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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: therapy regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subject is > 18 years to ≤ 70 years of age Subject has been diagnosed with type 2 diabetes mellitus for at least 1 year and is currently being treated with an oral anti-hyperglycemic medication and/or insulin Subject's A1C > 8.0% to ≤ 10% conducted in the last 4 weeks Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC) Subject is willing to comply with the study procedures Exclusion criteria: Subject is unable to tolerate tape adhesive in the area of sensor placement Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion. Subject has no experience with SMBG and blood glucose meter use Subject has undergone an iPro evaluation during the past 6 months Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection) Subject is actively participating or planning to actively participate in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator Subject has unresolved alcohol or drug addiction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPro2 Use<br>All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests | Behavioral: therapy regimen<br>* Subjects will be recommend changes in therapy regimens.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in A1C at 3 Months | Descriptive analysis of change in A1C from baseline to end of 3-month study period | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Serious Adverse Device Effects (SADE). | Evaluation of incidence of SADE during the study. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2