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Efficacy Study of the DIAMOND System to Treat Type 2 Diabetes Mellitus

NCT01529216 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-03-16

No results posted yet for this study

Summary

The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured as A1c, FBG and Post-Prandial Glucose levels.

The study hypothesis is that HbA1c will show greater improvement in patients receiving 12 months of therapy by the DIAMOMD System than in patients not receiving this therapy.

Conditions

Interventions

DEVICE

DIAMOND System

Electrical stimulation to the fundus

Sponsors & Collaborators

  • MetaCure Limited

    lead INDUSTRY

Principal Investigators

  • Jan W.M. Greve, MD · Atrium medisch centrum METC, Heerlen, The Netherlands

  • Chevallier, MD · Hôpital GEORGES POMPIDOU 20 Rue Leblanc 75015 Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • France
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01529216 on ClinicalTrials.gov