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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
181
Subjects will be recommend changes in therapy regimens.
Madras Diabetes Research Foundation
Gopalāpuram, Chennai, India
DIA Care
Ahmedabad, Gujarat, India
Medanta
Gurgaon, Haryana, India
Change From Baseline in A1C at 3 Months
Descriptive analysis of change in A1C from baseline to end of 3-month study period
Time frame: 3 months
Number of Serious Adverse Device Effects (SADE).
Evaluation of incidence of SADE during the study.
Time frame: 3 months
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...and 1 more locations