OBJECTIVE -Insulin detemir is a soluble basal insulin analog with a unique mechanism of protracted action designed to reduce the variability associated with conventional basal insulins. This trial compared the glycemic control, risk of hypoglycemia, and effect on body weight of insulin detemir and NPH insulin in patients with type 1 diabetes treated with rapid-acting insulin aspart at meals.
RESEARCH DESIGN AND METHODS-This study was a 6-month multinational open parallel-group comparison conducted at 46 centers in five countries and included 448 patients with type 1 diabetes randomized 2:1 to insulin detemir or NPH insulin, respectively. RESULTS -After 6 months, comparable HbA 1c levels were found between the two treatment groups. Fasting plasma glucose tended to be lower in patients treated with insulin detemir, but this difference was not statistically significant (Ϫ0.76 mmol/l, P ϭ 0.097). Within-subject variation in self-measured fasting blood glucose was lower with insulin detemir than with NPH insulin (SD 3.37 vs. 3.78 mmol/l, P Ͻ 0.001). Risk of hypoglycemia was 22% lower with insulin detemir than with NPH insulin (P Ͻ 0.05) and 34% lower for nocturnal (2300 -0600) hypoglycemia (P Ͻ 0.005). Nightly plasma glucose profiles were smoother and more stable with insulin detemir (P ϭ 0.05). Body weight was significantly lower with insulin detemir at the end of the trial (P Ͻ 0.001).CONCLUSIONS -Treatment with insulin detemir resulted in more predictable glycemic control, with smoother plasma glucose profiles than NPH insulin and a significant reduction in the risk of hypoglycemia. The reduction in body weight with insulin detemir is a potential additional advantage. Regimens optimized for insulin detemir may be able to improve glycemic control beyond that possible with NPH insulin.
The results suggest that use of TM technology can be a relevant alternative and supplement to usual care, at least for patients with more superficial ulcers.
In long-term basal-bolus therapy, insulin detemir with insulin aspart as mealtime insulin is well tolerated and reduces the risks of nocturnal hypoglycaemia and weight gain compared to NPH insulin.
Objective: To investigate the effect of different antithyroid drug (ATD) regimens on relapse rates of Graves' disease, and to look for predictors of relapse. Design and Methods: In a prospective two-way factorial randomized clinical trial, 218 patients with Graves' disease were assigned to ATD combined with L-thyroxine (L-T 4 ) or ATD alone for 12 months. After discontinuation of antithyroid therapy, each group was stratified to either 12 months further treatment with L-T 4 or no treatment. Clinical and biochemical assessments were carried out before treatment, after 3 and 6 weeks, and every third month for 12 months. If the patients lacked symptoms of relapse, laboratory tests were performed every third month for the second year, and thereafter annually. Results: The proportion of all patients with relapse was 47.7% 2 years after withdrawal of ATD. There was no difference in relapse rates between the treatment groups (P ¼ 0:217; log-rank test). Smokers had a higher relapse rate than non-smokers (58.4% vs 38.8%, P ¼ 0:009). Patients who were thyrotropin-receptor antibody (TRAb) positive after 12 months of antithyroid therapy had a higher relapse rate than those who were negative (72.5% vs 36.8%, P , 0:0001). Similarly, relapse was more frequent (55.5%) in patients having large goiter compared with subjects with small goiter (36.3%, P ¼ 0:0007). Conclusions: Relapse rates of Graves' disease were independent of ATD regimen whether followed by L-T 4 therapy or not. Smoking, large goiter and presence of TRAb at the end of ATD therapy were strong predictors of relapse.
ObjectivesTo investigate whether A) duration of ulcer before start of treatment in specialist health care, and B) severity of ulcer according to University of Texas classification system (UT) at start of treatment (baseline), are independent predictors of healing time.MethodsThis retrospective cohort study, based on electronic medical record data, included 105 patients from two outpatient clinics in Western Norway with a new diabetic foot ulcer during 2009–2011. The associations of duration of ulcer and ulcer severity with healing time were assessed using cumulative incidence curves and subdistribution hazard ratio estimated using competing risk regression with adjustment for potential confounders.ResultsOf the 105 participants, 45.7% achieved ulcer healing, 36.2% underwent amputations, 9.5% died before ulcer healing and 8.5% were lost to follow-up. Patients who were referred to specialist health care by a general practitioner ≥ 52 days after ulcer onset had a 58% (SHR 0.42, CI 0.18–0.98) decreased healing rate compared to patients who were referred earlier, in the adjusted model. High severity (grade 2/3, stage C/D) according to the UT classification system was associated with a decreased healing rate compared to low severity (grade1, stage A/B or grade 2, stage A) with SHR (95% CI) equal to 0.14 (0.05–0.43) after adjustment for referral time and other potential confounders.ConclusionEarly detection and referral by both the patient and general practitioner are crucial for optimal foot ulcer healing. Ulcer grade and severity are also important predictors for healing time, and early screening to assess the severity and initiation of prompt treatment is important.
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