Rationale, study design and methodology of the LANDMARC trial: a 3‐year, pan‐India, prospective, longitudinal study to assess management and real‐world outcomes of diabetes mellitus

Abstract

Aim India contributes towards a large part of the worldwide epidemic of diabetes and its associated complications. However, there are limited longitudinal studies available in India to understand the occurrence of diabetes complications over time. This pan-India longitudinal study was initiated to assess the real-world outcomes of diabetes across the country.Methods The LANDMARC study is the first prospective, multicentre, longitudinal, observational study investigating a large cohort of people with type 2 diabetes mellitus across India over a period of 3 years. The primary objective of this ongoing study is to determine the proportion of people developing macrovascular diabetes complications over the duration of the study (36 months AE 45 days) distributed over seven visits; the secondary objective is to evaluate microvascular diabetes complications, glycaemic control and time-to-treatment adaptation or intensification. Overall, 6300 participants (aged 25-60 years) diagnosed with type 2 diabetes for at least 2 years will be included from 450 centres across India. Data will be recorded for baseline demographics, comorbidities, glycaemic measurements, use of anti-hyperglycaemic medications and any cardiovascular or other diabetes-related events occurring during the observational study period.Conclusions The LANDMARC study is expected to reveal the trends in complications associated with diabetes, treatment strategies used by physicians, and correlation among treatment, control and complications of diabetes within the Indian context. The findings of this study will help to identify the disease burden, emergence of early-onset complications and dose titration patterns, and eventually develop person-centred care and facilitate public health agencies to invest appropriate resources in the management of diabetes.

One‐year trends from the LANDMARC trial: A 3‐year, pan‐India, prospective, longitudinal study on the management and real‐world outcomes of type 2 diabetes mellitus

“…The evaluation period of this multicentre, prospective, observational study was 36 months (March 2017–March 2021), which was divided into seven visits with an interval of 6 months. The results in this manuscript represent the first year (within a window period of −90 days or +45 days) of the 3‐year evaluation period 23 …”

Introduction to real-world evidence studies

“…It was found that the measurements were done less than that recommended by guidelines recommend[ 9 ] Prospective study: LANDMARC study is a prospective, multicenter study evaluating a large cohort of people with type 2 diabetes mellitus across India over a period of 3 years. This study will reveal the trends in complications associated with diabetes; treatment strategies used by physicians; and correlation among treatment, control, and complications of diabetes[ 10 ] Cross-sectional study: This multicenter study was designed to determine the control of dyslipidemia in the Indian diabetic population treated with lipid-lowering drugs. The study was conducted in 178 sites in India.…”

“…Prospective study: LANDMARC study is a prospective, multicenter study evaluating a large cohort of people with type 2 diabetes mellitus across India over a period of 3 years. This study will reveal the trends in complications associated with diabetes; treatment strategies used by physicians; and correlation among treatment, control, and complications of diabetes[ 10 ]…”

Baseline characteristics of participants in the LANDMARC trial: A 3‐year, pan‐india, prospective, longitudinal study to assess management and real‐world outcomes of diabetes mellitus

“…The details of the design and methodology of the LANDMARC study have been published earlier 14 and are briefly summarized in following sections.…”