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

NCT ID: NCT01995539

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-04-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iPro2 Use

All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests

Group Type: EXPERIMENTAL

therapy regimen

Intervention Type: BEHAVIORAL

Subjects will be recommend changes in therapy regimens.

Interventions

therapy regimen

Subjects will be recommend changes in therapy regimens.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Subject is > 18 years to ≤ 70 years of age

2. 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

3. Subject's A1C > 8.0% to ≤ 10% conducted in the last 4 weeks

4. Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC)

5. Subject is willing to comply with the study procedures

Exclusion Criteria

1. Subject is unable to tolerate tape adhesive in the area of sensor placement

2. Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion.

3. Subject has no experience with SMBG and blood glucose meter use

4. Subject has undergone an iPro evaluation during the past 6 months

5. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)

6. 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

7. 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

8. Subject has unresolved alcohol or drug addiction

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jothydev Kesavadev, MD

Role: PRINCIPAL_INVESTIGATOR

Jothydev's Diabetes and Research Centre

Mohan V, MD

Role: PRINCIPAL_INVESTIGATOR

Madras Diabetes Research Foundation

Vijay Viswanathan, MD

Role: PRINCIPAL_INVESTIGATOR

M.V Hospital for Diabetes Research centre

Ambrish Mithal, MD

Role: PRINCIPAL_INVESTIGATOR

Medanta Institute of Clinical Research

Manoj Chawla, MD

Role: PRINCIPAL_INVESTIGATOR

Lina Diabetes Care Mumbai Diabetes Research Centre

Rajiv Kovil, MD

Role: PRINCIPAL_INVESTIGATOR

Dr.Kovil's Diabetes Care centre

Banshi Saboo, MD

Role: PRINCIPAL_INVESTIGATOR

DIA Care

Sunil Jain, MD

Role: PRINCIPAL_INVESTIGATOR

TOTALL Diabetes Hormone Institute

Abhay Mutha, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Care & Research Center

Shehla Shaikh, MD

Role: PRINCIPAL_INVESTIGATOR

K.G.N DIABETES AND ENDOCRINE CENTRE

Dharmen Punatar, MD

Role: PRINCIPAL_INVESTIGATOR

Diab Care Centre

Scott Lee, MD

Role: STUDY_DIRECTOR

Medtronic Diabetes

Locations

Madras Diabetes Research Foundation

Gopālapuram, Chennai, India

DIA Care

Ahmedabad, Gujarat, India

Medanta

Gurgaon, Haryana, India

Jothydev's Diabetes and Research Centre

Trivandrum, Kerala, India

TOTALL Diabetes Hormone Institute

Indore, Madhya Pradesh, India

K.G.N Diabetes and Endocrine Centre

Mumbai, Maharashtra, India

Lina Diabetes Care Centre

Mumbai, Maharashtra, India

Dr.Kovil's Diabetes Care centre

Mumbai, Maharashtra, India

Diab Care Center

Mumbai, Maharashtra, India

Diabetes Care & Research Center

Pune, Maharashtra, India

M.V Hospital for Diabetes Research centre

Chennai, Tamil Nadu, India

Countries

India

Other Identifiers

CEP274

Identifier Type: -

Identifier Source: org_study_id