RESUMO
BACKGROUND: Autonomous cortisol secretion in patients with adrenal incidentalomas is associated with increased mortality, but detailed information about the risk associated with specific levels of autonomous cortisol secretion is not available. OBJECTIVE: To measure the association between mortality and levels of autonomous cortisol secretion in patients with adrenal incidentalomas. DESIGN: Retrospective cohort study. (ClinicalTrials.gov: NCT03919734). SETTING: Two hospitals in southern Sweden. PATIENTS: Consecutive patients who had adrenal incidentalomas identified between 2005 and 2015 and were followed for up to 14 years. Outcome data were collected from national registers. MEASUREMENTS: Patients were grouped according to plasma cortisol level after a 1-mg dexamethasone suppression test (cortisolDST; <50, 50 to 82, 83 to 137, or ≥138 nmol/L). RESULTS: During a median follow-up of 6.4 years, 170 of 1048 patients died. Compared with a cortisolDST less than 50 nmol/L, a cortisolDST of 50 to 82 nmol/L was not associated with increased mortality (hazard ratio [HR], 1.15 [95% CI, 0.78 to 1.70]). However, a cortisolDST of 83 to 137 nmol/L (n = 119) had an HR of 2.30 (CI, 1.52 to 3.49), and a cortisolDST of 138 nmol/L or higher (n = 82) had an HR of 3.04 (CI, 1.86 to 4.98). Analyses using restricted cubic splines indicated that the association between cortisolDST and mortality was linear up to a cortisolDST of 200 nmol/L. LIMITATION: The results are not based on verified autonomous cortisol secretion; thus, the association may be underestimated. CONCLUSION: The association between mortality and cortisolDST increased linearly until cortisolDST reached 200 nmol/L. A cortisolDST of 83 to 137 nmol/L was associated with a 2-fold increase in mortality, and a cortisolDST of 138 nmol/L or higher was associated with a 3-fold increase in mortality. Additional studies should be done, and until those studies are completed some clinicians may consider these findings when deciding which patients to recommend for surgery. PRIMARY FUNDING SOURCE: Lisa and Johan Grönberg Foundation and Gyllenstiernska Krapperup Foundation.
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Neoplasias das Glândulas Suprarrenais/sangue , Neoplasias das Glândulas Suprarrenais/mortalidade , Hidrocortisona/sangue , Idoso , Biomarcadores Tumorais/sangue , Causas de Morte , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Suécia/epidemiologiaRESUMO
AIMS/HYPOTHESIS: The aim of this work was to study the incidence over time of lower extremity amputations and determine variables associated with increased risk of amputations in people with type 1 diabetes. METHODS: Individuals with type 1 diabetes registered in the Swedish National Diabetes Registry with no previous amputation from 1 January 1998 and followed to 2 October 2019 were included. Time-updated Cox regression and gradient of risk per SD were used to evaluate the impact of risk factors on the incidence of amputation. Age- and sex-adjusted incidences were estimated over time. RESULTS: Of 46,088 people with type 1 diabetes with no previous amputation (mean age 32.5 years [SD 14.5], 25,354 [55%] male sex), 1519 (3.3%) underwent amputation. Median follow-up was 12.4 years. The standardised incidence for any amputation in 1998-2001 was 2.84 (95% CI 2.32, 3.36) per 1000 person-years and decreased to 1.64 (95% CI 1.38, 1.90) per 1000 person-years in 2017-2019. The incidence for minor and major amputations showed a similar pattern. Hyperglycaemia and renal dysfunction were the strongest risk factors for amputation, followed by older age, male sex, cardiovascular comorbidities, smoking and hypertension. Glycaemic control and age- and sex-adjusted renal function improved during the corresponding time period as amputations decreased. CONCLUSIONS/INTERPRETATION: The incidence of amputation and of the most prominent risk factors for amputation, including renal dysfunction and hyperglycaemia, has improved considerably during recent years for people with type 1 diabetes. This finding has important implications for quality of life, health economics and prognosis regarding CVD, indicating a trend shift in the treatment of type 1 diabetes.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Pé Diabético , Adulto , Amputação Cirúrgica , Estudos de Coortes , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 1/cirurgia , Diabetes Mellitus Tipo 2/complicações , Pé Diabético/epidemiologia , Pé Diabético/cirurgia , Humanos , Incidência , Extremidade Inferior/cirurgia , Masculino , Qualidade de Vida , Sistema de Registros , Fatores de Risco , Suécia/epidemiologiaRESUMO
OBJECTIVE: During the investigation of adrenal incidentalomas, it is important to accurately diagnose autonomous cortisol secretion (ACS) but the specificity of cortisol ≥50 nmol/L after overnight dexamethasone suppression (cortisolONDST ) is low. Therefore, ACTH following overnight dexamethasone suppression (ACTHONDST ) and cortisol following a 2-day dexamethasone suppression test (cortisol2-DAYDST ) were examined as markers of HPA axis suppression during ONDST. DESIGN: This cross-sectional study examined patients with adrenal incidentalomas and basal ACTH ≥ 2.0 pmol/L who underwent ONDST. MEASUREMENTS: ACTHONDST /ACTH ratio (ACTH ratio) was calculated for all patients. To define cut-off levels for ACTHONDST and ACTH ratio as markers of HPA axis suppression, ROC curves were used to separate patients with cortisolONDST <50 and ≥50 nmol/L. RESULTS: CortisolONDST was ≥50 nmol/L in 140 out of 373 patients. In patients with cortisolONDST <50 nmol/L, ACTHONDST was 0.28 pmol/L (<0.23-2.7). DHEAS was positively correlated to ACTHONDST , demonstrating a 9% increase with a doubling in ACTHONDST , p = 0.02. The best cut-off levels for ACTHONDST and ACTH ratio to detect cortisolONDST ≥50 nmol/L were ≥0.6 pmol/L and ≥18% respectively. These cut-off levels were tested on patients with cortisolONDST <50 nmol/L, considered to have adequate suppression (n = 233), and patients with reduction of ≥50 nmol/L from cortisolONDST to cortisol2-DAYDST , who were considered to have inadequate suppression (n = 16). ACTHONDST ≥0.6 pmol/L and ACTH ratio ≥18% had a sensitivity of 75% and 81% respectively, and a specificity of 78% and 85% respectively, for detecting patients with inadequate suppression. CONCLUSIONS: ACTHONDST and ACTH ratio can be markers of HPA axis suppression in the investigation of adrenal incidentalomas. CortisolONDST ≥50 nmol/L with ACTHONDST <0.6 pmol/L or ACTH ratio <18% should lead to the suspicion of ACS.
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Neoplasias das Glândulas Suprarrenais , Hormônio Adrenocorticotrópico , Estudos Transversais , Dexametasona , Humanos , Hidrocortisona , Sistema Hipotálamo-Hipofisário , Sistema Hipófise-SuprarrenalRESUMO
The use of hyperbaric oxygen therapy (HBO) in the treatment of certain types of diabetic foot ulcers (DFU) has been the topic of much debate and disagreement over the last several decades. In this review, the evidence for its use is presented and discussed by two experts in DFU management. Whereas some randomized controlled trials suggest that HBO may speed the healing of certain ischaemic or neuroischaemic ulcers after the failure of standard of care, most recent trials have been negative. No RCT is perfect, and the weaknesses of RCTs in this therapeutic area are discussed. It can be concluded that the indications for the use of HBO remain unclear, and that large, rigorously designed and executed RCTs are required to clarify the use of HBO in DFU treatment.
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Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Pé Diabético/terapia , Oxigenoterapia Hiperbárica/métodos , Cicatrização , Pé Diabético/etiologia , Humanos , PrognósticoRESUMO
The management of diabetic foot ulcers (DFU) remains a challenge, and there is continuing uncertainty concerning optimal approaches to wound healing. The International Working Group of the Diabetic Foot (IWGDF) working group on wound healing has previously published systematic reviews of the evidence in 2008, 2012 and 2016 to inform protocols for routine care and to highlight areas which should be considered for further study. The working group has now updated this review by considering papers on the interventions to improve the healing of DFU's published between June 2014 and August 2018. Methodological quality of selected studies was independently assessed by a minimum of two reviewers using the recently published 21-point questionnaire as recommended by IWGDF/European Wound Management Association, as well as the previously incorporated Scottish Intercollegiate Guidelines Network criteria. Of the 2275 papers identified, 97 were finally selected for grading following full text review. Overall, there has been an improvement in study design and a significant rise in the number of published studies. While previous systematic reviews did not find any evidence to justify the use of newer therapies, except for negative pressure wound therapy in post-surgical wounds, in this review we found additional evidence to support some interventions including a sucrose-octasulfate dressing, the combined leucocyte, fibrin and platelet patch as well as topical application of some placental membrane products, all when used in addition to usual best care. Nonetheless, the assessment and comparison of published trials remains difficult with marked clinical heterogeneity between studies: in patient selection, study duration, standard of usual care provision and the timing and description of the clinical endpoints.
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Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Pé Diabético/terapia , Oxigenoterapia Hiperbárica/métodos , Cicatrização , Doença Crônica , Pé Diabético/etiologia , HumanosRESUMO
The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. In conjunction with advice from internal and external reviewers and expert consultants in the field, this update is based on a systematic review of the literature centred on the following: the Population (P), Intervention (I), Comparator (C) and Outcomes (O) framework; the use of the SIGN guideline/Cochrane review system; and the 21 point scoring system advocated by IWGDF/EWMA. This has resulted in 13 recommendations. The recommendation on sharp debridement and the selection of dressings remain unchanged from the last recommendations published in 2016. The recommendation to consider negative pressure wound therapy in post-surgical wounds and the judicious use of hyperbaric oxygen therapy in certain non-healing ischaemic ulcers also remains unchanged. Recommendations against the use of growth factors, autologous platelet gels, bioengineered skin products, ozone, topical carbon dioxide, nitric oxide or interventions reporting improvement of ulcer healing through an alteration of the physical environment or through other systemic medical or nutritional means also remain. New recommendations include consideration of the use of sucrose-octasulfate impregnated dressings in difficult to heal neuro-ischaemic ulcers and consideration of the use of autologous combined leucocyte, platelet and fibrin patch in ulcers that are difficult to heal, in both cases when used in addition to best standard of care. A further new recommendation is the consideration of topical placental derived products when used in addition to best standard of care.
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Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Pé Diabético/prevenção & controle , Oxigenoterapia Hiperbárica/métodos , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica/normas , Cicatrização , Pé Diabético/etiologia , Gerenciamento Clínico , HumanosRESUMO
Hyperbaric oxygen (HBO2) therapy is an adjunct treatment for diabetic foot ulcers. Since plausible mechanisms of action for this treatment include increased angiogenesis and high tissue oxygen concentrations, concerns about deterioration of retinopathy have been raised. The aim of this study was to evaluate the effects of HBO2 on visual acuity (VA) and retinopathy in patients with chronic diabetic foot ulcers during a two-year follow-up period. This is a randomized, single-center, double-blinded and placebo-controlled clinical trial evaluating the effects of HBO2 in patients with diabetes mellitus and chronic foot ulcers. All study participants underwent an ophthalmological examination before the first study treatment and then at three, six, 12 and 24 months. Fifty patients with a median age of 67 years were included. Visual acuity was similar between groups and did not change during the two-year observation period. No differences in retinopathy were seen between groups; neither were any differences found in numbers or areas of bleedings, hard exudates, microaneurysms or edemas, nor between groups or visits. New clinically significant macular edema was identified in four eyes in the HBO2 group and in three eyes in the placebo group. In this population of diabetic foot ulcer patients HBO2 seems to be neutral in an ophthalmological perspective. From a retinal point of view, we could not identify any indication of harmful effects of HBO2 on the microvascular bed in the placebo group.
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Pé Diabético/complicações , Retinopatia Diabética/terapia , Oxigenoterapia Hiperbárica , Acuidade Visual , Idoso , Doença Crônica , Retinopatia Diabética/classificação , Retinopatia Diabética/diagnóstico , Método Duplo-Cego , Feminino , Humanos , Oxigenoterapia Hiperbárica/efeitos adversos , Oxigenoterapia Hiperbárica/métodos , Edema Macular/diagnóstico , Masculino , Pessoa de Meia-Idade , Placebos/uso terapêutico , Estatísticas não Paramétricas , Fatores de TempoRESUMO
OBJECTIVE: Charcot foot (CF) requires prolonged offloading of the affected foot to decrease the risk of deformity. The earliest phase in active CF (stage 0) is characterized by inflammatory signs without established fractures or skeletal deformity. We investigated whether offloading in stage 0 influences duration of total contact casting (TCC), risk of recurrence, and future need for surgery. RESEARCH DESIGN AND METHODS: All patients treated for active CF at Skåne University Hospital (Lund, Sweden) between 2006 and 2019 were screened for participation in a retrospective cohort study. CF events of included patients were classified as stage 0 or 1 according to X-ray and MRI reports. RESULTS: A total of 183 individuals (median age 61 [interquartile range (IQR) 52-68] years, 37% type 1 diabetes, 62% men) were followed for a median of 7.0 (IQR 3.9-11) years. In 198 analyzed CF events, 74 were treated with offloading in stage 0 and 124 in stage 1. Individuals offloading in stage 0 had significantly shorter TCC duration (median 75 [IQR 51-136] vs. 111.5 [72-158] days; P = 0.001). The difference was sustained when including only MRI-confirmed CF. The risk of developing new ipsilateral CF events >1 year after introduced definitive footwear was lower in those treated with offloading in stage 0 (2.7% vs. 9.7%; P < 0.05). No individual treated with offloading in stage 0 underwent reconstructive surgery, compared with 11 (8.9%) treated with offloading in stage 1 (P < 0.01). Amputation rates were similar. CONCLUSIONS: Offloading in stage 0 CF was associated with shorter TCC treatment, lower risk of a new CF event, and diminished need for reconstructive surgery. Future amputation risk was not affected.
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Pé Diabético , Cirurgia Plástica , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Feminino , Pé Diabético/cirurgia , Projetos Piloto , Estudos Retrospectivos , Pé/cirurgiaRESUMO
A young man presented unconscious with severe hyponatraemia, hypokalaemia, hypomagnesaemia and metabolic alkalosis. After 4 months of treatment in hospital, the hypomagnesaemia persisted. The patient had no signs of diabetes mellitus, and radiology showed no abnormalities of the kidneys, pancreas or genitourinary tract. A parenteral magnesium load demonstrated renal wasting with increased fractional urinary excretion of magnesium. Genetic tests for Gitelman as well as Bartter syndromes were negative. However, a wider genetic panel revealed that the patient was heterozygous for a deletion on chromosome band 17q12, encompassing the whole HNF1B gene.This case highlights the importance of considering pathogenic HNF1B variants in isolated profound hypomagnesaemia caused by renal wasting. Pathogenic HNF1B variants may partly mimic hypomagnesaemia found in Gitelman and Bartter syndromes and may be present without other features linked to HNF1B variants, including diabetes mellitus.
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Síndrome de Bartter , Hiperglicemia , Hipopotassemia , Masculino , Humanos , Magnésio , Hiperglicemia/genética , Hiperglicemia/complicações , Hipopotassemia/diagnóstico , Síndrome de Bartter/diagnóstico , Testes Genéticos , Fator 1-beta Nuclear de Hepatócito/genéticaRESUMO
AIMS: Intermittently scanned continuous glucose monitoring (isCGM) systems have not been thoroughly evaluated during in-hospital stay, and there are concerns about accuracy during various conditions. Patients undergoing pancreatoduodenectomy have an increased risk of hyperglycaemia after surgery which is aggravated by parenteral nutrition therapy. This study aims to evaluate glycaemic control and safety during insulin infusion in a surgical non-ICU ward, using a hybrid glucose monitoring approach with isCMG and periodic point-of-care (POC) testing. METHODS: We prospectively included 100 patients with a resectable pancreatic tumour. After surgery, continuous insulin infusion was initiated when POC glucose was > 7 mmol/l and titrated to maintain glucose between 7 and 10 mmol/l. Glucose was monitored with isCGM together with intermittent POC, every 3-6 h. Median absolute relative difference (MARD) and hypoglycaemic events were evaluated. Mean glucose was compared with a historic control (n = 100) treated with multiple subcutaneously insulin injections, monitored with POC only. RESULTS: The intervention group (isCGM/POC) had significantly lower POC glucose compared with the historic control group (8.8 ± 2.2 vs. 10.4 ± 3.4 mmol/l, p < 0.001). MARD was 17.8% (IQR 10.2-26.7). isCGM readings were higher than POC measurements in 91% of the paired cases, and isCGM did not miss any hypoglycaemic event. About 4.5% of all isCGM readings were < 3.9 mmol/l, but only six events were confirmed with POC, and none was < 3.0 mmol/l. CONCLUSIONS: A hybrid approach with isCGM/POC is a safe and effective treatment option in a non-ICU setting after pancreatoduodenectomy.
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Automonitorização da Glicemia , Diabetes Mellitus Tipo 1 , Humanos , Glicemia , Pancreaticoduodenectomia/efeitos adversos , Hipoglicemiantes , InsulinaRESUMO
CONTEXT: Mild autonomous cortisol secretion (MACS) is associated with increased mortality in patients with adrenal incidentalomas, but little is known regarding the potential risk associated with nonfunctional adrenal adenomas (NFAA), which constitute the majority of adrenal incidentalomas. OBJECTIVE: Compare mortality risk in patients with NFAA, and different levels of MACS, to matched controls. METHOD: This was a retrospective matched cohort study. All patients referred to 2 endocrine centers in southern Sweden because of an adrenal incidentaloma between 2005 and 2015 were enrolled. Controls (3:1) matched for sex, age, and residency were included. Primary endpoint was all-cause mortality. Outcome data were obtained from the Cause of Death Register. Patients were grouped according to cortisol level post 1-mg dexamethasone suppression test (cortisolDST) (<50 (NFAA), 50-82, 83-137, and ≥138 nmol/L). RESULTS: 1154 patients and 3462 matched controls were included. During a median follow-up of 6.6 years, 210 patients and 505 controls died. There were no statistically significant differences in mortality between patients with NFAA and their controls (HR 1.13 [0.87-1.46]) whereas mortality was increased compared to controls in patients with cortisolDST 83-137 (HR 1.99 [1.38-2.88]) and ≥138 nmol/L (HR 4.09 [2.41-6.93]). Likewise, the mortality risk was increased in patients younger than 65 years with cortisolDST 50-82 nmol/L compared with controls (HR 2.33 [1.30-4.17]). CONCLUSION: NFAA does not seem to pose a clinically relevant risk for increased mortality in patients with adrenal incidentalomas while patients with MACS, and especially younger patients and those with cortisolDST ≥83 nmol/L, have significantly increased mortality risk compared with matched controls.
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Adenoma , Neoplasias das Glândulas Suprarrenais , Adenoma Adrenocortical , Humanos , Neoplasias das Glândulas Suprarrenais/complicações , Hidrocortisona , Estudos de Coortes , Estudos Retrospectivos , Adenoma Adrenocortical/complicações , Adenoma/complicaçõesRESUMO
BACKGROUND: Diabetes is associated with systemic complications. Prevalence of diabetic nephropathy, and retinopathy, in type 1 diabetes mellitus (T1DM) is declining, but it is not known if this is true also for diabetic neuropathy. AIM: To investigate the relationship between large fibre diabetic neuropathy and other diabetic complications. MATERIALS AND METHODS: Neuropathy, defined here as large fibre neuropathy, was assessed by measuring vibration perception thresholds at four different frequencies on the sole of the foot, using a standard VibroSense Meter and/or neuropathic symptoms, in 599 individuals with T1DM. Retinopathy status was graded using the International Clinical Disease Severity Scale. Grade of albuminuria and previous history of any macrovascular complications were registered. RESULTS: Diabetic individuals without retinopathy had similar vibration thresholds as age- and gender-matched control participants without diabetes, whereas those without microalbuminuria had higher thresholds than controls. Two individuals out of 599 (0.3%) had microalbuminuria, but not retinopathy or neuropathy, and 12/134 (9%) without retinopathy had signs of neuropathy. Totally 119/536 (22%) of the patients without microalbuminuria had neuropathy. Vibration thresholds increased with the rising severity of retinopathy and grade of albuminuria. In a multinomial logistic regression analysis, neuropathy was associated with retinopathy (OR 2.96 [1.35-6.49], p=0.007), nephropathy (OR 6.25 [3.21-12.15]; p=6.7×10-8) and macrovascular disease (OR 2.72 [1.50-4.93], p=0.001). CONCLUSIONS: Despite recent changes in the incidence of diabetic complications, the onset of large fibre neuropathy follows that of retinopathy but precedes the onset of nephropathy in T1DM.
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Diabetes Mellitus Tipo 1 , Nefropatias Diabéticas , Neuropatias Diabéticas , Retinopatia Diabética , Humanos , Neuropatias Diabéticas/epidemiologia , Neuropatias Diabéticas/etiologia , Neuropatias Diabéticas/diagnóstico , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 1/epidemiologia , Albuminúria/epidemiologia , Albuminúria/etiologia , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/epidemiologia , Retinopatia Diabética/etiologia , Nefropatias Diabéticas/diagnóstico , Nefropatias Diabéticas/epidemiologia , Nefropatias Diabéticas/complicações , Fatores de RiscoRESUMO
BACKGROUND: Hyperglycemia is a risk factor for postoperative complications but its impact on outcome after pancreatoduodenectomy (PD) is scarcely studied. This prospective cohort study aimed to assess the effect of continuous insulin infusion on postoperative complications and blood glucose, as well as to evaluate the impact of hyperglycemia on complications, after PD. MATERIALS AND METHODS: One hundred patients planned for PD at Skåne University Hospital, Sweden were prospectively included for perioperative continuous insulin infusion and a historic cohort of 100 patients was included retrospectively. Median blood glucose levels were calculated and data on complications were analyzed and compared between the historic cohort and the intervention group as well as between normo- and hyperglycemic patients. RESULTS: Median glucose levels were significantly lower in the intervention group compared to the historic cohort up to 30 days postoperatively (median glucose 8.5 mmol/l (interquartile range 6.4-11) vs. 9.1 mmol/l (interquartile range 6.8-17) ( P =0.007)). No significant differences in complication rates were recorded between these two groups. The incidence of complications classified as Clavien ≥3 was higher in hyperglycemic patients (100 vs. 27%, P =0.024). Among hyperglycemic patients the prevalence of preoperative diabetes was higher compared to normoglycemic patients (52 vs.12%, P <0.001). In patients with a known diagnosis of diabetes, a trend, although not statistically significant, towards a lower incidence of postoperative pancreatic fistula grade B and C, as well as postpancreatectomy hemorrhage grade B and C, was seen compared to those without preoperative diabetes (6.8 vs. 14%, P =0.231 and 2.3 vs. 7.0%, P =0.238, respectively). CONCLUSION: Insulin infusion in the early postoperative phase after PD is feasible in a non-ICU setting and significantly decreased blood glucose levels. The influence on complications was limited. Preoperative diabetes was a significant predictor of postoperative hyperglycemia and was associated with a lower incidence of clinically significant postoperative pancreatic fistula.
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Diabetes Mellitus , Hiperglicemia , Humanos , Pancreaticoduodenectomia/efeitos adversos , Glicemia , Fístula Pancreática/epidemiologia , Fístula Pancreática/etiologia , Estudos Retrospectivos , Estudos Prospectivos , Estudos de Viabilidade , Hiperglicemia/epidemiologia , Hiperglicemia/etiologia , Insulina , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/epidemiologia , Diabetes Mellitus/etiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologiaRESUMO
INTRODUCTION: This study utilized continuous glucose monitoring data to analyze the effects of switching to treatment with fast-acting insulin aspart (faster aspart) in adults with type 1 diabetes (T1D) in clinical practice. METHODS: A noninterventional database review was conducted in Sweden among adults with T1D using multiple daily injection (MDI) regimens who had switched to treatment with faster aspart as part of basal-bolus treatment. Glycemic data were retrospectively collected during the 26 weeks before switching (baseline) and up to 32 weeks after switching (follow-up) to assess changes in time in glycemic range (TIR; 70-180 mg/dL), mean sensor glucose, glycated hemoglobin (HbA1c) levels, coefficient of variation, time in hyperglycemia (level 1, > 180 to ≤ 250 mg/dL; level 2, > 250 mg/dL), and time in hypoglycemia (level 1, ≥ 54 to < 70 mg/dL; level 2, < 54 mg/dL) (ClinicalTrials.gov Identifier NCT03895515). RESULTS: Overall, 178 participants were included in the study cohort. The analysis population included 82 individuals (mean age 48.5 years) with adequate glucose sensor data. From baseline to follow-up, statistically significant improvements were reported for TIR (mean increase 3.3%-points [approximately 48 min/day]; p = 0.006) with clinically relevant improvement (≥ 5%) in 43% of participants. Statistically significant improvements from baseline were observed for mean sensor glucose levels, HbA1c levels, and time in hyperglycemia (levels 1 and 2), with no statistically significant changes in time spent in hypoglycemia. CONCLUSIONS: Switching to faster aspart was associated with improvements in glycemic control without increasing hypoglycemia in adults with T1D using MDI in this real-world setting.
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Hyperbaric oxygen therapy (HBO) could be described as a short-term, high-dose oxygen inhalation and diffusion therapy, delivered systemically through airways and blood, achieved by having the patient breathing concentrated oxygen at a pressure higher than 1 absolute atmosphere. In clinical practice, monoplace or multiplace hyperbaric chambers are used to achieve this. Treatment is usually given as daily 90- to 120-min-long HBO sessions at pressures between 2.0 and 2.5 absolute atmosphere, aiming for 30-40 treatment sessions. The use of HBO as treatment of diabetic foot ulcers has been founded on weak scientific ground, although the outcomes from previous studies are in concert with the conclusions from preclinical studies and supports the theoretical framework of HBO reversing hypoxia-induced pathology. Two well-designed randomized double-blind trials have put HBO on firmer ground and may justify adjunctive HBO treatment to a selected group of patients with nonhealing diabetic foot ulcers. Some health economic studies suggest potential cost effectiveness, but these studies are limited by deficient primary clinical data and should be interpreted with caution. Several issues remain to be addressed, such as developing robust criteria to improve treatment protocols, determining which patients are likely to benefit, and when to start and stop treatment.
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Pé Diabético/terapia , Oxigenoterapia Hiperbárica/métodos , Cicatrização , Ensaios Clínicos como Assunto , Humanos , Oxigenoterapia Hiperbárica/instrumentaçãoRESUMO
OBJECTIVES: Peripheral vascular disease (PVD) is an important limiting factor for healing in neuroischemic or ischemic diabetic foot ulcer. The purpose of this study was to identify factors related to healing in patients with diabetes with foot ulcers and severe PVD. METHODS: Patients with diabetes with a foot ulcer, consecutively presenting at a multidisciplinary foot center with a systolic toe pressure <45 mm Hg or an ankle pressure <80 mm Hg were prospectively included, followed according to a preset program, and with the exception of specified exclusions, subjected to angiography offered vascular intervention when applicable. All patients had continuous follow-up until healing or death irrespective of the type of vascular intervention. RESULTS: One thousand one hundred fifty-one patients were included. Eighty-two percent had a toe pressure <45 mm Hg and 49% had an ankle pressure <80 mm Hg. Eight hundred one patients (70%) underwent an angiography. Out of these, 63% had vascular intervention, either percutaneous transluminal angioplasty (PTA; 39%) or reconstructive surgery (24%). Nine percent of the patients had one or more complications after angiography. PTA was multisegmental in 46% and to the crural arteries in 46%. Reconstructive surgery was distal in 51%. Age (P < .001), renal function impairment (P = .005), congestive heart failure (P = .01), number and type of ulcer (P < .001), and severity of PVD (P = .003) affected the outcome of ulcers. PTA and reconstructive vascular surgery increased the probability of healing without amputation (odds ratio [OR], 1.77 and 2.05, respectively). CONCLUSION: Probability of ulcer healing is strongly related to comorbidity, extent of tissue involvement, and severity of PVD in patients with diabetes with severe PVD.
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Pé Diabético/terapia , Neuropatias Diabéticas/terapia , Úlcera do Pé/terapia , Doenças Vasculares Periféricas/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Pé Diabético/fisiopatologia , Neuropatias Diabéticas/fisiopatologia , Feminino , Úlcera do Pé/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Vasculares Periféricas/fisiopatologia , CicatrizaçãoRESUMO
Systemic hyperbaric oxygen (HBO) is accomplished when a patient is breathing 100% oxygen in an environment with increased barometric pressure. A typical HBO treatment protocol of diabetic foot ulcer involves 20 to 40 sessions. Treatment is usually given as daily 90- to 120-minute HBO sessions at pressures between 2.0 and 2.5 absolute atmospheres. The wide use of HBO as treatment of diabetic foot ulcers over the past decades has been founded on weak scientific ground (ie, few and small prospective studies with methodologic limitations on top of case series). However, the consistency in positive outcome in these trials evaluating HBO on ulcer healing is noteworthy because these findings are in concert with data from in vitro and physiologic studies supporting the theoretic framework of HBO reversing hypoxia-induced pathology. Two well-designed randomized double-blinded placebo-controlled studies have in recent years put HBO on firmer ground as treatment of a selection of diabetic patients with chronic foot. Some evidence indicates that microvascular parameters such as transcutaneous (partial) oxygen pressure (TcPO(2)) could be useful in predicting which patients will benefit from therapy. Health economic studies suggest potential cost-effectiveness of HBO. But because these analyses are limited by their deficient primary clinical data, they should be interpreted with caution. Thus, HBO is only indicated in a selected group of patients with chronic diabetic foot ulcers. Several key issues remain to be addressed such as developing robust criteria to determine which patients are likely to benefit and when to start and stop treatment.
Assuntos
Pé Diabético/terapia , Oxigenoterapia Hiperbárica/métodos , Pé Diabético/fisiopatologia , Humanos , Oxigenoterapia Hiperbárica/economia , Microcirculação/fisiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
AIMS: A diabetic foot ulcer (DFU) is associated with increased cardiovascular risk and mortality, independently of ulcer etiology (ischemic, neuro-ischemic or neuropathic). Ankle-brachial index (ABI) is the most commonly used test when diagnosing peripheral macrovascular disease and is a well-known marker for increased cardiovascular risk. Transcutaneous oxygen pressure (TcPO2) is considered to better evaluate microvascular function and has in previous studies shown correlations with both wound healing and survival. The aim of this study was to evaluate the combined impact of a low TcPO2 (<30 mmHg) and a pathological ABI (<0.9 or ≥1.4) on three-year mortality in patients with DFU. METHODS: Type 2 diabetes patients aged <90 years, with at least one DFU who underwent vascular assessment with ABI and TcPO2 were screened for participation. The primary endpoint was mortality after three years, assessed from the National Death Registry in Sweden. RESULTS: The study enrolled 235 participants with a median age of 76 years. Individuals with either an abnormally high or low ABI in combination with a low TcPO2 had the worst survival rates, with three-year mortality of 54%, compared to 42% in those with one abnormal variable (either ABI or TcPO2), and 21% in those with normal ABI and TcPO2. CONCLUSIONS: Combining ABI and TcPO2 when risk stratifying DFU patients seems to provide additional predictive information, not only concerning ulcer healing and limb salvage, but also on survival.
Assuntos
Diabetes Mellitus Tipo 2 , Pé Diabético , Úlcera do Pé , Idoso , Índice Tornozelo-Braço , Diabetes Mellitus Tipo 2/complicações , Humanos , OxigênioRESUMO
Deformities such as hammer and claw toes are common in people with diabetes and neuropathy. These deformities increase pressure on the tip of toes, leading to callosity and subsequent pressure ulcers. Conventional flexor tenotomy has been shown to decrease the risk of pressure ulcers. During the first decade of the 21 century, a less traumatizing percutaneous method was introduced, and more recently a needle-based minimal flexor tenotomy method. In this paper, based on the outcome of 164 consecutive needle-based flexor tenotomies performed by diabetologists in routine clinics, we verify the simplicity and safety of this inexpensive method.