Use of iProâ„¢2 in Real Life Diabetes Management of Type 2 Patients in India
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: therapy regimen
- Registration Number
- NCT01995539
- Lead Sponsor
- Medtronic Diabetes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description iPro2 Use therapy regimen All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
- Primary Outcome Measures
Name Time Method Change From Baseline in A1C at 3 Months 3 months Descriptive analysis of change in A1C from baseline to end of 3-month study period
- Secondary Outcome Measures
Name Time Method Number of Serious Adverse Device Effects (SADE). 3 months Evaluation of incidence of SADE during the study.
Trial Locations
- Locations (11)
M.V Hospital for Diabetes Research centre
🇮🇳Chennai, Tamil Nadu, India
Medanta
🇮🇳Gurgaon, Haryana, India
Dr.Kovil's Diabetes Care centre
🇮🇳Mumbai, Maharashtra, India
Madras Diabetes Research Foundation
🇮🇳Gopalapuram, Chennai, India
Jothydev's Diabetes and Research Centre
🇮🇳Trivandrum, Kerala, India
DIA Care
🇮🇳Ahmedabad, Gujarat, India
TOTALL Diabetes Hormone Institute
🇮🇳Indore, Madhya Pradesh, India
K.G.N Diabetes and Endocrine Centre
🇮🇳Mumbai, Maharashtra, India
Lina Diabetes Care Centre
🇮🇳Mumbai, Maharashtra, India
Diab Care Center
🇮🇳Mumbai, Maharashtra, India
Diabetes Care & Research Center
🇮🇳Pune, Maharashtra, India