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Background The prevalence of gestational diabetes mellitus (GDM) is increasing globally. When diet and lifestyle modifications are inadequate for control, managing GDM often involves insulin or metformin. Metformin's oral administration option improves patient compliance and acceptance, but concerns about its use persist, necessitating careful evaluation. Comparative studies between insulin and metformin in GDM are scarce. In pregnancies complicated by diabetes, precise glucose control is crucial for maternal-fetal well-being, and continuous glucose monitoring (CGM) plays a valuable role in achieving recommended targets. CGM provides comprehensive glucose profiles, including postprandial glucose excursions and details about time spent in hypoglycemia, euglycemia, and hyperglycemia. The time-in-range (TIR) metric, when used alongside A1C, offers more actionable information than A1C alone. To the best of our knowledge, no published trials compare TIR in GDM with metformin or insulin aspart/detemir, specifically focusing on CGM metrics. This randomized controlled trial (RCT) aims to assess TIR in women with GDM treated with either metformin or insulin. Materials and methods This study was a non-inferiority randomized control trial evaluating TIR in GDM using continuous glucose monitoring with metformin or insulin. Forty-four women with GDM were enrolled. The diagnosis of GDM was based on the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria. CGM readings were collected for 14 days after sensor activation. Results In our study, 44 women with GDM completed the protocol, with 22 in the Metformin group and 22 in the Insulin group. Baseline characteristics did not differ between the groups. Age, BMI pre-gravid, BMI at 28 weeks, parity, family history of diabetes mellitus, previous history of GDM, glycated hemoglobin (HbA1c), oral glucose tolerance tests (OGTT) at zero hours, one hour, and two hours, as well as gestational weeks, did not significantly differ between the two groups. The metformin and insulin groups did not differ significantly in CGM metrics, including TIR, time above range, time below range, mean glucose, and glucose management indicator. Conclusion Based on our findings, the metformin and insulin groups did not differ in CGM metrics, including TIR, time above range, time below range, mean glucose, and glucose management indicator. In clinical practice, CGM metrics complement fasting blood glucose, postprandial glucose, and HbA1c as appropriate and useful clinical targets and outcome measurements. Metformin's oral administration option offers advantages such as improved patient compliance and acceptance in women with GDM.
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Context: As synacthen use is not licensed in India and there are concerns about the safety of the insulin tolerance test (ITT), an alternative dynamic test to diagnose adrenal insufficiency (AI) is required. Objective: The study aimed to evaluate the diagnostic performance of the Acton Prolongatum stimulation test (APST) with a standard ITT for the diagnosis of AI. Design: Prospective study comparing two diagnostic tests. Participants: Six healthy volunteers and 53 suspected or known AI patients. Measurements: Serum cortisol response to ITT and APST. Results: The median (95% confidence interval [CI]) peak cortisol levels among healthy volunteers in ITT and APST were 17 (14.58-19.08) and 30.5 (22.57-34.5) µg/dL. Of the 53 patients (age: 39.6 ± 9.38 years; females: 38 [71.1%]), 34 had AI (peak ITT serum cortisol < 14.5 µg/dL) whereas 19 had a normal hypothalamic-pituitary-adrenocortical (HPA) axis. In the receiver operator characteristic curve analysis, 60-min APST cortisol had an area under the curve of 0.984 (95% CI: 0.904-1.00, P < 0.0001). The best accuracy was obtained at a cut-off of 16.42 µg/dL (sensitivity: 97.7% [95% CI: 87.7-99.9%]; specificity: 100% [69.2-100%]). Forty-three of the 53 patients with suspected AI had hypoglycemic symptoms during ITT and two of them required intravenous dextrose, whereas, none had adverse events during APST. The ITT was incomplete in two patients whereas all completed APST. Conclusions: APST is a simple, safe, and reliable alternative to ITT for the diagnosis of AI; 60-min serum cortisol of 16.42 µg/dL in APST best distinguishes the AI patients from those with adequate cortisol response.
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Background and Aims: The American Diabetes Association recommends statin therapy for young type 2 diabetes mellitus (T2DM) adults only if one additional cardiovascular (CV) risk factor coexists. The data regarding CV risk factors in young Indian T2DM adults is limited. Hence, we assessed the prevalence of CV risk factors in young adults with T2DM from eastern India. Methods: In this cross-sectional study, diabetic medical health check records of eastern-Indian T2DM patients performed between March 2018 and March 2019 were retrospectively reviewed and the relevant data of T2DM patients (n = 3564) including CV risk factors [serum LDL-cholesterol of ≥100 mg/dL, hypertension (>140/90 mmHg), smoking, chronic kidney disease (eGFR of <60 ml/min), microalbumin to creatinine ratio of ≥30 mg/mg, and obesity/overweight (body mass index ≥23 kg/m2)] were analysed. Results: There were 3280 T2DM patients from eastern India and 679 (20.7%) were ≤40 years of age. Overweight/obesity (74.3%) and serum LDL-cholesterol of ≥100 mg/dL (69.2%) were the two most common additional CV risk factors. At least one additional CV risk factor was present in 576 (95.36%) patients, whereas at least two additional CV risk factors were present in 409 (67.7%) patients. At least one non-obesity/overweight CV risk factor was present in 472 (78.1%) patients. Conclusions: The study demonstrates a high prevalence of additional CV risk factors in young eastern-Indian adults with T2DM. Hence, there is a need for an intensive approach to managing the CV risk factors in young Indian adults with T2DM.