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

• ClinicalTrials.gov Identifier: NCT01995539
• Recruitment Status: Completed
• First Posted: November 26, 2013
• Results First Posted: October 18, 2018
• Last Update Posted: December 4, 2018
• Sponsor: Medtronic Diabetes
• Collaborator: Medtronic
• Information provided by (Responsible Party): Medtronic Diabetes

Tracking Information

• First Submitted Date: November 8, 2013
• First Posted Date: November 26, 2013
• Results First Submitted Date: March 22, 2018
• Results First Posted Date: October 18, 2018
• Last Update Posted Date: December 4, 2018
• Study Start Date: December 2012
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 8, 2018)

Change From Baseline in A1C at 3 Months [ Time Frame: 3 months ]

Descriptive analysis of change in A1C from baseline to end of 3-month study period

• Original Primary Outcome Measures (submitted: November 25, 2013): Change From Baseline in A1C at 3 Months [ Time Frame: Change from Baseline A1C at 3 months ]

Current Secondary Outcome Measures (submitted: November 8, 2018)

Number of Serious Adverse Device Effects (SADE). [ Time Frame: 3 months ]

Evaluation of incidence of SADE during the study.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
• Official Title: Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 2

Intervention

Behavioral: therapy regimen

Subjects will be recommend changes in therapy regimens.

Study Arms

Experimental: iPro2 Use

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

Intervention: Behavioral: therapy regimen

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 22, 2018): 181
• Original Actual Enrollment (submitted: November 25, 2013): 180
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT01995539
• Other Study ID Numbers: CEP274
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medtronic Diabetes
• Study 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

• PRS Account: Medtronic Diabetes
• Verification Date: November 2018