PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Fri, 05 Oct :16:50 GMT) CTRI Number Last Modified On 07/08/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/03/ [Registered on: 19/03/2013] - Trial Registered Retrospectively No PMS Medical Device Other 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. Use of ipro 2 in Real Life Diabetes Management of Type 2 Patients in India. An interventional post-market, prospective, multi-center study Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) CEP274 Designation Affiliation Address Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Mr Rajesh Radhakrishnan Director - Clinical Studies, India Medtronic Pvt Ltd India Medtronic Pvt Ltd Address India Medtronic Pvt Ltd Solitaire Corporate Park Building Number 12, 4th Floor, Andheri (East) India Phone Fax Designation Affiliation rajesh.radhakrishnan@medtronic.com Details Contact Person (Public Query) Mr Rajesh Radhakrishnan Director - Clinical Studies, India Medtronic Pvt Ltd India Medtronic Pvt Ltd Address India Medtronic Pvt Ltd Solitaire Corporate Park Building Number 12, 4th Floor, Andheri (East) India page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > India Medtronic Pvt Ltd Address Type of Sponsor NIL List of Countries India of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details India Medtronic Pvt Ltd Solitaire Corporate Park Building Number 12, 4th Floor, Andheri East Other [Medical Device Organization] Address NIL of Site Site Address Phone/Fax/ Dr Banshi Saboo DIA Care Department of Diabetology, Nr Nehrunagar Cross Road, Opp L Colony, Ambavadi, Ahmedabad Ahmadabad GUJARAT Dr Dharmen Punatar Diab Care Centre 1st Floor, B.P.S. Plaza, Devidayal Road, Mulund (W), (Suburban) DrAbhay Mutha Dr Rajiv Kovil DrRitesh Gupta Diabetes Care & Research centre Dr.Kovil s Diabetes Care centre Fortis C-DOC Healthcare Ltd. Dr Jothydev Kesavadev Jothydev s Diabetes and Research Centre B-5 Mittal Court.478 Rasta peth.pune Pune D 17 Ground Floor Shivashish Building, Department of Diabetology, Near Shoppers Stop Opp ICICI Bank, S V Road, Andheri West, Fortis C-DOC Healthcare Ltd. B-16, Chirag Enclave,(Opp. Nehru Place), New Delhi New Delhi DELHI Jothydev s Diabetes and Research banshisaboo@hotmail.c om drdharmen@yahoo.co.i n drabhaymutha@gmail.c om drrajivkovil@gmail.com riteshgupta72@gmail.c om page 2 / 6

3 Details of Ethics Committee Dr Shehla Shaikh Dr Manoj Chawla Dr Vijay Vishwanathan Dr V Mohan Dr Ambrish Mithal Dr Sunil Jain K.G.N Diabetes and Endocrine Centre. Lina Diabetes Care Centre M.V Hospital for centre Madras Diabetes Research Foundation Centre,Department of Diabetology, Mudavanmugal, Trivandrum Thiruvananthapuram KERALA 9/10,1st floor arcade,nagpada junction /2,Yashodhan Apt,four Bunglows,J.P Road,Andheri (west) M.V Hospital for centre, Department of Diabetology, Royapuram, Chennai Chennai TAMIL NADU Dr.Mohans Diabetes Specialties centre Department of Diabetology,Conran Smith rd, Chennai Chennai TAMIL NADU Medanta The medicity Department of Diabetology, Sector 38, Gurgaon Gurgaon HARYANA TOTALL Diabetes Hormone Institute PU-4 Scheme No.54,Near Bombay Prestige management institute,indore.madhya Pradesh Indore MADHYA PRADESH jothydev@gmail.com drshehla@rediffmail.co m linadiabetes@gmail.co m drvijay@mvdiabetes.co m drmohans@diabetes.in d.in ambrishmithal@hotmail.com suniljain@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Clinical Ethics Forum//Dr. Kovil Clinical Ethics Forum//Dr. Manoj Chawla Clinical Ethics Forum/M umbai/dr.punatar Clinical Ethics Forum/M umbai/dr.shehla Approved 23/01/2013 Yes Approved 20/02/2013 Yes Approved 23/01/2013 Yes Approved 20/02/2013 Yes page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria DIA Care Research Ethics Committee Ethics committee - Prof.M.Viswanathan Centre, M.V. Hospital for Diabetes Pvt. Ltd Ethics Committee for Submittted/Under Research-Fortis C-DOC Review Ethics Committee, Diabetes Thyroid Hormone Research Institute Pvt Ltd, Indore Ethics Committee, Jothydevs Diabetes & Research Center Institutional ethics committee of Diabetes Care & Research Centre Institutional Ethics Committee, Madras Foundation - Dr. Mohans Diabetes Specialities Center Medanta Institutional Ethics Committee Status Health Type Patients Approved 03/12/2012 No Approved 04/01/2013 No No Approved 07/01/2013 No Approved 07/12/2012 No Approved 12/02/2013 No Approved 11/12/2012 No Submittted/Under Review Date Condition No Patients with Type 2 Diabetes Type Details Intervention 2 additional visit 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]) Teh 2nd ipro2 evaluation would be an intervention Comparator Agent Not applicable Not applicable Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 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 page 4 / 6

5 Exclusion Criteria Details 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 Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints The objective of the India ipro2 Study is to 3 months generate local evidence to demonstrate that the ipro2 CGMS evaluation (including process and educational tools) enables HCPs, treating patients with type 2 diabetes, to get a better understanding of their patient s metabolic fluctuations and support appropriate therapeutic intervention leading to improved glycemic control in type 2 diabetes patients Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary None Total Sample Size=250 Sample Size from India=250 Post Marketing Surveillance 25/12/2012 Years=1 Months=0 Days=0 Completed Not applicable Publications and presentations referring to India ipro2 Study will be coordinated by Medtronic to allow the use of all available data The device (ipro) is a Continuous Glucose Monitoring System. The subjects Blood Glucose level will be evaluated twice - ipro2 test (Visit 1 [application] & 2 [removal]) Second ipro2 test (Visit 3 page 5 / 6

6 Powered by TCPDF ( PDF of Trial [application] & 4 [removal]). In routine practice it is evaluated only once. Since the subject is coming for the second time because of study requirement it is an Interventional study. page 6 / 6