Dear {{$doctorName}},
Subject: {{$ActivityName}}
Type 2 Diabetes Mellitus (T2DM) is a major health problem across the globe with a worldwide prevalence of 537 million
people. Diabetes is associated with reduced quality of life and a wide range of long-term complications, including both
microvascular and macrovascular diseases. T2DM is a major risk factor for cardiovascular disease (CVD). Patients with
T2DM have 2–4 times higher risk of CVD mortality than those without T2DM. Correction of hyperglycemia is the primary
goal in the treatment of individuals with T2DM, and achievement of tight glycemic control in these patients has been shown
to significantly reduce the risk of long-term complications of this disease. Real-world evidence can help in obtaining
insights into drug utilization pattern, treatment adherence, comorbidities, and effects of switching or adjusting
medications in the real-world setting. However, real-world data on glycemic control among adult patients from India are
scarce. In lieu of the same, the current retrospective cross sectional chart analysis is planned to understand the status of
glycemic control in Indian patients with T2DM with or without co-morbidities after receiving anti-diabetic treatment.
In this Real World Evidence generation study, we intend to determine the status of glycemic control in Indian T2DM
patients with or without co-morbidities after receiving anti-diabetic treatment. We invite you to participate in this study. On
acceptance, you will need to capture the relevant data as mentioned in the standard Data Collection Form (DCF) provided,
from the patient’s medical records (case papers and investigational reports – hereafter referred as source documents).
We would recommend you to capture data fulfilling the criteria as outlined in the protocol and whose relevant laboratory
investigations are available for the preceding 3 months.
We wish to inform you that the DCF will capture all data in de-identified form and any identifiable parameters which may
potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we
maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as
recommended in the DCF.
In alignment with good clinical research practices, an independent CRO will monitor this study and do the source data
verification of the data captured in the DCF with copies of the patients’ source medical records (case papers and
investigational reports) to ensure that the data entered in the DCFs are accurate and in alignment with the patients’
medical records. If you agree to participate in the said study, we would request you to sign and return the enclosed reply
along with your visiting card for accuracy of records.
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