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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: therapy regimen Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
Study Start Date : December 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : April 2014
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of Serious Adverse Device Effects (SADE). [ Time Frame: 3 months ]
    Evaluation of incidence of SADE during the study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995539


Locations
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India
Madras Diabetes Research Foundation
Gopalapuram, Chennai, India, 600086
DIA Care
Ahmedabad, Gujarat, India, 380015
Medanta
Gurgaon, Haryana, India, 122 001
Jothydev's Diabetes and Research Centre
Trivandrum, Kerala, India, 695032
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India, 452010
K.G.N Diabetes and Endocrine Centre
Mumbai, Maharashtra, India, 400008
Lina Diabetes Care Centre
Mumbai, Maharashtra, India, 400053
Dr.Kovil's Diabetes Care centre
Mumbai, Maharashtra, India, 400058
Diab Care Center
Mumbai, Maharashtra, India, 400080
Diabetes Care & Research Center
Pune, Maharashtra, India, 411011
M.V Hospital for Diabetes Research centre
Chennai, Tamil Nadu, India, 600013
Sponsors and Collaborators
Medtronic Diabetes
Medtronic
Investigators
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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
More Information
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01995539    
Other Study ID Numbers: CEP274
First Posted: November 26, 2013    Key Record Dates
Results First Posted: October 18, 2018
Last Update Posted: December 4, 2018
Last Verified: November 2018
Keywords provided by Medtronic Diabetes:
Type 2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases