Retrospective EMR Database Study in India: Assessment of Overall Insulin Pattern in Insulin Naive T2DM Patients(REALITY)

This is an observational, retrospective study in India to examine the real-world usage patterns of insulin initiated in the treatment of type 2 diabetes (T2DM) and the longitudinal outcomes of those who were initiated on insulin glargine (Glargine 100 U/mL and Glargine 300 U/ML). Eligible patients would be adult (≥ 18 years) male or female insulin naïve with known case of T2DM who had been initiated with any type of insulin during the index period from 01 January 2016 to 31 December 2018. Baseline visit will be defined as the index date. Data would be collected for a follow up of a minimum of 6 months to a maximum of 12 months of those patients who were initiated on insulin glargine. Required data mentioned in baseline characteristics will be recorded at index date, second visit at 3 months (+/-1 month), 6 months (+/-2 months) and 12 months (+/-2 months) after index date of treatment. Data will be collected through the abstraction of electronic medical records (EMRs) from 15 sites in India. Collected study data will include patient characteristics, duration of diabetes, treatment details, comorbidities, glycemic parameters and hypoglycaemia as reported.

Data from the patients who had received any type of insulin during the index period will be recorded as per the defined outcomes. Data will be extracted from electronic health records and will be abstracted by a CRO (clinical research organization), the principal investigator (PI)or a reviewer (clinical research associate) nominated by the sponsor. For the records missing any of the requested information, data will be reported as missing