Maintaining a good glycemic control is crucial in the management of diabetes mellitus (DM) as it is associated with the reduction in both macro and microvascular complications of the disease. Self-monitoring of blood glucose (SMBG), which provides the day-today blood glucose levels, is a simple and practical tool for maintaining a good glycemic control. Although SMBG is widely practiced in other countries, its use in India is very limited. Even when used, it is not carried out is a structured manner. There seems to be a lack of education about the purpose of SMBG and the correct process and schedule to be followed. This highlights the unmet need for country-specific SMBG recommendations. In order to fulfil this need, a panel of expert endocrinologists/ diabetologists came together under the aegis of Research Society for the Study of Diabetes in India (RSSDI). They reviewed the current literature, combined the evidences with their clinical knowledge and expertise, and developed consensus recommendations for SMBG practice in India. This document provides a comprehensive review of the current literature on SMBG and presents the recommendations made by the expert panel.

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Aim To compare (in the LIRA‐PRIME [NCT02730377], a randomized open‐label trial), the efficacy of liraglutide in controlling glycaemia versus an oral antidiabetic drug (OAD) in patients with uncontrolled type 2 diabetes (T2D), despite metformin use in a primary care setting (n = 219 sites, n = 9 countries). Materials and Methods Adults (n = 1991) with T2D (HbA1c 7.5%‐9.0%) receiving metformin were randomized 1:1 to liraglutide (≤1.8 mg/d) or one OAD, selected by the investigator, added to metformin, for up to 104 weeks. Primary endpoint: time to inadequate glycaemic control (HbA1c > 7.0%) at two scheduled consecutive visits after week 26. Outcomes were assessed for liraglutide versus a pooled OAD group, and (post hoc) liraglutide versus sodium‐glucose co‐transporter‐2 inhibitors, dipeptidyl peptidase‐4 inhibitors, and sulphonylureas individually. Results Among randomized patients (liraglutide, n = 996; OAD, n = 995), 47.6% were female, mean age was 57.4 years and mean HbA1c was 8.2%. Median time to inadequate glycaemic control was 44 weeks longer with liraglutide versus OAD (109 weeks [25% percentile, 38; 75% percentile, not available] vs. 65 weeks [25% percentile, 35; 75% percentile, 107], P < .0001). Changes in HbA1c and body weight at week 104 or at premature treatment discontinuation significantly favoured liraglutide over OAD. Hypoglycaemia rates were comparable between groups and few patients discontinued because of adverse events (liraglutide, 7.9% [n = 79]; OAD, 4.1% [n = 41]). Similar results were observed in the post hoc analysis for liraglutide versus individual OAD classes. Conclusions Glycaemic control was better maintained with liraglutide versus OAD, supporting liraglutide use when intensifying therapy in primary care patients with T2D.

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Aims Using a pragmatic approach, the LIRA‐PRIME trial aims to address a knowledge gap by comparing efficacy in controlling glycaemia with glucagon‐like peptide‐1 analog liraglutide vs oral antidiabetic drugs (OADs) in patients with type 2 diabetes (T2D) uncontrolled with metformin monotherapy in primary care practice. We report the study design and patient baseline characteristics. Materials and methods This 104‐week, two‐arm, open‐label, active‐controlled trial is active in 219 primary care practices across nine countries. At screening, eligible patients with T2D were at least 18 years of age, had been using a stable daily dose of metformin ≥1500 mg or the maximum tolerated dose for ≥60 days, and had a glycated haemoglobin (HbA1c) of 7.5% to 9.0%, measured ≤90 days before screening. Patients were randomized (1:1) to liraglutide or OAD, both in addition to pre‐trial metformin. Individual OADs were chosen by the treating physician based on local guidelines. The primary endpoint is time to inadequate glycaemic control, defined as HbA1c above 7.0% at two scheduled consecutive visits after the first 26 weeks of treatment. Results The trial randomized 1997 patients with a mean (standard deviation) age of 56.9 (10.8) years, T2D duration of 7.2 (5.9) years (range, <1‐47 years), and HbA1c of 8.2%. One‐fifth of patients had a history of diabetes complications, and most were overweight (24.8%) or had obesity (65.3%). Conclusions This pragmatically designed, large‐scale, multinational, randomized clinical trial will help guide treatment decisions for patients with T2D who are inadequately controlled with metformin monotherapy and treated in primary care.

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