-cell function in type 2 diabetes. Diabetes Care. 2009 Mar;32(3):514-20. doi: 10.2337/dc08-1762. No abstract available.

Results Reference

background

PubMed Identifier

20152737

Citation

Mingrone G, Castagneto-Gissey L. Mechanisms of early improvement/resolution of type 2 diabetes after bariatric surgery. Diabetes Metab. 2009 Dec;35(6 Pt 2):518-23. doi: 10.1016/S1262-3636(09)73459-7.

Results Reference

background

PubMed Identifier

23526068

Citation

de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Schaper NC, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes. Obes Surg. 2013 Sep;23(9):1354-60. doi: 10.1007/s11695-013-0921-3.

Results Reference

background

Links:

URL

https://www.digmamedical.com

Description

Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs