Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iPro2 Use | Experimental | All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapy regimen | Behavioral | Subjects will be recommend changes in therapy regimens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at 3 Months | Descriptive analysis of change in A1C from baseline to end of 3-month study period | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Device Effects (SADE). | Evaluation of incidence of SADE during the study. | 3 months |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madras Diabetes Research Foundation | Gopālapuram | Chennai | 600086 | India | ||
| DIA Care |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | iPro2 Use | All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | iPro2 Use | All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in A1C at 3 Months | Descriptive analysis of change in A1C from baseline to end of 3-month study period | 181 subjects consented and screened; 1 subject screen failed; 148 subjects completed study; 32 subjects not completed study. | Posted | Mean | Standard Deviation | percent | 3 months |
|
|
3 Month
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iPro2 Use | All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pricking sensation at insertion site | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suiying Huang, Statistician | Medtronic Minimed | 8184763319 | suiying.huang@medtronic.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Shehla Shaikh, MD |
| K.G.N DIABETES AND ENDOCRINE CENTRE |
| Principal Investigator |
| Dharmen Punatar, MD | Diab Care Centre | Principal Investigator |
| Scott Lee, MD | Medtronic MiniMed, Inc. | Study Director |
| Ahmedabad |
| Gujarat |
| 380015 |
| India |
| Medanta | Gurgaon | Haryana | 122 001 | India |
| Jothydev's Diabetes and Research Centre | Trivandrum | Kerala | 695032 | India |
| TOTALL Diabetes Hormone Institute | Indore | Madhya Pradesh | 452010 | India |
| K.G.N Diabetes and Endocrine Centre | Mumbai | Maharashtra | 400008 | India |
| Lina Diabetes Care Centre | Mumbai | Maharashtra | 400053 | India |
| Dr.Kovil's Diabetes Care centre | Mumbai | Maharashtra | 400058 | India |
| Diab Care Center | Mumbai | Maharashtra | 400080 | India |
| Diabetes Care & Research Center | Pune | Maharashtra | 411011 | India |
| M.V Hospital for Diabetes Research centre | Chennai | Tamil Nadu | 600013 | India |
| Lost to Follow-up |
|
| Subject missed visit 3,4, came in for V5 |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Serious Adverse Device Effects (SADE). | Evaluation of incidence of SADE during the study. | Posted | Number | events | 3 months |
|
|
|
| 0 |
| 181 |
| 0 |
| 181 |
| 5 |
| 181 |
| BLEEDING AT SENSOR INSERTION SITE | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| itching at sensor insertion site | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pain at insertion site area | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Skin irritation at sensor insertion site | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |