NCT01995539

Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
BEHAVIORAL	therapy regimen	Subjects will be recommend changes in therapy regimens.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-01-01
• Completion: 2014-04-01
• First posted: 2013-11-26
• Last updated: 2018-12-04
• Results posted: 2018-10-18

Locations

11 sites across 1 country: India