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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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Behavioral: therapy regimen | Not Applicable |
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 (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 |
Arm | Intervention/treatment |
---|---|
Experimental: iPro2 Use
All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
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Behavioral: therapy regimen
Subjects will be recommend changes in therapy regimens. |
- 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
- Number of Serious Adverse Device Effects (SADE). [ Time Frame: 3 months ]Evaluation of incidence of SADE during the study.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Subject is > 18 years to ≤ 70 years of age
- 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
- Subject's A1C > 8.0% to ≤ 10% conducted in the last 4 weeks
- Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC)
- Subject is willing to comply with the study procedures
Exclusion criteria:
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion.
- Subject has no experience with SMBG and blood glucose meter use
- Subject has undergone an iPro evaluation during the past 6 months
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
- 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
- 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
- Subject has unresolved alcohol or drug addiction

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
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 |
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 |
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 |
Type 2 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |