Value of team approach combined with clinical pathway for diabetic foot problems: a clinical evaluation

Aims: To evaluate the effectiveness of management of diabetic foot problems (DFP) by the National University Hospital (NUH) Multidisciplinary Diabetic Foot Team combined with a clinical pathway in terms of average length of stay (ALOS), readmission rates, hospitalisation cost per patient, major reamputation rate, and complication rate. Methods: 939 patients admitted to the Department of Orthopaedic Surgery, NUH, for DFP from 2002 (before team formation) to 2007 (after team formation). It consisted of six cohorts of patients – 61 for 2002, 70 for 2003, 148 for 2004, 180 for 2005, 262 for 2006, and 218 for 2007. All patients were managed by the NUH Multidisciplinary Diabetic Foot Team combined with a clinical pathway. Statistical analyses were carried out for five parameters (ALOS, hospitalisation cost per patient, major amputation rate, readmission rate, and complication rate). Results: From 2002 to 2007, the ALOS was significantly reduced from 20.36 days to 12.20 days (p=0.0005). Major amputation rate was significantly reduced from 31.15 to 11.01% (p<0.0005). There was also a significant reduction in complication rate from 19.67 to 7.34% (p=0.005). There were reductions in the hospitalisation cost per patient and readmission rate after formation of the multidisciplinary team but they were not statistically significant. Conclusion: Our evaluation showed that a multidisciplinary team approach combined with the implementation of a clinical pathway in NUH was effective in reducing the ALOS, major amputation rate, and complication rate of DFP

Comparison of treatment with insulin degludec and glargine U100 in patients with type 1 diabetes prone to nocturnal severe hypoglycaemia:The HypoDeg randomized, controlled, open-label, crossover trial

AIM: To investigate whether the long‐acting insulin analogue insulin degludec compared with insulin glargine U100 reduces the risk of nocturnal symptomatic hypoglycaemia in patients with type 1 diabetes (T1D). METHODS: Adults with T1D and at least one episode of nocturnal severe hypoglycaemia during the last 2 years were included in a 2‐year prospective, randomized, open, multicentre, crossover trial. A total of 149 patients were randomized 1:1 to basal‐bolus therapy with insulin degludec and insulin aspart or insulin glargine U100 and insulin aspart. Each treatment period lasted 1 year and consisted of 3 months of run‐in or crossover followed by 9 months of maintenance. The primary endpoint was the number of blindly adjudicated nocturnal symptomatic hypoglycaemic episodes. Secondary endpoints included the occurrence of severe hypoglycaemia. We analysed all endpoints by intention‐to‐treat. RESULTS: Treatment with insulin degludec resulted in a 28% (95% CI: 9%‐43%; P = .02) relative rate reduction (RRR) of nocturnal symptomatic hypoglycaemia at level 1 (≤3.9 mmol/L), a 37% (95% CI: 16%‐53%; P = .002) RRR at level 2 (≤3.0 mmol/L), and a 35% (95% CI: 1%‐58%; P = .04) RRR in all‐day severe hypoglycaemia compared with insulin glargine U100. CONCLUSIONS: Patients with T1D prone to nocturnal severe hypoglycaemia have lower rates of nocturnal symptomatic hypoglycaemia and all‐day severe hypoglycaemia with insulin degludec compared with insulin glargine U100

Quality of life, patient satisfaction, and cardiovascular outcomes of the randomised 2 x 3 factorial Copenhagen insulin and Metformin therapy (CIMT) trial – A detailed statistical analysis plan

Background: The evidence on the effects of metformin and insulin in type 2 diabetes patients on quality of life, patient satisfaction, and cardiovascular outcomes is unclear. Methods: The Copenhagen Insulin and Metformin Therapy (CIMT) trial is an investigator-initiated multicentre, randomised, placebo-controlled trial with a 2 × 3 factorial design conducted at eight hospitals in Denmark. Participants with type 2 diabetes were randomised to metformin (n = 206) versus placebo (n = 206); in combination with open-label biphasic insulin aspart one to three times daily (n = 137) versus insulin aspart three times daily in combination with insulin detemir once daily (n = 138) versus insulin detemir once daily (n = 137).We present a detailed description of the methodology and statistical analysis of the clinical CIMT outcomes including a detailed description of tests of the assumptions behind the statistical analyses. The outcomes are quality of life (Short Form Health Survey (SF-36)), Diabetes Medication Satisfaction Questionnaire, and Insulin Treatment Satisfaction Questionnaire (assessed at entry and 18 months after randomisation) and cardiovascular outcomes including time to a composite of either myocardial infarction, stroke, peripheral amputation, coronary revascularisation, peripheral revascularisation, or death. Discussions: This statistical analysis plan ensure the highest possible quality of the subsequent post-hoc analyses. Trial registration: The protocol was approved by the Regional Committee on Biomedical Research Ethics (H-D-2007-112), the Danish Medicines Agency (EudraCT: 2007-006665-33 CIMT), and registered within ClinicalTrials.gov (NCT00657943, 8th of April 2008)