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 patientâ??s metabolic fluctuations, and support appropriate therapeutic intervention.

Use of iProâ?¢2 in Real Life Diabetes Management of Type 2 Patients in India. An interventional post-market, prospective, multi-center study - iPro 2 Registry

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2013/03/003499

Enrollment

250

Registered

2013-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with Type 2 Diabetes

Interventions

Intervention1: 2 additional Follow Up visits: The intervention is when the patient will undergo for 2nd iPro2 evaluation Intervention2: 2 additional visit: During the course of the study, patients wil

Eligibility

Inclusion criteria

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. Subjectâ??s A1C > 8.0% to 4. Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC) 5. Subject is willing to comply with the study procedures

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The objective of the India iPro2 Study is to 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 patientâ??s metabolic fluctuations and support appropriate therapeutic intervention leading to improved glycemic control in type 2 diabetes patientsTimepoint: 3 months	—

Measure

Time frame

The objective of the India iPro2 Study is to 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 patientâ??s metabolic fluctuations and support appropriate therapeutic intervention leading to improved glycemic control in type 2 diabetes patientsTimepoint: 3 months

—

Secondary

Measure	Time frame
NoneTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactMr Rajesh Radhakrishnan

India Medtronic Pvt Ltd

rajesh.radhakrishnan@medtronic.com02233074700

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026