N/A
Completed N=181
Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
Source: ClinicalTrials.gov NCT01995539 ↗Enrolled (actual)
181
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Change From Baseline in A1C at 3 Months — -0.6 percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in A1C at 3 Months |
-0.6 | — |
| SECONDARY Number of Serious Adverse Device Effects (SADE). |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01995539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.