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1.
Sensors (Basel) ; 20(6)2020 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-32204318

RESUMO

(1) Background: nocturnal hypoglycemia (NH) is one of the most challenging side effects of multiple doses of insulin (MDI) therapy in type 1 diabetes (T1D). This work aimed to investigate the feasibility of a machine-learning-based prediction model to anticipate NH in T1D patients on MDI. (2) Methods: ten T1D adults were studied during 12 weeks. Information regarding T1D management, continuous glucose monitoring (CGM), and from a physical activity tracker were obtained under free-living conditions at home. Supervised machine-learning algorithms were applied to the data, and prediction models were created to forecast the occurrence of NH. Individualized prediction models were generated using multilayer perceptron (MLP) and a support vector machine (SVM). (3) Results: population outcomes indicated that more than 70% of the NH may be avoided with the proposed methodology. The predictions performed by the SVM achieved the best population outcomes, with a sensitivity and specificity of 78.75% and 82.15%, respectively. (4) Conclusions: our study supports the feasibility of using ML techniques to address the prediction of nocturnal hypoglycemia in the daily life of patients with T1D on MDI, using CGM and a physical activity tracker.

2.
J Diabetes Complications ; : 107575, 2020 Mar 05.
Artigo em Inglês | MEDLINE | ID: mdl-32220551

RESUMO

AIMS: To determine the early benefit:risk balance of dulaglutide versus insulin glargine in patients with type 2 diabetes mellitus (T2DM). METHODS: This post hoc analysis used data from a randomized, open-label study (AWARD-2; modified intention-to-treat group) in which suboptimally controlled metformin + glimepiride-treated patients received dulaglutide 1.5 mg (n = 273) or insulin glargine (n = 262). Two composite endpoints were used: for weeks 2-20, fasting serum glucose (FSG) <130 mg/dL (<7.2 mmol/L) without hypoglycemia (blood glucose ≤70 mg/dL [≤3.9 mmol/L] or severe hypoglycemia); at week 26, patients with glycated hemoglobin (HbA1c) <7.0% (<53.0 mmol/mol) or reduction from baseline ≥1.0% (≥10.9 mmol/mol), no hypoglycemia (as defined above) and no weight gain. Odds ratios (ORs) were generated using logistic regression analysis. RESULTS: The probability of reaching the FSG target without hypoglycemia was higher with dulaglutide than with insulin glargine at weeks 4 (OR 1.78; 95% confidence interval [CI] 1.22-2.60) and 8 (OR 1.69; 95% CI 1.15-2.48). The proportion of patients achieving the 26-week endpoint was higher with dulaglutide (37.4% vs. 10.3%; OR 5.28; 95% CI 3.28-8.48). CONCLUSIONS: Dulaglutide's balanced efficacy-to-safety profile compares favorably with that of insulin glargine and is apparent soon after treatment initiation and after 6 months of therapy.

3.
Lancet Diabetes Endocrinol ; 8(2): 106-114, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31924562

RESUMO

BACKGROUND: Cardiovascular outcome trials have suggested that glucagon-like peptide 1 (GLP-1) receptor agonists might reduce strokes. We analysed the effect of dulaglutide on stroke within the researching cardiovascular events with a weekly incretin in diabetes (REWIND) trial. METHODS: REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries. Men and women (aged ≥50 years) with established or newly detected type 2 diabetes whose HbA1c was 9·5% or less (with no lower limit) on stable doses of up to two oral glucose-lowering drugs with or without basal insulin therapy were eligible if their body-mass index was at least 23 kg/m2. Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide). Randomisation was done by a computer-generated random code with an interactive web response system with stratification by site. Participants, investigators, the trial leadership, and all other personnel were masked to treatment allocation until the trial was completed and the database was locked. During the treatment period, participants in both groups were instructed to inject study drug on the same day at around the same time, each week. Strokes were categorised as fatal or non-fatal, and as either ischaemic, haemorrhagic, or undetermined. Stroke severity was assessed using the modified Rankin scale. Participants were seen at 2 weeks, 3 months, 6 months, and then every 3 months for drug dispensing and every 6 months for detailed assessments, until 1200 confirmed primary outcomes accrued. The primary endpoint was the first occurrence of any component of the composite outcome, which comprised non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular or unknown causes. All analyses were done according to an intention-to-treat strategy that included all randomly assigned participants, irrespective of adherence. The trial is registered with ClinicalTrials.gov, number NCT01394952. FINDINGS: Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952). During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated. 158 (3·2%) of 4949 participants assigned to dulaglutide and 205 (4·1%) of 4952 participants assigned to placebo had a stroke during follow-up (hazard ratio [HR] 0·76, 95% CI 0·62-0·94; p=0·010). Dulaglutide reduced ischaemic stroke (0·75, 0·59-0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55-1·99; p=0·89). Dulaglutide also reduced the composite of non-fatal stroke or all-cause death (0·88, 0·79-0·98; p=0·017) and disabling stroke (0·74, 0·56-0·99; p=0·042). The degree of disability after stroke did not differ by treatment group. INTERPRETATION: Long-term dulaglutide use might reduce clinically relevant ischaemic stroke in people with type 2 diabetes but does not affect stroke severity. FUNDING: Eli Lilly and Company.

4.
J Clin Endocrinol Metab ; 105(1)2020 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-31529047

RESUMO

PURPOSE: Although preeclampsia (PE) is a well-established cardiovascular risk factor (CVRF) in the general population, its role in type 1 diabetes (T1D) has been scarcely studied. We assessed the association between PE and preclinical atherosclerosis in T1D. METHODS: We recruited 112 women without cardiovascular disease and last pregnancy ≥5 years before: (1) T1D and previous PE (T1D+/PE+; n = 28); (2) T1D without preeclampsia (T1D+/PE-; n = 28); (3) previous PE without T1D (T1D-/PE+; n = 28); and (4) controls (without T1D or PE; T1D-/PE-; n = 28). Groups were matched by age, several CVRFs, and diabetes duration and retinopathy (in T1D participants). Carotid intima-media thickness (IMT) and the presence of plaque (IMT ≥ 1.5 mm) were assessed by standardized ultrasonography protocol. RESULTS: Mean age of the participants was 44.9 ± 7.8 years (14.3% hypertension and 21.4% active smokers). Groups including T1D (T1D+/PE+ and T1D+/PE-) more frequently presented hypertension and statin treatment (23.2% vs 5.4% and 37.5% vs 8.9%; respectively; P < 0.01), without differences in other CVRFs. Carotid plaques were observed in 20.5%. In multivariate models adjusted for age, CVRF, and statins, both T1D and PE showed a similar impact on the presence of plaque, with odds ratios (95% confidence interval), 5.45 (1.36-21.9) and 4.24 (1.04-17.3), respectively. Both entities showed an additive effect when combined, both in common carotid-IMT (T1D+/PE- or T1D-/PE+, ß = 0.198; T1D+/PE+, ß = 0.297) and in the presence of plaque (8.53 [1.07-68.2] and 28.1 [2.67-296.4], respectively). CONCLUSIONS: Previous PE was independently associated with preclinical atherosclerosis in T1D. Further studies are needed to ascertain its usefulness for stratifying risk in T1D women.

5.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31668682

RESUMO

OBJECTIVE: To evaluate frequency of hypoglycaemia unawareness (HU) in patients with type 1 diabetes (T1D) transferred from Paediatrics following a specific therapeutic education programme (TEP) in an adult hospital. PATIENTS AND METHODS: Young patients transferred from 2009-2011 were evaluated. The TEP included a coordinated transfer process, individual appointments and a group course. At baseline and at 12 months we evaluated glycated haemoglobin (HbA1c) frequency of severe (SH) hypoglycaemia/patient/year and non severe hypoglycaemia (NSH). The patients were classified into two groups and compared: hypoglycaemia awareness (HA) and HU according to the Clarke Test <3R or>3R respectively. RESULTS: Fifty-six patients (age 18.1±0.3 years, 46% females, HbA1c 8.0±1.2%) underwent the TEP. In the baseline evaluation 16% presented HU. The number of SH was higher in the HU Group (0.33±0.50 vs. 0.09±0.28 P<.05). The percentage of patients with>2 NSH/week was higher, albeit not significantly, in the HU group (66% vs. 34%, p=0.06). At 12 months 11% of the patients continued to present HU. The number of SH remained higher in the HU group (0.38±1.06 vs. 0.02±0.15 P=.04). CONCLUSIONS: The percentage of young people with T1D with HU is quite high at transfer. Although the TEP improves hypoglycaemia awareness it does not solve this important problem. Patients with HU more frequently present SH. It is necessary to identify HU in order to reduce SH which continues to be a problem in people with T1D.

6.
Endocrinol. diabetes nutr. (Ed. impr.) ; 66(9): 534-539, nov. 2019. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-184375

RESUMO

Objetivo: Menos de un tercio de los pacientes con diabetes tipo 1 (DT1) consiguen el objetivo de punto de corte establecido como control metabólico óptimo (HbA1c < 7%). Sin embargo, reducciones porcentuales de HbA1c y la prevención de hipoglucemias graves (HG) han demostrado beneficios clínicamente relevantes. Por ello, el objetivo de este estudio ha sido evaluar la efectividad de la terapia con infusión subcutánea continua de insulina (ISCI) a los 5 años de seguimiento en una cohorte de pacientes de una unidad especializada mediante objetivos combinados de descenso de HbA1c y ausencia de HG. Material y métodos: Estudio observacional retrospectivo que incluye a 178 pacientes que iniciaron terapia ISCI de manera consecutiva entre los años 2003 y 2008. Se han analizado las características basales de los individuos, la HbA1c inicial y a los 5 años de tratamiento con ISCI y la presencia o no de HG. Se calcularon las variables combinadas: a) descenso de al menos 0,5 puntos de HbA1c y ausencia de HG en los últimos 2 años; b) HbA1c a los 5 años < 7,5% sin HG en los últimos 2 años; c) HbA1c < 8,5% sin HG en los últimos 2 años, y d) descenso ≥ 0,5 puntos y/o HbA1c < 7,5% a los 5 años sin presencia de HG en los 2 últimos años de seguimiento. Resultados: Veintisiete de los 178 pacientes fueron excluidos debido a pérdida del seguimiento o abandono de la terapia ISCI. Se analizó a 151 pacientes (edad 37,4 ± 10,5 años, 64% mujeres, 19,2 ± 10,7 años de evolución de la DT1). Las 2 indicaciones principales para el inicio de ISCI fueron: control metabólico subóptimo (60,9%) e HG o hipoglucemia desapercibida (28,5%). Las HbA1c de la cohorte total y de control metabólico subóptimo fueron de 8,0 ± 1,2 y 8,4 ± 1,1% al inicio de la terapia ISCI y de 7,8 ± 1,2 y 8,0 ± 1,3% a los 5 años (p = 0,104 y p = 0,016), respectivamente. En la cohorte global un 55,5% de los pacientes alcanzaron a los 5 años el objetivo combinado HbA1c < 7,5% y/o un descenso ≥ 0,5% sin HG. Conclusiones: Tras 5 años de terapia ISCI más de la mitad de nuestros pacientes consiguen el objetivo combinado de reducción significativa de HbA1c y ausencia de HG. La utilización de objetivos combinados nos ofrece la posibilidad de evaluar la efectividad de las terapias en la DT1 desde un punto de vista más cercano a su significado clínico


Objective: Less than one third of patients with type 1 diabetes mellitus (T1DM) achieve the cut-off value proposed as good metabolic control by most guidelines, HbA1c < 7%. However, HbA1c reductions and prevention of severe hypoglycemia (SH) have shown clinically relevant benefits. The study objective therefore was to assess the effectiveness of continuous subcutaneous insulin infusion (CSII) therapy at 5 years of follow-up in a cohort of patients attending a specialized unit using HbA1c reduction and abscence of SH as combined goals. Methods: A retrospective, observational study on 178 patients with T1DM who started CSII treatment at Hospital Clinic of Barcelona between 2003 and 2008. HbA1c levels at baseline and after 5 years of treatment with CSII and presence or absence of SH were recorded. The combined variables calculated included: a) HbA1c reduction by ≥ 0.5 points and absence of SH in the last 2 years; b) HbA1c at 5 years < 7.5% and no SH in the last 2 years; c) HbA1c < 8.5% and no HG in the last 2 years, and d) HbA1c reduction by ≥ 0.5 points and/or HbA1c < 7.5% at 5 years with no SH in the last 2 years of follow-up. Results: Twenty-seven of the 178 patients were excluded due to loss to follow-up or CSII discontinuation. A total of 151 patients (aged 37.4 ± 10.5 years, 64% women, diabetes duration of 19.2 ± 10.7 years) were therefore analyzed. The 2 main reasons for starting CSII were suboptimal metabolic control (60.9%) and severe hypoglycemia/hypoglycemia unawareness (28.5%). HbA1c levels in the total cohort and in patients with suboptimal metabolic control were 8.0 ± 1.2 and 8.4 ± 1.1% at CSII start and 7.8 ± 1.2 and 8.0 ± 1.3% at 5 years of treatment (P = .104 and P = .016) respectively. In the overall cohort, 55.5% of patients achieved at 5 years the combined goal of HbA1c < 7.5% and/or HbA1c reductions ≥ 0.5% without SH. Conclusions: After 5 years of CSII therapy, more than half of the patients achieved the combined goal of significant HbA1c reduction and absence of SH. The use of combined goals offers the opportunity to assess the effectiveness of T1DM treatment from a clinically more meaningful point of view


Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Resultado do Tratamento , Insulina/administração & dosagem , Sistemas de Infusão de Insulina , Hipoglicemia/diagnóstico , Hipoglicemiantes/administração & dosagem , Hipoglicemia/tratamento farmacológico , Estudos Retrospectivos
7.
Endocrinol. diabetes nutr. (Ed. impr.) ; 66(8): 512-519, oct. 2019. tab, graf
Artigo em Inglês | IBECS | ID: ibc-184145

RESUMO

Introduction: The use of statins in non-selected type 1 diabetes (T1D) populations is low. We assessed the prevalence and factors associated with statin treatment in patients meeting criteria for this therapy for primary prevention of cardiovascular disease (CVD). Material and Methods: From 2015 to 2018, T1D patients from a tertiary hospital were selected. Inclusion criteria were: ≥40 years-old, diabetic nephropathy, or T1D duration ≥10 years with ≥1 cardiovascular risk factor (CVRF). A standardized cardiovascular risk evaluation protocol was performed. Prevalence of statin treatment was evaluated according to presence of several CVRFs, and multivariable models were constructed to assess independent determinants of statin use. Results: We included 241 patients (50% women, age 48.2 ± 9.9 years, T1D duration 26.6 ± 9.0 years). Diabetic retinopathy and nephropathy, active smoking, and hypertension were present in 38%, 12%, 28%, and 27%, respectively. Overall, 43% of patients were on statins and 27% had LDL-cholesterol < 100 mg/dl. Statin users were older, and had higher body mass index (BMI), prevalence of kidney dysfunction, and hypertension (p < 0.05 for all). However, among both T1D-related and classical CVRFs, only hypertension (odds ratio [OR], 2.96; 95% confidence interval [CI] 1.48-5.91) and BMI (OR, 1.08; CI, 1.01-1.16) were independently associated with statin use in multiple regression analysis. Conclusions: Less than half of T1D patients from a tertiary hospital who met criteria for statin use were on treatment. Hypertension and BMI emerged as the only CVRFs independently associated with statin therapy. New strategies are needed to better address CVD prevention in this very high-risk population


Introducción: El uso de estatinas en población con diabetes tipo 1 (DT1) general es bajo. Estudiamos la prevalencia y factores asociados con su uso en pacientes que cumplían los criterios para esta terapia para la prevención primaria de la enfermedad cardiovascular (ECV). Material y métodos: Del 2015-2018 seleccionamos a pacientes con DT1 de un hospital terciario. Los criterios de inclusión fueron: ≥ 40 años, nefropatía diabética, o duración de DT1≥10 años con ≥ 1 factor de riesgo cardiovascular (FRCV). Se realizó un protocolo estandarizado de evaluación del riesgo cardiovascular. Finalmente, estudiamos el uso de estatinas en función de diferentes FRCV y los factores independientemente asociados con su uso (modelos multivariantes). Resultados: Incluimos 241 pacientes (50% mujeres, edad 48,2 ± 9,9 años, duración de diabetes 26,6 ± 9 años). La presencia de retinopatía, nefropatía, tabaquismo e hipertensión fue del 38, 12, 28 y 27%, respectivamente. Un 43% tomaba estatinas y un 27% presentó un colesterol-LDL<100 mg/dL. Los usuarios de estatinas tenían mayor edad, índice de masa corporal (IMC), deterioro de la función renal e hipertensión (p < 0,05). Entre todos los FRCV clásicos y específicos de la DT1, únicamente la hipertensión (odds ratio [OR], 2,96; intervalo de confianza al 95% [IC], 1,48-5,91) y el IMC (OR, 1,08; IC, 1,01-1,16) fueron los que se asociaron independientemente con su uso. Conclusiones: Menos de la mitad de pacientes con DT1 que cumplen criterios para estatinas de un hospital terciario están en tratamiento. Únicamente la hipertensión y el IMC se asociaron independientemente con su uso. Nuevas estrategias son necesarias para la prevención cardiovascular en esta población de alto riesgo


Assuntos
Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Adulto , Diabetes Mellitus Tipo 1/epidemiologia , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Fatores de Risco , Análise Multivariada , Retinopatia Diabética/complicações , Razão de Chances , Inibidores de Hidroximetilglutaril-CoA Redutases/metabolismo
8.
Prim Care Diabetes ; 2019 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-31474469

RESUMO

AIMS: To assess the frequency of hypoglycemia events, patient characteristics and the prevalence of impaired awareness of hypoglycemia (IAH) in patients with Type 2 Diabetes (T2D) using two or more insulin injections in primary care. METHODS: Cross-sectional study performed at 9 Primary Care Centers including review of electronic medical records and an on-site visit to patients using >2 insulin injections with suboptimal control. Episodes of severe hypoglycemia (SH) in the last 12months were recorded. Non-severe hypoglycemia (NSH) was considered as self-monitoring blood glucose <70mg/dl. IAH was evaluated and HbA1c was obtained. RESULTS: 157 subjects were included (age 68.4+10.7years, 82 women, T2D duration 18.3+8.7years). 57% used multiple daily injections. Total insulin was 66.9+43.4 units/day. The mean HbA1c was 9.2±1.4% (77±12mmol/mol) and only 13.4% had HbA1c <8% (64mmol/mol). The frequency of NSH was 0.74±1.37 episodes/week. Only one patient had a SH the last 12months. Around 10-12% of patients had IAH. In comparison with normal awareness, those with IAH had a longer duration of T2D (25.3±11.6 vs. 16.1±8.2 years, respectively, p<0.01). In the multiple linear regression analysis, only the IAH score and the total insulin dose independently determined the NSH number. CONCLUSIONS: NSH/SH in patients with T2D treated with two or more insulin injections in primary care settings seems to be relatively common. Although hypoglycemia awareness is predominantly preserved, the presence of IAH should not be ignored as it increases the risk of hypoglycemia and constitutes an additional barrier to recognize and address this burden in T2D.

10.
Comput Methods Programs Biomed ; 178: 175-180, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31416546

RESUMO

BACKGROUND: Diabetic patients treated with intensive insulin therapies require a tight glycemic control and may benefit from advanced tools to predict blood glucose (BG) concentration levels and hypo/hyperglycemia events. Prediction systems using machine learning techniques have mainly focused on applications for sensor augmented pump (SAP) therapy. In contrast, insulin bolus calculators that rely on BG prediction for multiple daily insulin (MDI) injections for patients under self-monitoring blood glucose (SMBG) are scarce because of insufficient data sources and limited prediction capability of forecasting models. METHODS: We trained individualized models that can predict postprandial hypoglycemia via different machine learning algorithms using retrospective data from 10 real patients. In addition, we designed and tested a hypoglycemia reduction strategy for a similar in silico population. The system generates a bolus reduction suggestion as the scaled weighted sum of the predictions. We evaluated the general and postprandial glycemic outcomes of the in silico population to assess the systems capability of avoiding hypoglycemias. RESULTS: The median [IQR] sensitivity and specificity for hypoglycemia cases where the BG level was below 70 mg/dL were 0.49 [0.2-0.5] and 0.74 [0.7-0.9], respectively. For hypoglycemia cases where the BG level was below 54 mg/dL, the median [IQR] sensitivity and specificity were 0.51 [0.4-0.6] and 0.74 [0.7-0.8], respectively. CONCLUSIONS: The results indicated a decrease of 37% in the median number of postprandial hypoglycemias median decrease of 44% for hypoglycemias of 70 mg/dL and 54 mg/dL, respectively. This dramatic reduction makes this method a good candidate to be integrated into any Decision Support System for diabetes management.


Assuntos
Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/sangue , Hipoglicemia/sangue , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Aprendizado de Máquina , Adulto , Algoritmos , Teorema de Bayes , Glicemia , Capilares/patologia , Simulação por Computador , Reações Falso-Positivas , Feminino , Humanos , Hipoglicemia/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Masculino , Pessoa de Meia-Idade , Distribuição Normal , Período Pós-Prandial , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e Especificidade
11.
Diabetes Res Clin Pract ; 154: 75-81, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31271810

RESUMO

AIMS: To evaluate the impact of a prepregnancy care (PPC) programme, beyond HbA1c, on hypoglycaemia awareness and glycaemic variability (GV). METHODS: Prospective pilot study. We selected women with Type 1 diabetes who initiated a PPC programme with normal hypoglycaemia awareness (n = 24). Hypoglycaemia awareness, hypoglycaemic events and GV derived from masked-continuous glucose monitoring were evaluated in the first visit and within 2 weeks after pregnancy confirmation. RESULTS: The duration was 16.5 ±â€¯13.0 months. HbA1c significantly decreased (-0.8 ±â€¯0.7; p < 0.001). The Clarke score increased (0[0-1] vs. 1[0-2] points, p = 0.164), 2 out of 24 were reclassified as having impaired awareness of hypoglycaemia and 2 presented severe hypoglycaemia. GV decreased: standard deviation (p = 0.008), coefficient of variation (p = 0.021), mean amplitude of glycaemic excursions (p = 0.007), average daily risk range (p < 0.001), J-index (p = 0.010), high blood glucose index (HBGI) (p = 0.004), continuous overall net glycaemic action (CONGA) (p = 0.018), mean of daily differences (p = 0.045) and glycaemic risk assessment diabetes equation (p = 0.012). Final HbA1c was associated with baseline J-index, CONGA and HBGI (ß = 0.535, ß = 0.466, ß = 0.534, respectively; p < 0.05). CONCLUSIONS: A PPC programme improved HbA1c as well as GV with no significant impact on hypoglycaemia awareness. Moreover, GV could help to identify women less likely to achieve glycaemic targets. Larger studies are needed to confirm these results.


Assuntos
Automonitorização da Glicemia/normas , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Conhecimentos, Atitudes e Prática em Saúde , Hiperglicemia/prevenção & controle , Hipoglicemia/prevenção & controle , Cuidado Pré-Concepcional/métodos , Adulto , Automonitorização da Glicemia/métodos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Hemoglobina A Glicada/análise , Humanos , Hiperglicemia/sangue , Hiperglicemia/induzido quimicamente , Hiperglicemia/diagnóstico , Hipoglicemia/sangue , Hipoglicemia/induzido quimicamente , Hipoglicemia/diagnóstico , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Projetos Piloto , Prognóstico , Estudos Prospectivos
12.
Lancet ; 394(10193): 131-138, Jul. 2019. gráfico, tabela
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1046322

RESUMO

Background Two glucagon-like peptide-1 (GLP-1) receptor agonists reduced renal outcomes in people with type 2 diabetes at risk for cardiovascular disease. We assessed the long-term effect of the GLP-1 receptor agonist dulaglutide on renal outcomes in an exploratory analysis of the REWIND trial of the effect of dulaglutide on cardiovascular disease. Methods REWIND was a multicenter, randomized, double-blind, placebo-controlled trial at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo and followed up at least every 6 months for outcomes. Urinary albumin-to-creatinine ratios (UACRs) and estimated glomerular filtration rates (eGFRs) were estimated from urine and serum values measured in local laboratories every 12 months. The primary outcome (first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes), secondary outcomes (including a composite microvascular outcome), and safety outcomes of this trial have been reported elsewhere. In this exploratory analysis, we investigate the renal component of the composite microvascular outcome, defined as the first occurrence of new macroalbuminuria (UACR >33·9 mg/mmol), a sustained decline in eGFR of 30% or more from baseline, or chronic renal replacement therapy. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01394952. Findings Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). At baseline, 791 (7·9%) had macroalbuminuria and mean eGFR was 76·9 mL/min per 1·73 m² (SD 22·7). During a median follow-up of 5·4 years (IQR 5·1­5·9) comprising 51 820 person years, the renal outcome developed in 848 (17·1%) participants at an incidence rate of 3·5 per 100 person-years in the dulaglutide group and in 970 (19·6%) participants at an incidence rate of 4·1 per 100 person-years in the placebo group (hazard ratio [HR] 0·85, 95% CI 0·77­0·93; p=0·0004). The clearest effect was for new macroalbuminuria (HR 0·77, 95% CI 0·68­0·87; p<0·0001), with HRs of 0·89 (0·78­1·01; p=0·066) for sustained decline in eGFR of 30% or more and 0·75 (0·39­1·44; p=0·39) for chronic renal replacement therapy. (AU)


Assuntos
Masculino , Pessoa de Meia-Idade , Creatinina/urina , Diabetes Mellitus Tipo 2/tratamento farmacológico , Nefropatias Diabéticas/prevenção & controle , Albuminúria/prevenção & controle , Hipoglicemiantes/administração & dosagem
13.
Lancet ; 394(10193): 131-138, 2019 07 13.
Artigo em Inglês | MEDLINE | ID: mdl-31189509

RESUMO

BACKGROUND: Two glucagon-like peptide-1 (GLP-1) receptor agonists reduced renal outcomes in people with type 2 diabetes at risk for cardiovascular disease. We assessed the long-term effect of the GLP-1 receptor agonist dulaglutide on renal outcomes in an exploratory analysis of the REWIND trial of the effect of dulaglutide on cardiovascular disease. METHODS: REWIND was a multicentre, randomised, double-blind, placebo-controlled trial at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo and followed up at least every 6 months for outcomes. Urinary albumin-to-creatinine ratios (UACRs) and estimated glomerular filtration rates (eGFRs) were estimated from urine and serum values measured in local laboratories every 12 months. The primary outcome (first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes), secondary outcomes (including a composite microvascular outcome), and safety outcomes of this trial have been reported elsewhere. In this exploratory analysis, we investigate the renal component of the composite microvascular outcome, defined as the first occurrence of new macroalbuminuria (UACR >33·9 mg/mmol), a sustained decline in eGFR of 30% or more from baseline, or chronic renal replacement therapy. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01394952. FINDINGS: Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). At baseline, 791 (7·9%) had macroalbuminuria and mean eGFR was 76·9 mL/min per 1·73 m2 (SD 22·7). During a median follow-up of 5·4 years (IQR 5·1-5·9) comprising 51 820 person-years, the renal outcome developed in 848 (17·1%) participants at an incidence rate of 3·5 per 100 person-years in the dulaglutide group and in 970 (19·6%) participants at an incidence rate of 4·1 per 100 person-years in the placebo group (hazard ratio [HR] 0·85, 95% CI 0·77-0·93; p=0·0004). The clearest effect was for new macroalbuminuria (HR 0·77, 95% CI 0·68-0·87; p<0·0001), with HRs of 0·89 (0·78-1·01; p=0·066) for sustained decline in eGFR of 30% or more and 0·75 (0·39-1·44; p=0·39) for chronic renal replacement therapy. INTERPRETATION: Long-term use of dulaglutide was associated with reduced composite renal outcomes in people with type 2 diabetes. FUNDING: Eli Lilly and Company.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Nefropatias Diabéticas/prevenção & controle , Peptídeos Semelhantes ao Glucagon/análogos & derivados , Hipoglicemiantes/uso terapêutico , Fragmentos Fc das Imunoglobulinas/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Idoso , Albuminúria/prevenção & controle , Creatinina/urina , Método Duplo-Cego , Feminino , Taxa de Filtração Glomerular/efeitos dos fármacos , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade
14.
Lancet ; 394(10193): 121-130, 2019 07 13.
Artigo em Inglês | MEDLINE | ID: mdl-31189511

RESUMO

BACKGROUND: Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin A1c (HbA1c) concentrations. We assessed the effect of the GLP-1 receptor agonist dulaglutide on major adverse cardiovascular events when added to the existing antihyperglycaemic regimens of individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control. METHODS: This multicentre, randomised, double-blind, placebo-controlled trial was done at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo. Randomisation was done by a computer-generated random code with stratification by site. All investigators and participants were masked to treatment assignment. Participants were followed up at least every 6 months for incident cardiovascular and other serious clinical outcomes. The primary outcome was the first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01394952. FINDINGS: Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA1c 7·2% [IQR 6·6-8·1], 4589 [46·3%] women) were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). During a median follow-up of 5·4 years (IQR 5·1-5·9), the primary composite outcome occurred in 594 (12·0%) participants at an incidence rate of 2·4 per 100 person-years in the dulaglutide group and in 663 (13·4%) participants at an incidence rate of 2·7 per 100 person-years in the placebo group (hazard ratio [HR] 0·88, 95% CI 0·79-0·99; p=0·026). All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067). 2347 (47·4%) participants assigned to dulaglutide reported a gastrointestinal adverse event during follow-up compared with 1687 (34·1%) participants assigned to placebo (p<0·0001). INTERPRETATION: Dulaglutide could be considered for the management of glycaemic control in middle-aged and older people with type 2 diabetes with either previous cardiovascular disease or cardiovascular risk factors. FUNDING: Eli Lilly and Company.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2/tratamento farmacológico , Peptídeos Semelhantes ao Glucagon/análogos & derivados , Hipoglicemiantes/uso terapêutico , Fragmentos Fc das Imunoglobulinas/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Idoso , Doenças Cardiovasculares/mortalidade , Diabetes Mellitus Tipo 2/complicações , Método Duplo-Cego , Feminino , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/prevenção & controle , Acidente Vascular Cerebral/prevenção & controle
15.
Endocrinol Diabetes Nutr ; 66(9): 534-539, 2019 Nov.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31133475

RESUMO

OBJECTIVE: Less than one third of patients with type 1 diabetes mellitus (T1DM) achieve the cut-off value proposed as good metabolic control by most guidelines, HbA1c<7%. However, HbA1c reductions and prevention of severe hypoglycemia (SH) have shown clinically relevant benefits. The study objective therefore was to assess the effectiveness of continuous subcutaneous insulin infusion (CSII) therapy at 5 years of follow-up in a cohort of patients attending a specialized unit using HbA1c reduction and abscence of SH as combined goals. METHODS: A retrospective, observational study on 178 patients with T1DM who started CSII treatment at Hospital Clinic of Barcelona between 2003 and 2008. HbA1c levels at baseline and after 5 years of treatment with CSII and presence or absence of SH were recorded. The combined variables calculated included: a) HbA1c reduction by≥0.5 points and absence of SH in the last 2 years; b) HbA1c at 5 years<7.5% and no SH in the last 2 years; c) HbA1c<8.5% and no HG in the last 2 years, and d) HbA1c reduction by≥0.5 points and/or HbA1c<7.5% at 5 years with no SH in the last 2 years of follow-up. RESULTS: Twenty-seven of the 178 patients were excluded due to loss to follow-up or CSII discontinuation. A total of 151 patients (aged 37.4±10.5 years, 64% women, diabetes duration of 19.2±10.7 years) were therefore analyzed. The 2 main reasons for starting CSII were suboptimal metabolic control (60.9%) and severe hypoglycemia/hypoglycemia unawareness (28.5%). HbA1c levels in the total cohort and in patients with suboptimal metabolic control were 8.0±1.2 and 8.4±1.1% at CSII start and 7.8±1.2 and 8.0±1.3% at 5 years of treatment (P=.104 and P=.016) respectively. In the overall cohort, 55.5% of patients achieved at 5 years the combined goal of HbA1c<7.5% and/or HbA1c reductions≥0.5% without SH. CONCLUSIONS: After 5 years of CSII therapy, more than half of the patients achieved the combined goal of significant HbA1c reduction and absence of SH. The use of combined goals offers the opportunity to assess the effectiveness of T1DM treatment from a clinically more meaningful point of view.

16.
Diabetes Metab Res Rev ; 35(7): e3176, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31066196

RESUMO

AIM: The aim of this study is to evaluate the impact of impaired awareness of hypoglycaemia (IAH) on metabolic control and pregnancy outcomes in women with type 1 diabetes. MATERIAL AND METHODS: This was a single-centre prospective cohort study of singleton pregnant women with type 1 diabetes. IAH was assessed at the first antenatal visit using Clarke's test (score ≥ 3). Data on metabolic control, hypoglycaemic events, and the lipid profile were collected from prior to pregnancy and in each trimester of gestation. Pregnancy outcomes were also recorded. RESULTS: A total of 77 patients with type 1 diabetes were included; 24 (31.2%) were classified as having IAH. Compared with the normal awareness of hypoglycaemia (NAH) group, the IAH group did not show differences in HbA1c , weight gain, insulin doses, or severe and nonsevere hypoglycaemia events throughout pregnancy. IAH was associated with higher triglyceride concentrations in the second trimester (IAH: 154.8 ± 61.1 mg/dL, NAH: 128.6 ± 31.2 mg/dL, P = .034) and an increased risk of neonatal respiratory distress (odds ratio [OR] 11.24; 95% CI, 1.01-124.9, P = .041) in adjusted models. Increased risk of pre-eclampsia was related to higher second trimester triglyceride concentrations (OR 1.028; 95% CI, 1.004-1.053, P = .023) adjusted for confounders. CONCLUSIONS: The IAH was associated with increased risk of neonatal respiratory distress and pre-eclampsia, despite showing no differences in metabolic control. Hypoglycaemia awareness in the first antenatal visit should be assessed to identify the subgroup of pregnant women with increased risk of complications.

17.
Int J Med Inform ; 126: 1-8, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31029250

RESUMO

BACKGROUND: Predicting insulin-induced postprandial hypoglycemic events is critical for the safety of type 1 diabetes patients because an early warning of hypoglycemia facilitates correction of the insulin bolus before its administration. The postprandial hypoglycemic event counts can be lowered by reducing the size of the bolus based on a reliable prediction but at the cost of increasing the average blood glucose. METHODS: We developed a method for predicting postprandial hypoglycemia using machine learning techniques personalized to each patient. The proposed system enables on-line therapeutic decision making for patients using a sensor augmented pump therapy. Two risk-based approaches were developed for a window of 240 min after the meal/bolus, and they were tested based on real retrospective data from 10 patients using 70 mg/dL and 54 mg/dL as thresholds according to the consensus for Level 1 and Level 2 hypoglycemia, respectively. Due to the small size of the patient cohort, we trained personalized models for each patient. RESULTS: The median specificity and sensitivity were 79% and 71% for Level 1 hypoglycemia, respectively, and 81% and 77% for Level 2. CONCLUSIONS: The results demonstrated that it is feasible to anticipate hypoglycemic events with a reasonable false-positive rate. The accuracy of the results and the trade-off between performance metrics allow its use in decision support systems for patients who wear insulin pumps.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Hipoglicemia/epidemiologia , Período Pós-Prandial , Aprendizado de Máquina Supervisionado , Feminino , Previsões , Humanos , Hipoglicemia/diagnóstico , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Sistemas de Infusão de Insulina , Masculino , Estudos Retrospectivos
18.
Endocrinol Diabetes Nutr ; 66(8): 512-519, 2019 Oct.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31000451

RESUMO

INTRODUCTION: The use of statins in non-selected type 1 diabetes (T1D) populations is low. We assessed the prevalence and factors associated with statin treatment in patients meeting criteria for this therapy for primary prevention of cardiovascular disease (CVD). MATERIAL AND METHODS: From 2015 to 2018, T1D patients from a tertiary hospital were selected. Inclusion criteria were: ≥40 years-old, diabetic nephropathy, or T1D duration ≥10 years with ≥1 cardiovascular risk factor (CVRF). A standardized cardiovascular risk evaluation protocol was performed. Prevalence of statin treatment was evaluated according to presence of several CVRFs, and multivariable models were constructed to assess independent determinants of statin use. RESULTS: We included 241 patients (50% women, age 48.2±9.9 years, T1D duration 26.6±9.0 years). Diabetic retinopathy and nephropathy, active smoking, and hypertension were present in 38%, 12%, 28%, and 27%, respectively. Overall, 43% of patients were on statins and 27% had LDL-cholesterol <100mg/dl. Statin users were older, and had higher body mass index (BMI), prevalence of kidney dysfunction, and hypertension (p<0.05 for all). However, among both T1D-related and classical CVRFs, only hypertension (odds ratio [OR], 2.96; 95% confidence interval [CI] 1.48-5.91) and BMI (OR, 1.08; CI, 1.01-1.16) were independently associated with statin use in multiple regression analysis. CONCLUSIONS: Less than half of T1D patients from a tertiary hospital who met criteria for statin use were on treatment. Hypertension and BMI emerged as the only CVRFs independently associated with statin therapy. New strategies are needed to better address CVD prevention in this very high-risk population.

19.
Diabetes Ther ; 10(3): 929-936, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30900146

RESUMO

INTRODUCTION: To describe and compare the routine use of continuous subcutaneous insulin infusion (CSII) in type 1 diabetes (T1D) patients with and without continuous glucose monitoring (CGM) in routine clinical practice and its relationship with glycemic outcomes. METHODS: Retrospective observational case-control study collecting routine use of CSII and CGM in T1D patients between January 2016 and December 2016. Patients with T1D using sensor augmented pump (SAP) were matched by sex and disease duration in a 1:3 ratio with those treated only with CSII. Patients used a Paradigm Veo or 640G Medtronic-Minimed® insulin pump with or without a glucose sensor (Enlite, Medtronic-Minimed®) for at least 12 months. RESULTS: A total of 160 subjects with T1D were included, 40 using SAP and 120 on CSII (age 47 ± 12 years, 88 women, diabetes duration 29 ± 9.0 years, 10 ± 4.7 years on CSII, HbA1C 7.6 ± 0.8%). Those in SAP therapy used the sensor 63% of time, performed less self-monitored blood glucose (SMBG)/day (3.3 ± 1.9 vs. 4.5 ± 2.0; p < 0.01), more bolus/day (6.2 ± 3.6 vs. 4.8 ± 1.6; p < 0.05), more basal insulin segment/day (6.5 ± 2.1 vs. 5.9 ± 1.5; p < 0.05), and more suspension time of the pump (97 ± 93 vs. 9.6 ± 20 min/day; p < 0.0001). Regarding metabolic control, SAP therapy patients had lower HbA1c (7.4 ± 0.7 vs. 7.7 ± 0.9%; p = 0.068), lower average SMBG value (151 ± 32 vs. 163 ± 30 mg/dL; p < 0.05), a lower percentage of SMBG values greater than 180 mg/dL (30 ± 19 vs. 37 ± 16%; p < 0.05) with no differences in SMBG values less than 70 mg/dL (12 ± 8.0 vs. 9.8 ± 9.8%; p = 0.33) compared with patients on CSII. There were no differences in bolus wizard targets or in insulin/carbohydrate ratios per day. CONCLUSION: In a real-world setting, SAP therapy is associated with more self-adjustments of insulin therapy when compared to CSII alone. This could result in an improvement in glucose control.

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