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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: therapy regimen

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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chennai
    • Gopalapuram, Chennai, India, 600086
      • Madras Diabetes Research Foundation
  • Gujarat
    • Ahmedabad, Gujarat, India, 380015
      • DIA Care
  • Haryana
    • Gurgaon, Haryana, India, 122 001
      • Medanta
  • Kerala
    • Trivandrum, Kerala, India, 695032
      • Jothydev's Diabetes and Research Centre
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452010
      • TOTALL Diabetes Hormone Institute
  • Maharashtra
    • Mumbai, Maharashtra, India, 400008
      • K.G.N Diabetes and Endocrine Centre
    • Mumbai, Maharashtra, India, 400053
      • Lina Diabetes Care Centre
    • Mumbai, Maharashtra, India, 400058
      • Dr.Kovil's Diabetes Care centre
    • Mumbai, Maharashtra, India, 400080
      • Diab Care Center
    • Pune, Maharashtra, India, 411011
      • Diabetes Care & Research Center
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600013
      • M.V Hospital for Diabetes Research centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Medtronic Diabetes
• Collaborators: Medtronic
• Investigators: Principal Investigator: Jothydev Kesavadev, MD, Jothydev's Diabetes and Research Centre; Principal Investigator: Mohan V, MD, Madras Diabetes Research Foundation; Principal Investigator: Vijay Viswanathan, MD, M.V Hospital for Diabetes Research centre; Principal Investigator: Ambrish Mithal, MD, Medanta Institute of Clinical Research; Principal Investigator: Manoj Chawla, MD, Lina Diabetes Care Mumbai Diabetes Research Centre; Principal Investigator: Rajiv Kovil, MD, Dr.Kovil's Diabetes Care centre; Principal Investigator: Banshi Saboo, MD, DIA Care; Principal Investigator: Sunil Jain, MD, TOTALL Diabetes Hormone Institute; Principal Investigator: Abhay Mutha, MD, Diabetes Care & Research Center; Principal Investigator: Shehla Shaikh, MD, K.G.N Diabetes and Endocrine Centre; Principal Investigator: Dharmen Punatar, MD, Diab Care Centre; Study Director: Scott Lee, MD, Medtronic Diabetes

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: November 8, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): November 26, 2013

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Type 2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CEP274

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No