BackgroundEvidence supporting the addition of specific insulin regimens to oral therapy in patients with type 2 diabetes mellitus is limited.
MethodsIn this 3-year open-label, multicenter trial, we evaluated 708 patients who had suboptimal glycated hemoglobin levels while taking metformin and sulfonylurea therapy. Patients were randomly assigned to receive biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (twice if required). Sulfonylurea therapy was replaced by a second type of insulin if hyperglycemia became unacceptable during the first year of the study or subsequently if glycated hemoglobin levels were more than 6.5%. Outcome measures were glycated hemoglobin levels, the proportion of patients with a glycated hemoglobin level of 6.5% or less, the rate of hypoglycemia, and weight gain.
ResultsMedian glycated hemoglobin levels were similar for patients receiving biphasic (7.1%), prandial (6.8%), and basal (6.9%) insulin-based regimens (P = 0.28). However, fewer patients had a level of 6.5% or less in the biphasic group (31.9%) than in the prandial group (44.7%, P = 0.006) or in the basal group (43.2%, P = 0.03), with 67.7%, 73.6%, and 81.6%, respectively, taking a second type of insulin (P = 0.002). Median rates of hypoglycemia per patient per year were lowest in the basal group (1.7), higher in the biphasic group (3.0), and highest in the prandial group (5.7) (P<0.001 for the overall comparison). The mean weight gain was higher in the prandial group than in either the biphasic group or the basal group. Other adverse event rates were similar in the three groups.
ConclusionsPatients who added a basal or prandial insulin-based regimen to oral therapy had better glycated hemoglobin control than patients who added a biphasic insulin-based regimen. Fewer hypoglycemic episodes and less weight gain occurred in patients adding basal insulin. (Current Controlled Trials number, ISRCTN51125379.)The New England Journal of Medicine Downloaded from nejm.org at UQ Library on March 30, 2017. For personal use only. No other uses without permission.
IntroductionPatients in intensive care units (ICUs) suffer from sleep deprivation arising from nursing interventions and ambient noise. This may exacerbate confusion and ICU-related delirium. The World Health Organization (WHO) suggests that average hospital sound levels should not exceed 35 dB with a maximum of 40 dB overnight. We monitored five ICUs to check compliance with these guidelines.MethodsSound levels were recorded in five adult ICUs in the UK. Two sound level monitors recorded concurrently for 24 hours at the ICU central stations and adjacent to patients. Sample values to determine levels generated by equipment and external noise were also recorded in an empty ICU side room.ResultsAverage sound levels always exceeded 45 dBA and for 50% of the time exceeded between 52 and 59 dBA in individual ICUs. There was diurnal variation with values decreasing after evening handovers to an overnight average minimum of 51 dBA at 4 AM. Peaks above 85 dBA occurred at all sites, up to 16 times per hour overnight and more frequently during the day. WHO guidelines on sound levels could be only achieved in a side room by switching all equipment off.ConclusionAll ICUs had sound levels greater than WHO recommendations, but the WHO recommended levels are so low they are not achievable in an ICU. Levels adjacent to patients are higher than those recorded at central stations. Unit-wide noise reduction programmes or mechanical means of isolating patients from ambient noise, such as earplugs, should be considered.
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