SGLT2i as a First-line Antihyperglycemic in the Management of Type 2 Diabetes in the Context of Indians: A Systematic Review and Consensus.

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have been used for almost a decade and have proven to be effective not only in managing Type 2 diabetes (T2D), but their cardio and renal protective features make them very useful in managing patients with risk of multiple comorbidities. This systematic review was undertaken by the authors because there is no evidence currently available in India that has studied the suitability of SGLT2i as a first-line agent in patients newly diagnosed with T2D in India. MATERIALS AND METHODS: First, literature was searched to identify features that are considered important when deciding on a first-line agent for managing T2D. A total of 5 broad topics were identified-glycemic control, extra glycemic effects, antihyperglycemic combination therapy, safety, and cost-effectiveness. These domains had further subheadings, and a total of 16 domains were identified. Metformin is the drug of choice as a first-line agent in such situations and has been considered the gold standard for evaluating the effects of SGLT2i across these domains. A systematic literature review on each domain was conducted to compare SGLT2i with the gold standard in Indian patients newly diagnosed with T2D. Evidence was graded (levels of evidence (LoE)-A, B, and C), and recommendations (class of recommendation (CoR)-I, II, and III) were classified by the expert group as defined in the methodology. RESULTS: According to the systematic reviews conducted, 11 domains had Level A evidence, 2 domains (impact on lipids and gut microbiome) had Level B, and 3 domains had Level C (ß-cell function, renal protection, and glycemic variability) evidence. Based on evidence and expert opinion, the authors recommend SGLT2i as a first-line agent for managing newly diagnosed patients with T2D with a Class I recommendation for 13 domains and Class II for the remaining 3 (impact on lipids, gut microbiome, and ß-cell function). Although a poorer level of evidence (Level C) was available for the glycemic variability domain, the authors still reported this as Class I recommendations according to their expert opinion and consensus. CONCLUSION: This article advocates adopting SGLT2 inhibitors as the primary treatment choice for treating patients with newly diagnosed T2D in India.

Effect of Insulin-Like Growth Factor-1 on Diabetic Retinopathy in Pubertal Age Patients With Type 1 Diabetes.

PURPOSE: The aims of this study were to correlate diabetic retinopathy (DR) changes with insulin-like growth factor 1 (IGF-1) levels in patients with type 1 diabetes of pubertal age group and to correlate the level of retinopathy with IGF-1 levels. METHODS: This cross-sectional study was done over 2 years and involved patients with type 1 diabetes of age 8 to 25 years. Patients presenting to Ophthalmology OPD and inpatient department along with active recruitment from old pediatrics and endocrinology records were taken for the study. Fasting serum IGF-1 was calculated using enzyme-linked immunosorbent assay technique. Fasting blood sugar levels were taken. Detailed ophthalmic examination was done and DR was noted in all the patients and correlated with IGF-1 levels. RESULTS: A total of 46 patients with type 1 diabetes were recruited into the study. The mean age of the patients was 14.33 ±â€Š4.36 years, with a female-to-male ratio of 3:2. No relationship of IGF-1 with age of onset of diabetes (P = 0.7) or fasting capillary blood glucose (CBG) (P = 0.6) was found, but a significant relationship was found with duration of diabetes (P = 0.001) and low IGF-1 levels (P < 0.0001). CONCLUSIONS: Severity of DR in patients with type 1 diabetes is inversely related to serum IGF-1 levels. Low IGF levels are an indicator for closer follow-up and strict management of diabetes and retinopathy.

Prevalence, clinical and biochemical profile of subclinical hypothyroidism in normal population in Mumbai.

BACKGROUND: Subclinical Hypothyroidism (ScHt) affects 3-15% of the adult population. It's clinical and biochemical profile is not well defined, especially in Indian scenario. Our study aimed at screening normal population to define normative ranges of thyroid hormones and Serum thyroid stimulating hormone (S.TSH) and prevalence of ScHt and thyroid autoimmunity. MATERIALS AND METHODS: Two-hundred thirty-seven normal subjects without family history of thyroid disease were evaluated for symptoms and laboratory tests for thyroid dysfunction and autoimmunity. RESULTS: The thyroid function tests were as follows: EUTHYROID GROUP: MEAN VALUES WERE: T3: 1.79 ± 0.42 ng/mL, T4: 10.23 ± 2.25 µg/dL, FT3: 1.88 ± 0.19 pg/mL, FT4: 1.12 ± 0.21 ng/dL, S.TSH: 2.22 ± 1.06 µlu/mL. 10.2% of euthyroid subjects had antimicrosomal antibodies (AMA) +ve (mean titer 1:918) and 23.6% were anti-thyroid peroxidase autoantibody (anti-TPO) +ve (mean titer 15.06 Au/mL). The euthyroid outlier range for S.TSH was 0.3-4.6 µlu/mL. The values were comparable in both the sexes. Those with S.TSH ≥ 5 µlu/mL were defined to have ScHt. SCHT GROUP: Prevalence of ScHt was 11.3% (M:F ratio 1:3.7). 74% belonged to 35-54 years age group and prevalence increased with age (post-menopausal females: prevalence 20%). S.TSH was 9.8 ± 7.22 µlu/mL, mean S.AMA was 1:5079 (40.7% positivity) and mean S.anti-TPO was 260 Au/mL (47.6% positivity). Majority were agoitrous (74%), and stage I goiter was seen in 26% of this population. Symptom score of 5-8 was seen in 55% ScHt subjects versus 35% normal subjects. CONCLUSION: Mean S.TSH in our population was 2.22 µlu/mL (euthyroid outliers: 0.3-4.6 µlu/mL); hence, S.TSH above 4.6 µlu/mL should be considered as abnormal. The prevalence of thyroid autoimmunity increases after age of 35 years. ScHt presents mainly in agoitrous form and with positive antibodies, suggesting autoimmunity as the cause.

Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Karnataka cohort of the A1chieve study.

BACKGROUND: The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. MATERIALS AND METHODS: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Karnataka, India. RESULTS: A total of 2243 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Patients had started on or were switched to biphasic insulin aspart (n = 1855), insulin detemir (n = 211), insulin aspart (n = 111), basal insulin plus insulin aspart (n = 16) and other insulin combinations (n = 40). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.2%) and insulin user (mean HbA1c: 9.0%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: -1.4%, insulin users: -1.7%). SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients. CONCLUSION: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.