Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
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ClinicalTrials.gov Identifier: NCT01995539 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Results First Posted : October 18, 2018
Last Update Posted : December 4, 2018
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Tracking Information | |||||||||||||||||||||||||||||||||||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
Change From Baseline in A1C at 3 Months [ Time Frame: Change from Baseline A1C at 3 months ] | ||||||||||||||||||||||||||||||||||||
Change History | |||||||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
Number of Serious Adverse Device Effects (SADE). [ Time Frame: 3 months ] Evaluation of incidence of SADE during the study.
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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:
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. |
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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 |
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Condition ICMJE | Diabetes Mellitus, Type 2 | ||||||||||||||||||||||||||||||||||||
Intervention ICMJE | Behavioral: therapy regimen
Subjects will be recommend changes in therapy regimens.
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Study Arms ICMJE | Experimental: iPro2 Use
All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Intervention: Behavioral: therapy regimen
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Publications * | Not Provided | ||||||||||||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||||||||
Actual Enrollment ICMJE |
181 | ||||||||||||||||||||||||||||||||||||
Original Actual Enrollment ICMJE |
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:
Exclusion criteria:
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Sex/Gender ICMJE |
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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 |
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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 |