Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
The purpose of the India iPro2 study is to demonstrate that iPro2 Continuous Glucose Monitoring System (CGMS) evaluation enables Health Care Professional (HCP)s treating patients in India with type 2 diabetes to get a better understanding of their patient's metabolic fluctuations, and support appropriate therapeutic intervention.
The study will be designed to demonstrate the value of iPro2 in real-world diabetes
management in type 2 patients in India. It will be an interventional post-market,
prospective, multi-center study with a data review performed after 30 subjects have completed
the trial.
During the course of the study, patients will undergo two iPro2 evaluations:
- First iPro2 test (Visit 1 [application] & 2 [removal])
- Second iPro2 test (Visit 3 [application] & 4 [removal])
Patient and HCP questionnaires will be administered at Visit 1, 2, 3, 4 and 5. These
questionnaires aim to assess the impact of an iPro2 evaluation on the physicians
understanding of their patient's metabolic fluctuations and its support of therapeutic
interventions. They will also investigate the subjects understanding (both pre & post iPro2
evaluation) of the concept of glycemic variability and the importance of compliance to HCP
recommendations.
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