Time-in-range and frequency of continuous glucose monitoring: Recommendations for South Asia

Background and aim: The prevalence of diabetes is on its rise and South Asia bears a huge burden. Several factors such as heterogeneity in genetics, socio-economic factors, diet, and sedentary behavior contribute to the heightened risk of developing diabetes, its rapid progression, and the development of complications in this region. Even though there have been considerable advances in glucose monitoring technologies, diabetes treatments and therapeutics, glycemic control in South Asia remains suboptimal. The successful implementation of treatment interventions and metrics for the attainment of glycemic goals depends on appropriate guidelines that accord with the characteristics of the diabetes population. Method: The data were collected from studies published for more than the last ten years in the electronic databases PubMed and Google Scholar on the various challenges in the assessment and achievement of recommended TIR targets in the SA population using the keywords: Blood glucose, TIR, TAR, TBR, HbA1c, hypoglycemia, CGM, Gestational diabetes mellitus (GDM), and diabetes. Results: The objective of this recommendation is to discuss the limitations in considering the IC-TIR Expert panel recommendations targets and to propose some modifications in the lower limit of TIR in older/high-risk population, upper limit of TAR, and flexibility in the percentage of time spent in TAR for pregnant women (GDM, T2DM) for the South Asian population. Conclusion: The review sheds insights into some of the major concerns in implementing the IC-TIR recommendations in South Asian population where the prevalence of diabetes and its complications are significantly higher and modifications to the existing guidelines for use in routine clinical practice

Continuous glucose monitoring and metrics for clinical trials: an international consensus statement

Randomised controlled trials and other prospective clinical studies for novel medical interventions in people with diabetes have traditionally reported HbA1c as the measure of average blood glucose levels for the 3 months preceding the HbA1c test date. The use of this measure highlights the long-established correlation between HbA1c and relative risk of diabetes complications; the change in the measure, before and after the therapeutic intervention, is used by regulators for the approval of medications for diabetes. However, with the increasing use of continuous glucose monitoring (CGM) in clinical practice, prospective clinical studies are also increasingly using CGM devices to collect data and evaluate glucose profiles among study participants, complementing HbA1c findings, and further assess the effects of therapeutic interventions on HbA1c. Data is collected by CGM devices at 1–5 min intervals, which obtains data on glycaemic excursions and periods of asymptomatic hypoglycaemia or hyperglycaemia (ie, details of glycaemic control that are not provided by HbA1c concentrations alone that are measured continuously and can be analysed in daily, weekly, or monthly timeframes). These CGM-derived metrics are the subject of standardised, internationally agreed reporting formats and should, therefore, be considered for use in all clinical studies in diabetes. The purpose of this consensus statement is to recommend the ways CGM data might be used in prospective clinical studies, either as a specified study endpoint or as supportive complementary glucose metrics, to provide clinical information that can be considered by investigators, regulators, companies, clinicians, and individuals with diabetes who are stakeholders in trial outcomes. In this consensus statement, we provide recommendations on how to optimise CGM-derived glucose data collection in clinical studies, including the specific glucose metrics and specific glucose metrics that should be evaluated. These recommendations have been endorsed by the American Association of Clinical Endocrinologists, the American Diabetes Association, the Association of Diabetes Care and Education Specialists, DiabetesIndia, the European Association for the Study of Diabetes, the International Society for Pediatric and Adolescent Diabetes, the Japanese Diabetes Society, and the Juvenile Diabetes Research Foundation. A standardised approach to CGM data collection and reporting in clinical trials will encourage the use of these metrics and enhance the interpretability of CGM data, which could provide useful information other than HbA1c for informing therapeutic and treatment decisions, particularly related to hypoglycaemia, postprandial hyperglycaemia, and glucose variability