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- Bergqvist, Karin, et al.
(author)
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The role of chloramines in treatment of diabetic foot ulcers: an exploratory multicentre randomised controlled trial
- 2016
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In: Clinical Diabetes and Endocrinology. - : Springer Science and Business Media LLC. - 2055-8260. ; 2:6
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Journal article (peer-reviewed)abstract
- Background Chronic foot ulcers in diabetes are serious, costly and frequently difficult to heal. Recent guidelines conclude that new dressings and treatments generally fail to show superiority compared with standard of care. Several mechanisms are probably responsible for impaired healing of chronic foot ulcers, including inflammation and infection. Chloramines have presumed antiseptic and antibacterial properties, and have shown to be a useful treatment in odontology. Methods In an explorative open randomised controlled multi-centre study, we compared chloramine-based treatment with current standard of care for 12 weeks and follow-up for 24 weeks. Seventeen patients in each group, mean age about 70, duration of diabetes > 20 years and foot ulcers about 1.5 years, completed the 12 weeks study. Results After 5 weeks, the difference between the groups in relative reduction in ulcer area was statistically significant (p=0.016). Absolute change in ulcer area was first statistically significant within the chloraminetreated group after 2 weeks (p=0.026), after 8 weeks in the control group (p=0.0023), with significant difference between groups after 5 weeks (p=0.024). The approximate relative decrease per week was 19.4% (95%CI 12.2, 26.0; p<0.0001) in the chloramine-treated group and 11.7% (95%CI 6.4, 16.7; p<0.0001; between-group difference p=0.083). After 9 weeks 7 patients had healed in the chloraminetreated group, but only one in the control group (p=0.039). There were no statistically significant differences in wound healing at 12 or 24 weeks, and no marked differences in signs of infection, pain, quality of life (EQ-5D), or incidence of adverse events. Conclusions Chloramine-based treatment seems to be efficacious, particularly in the early phase of the care of infected diabetic foot ulcers. It is safe and easy to use, and could prove to be a valuable addition in the treatment arsenal, providing non-surgical debridement. Future studies will evaluate its role in wound care.
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| 2. |
- Martinez, Maria Månsson, et al.
(author)
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Heterogeneity of beta-cell function in subjects with multiple islet autoantibodies in the TEDDY family prevention study - TEFA
- 2022
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In: Clinical diabetes and endocrinology. - : Springer Science and Business Media LLC. - 2055-8260. ; 7:1
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Journal article (peer-reviewed)abstract
- BACKGROUND: Individuals with multiple islet autoantibodies are at increased risk for clinical type 1 diabetes and may proceed gradually from stage to stage complicating the recruitment to secondary prevention studies. We evaluated multiple islet autoantibody positive subjects before randomisation for a clinical trial 1 month apart for beta-cell function, glucose metabolism and continuous glucose monitoring (CGM). We hypothesized that the number and type of islet autoantibodies in combination with different measures of glucose metabolism including fasting glucose, HbA1c, oral glucose tolerance test (OGTT), intra venous glucose tolerance test (IvGTT) and CGM allows for more precise staging of autoimmune type 1 diabetes than the number of islet autoantibodies alone.METHODS: Subjects (n = 57) at 2-50 years of age, positive for two or more islet autoantibodies were assessed by fasting plasma insulin, glucose, HbA1c as well as First Phase Insulin Response (FPIR) in IvGTT, followed 1 month later by OGTT, and 1 week of CGM (n = 24).RESULTS: Autoantibodies against GAD65 (GADA; n = 52), ZnT8 (ZnT8A; n = 40), IA-2 (IA-2A; n = 38) and insulin (IAA; n = 28) were present in 9 different combinations of 2-4 autoantibodies. Fasting glucose and HbA1c did not differ between the two visits. The estimate of the linear relationship between log2-transformed FPIR as the outcome and log2-transformed area under the OGTT glucose curve (AUC) as the predictor, adjusting for age and sex was - 1.88 (- 2.71, - 1.05) p = 3.49 × 10-5. The direction of the estimates for all glucose metabolism measures was positive except for FPIR, which was negative. FPIR was associated with higher blood glucose. Both the median and the spread of the CGM glucose data were significantly associated with higher glucose values based on OGTT, higher HbA1c, and lower FPIR. There was no association between glucose metabolism, autoantibody number and type except that there was an indication that the presence of at least one of ZnT8(Q/R/W) A was associated with a lower log2-transformed FPIR (- 0.80 (- 1.58, - 0.02), p = 0.046).CONCLUSIONS: The sole use of two or more islet autoantibodies as inclusion criterion for Stage 1 diabetes in prevention trials is unsatisfactory. Staging type 1 diabetes needs to take the heterogeneity in beta-cell function and glucose metabolism into account.TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02605148 , November 16, 2015.
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| 3. |
- Svensson, Ann-Marie, 1961, et al.
(author)
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Clinical effects, cardiovascular and renal outcomes associated with rapid-acting insulin analogs among individuals with type 2 diabetes: a nation-wide observational cohort study.
- 2017
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In: Clinical diabetes and endocrinology. - : Springer Science and Business Media LLC. - 2055-8260. ; 3
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Journal article (peer-reviewed)abstract
- Rapid-acting insulin analogs (RAIs) have not been examined for long-term safety in randomized clinical trials. We performed a nationwide longitudinal cohort study among individuals with type 2 diabetes (T2DM) to address cardiovascular safety and mortality among users of lispro, aspart and glulisine insulins.We used four national registers, following patients previously not treated with RAI but with continuous use of RAIs in 2005-2014 up to 6.4 years, to examine HbA1c and weight, and the occurrence of severe hyperglycemia or hypoglycemia, renal failure, cardiovascular events or death. The treatment groups were compared using a weighted Cox proportional hazards model.We included 17,620 patients, mean age slightly higher than 60years, diabetes duration 9.9-11.7years, mean BMI 30.5kg/m(2), HbA1c around 70mmol/mol (8.6% NGSP), and 40.9-54.0% of the patients exhibiting eGFR <60ml/min/1.73m(2) in the three groups. Around 95% of the patients also used another insulin, and 24.2-24.7% had a history of cardiovascular disease (CVD). Mean HbA1c and weight levels were stable and similar. Incidence rates of death were 234.4, 284.9 and 156.7 per 1000 person-years among users of lispro, aspart, and glulisine; incidence rates of all cardiovascular events were 668.4, 622.4, and 699.5 per 1000 person-years, respectively. There were no differences in mortality, CVD, renal failure or severe hypoglycemia or hyperglycemia, although a lower mortality risk in patients on glulisine compared with aspart, and lower risk of stroke in users of glulisine was suggested. The risk of severe hyperglycemia was higher with lispro than aspart, and lower of severe hypoglycemia than aspart or glulisine among the older age group.Overall, there do not appear to be any major important differences in effects on hypoglycemia, hyperglycemia, weight or long-term safety between the three available RAIs among insulin-naive individuals with T2DM in clinical practice.
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| 4. |
- Svensson, Ann-Marie, 1961, et al.
(author)
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Total costs of basal or premixed insulin treatment in 5077 insulin-naïve type 2 diabetes patients: register-based observational study in clinical practice.
- 2015
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In: Clinical diabetes and endocrinology. - : Springer Science and Business Media LLC. - 2055-8260. ; 1
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Journal article (peer-reviewed)abstract
- To investigate the costs of treatment with basal insulin (insulin NPH [NPH], insulin glargine [IG], insulin determir [IG]), and premixed insulin (PM) in routine clinical care.Cohort study based on data from the Swedish National Diabetes Register, including 5077 insulin-naïve men and women with type 2 diabetes, resident in a distinct geographical region of Sweden. Patients were included between 1 July 2006 and 31 December 2009 and followed for 12months. All drug- and healthcare-related costs, stratified by diabetes-related or non-diabetes care contacts, were quantified and compared to baseline.Initiation of insulin treatment generally entails increased diabetes-related health care contacts and treatment costs, and decrease in health care costs. The median changes in costs were generally smaller than the mean changes, reflecting great variations between patients. The treatment costs were higher for IG, ID and PM compared with NPH, although higher age, history cardiovascular disease and diabetes complications as well as higher diabetes-related and other treatment costs were independent predictors. Overall, only PM (but not IG or ID) were associated with higher diabetes-related health care costs, although these were also independently predicted by cardiovascular morbidity and markers of complicated diabetes.This study demonstrates that the initiation of insulin in patients with type 2 diabetes in clinical practice leads to increased health care contacts, overall and treatment costs, but also generally results in a decrease in health care costs. The diabetes-related treatment cost was lowest using NPH insulin but only premixed insulin was associated with higher diabetes-related health care costs than NPH.
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