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Introduction: Use of continuous glucose monitoring (CGM) in people with diabetes may provide a more complete picture of glycemic control than glycated hemoglobin (HbA1c) measurements, which do not capture day-to-day fluctuations in blood glucose levels. The randomized, crossover, phase IV SWITCH PRO study assessed time in range (TIR), derived from CGM, following treatment with insulin degludec or insulin glargine U100 in patients with type 2 diabetes at risk for hypoglycemia. This post hoc analysis evaluated the relationship between TIR and HbA1c, following treatment intensification during the SWITCH PRO study., Methods: Correlation between absolute values for TIR (assessed over 2-week intervals) and HbA1c, at baseline and at the end of maintenance period 1 (M1; week 18) or maintenance period 2 (M2; week 36), were assessed by linear regression and using the Spearman correlation coefficient (r s ). These methods were also used to assess correlation between change in TIR and change in HbA1c from baseline to the end of M1, both in the full cohort and in subgroups stratified by baseline median HbA1c (≥ 7.5% [≥ 58.5 mmol/mol] or < 7.5% [< 58.5 mmol/mol])., Results: A total of 419 participants were included in the analysis. A moderate inverse linear correlation was observed between TIR and HbA1c at baseline (r s  -0.54), becoming stronger following treatment intensification during maintenance periods M1 (weeks 17-18: r s  -0.59) and M2 (weeks 35-36: r s  -0.60). Changes in TIR and HbA1c from baseline to end of M1 were also linearly inversely correlated in the full cohort (r s -0.40) and the subgroup with baseline HbA1c ≥ 7.5% (r s  -0.43). This was less apparent in the subgroup with baseline HbA1c < 7.5% (r s  -0.17) (p-interaction = 0.07)., Conclusion: Results from this post hoc analysis of data from SWITCH PRO, one of the first large interventional clinical studies to use TIR as the primary outcome, further support TIR as a valid clinical indicator of glycemic control., Trial Registration: ClinicalTrials.gov identifier, NCT03687827., (© 2023. The Author(s).)

Background: Insulin degludec (degludec) is a second-generation basal insulin with an improved pharmacokinetic-pharmacodynamic profile compared with first-generation basal insulins, but there are few data regarding its use during pregnancy. In this non-inferiority trial, we aimed to compare the efficacy and safety of degludec with insulin detemir (detemir), both in combination with insulin aspart (aspart), in pregnant women with type 1 diabetes., Methods: This open-label, multinational, randomised, controlled, non-inferiority trial (EXPECT) was conducted at 56 sites (hospitals and medical centres) in 14 countries. Women aged at least 18 years with type 1 diabetes who were between gestational age 8 weeks (+0 days) and 13 weeks (+6 days) or planned to become pregnant were randomly assigned (1:1), via an interactive web response system, to degludec (100 U/mL) once daily or detemir (100 U/mL) once or twice daily, both with mealtime insulin aspart (100 U/mL), all via subcutaneous injection. Participants who were pregnant received the trial drug at randomisation, throughout pregnancy and until 28 days post-delivery (end of treatment). Participants not pregnant at randomisation initiated the trial drug before conception. The primary endpoint was the last planned HbA 1c measurement before delivery (non-inferiority margin of 0·4% for degludec vs detemir). Secondary endpoints included efficacy, maternal safety, and pregnancy outcomes. The primary endpoint was assessed in all randomly assigned participants who were pregnant during the trial. Safety was assessed in all randomly assigned participants who were pregnant during the trial and exposed to at least one dose of trial drug. This study is registered with ClinicalTrials.gov, NCT03377699, and is now completed., Findings: Between Nov 22, 2017, and Nov 8, 2019, from 296 women screened, 225 women were randomly assigned to degludec (n=111) or detemir (n=114). Mean HbA 1c at pregnancy baseline was 6·6% (SD 0·6%; approximately 49 mmol/mol; SD 7 mmol/mol) in the degludec group and 6·5% (0·8%; approximately 48 mmol/mol; 9 mmol/mol) in the detemir group. Mean last planned HbA 1c measurement before delivery was 6·2% (SE 0·07%; approximately 45 mmol/mol; SE 0·8 mmol/mol) in the degludec group and 6·3% (SE 0·07%; approximately 46 mmol/mol; SE 0·8 mmol/mol) in the detemir group (estimated treatment difference -0·11% [95% CI -0·31 to 0·08]; -1·2 mmol/mol [95% CI: -3·4 to 0·9]; p non-inferiority <0·0001), confirming non-inferiority. Compared with detemir, no additional safety issues were observed with degludec., Interpretation: In pregnant women with type 1 diabetes, degludec was found to be non-inferior to detemir., Funding: Novo Nordisk., Competing Interests: Declaration of interests All clinical authors received research support from Novo Nordisk for this study. ERM has received speakers' fees from Novo Nordisk, Lilly, and Sanofi Aventis, and has participated in steering committee tasks and guidance involving writing protocols for Novo Nordisk. ACA, TJ, BK, SK, and CM are employees of Novo Nordisk and own stocks in the company. RC has received speakers' fees or support for attending meetings from Novo Nordisk, Lilly, Sanofi, and Roche. FD has received speakers' fees from Novo Nordisk. DSF is a member of an international scientific advisory board for Novo Nordisk. MH is a member of an international scientific advisory board for Novo Nordisk. AK-W has received speakers' fees from Novo Nordisk. RDR has received speakers' fees from Novo Nordisk, Johnson & Johnson, and Boehringer Ingelheim. PD is a member of an international scientific advisory board for Novo Nordisk and participates in clinical studies on the use of insulin in pregnant women with pre-existing diabetes in collaboration with Novo Nordisk; no personal honorarium is involved., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Introduction: Increased postprandial glucose (PPG) is associated with high glycated haemoglobin levels and is an independent risk factor for cardiovascular diseases. The aim of this study was to compare PPG increments in Asian versus non-Asian adults with type 2 diabetes (T2D), who were insulin-naïve or insulin-experienced, from the phase 3 insulin degludec/insulin aspart (IDegAsp) clinical trials., Methods: This was a post hoc analysis of data from 13 phase 3, randomised, parallel-group, open-label IDegAsp trials in patients with T2D. The pooled baseline clinical data were analysed for insulin-naïve and insulin-experienced groups; and each group was split into subgroups of Asian and non-Asian patients, respectively, and analysed accordingly. Baseline self-monitored blood glucose (SMBG) values at breakfast, lunch and the evening meal (before and 90 min after each meal) were used to assess PPG increments. The estimated differences in baseline SMBG increment between the Asian and non-Asian subgroups were analysed., Results: Clinical data from 4750 participants (insulin-naïve, n = 1495; insulin-experienced, n = 3255) were evaluated. In the insulin-naïve group, the postprandial SMBG increment was significantly greater in the Asian versus the non-Asian subgroup at breakfast (estimated difference 28.67 mg/dL, 95% confidence interval [CI] 18.35, 38.99; p < 0.0001), lunch (17.34 mg/dL, 95% CI 6.47, 28.21; p = 0.0018) and the evening meal (16.19 mg/dL, 95% CI 5.04, 27.34; p = 0.0045). In the insulin-experienced group, the postprandial SMBG increment was significantly greater in the Asian versus non-Asian subgroup at breakfast (estimated difference 13.81 mg/dL, 95% CI 9.19, 18.44; p < 0.0001) and lunch (29.18 mg/dL, 95% CI 24.22, 34.14; p < 0.0001), but not significantly different at the evening meal., Conclusion: In this post hoc analysis, baseline PPG increments were significantly greater in Asian participants with T2D than in their non-Asian counterparts at all mealtimes, with the exception of the evening meal in insulin-experienced participants. Asian adults with T2D may benefit from the use of regimens that control PPG excursions., Clinical Trial Numbers: NCT02762578, NCT01814137, NCT01513590, NCT01009580, NCT01713530, NCT02648217, NCT01045447, NCT01365507, NCT01045707, NCT01272193, NCT01059812, NCT01680341, NCT02906917., (© 2022. The Author(s).)

Background: Cisplatin is one of the anticancer drugs used for head and neck cancers. Although some studies have shown that cisplatin can cause ototoxicity, periodic audiometric assessments have not been extensively studied in the Indian rural population. Hence, this study has been undertaken to evaluate the effects of cisplatin on hearing., Materials and Methods: Fifty-nine patients with squamous cell carcinomas of head and neck, who received cisplatin chemotherapy, were recruited. Serum creatinine, blood urea, serum proteins, and audiometry were assessed before and after the first, second, and third chemotherapy cycle. The cochleotoxic effect of cisplatin was assessed by pure tone audiometry. Hearing loss was graded accordingly. All patients were administered a quality of life questionnaire at baseline and at the end of the third cycle., Results: Hearing loss was observed in 12 patients at speech frequencies and those at higher frequencies were 12 (4000 Hz), 18 (6000 Hz), and 28 (8000 Hz). The hearing loss was symmetrical, sensorineural, and showed a strong correlation with the low serum albumin levels at the end of the third cycle. Dizziness was seen in eight patients, at the end of the study. The commonly observed adverse effects were nausea, vomiting, hair loss, fatigue, and tinnitus., Conclusion: The studies have shown hearing loss in higher frequencies, but in our study, we have observed hearing loss at speech frequency in 22.2% of patients receiving cisplatin, who also had low serum albumin levels. Periodic audiometric monitoring and serum albumin level may be helpful to provide timely intervention to prevent further hearing loss and deterioration in the quality of life., Competing Interests: There are no conflicts of interest