Safety and Initial Performance of the DiaGone Device on T... | NCT03390322

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

NCT03390322

Sponsor

Digma Medical Ltd.

Status

Completed

Last Update Posted

Dec 18, 2024Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2

Interventions

DiaGone™

Countries

Czechia
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2017Actual

Primary Completion Date

Aug 31, 2024Actual

Completion Date

Aug 31, 2024Actual

First Submitted Date

Dec 26, 2017

First Submission Date that Met QC Criteria

Jan 3, 2018

First Posted Date

Jan 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2024

Last Update Posted Date

Dec 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Duodenal Glycemic Control™	Experimental		Device: DiaGone™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DiaGone™	Device	Duodenal Glycemic Control™ using the DiaGone™ system	Duodenal Glycemic Control™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of procedure related SAEs.		7 days
Incidence of procedure related SAEs.		6 months

Secondary Outcomes

Measure	Description	Time Frame
Change to Fasting Glucose levels		12 months
Change to Post Prandial Glucose levels		12 months
Change to HbA1c levels

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IKEM		Prague			Czechia
Soroka Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23388352	Background	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.
19246589	Background	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases