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.
The study protocol will also apply measures to better understand the mechanism of action of the effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2
Electrical stimulation to the fundus
Hospital Georges Pompidou
Paris, France
Atrium Medisch Centrum
Heerlen, Netherlands
HbA1c
The primary end point will be the difference, at 12 months, in HbA1c change from baseline, between the pts treated with the active signal compared to patients treated with a Sham System.
Time frame: 12 months
HbA1c
The difference, at 6 months in HbA1c change from baseline, between the pts treated with the active signal compared to patients treated with a Sham System.
Time frame: 6 months
GI hormones (C-peptide, Glucagon, Ghrelin, GLP-1, PYY, Gastrin and Somatostatin)
To detect differences in the pattern of meal-related release of GI hormones (slope / area under the curve, etc)between the treatment and the control groups, as analyzed by repeated-measures ANOVA. Glucose, insulin and the following GI hormones will be measured prior and post meal consumption: C-peptide, Glucagon, Ghrelin, GLP-1, PYY, Gastrin and Somatostatin.
Time frame: 6 and 12 months
Metabolic parameters (fasting and post Prandial glucose, blood pressure, lipids and cholesterol, weight and waist circumference)
The difference in metabolic parameters at 6 and 12 months from baseline between the two arms. Including: fasting and post Prandial glucose, blood pressure, lipids and cholesterol, weight and waist circumference.
Time frame: 6 and 12 months
Triglycerides
The effect of the TG level at baseline on treatment efficacy
Time frame: Baseline
HbA1c
The change in HbA1c from baseline to 12 months and 24 months
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.