Aims/hypothesis. The aim of the trial was to compare the efficacy and tolerability of two types of basal-bolus therapy, using either the soluble long-acting basal insulin analogue, insulin detemir, in combination with the rapid-acting analogue, insulin aspart, or NPH insulin in combination with mealtime regular human insulin. Methods. In this 18-week, 1:1 randomised, open-labelled, parallel trial, 595 patients with Type 1 diabetes mellitus received insulin detemir or NPH insulin in the morning and at bedtime in combination with mealtime insulin aspart or regular human insulin respectively. Results. Glycaemic control with insulin detemir/insulin aspart was improved in comparison with NPH insulin/regular human insulin (HbA 1 c: 7.88% vs 8.11%; mean difference: −0.22% point [95% CI: −0.34 to −0.10]; p<0.001). Self-measured 8-point plasma glucose profiles differed between the groups (p<0.001), with lower postprandial plasma glucose levels in the insulin detemir/insulin aspart group. Within-person day-to-day variation in plasma glucose was lower with insulin detemir/insulin aspart than with NPH insulin/regular human insulin (SD: 2.88 vs 3.12 mmol/l; p<0.001). Risk of overall and nocturnal hypoglycaemia (23.00-06.00 hours) was, respectively, 21% (p=0.036) and 55% (p<0.001) lower in the insulin detemir/insulin aspart group than in the NPH insulin/regular human insulin group. Body weight (adjusted for baseline and change in HbA 1 c) was 1 kg lower with insulin detemir/insulin aspart than with NPH insulin/regular human insulin (p<0.001). Conclusions/interpretation. Basal-bolus therapy using insulin detemir/insulin aspart offers a better balance of control and tolerability than with NPH insulin/regular human insulin. The low variability and more physiological action profiles generated with these insulin analogues resulted in improved glycaemic control with lower risk of hypoglycaemia and no concomitant body weight increase.
OBJECTIVE -The purpose of this article was to identify criteria predictive of remission in nonsurgical treatment of diabetic foot osteomyelitis.RESEARCH DESIGN AND METHODS -Diabetic patients who were initially treated without orthopedic surgery for osteomyelitis of the toe or metatarsal head of a nonischemic foot between June 2002 and June 2003 in nine French diabetic foot centers were identified, and their medical records were reviewed. Remission was defined as the absence of any sign of infection at the initial or contiguous site assessed at least 1 year after the end of treatment. A total of 24 demographic, clinical, and therapeutic variables including bone versus swab culture-based antibiotic therapy were analyzed.RESULTS -Fifty consecutive patients aged 62.2 Ϯ 11.1 years (mean Ϯ SD) with diabetes duration of 16 Ϯ 10.9 years were included. The mean duration of antibiotic treatment was 11.5 Ϯ 4.21 weeks. Bone biopsy was routinely available in four of the nine centers. Overall patient management was similar in the different centers except for the use of rifampin, which was recorded more frequently in patients from centers in which a bone biopsy was available. At the end of a 12.8-month posttreatment mean follow-up, 32 patients (64%) were in remission. CONCLUSIONS -Bone culture-based antibiotic therapy is a factor predictive of success in diabetic patients treated nonsurgically for osteomyelitis of the foot.
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