Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Prospective, Single Center Study to Assess the Performance, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).
This is a prospective, single center, open-label, uncontrolled study to assess the efficacy, safety, and patient reported outcomes of insulin delivery with PaQ® in patients with type 2 diabetes mellitus (T2DM) who are currently receiving basal/bolus insulin therapy with or without oral anti-diabetic drugs (OADs) for glycemic control. The patient's participation in the study is comprised of three phases: screening/baseline evaluation, transition to PaQ use and optimization, and PaQ treatment period. The use of these phases will allow an orderly transition to PaQ treatment as well as a reliable construct from which to interpret the final data. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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