Insulin Glargine in Type 1 Diabetes Mellitus: A Review of Clinical Trials and Real-world Evidence Across Two Decades.

BACKGROUND: Over the past two decades, insulin glargine 100 U/mL (Gla-100) has emerged as the "standard of care" basal insulin for the management of type 1 diabetes mellitus (T1DM). Both formulations, insulin glargine 100 U/mL (Gla-100) and glargine 300 U/mL (Gla- 300) have been extensively studied against various comparator basal insulins across various clinical and real-world studies. In this comprehensive article, we reviewed the evidence on both insulin glargine formulations in T1DM across clinical trials and real-world studies. METHODS: Evidence in T1DM for Gla-100 and Gla-300 since their approvals in 2000 and 2015, respectively, were reviewed. RESULTS: Gla-100 when compared to the second-generation basal insulins, Gla-300 and IDeg-100, demonstrated a comparable risk of overall hypoglycemia, but the risk of nocturnal hypoglycemia was higher with Gla-100. Additional benefits of Gla-300 over Gla-100 include a prolonged (>24- hours) duration of action, a more stable glucose-lowering profile, improved treatment satisfaction, and greater flexibility in the dose administration timing. CONCLUSION: Both glargine formulations are largely comparable to other basal insulins in terms of glucose-lowering properties in T1DM. Further, risk of hypoglycemia is lower with Gla-100 than Neutral Protamine Hagedorn but comparable to insulin detemir.

Estimating the total incidence of type 1 diabetes in children and adolescents aged 0-19 years from 1990 to 2050: a global simulation-based analysis.

BACKGROUND: Previous studies of type 1 diabetes in childhood and adolescence have found large variations in reported incidence around the world. However, it is unclear whether these reported incidence levels are impacted by differences in country health systems and possible underdiagnosis and if so, to what degree. The aim of this study was to estimate both the total and diagnosed incidence of type 1 diabetes globally and to project childhood type 1 diabetes incidence indicators from 1990 to 2050 for each country. METHODS: We developed the type 1 diabetes global microsimulation model to simulate the natural history and diagnosis of type 1 diabetes for children and adolescents (aged 0-19 years) in 200 countries and territories, accounting for variability in underlying incidence and health system performance. The model follows an open population of children and adolescents in monthly intervals and simulates type 1 diabetes incidence and progression, as well as health system factors which influence diagnosis. We calibrated the model to published data on type 1 diabetes incidence, autoantibody profiles, and proportion of cases diagnosed with diabetic ketoacidosis from 1990 to 2020 and assessed the predictive accuracy using a randomly sampled test set of data withheld from calibration. FINDINGS: We estimate that in 2021 there were 355 900 (95% UI 334 200-377 300) total new cases of type 1 diabetes globally among children and adolescents, of which 56% (200 400 cases, 95% UI 180 600-219 500) were diagnosed. Estimated underdiagnosis varies substantially by region, with over 95% of new cases diagnosed in Australia and New Zealand, western and northern Europe, and North America, but less than 35% of new cases diagnosed in west Africa, south and southeastern Asia, and Melanesia. The total number of incident childhood cases of type 1 diabetes is projected to increase to 476 700 (95% UI 449 500-504 300) in 2050. INTERPRETATION: Our research indicates that the total global incidence of childhood and adolescent type 1 diabetes is larger than previously estimated, with nearly one-in-two children currently undiagnosed. Policymakers should plan for adequate diagnostic and medical capacity to improve timely type 1 diabetes detection and treatment, particularly as incidence is projected to increase worldwide, with highest numbers of new cases in Africa. FUNDING: Novo Nordisk.

Blood pressure reference tables for children and adolescents of Karnataka.

BACKGROUND: The blood pressure levels may vary in population because of genetic, ethnic and socio economic factors. Local reference values have to be established to understand the blood pressure variable. METHODS: Blood pressure data of 2278 boys and 2930 girls in the age group of 3-18 years were analysed to study the distribution pattern of systolic blood pressure and diastolic blood pressure and to develop reference values to define hypertension. Blood pressure was measured using standardised techniques in all. The first and fifth phases of Korotkoff sounds were taken as indicative of systolic blood pressure and diastolic blood pressure respectively. Height percentiles were computed for each one year age group. According to percentiles of height 50th, 90th, 95th and 99th percentiles of systolic blood pressure and diastolic blood pressure were estimated for every one year age. RESULTS: The blood pressure (both systolic and diastolic) tends to increase with age. The stepwise regression analysis revealed that the age and height but not gender, are important determinants of blood pressure. Age and height specific, 50th, 90th and 95th and 99th percentiles of systolic and diastolic blood pressure were derived and are presented in tabular form. CONCLUSION: The blood pressure of children and adolescents can be evaluated using the reference table according to body size. The table provided helps to classify blood pressure as normal or pre hypertension and to define different stages of hypertension.

The burden of diabetes and impaired glucose tolerance in India using the WHO 1999 criteria: prevalence of diabetes in India study (PODIS).

This random multistage cross-sectional population survey was undertaken to determine the prevalence of diabetes mellitus (DM) and impaired glucose tolerance (IGT) in subjects aged 25 years and above in India. The study was carried out in 77 centers (40 urban and 37 rural). 18363 (9008 males and 9355 females) subjects were studied. 10617 (5379 males and 5238 females) were from urban areas and 7746 (3629 males and 4117 females) from rural areas. Blood samples were taken after a fast of 10-12 h and 2 h after 75 g of oral glucose. Subjects were categorized as having IGT or DM using the World Health Organisation (WHO) (1999) criteria. The standardized prevalence rate for DM in the total Indian, urban and rural populations was 4.3, 5.9 and 2.7%, respectively. The corresponding IGT rates in the three populations was 5.2, 6.3 and 3.7%, respectively. The urban prevalence of DM and IGT was significantly greater than in the rural population (P < 0.001 in both instances). The prevalence of DM was significantly, more than that of IGT (P < 0.001) within both the rural and urban populations. Type 2 diabetes is a major health problem is India.

The burden of diabetes and impaired fasting glucose in India using the ADA 1997 criteria: prevalence of diabetes in India study (PODIS).

This random multistage cross sectional population survey was undertaken to determine the prevalence of diabetes mellitus (DM) and impaired fasting glycemia/glucose (IFG) in subjects aged 25 years and above in India. The study was carried out in 108 centers (49 urban and 59 rural) to reflect the size and heterogeneity of the Indian population. 41,270 (20,534 males and 20,736 females) subjects were studied. 21,516 (10,865 males and 10,651 females) were from urban areas and 19,754 (9669 males and 10,085 females) from rural areas. Blood samples were taken after a fast of 10-12h and the subjects were categorized as having IFG or DM using the 1997 American Diabetes Association criteria. The age and gender standardized prevalence rate for DM and IFG in the total Indian population was 3.3 and 3.6% respectively (P < 0.001). The standardized prevalence of DM and IFG in urban areas was significantly higher than that for the rural population (urban DM prevalence 4.6% versus rural DM prevalence 1.9%, P < 0.001; urban IFG prevalence 4.8% versus rural IFG prevalence 2.5%, P < 0.001). There was no statistically significant difference in the prevalence between DM (4.6%) and IFG (4.8%) in the urban population. The rural prevalence of IFG (2.5%) was significantly (P <0.001) more than the rural prevalence of DM (1.9%). Type 2 diabetes is a major health problem is India.

Comparing the ADA 1997 and the WHO 1999 criteria: Prevalence of Diabetes in India Study.

This random multistage cross-sectional population survey was undertaken to determine the prevalence of type 2 diabetes mellitus (DM) in subjects aged 25 years and above in India. The study was carried out in 77 centres (42 urban and 35 rural) to reflect the size and heterogeneity of the Indian population. 18,363 (9008 male and 9355 female) subjects were studied. 10,617 (5379 males and 5238 females) were from urban areas and 7746 (3629 males and 4117 females) from rural areas. Blood samples were taken after a fast of 10-12 and 2 h after 75 g of oral glucose. Subjects were categorized as having impaired fasting glycemia (IFG) or DM using the 1997 ADA or having impaired glucose tolerance (IGT) or DM using the 1999 WHO criteria. The age- and gender-standardized prevalence rate for DM using the ADA criteria was 3.6% whilst that using the WHO criteria was 4.3% (P < 0.001). The respective standardized prevalence of DM, using the two criteria was, 4.7 and 5.6%, respectively (P < 0.001) in the urban Indian population and 2.0 and 2.7% (P < 0.02) in the rural Indian population. Using the WHO criteria, 581 subjects were newly diagnosed whilst the ADA criteria newly diagnosed 437 subjects. The respective numbers for the urban population were 425 and 323, and for the rural population were 146 and 114, respectively. The ADA criteria could diagnose 75.2, 76.0 and 73.0% of the subjects who had DM as per the WHO criteria. Of 739 Indian subjects who had IFG, 106 (14.3%) were diagnosed as having DM by the WHO criteria whilst 505 (68.3%) had values compatible with a diagnosis of IGT. Of the 536 urban subjects with IFG, 74 (13.8%) had DM and 350 (65.3%) had IGT using the WHO criteria. Of the 302 rural subjects with IFG, 32 (15.8%) had DM and 155 (76.3%) had IGT using the WHO criteria. 505 (49.9%) of 1012 Indian subjects with IGT as per the WHO criteria had IFG. 350 (47.7%) of 733 urban subjects and 155 (55.5%) of 279 rural subjects with IGT had values compatible with IFG as per the ADA criteria. Type 2 diabetes is a major health problem is India. The use of the ADA criteria would underestimate the prevalence of DM by not diagnosing subjects showing a poor response to a glucose challenge. This along with the discrepancies between subjects showing IGF or IGT could be a challenge to any prevention program.