Diabetes Mellitus, Type 2 Clinical Trial
Official title:
The TANTALUS® II for the Treatment of Type 2 Diabetes: A Single-Blind Cross-Over Study
Evaluation of the safety and efficacy of gastric contractility modulation (GCM) stimulation using the TANTALUS System in the improvement of glycemic control measured by changes in HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be evaluated
This is a multi-center, single blind, randomized, cross-over study. Subject enrollment will
continue until forty (40) eligible participants have been randomized into one of the two
groups. Subjects will undergo baseline valuation (Visit 1) during which the stability of
their glycemic parameters, medical treatment and medical condition will be assessed.
Subjects meeting all inclusion/exclusion criteria at Visit 2 will be implanted.
Approximately three days prior to their implantation, subjects will be seen for their
'pre-implant' medical evaluation (Visit 3). One week after implant (Visit 5, Week 1)subjects
will be randomized into one of two groups (A and B).
"Group A" subjects will have their device programmed to deliver GCM signal including the
setting of automatic eating detection parameters for the first 24 week period (Period 1). At
Visit 10, (week 25 and end of Period 1), Group A subjects will have their devices turned
"OFF" for the next 24 weeks period (Period 2). At Visit 15, (week 49 and end of Period 2),
Group A subjects will have their devices turned "On" for the next 24 weeks period (Period 3)
"Group B" subjects will not have their device activated for the first 24 weeks (Period 1) of
their study. At Visit 10 (week 25 end of Period 1), Group B subjects devices will have their
device turned "ON" (i.e. activated to deliver CGM signals) for the 24 weeks period (Period
2). At Visit 15, (week 49 and end of Period 2), Group B subjects will have their devices
turned "OFF" for the next 24 weeks period (Period 3).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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