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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Diabetes

Tracking Information
First Submitted Date  ICMJE November 8, 2013
First Posted Date  ICMJE November 26, 2013
Results First Submitted Date  ICMJE March 22, 2018
Results First Posted Date  ICMJE October 18, 2018
Last Update Posted Date December 4, 2018
Study Start Date  ICMJE December 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: November 25, 2013)
Change From Baseline in A1C at 3 Months [ Time Frame: Change from Baseline A1C at 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Behavioral: therapy regimen
Subjects will be recommend changes in therapy regimens.
Study Arms  ICMJE Experimental: iPro2 Use
All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Intervention: Behavioral: therapy regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2018)
181
Original Actual Enrollment  ICMJE
 (submitted: November 25, 2013)
180
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995539
Other Study ID Numbers  ICMJE CEP274
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Diabetes
Study Sponsor  ICMJE Medtronic Diabetes
Collaborators  ICMJE Medtronic
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP