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OBJECTIVETo determine whether impaired awareness of hypoglycemia (IAH) can be improved and severe hypoglycemia (SH) prevented in type 1 diabetes, we compared an insulin pump (continuous subcutaneous insulin infusion [CSII]) with multiple daily injections (MDIs) and adjuvant real-time continuous glucose monitoring (RT) with conventional self-monitoring of blood glucose (SMBG). RESEARCH DESIGN AND METHODSA 24-week 2 3 2 factorial randomized controlled trial in adults with type 1 diabetes and IAH was conducted. All received comparable education, support, and congruent therapeutic targets aimed at rigorous avoidance of biochemical hypoglycemia without relaxing overall control. Primary end point was between-intervention difference in 24-week hypoglycemia awareness (Gold score). RESULTSA total of 96 participants (mean diabetes duration 29 years) were randomized. Overall, biochemical hypoglycemia (£3.0 mmol/L) decreased (53 6 63 to 24 6 56 min/24 h; P = 0.004 [t test]) without deterioration in HbA 1c . Hypoglycemia awareness improved (5.1 6 1.1 to 4.1 6 1.6; P = 0.0001 [t test]) with decreased SH (8.9 6 13.4 to 0.8 6 1.8 episodes/patient-year; P = 0.0001 [t test]). At 24 weeks, there was no significant difference in awareness comparing CSII with MDI (4.1 6 1.6 vs. 4.2 6 1.7; difference 0.1; 95% CI 20.6 to 0.8) and RT with SMBG (4.3 6 1.6 vs. 4.0 6 1.7; difference 20.3; 95% CI 21.0 to 0.4). Between-group analyses demonstrated comparable reductions in SH, fear of hypoglycemia, and insulin doses with equivalent HbA 1c . Treatment satisfaction was higher with CSII than MDI (32 6 3 vs. 29 6 6; P = 0.0003 [t test]), but comparable with SMBG and RT (30 6 5 vs. 30 6 5; P = 0.79 [t test]). CONCLUSIONSHypoglycemia awareness can be improved and recurrent SH prevented in longstanding type 1 diabetes without relaxing HbA 1c . Similar biomedical outcomes can be attained with conventional MDI and SMBG regimens compared with CSII/RT, although satisfaction was higher with CSII.

Background: In some patients chronic asthma results in irreversible airflow obstruction. High resolution computed tomography (HRCT) has been advocated for assessing the structural changes in the asthmatic lung and permits investigation of the relationships between airway wall thickening and clinical parameters in this condition. Methods: High resolution CT scanning was performed in 49 optimally controlled asthmatic patients and measurements of total airway and lumen diameter were made by two independent radiologists using electronic callipers. Wall area as % total airway cross sectional area (WA%) and wall thickness to airway diameter ratio (T/D) were calculated for all airways clearly visualised with a transverse diameter of more than 1.5 mm, with a mean value derived for each patient. Intra-and inter-observer variability was assessed for scope of agreement in a subgroup of patients. Measurements were related to optimum forced expiratory volume in 1 second (FEV 1 ), forced mid expiratory flow, carbon monoxide gas transfer, two scores of asthma severity, airway inflammation as assessed with induced sputum, and exhaled nitric oxide. Results: Neither observer produced a statistically significant difference between measurements performed on two occasions but there was a significant difference between observers (limits of agreement -2.6 to 6.8 for WA%, p<0.0001). However, mean WA% measured on two occasions differed by no more than 5.4% (limits of agreement -4.0 to 5.4; mean (SD) 0.7 (2.4)). Statistically significant positive associations were observed between both WA% and T/D ratio and asthma severity (r S =0.29 and 0.30, respectively, for ATS score), and an inverse association with gas transfer coefficient was observed (r S =-0.43 for WA% and r S =-0.41 for T/D). No association was identified with FEV 1 or airway inflammation. Conclusions: The airway wall is thickened in more severe asthma and is associated with gas transfer coefficient. This thickening does not relate directly to irreversible airflow obstruction as measured with FEV 1 .

Background-Sputum eosinophil counts and exhaled nitric oxide (NO) levels are increased in asthma and both measurements fall in response to corticosteroids. Methods-Exhaled NO levels and sputum eosinophil counts were assessed as noninvasive markers of the response to an oral steroid in 37 patients (19 women) with stable chronic asthma (mean (SD) age 48.6 (12.2) years, asthma duration 25.9 (17.3) years, and baseline forced expiratory volume in one second (FEV 1 ) 76.3 (21.9)% predicted). Spirometric tests, with reversibility to a agonist (2.5 mg nebulised salbutamol), and induced sputum (using nebulised 3% saline) were performed at recruitment and following treatment with 30 mg prednisolone/day for 14 days. Results-Baseline NO levels correlated with the percentage improvement in FEV 1 from baseline to the post-steroid, postbronchodilator value (r s = 0.47, p = 0.003), with an NO level of >10 ppb at baseline having a positive predictive value of 83% for an improvement in FEV 1 of >15% (sensitivity 59%, specificity 90%). Sputum eosinophilia (>4%) had a positive predictive value of 68% (sensitivity 54%, specificity 76%) for an increase in FEV 1 of >15%. A combination of sputum eosinophilia and increased NO levels resulted in a positive predictive value of 72% and a negative predictive value of 79% (sensitivity 76%, specificity 75%). Conclusion-Exhaled NO levels and sputum eosinophilia may be useful in predicting the response to a trial of oral steroid in asthma. (Thorax 2000;55:232-234)