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1.
Eur J Obstet Gynecol Reprod Biol ; 296: 371-375, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38552506

RESUMO

OBJECTIVE: The WHO 2013 guidelines recommend screening for gestational diabetes mellitus (GDM) by 3-point oral glucose tolerance test (OGTT). The objective of this retrospective cohort study was to evaluate GDM diagnosed by an isolated high glucose. STUDY DESIGN: We included pregnant women deemed at risk for GDM were offered GDM screening. We examined the records of 1939 consecutively screened pregnancies at two teaching hospitals in Amsterdam during 2016-2020. Using the WHO 2013 diagnostic criteria, we calculated the proportion of GDM cases diagnosed by isolated abnormal glucose values. RESULTS: Among those screened in our high risk cohort, GDM incidence was 31.5%. Of the GDM diagnoses, 57.0% were based on an isolated fasting glucose value, 30.9% based on multiple raised glucose measurements, 7.4% on an isolated raised 2-hour glucose and 4.7% on an isolated raised 1-hour glucose. For 1-hour glucose, the number needed to screen was 67 persons for one additional GDM case. CONCLUSION: The 1-hour glucose in the 3 point OGTT, as suggested by the WHO 2013 guidelines for GDM, contributes only small numbers of GDM cases and a high number needed to screen (67 for 1 additional case in a selective high risk GDM screening strategy), and is likely even less effective in universally screened populations.


Assuntos
Glicemia , Diabetes Gestacional , Gravidez , Feminino , Humanos , Teste de Tolerância a Glucose , Estudos Retrospectivos , Diabetes Gestacional/epidemiologia , Organização Mundial da Saúde
2.
Lancet Digit Health ; 6(4): e272-e280, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38443309

RESUMO

BACKGROUND: Management of insulin administration for intake of carbohydrates and physical activity can be burdensome for people with type 1 diabetes on hybrid closed-loop systems. Bihormonal fully closed-loop (FCL) systems could help reduce this burden. In this trial, we assessed the long-term performance and safety of a bihormonal FCL system. METHODS: The FCL system (Inreda AP; Inreda Diabetic, Goor, Netherlands) that uses two hormones (insulin and glucagon) was assessed in a 1 year, multicentre, prospective, single-arm intervention trial in adults with type 1 diabetes. Participants were recruited in eight outpatient clinics in the Netherlands. We included adults with type 1 diabetes aged 18-75 years who had been using flash glucose monitoring or continuous glucose monitors for at least 3 months. Study visits were integrated into standard care, usually every three months, to evaluate glycaemic control, adverse events, and person-reported outcomes. The primary endpoint was time in range (TIR; glucose concentration 3·9-10·0 mmol/L) after 1 year. The study is registered in the Dutch Trial Register, NL9578. FINDINGS: Between June 1, 2021, and March 2, 2022, we screened 90 individuals and enrolled 82 participants; 78 were included in the analyses. 79 started the intervention and 71 were included in the 12 month analysis. Mean age was 47.7 (SD 12·4) years and 38 (49%) were female participants. The mean preintervention TIR of participants was 55·5% (SD 17·2). After 1 year of FCL treatment, mean TIR was 80·3% (SD 5·4) and median time below range was 1·36% (IQR 0·80-2·11). Questionnaire scores improved on Problem Areas in Diabetes (PAID) from 30·0 (IQR 18·8-41·3) preintervention to 10·0 (IQR 3·8-21·3; p<0·0001) at 12 months and on World Health Organization-Five Well-Being Index (WHO-5) from 60·0 (IQR 44·0-72·0) preintervention to 76·0 (IQR 60·0-80·0; p<0·0001) at 12 months. Five serious adverse events were reported (one cerebellar stroke, two severe hypoglycaemic, and two hyperglycaemic events). INTERPRETATION: Real-world data obtained in this trial demonstrate that use of the bihormonal FCL system was associated with good glycaemic control in patients who completed 1 year of treatment, and could help relieve these individuals with type 1 diabetes from making treatment decisions and the burden of carbohydrate counting. FUNDING: Inreda Diabetic.


Assuntos
Diabetes Mellitus Tipo 1 , Hipoglicemia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , Países Baixos , Estudos Prospectivos
3.
Diabet Med ; 41(2): e15243, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37845186

RESUMO

AIMS: The impact of maternal metformin use during pregnancy on fetal, infant, childhood and adolescent growth, development, and health remains unclear. Our objective was to systematically review the available evidence from animal experiments on the effects of intrauterine metformin exposure on offspring's anthropometric, cardiovascular and metabolic outcomes. METHODS: A systematic search was conducted in PUBMED and EMBASE from inception (searched on 12th April 2023). We extracted original, controlled animal studies that investigated the effects of maternal metformin use during pregnancy on offspring anthropometric, cardiovascular and metabolic measurements. Subsequently, risk of bias was assessed and meta-analyses using the standardized mean difference and a random effects model were conducted for all outcomes containing data from 3 or more studies. Subgroup analyses were planned for species, strain, sex and type of model in the case of 10 comparisons or more per subgroup. RESULTS: We included 37 articles (n = 3133 offspring from n = 716 litters, containing n = 51 comparisons) in this review, mostly (95%) on rodent models and 5% pig models. Follow-up of offspring ranged from birth to 2 years of age. Thirty four of the included articles could be included in the meta-analysis. No significant effects in the overall meta-analysis of metformin on any of the anthropometric, cardiovascular and metabolic offspring outcome measures were identified. Between-studies heterogeneity was high, and risk of bias was unclear in most studies as a consequence of poor reporting of essential methodological details. CONCLUSION: This systematic review was unable to establish effects of metformin treatment during pregnancy on anthropometric, cardiovascular and metabolic outcomes in non-human offspring. Heterogeneity between studies was high and reporting of methodological details often limited. This highlights a need for additional high-quality research both in humans and model systems to allow firm conclusions to be established. Future research should include focus on the effects of metformin in older offspring age groups, and on outcomes which have gone uninvestigated to date.


Assuntos
Experimentação Animal , Metformina , Gravidez , Feminino , Humanos , Animais , Suínos , Adolescente , Criança , Idoso , Metformina/efeitos adversos , Hipoglicemiantes/efeitos adversos , Cuidado Pré-Natal , Antropometria
5.
Diabet Med ; 38(4): e14406, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32961611

RESUMO

AIM: To describe the prevalence and characteristics of polypharmacy in a Dutch cohort of individuals with type 2 diabetes. METHODS: We included people with type 2 diabetes from the Diabetes Pearl cohort, of whom 3886 were treated in primary care and 2873 in academic care (secondary/tertiary). With multivariable multinomial logistic regression analyses stratified for line of care, we assessed which sociodemographic, lifestyle and cardiometabolic characteristics were associated with moderate (5-9 medications) and severe polypharmacy (≥10 medications) compared with no polypharmacy (0-4 medications). RESULTS: Mean age was 63 ± 10 years, and 40% were women. The median number of daily medications was 5 (IQR 3-7) in primary care and 7 (IQR 5-10) in academic care. The prevalence of moderate and severe polypharmacy was 44% and 10% in primary care, and 53% and 29% in academic care respectively. Glucose-lowering and lipid-modifying medications were most prevalent. People with severe polypharmacy used a relatively large amount of other (i.e. non-cardiovascular and non-glucose-lowering) medication. Moderate and severe polypharmacy across all lines of care were associated with higher age, low educational level, more smoking, longer diabetes duration, higher BMI and more cardiovascular disease. CONCLUSIONS: Severe and moderate polypharmacy are prevalent in over half of people with type 2 diabetes in primary care, and even more in academic care. People with polypharmacy are characterized by poorer cardiometabolic status. These results highlight the significance of polypharmacy in type 2 diabetes.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Polimedicação , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/epidemiologia , Estudos de Coortes , Comorbidade , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Polimedicação/estatística & dados numéricos , Prevalência , Fatores Socioeconômicos
6.
Diabetes Res Clin Pract ; 168: 108367, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32791160

RESUMO

AIM: We assessed the association between ethnicity and the risk of gestational diabetes mellitus (GDM) in the Netherlands. METHODS: A cohort of 7815 women with known GDM status and ethnicity, including women of Sub-Saharan African ethnicity who are currently not identified as high-risk in guidelines. We compared GDM rates among participants of ethnicity to those of ethnic Dutch participants. We employed multivariable regression to correct for possible confounders, including maternal age, pre-pregnancy body mass index (BMI), and education. GDM prevalence and odds ratios based on ethnicity were the main outcome measures. RESULTS: The prevalence rates of GDM according to ethnicity were: Dutch 0.6%, South-Asian Surinamese 6.9%, African-Surinamese 3.5%, Antillean 1.0%, Turkish 1.0%, Moroccan 1.4%, Ghanaian 6.8%, Sub-Saharan African 3.5%, other Western 0.5% and other non-Western 2.8%. After adjustment for age, pre-pregnancy BMI, and education duration, compared with the reference Dutch-ethnicity population, adjusted odds ratios (aOR) for GDM were statistically significantly higher in South-Asian Surinamese (aOR 10.9; 95% Confidence Interval (CI), 4.7-25.0), African-Surinamese (4.3; 2.0-9.2), Ghanaian (6.5; 3.0-14.5), Sub-Saharan African (5.7; 2.0-16.0), and other non-Western women (4.5; 2.2-9.0). GDM was not significantly increased among Antillean (1.4; 0.2-10.3), Turkish (1.4; 0.4-4.2), Moroccan (1.8; 0.8-4.0), and other Western women (0.8; 0.3-2.2). CONCLUSIONS: This study shows for the first time in the Netherlands that women of Ghanaian or other Sub-Saharan African ethnicity have an increased risk of developing GDM than the Dutch. This calls for adaptation of the Dutch guidelines of screening high-risk groups for GDM and more awareness amongst obstetric caregivers.


Assuntos
Diabetes Gestacional/epidemiologia , Adulto , África , Estudos de Coortes , Etnicidade , Feminino , Humanos , Países Baixos , Gravidez , Estudos Prospectivos , Fatores de Risco , Suriname
7.
Sci Rep ; 10(1): 4968, 2020 03 18.
Artigo em Inglês | MEDLINE | ID: mdl-32188890

RESUMO

Land-use intensification on arable land is expanding and posing a threat to biodiversity and ecosystem services worldwide. We develop methods to link funding for avian breeding habitat conservation and management at landscape scales to equilibrium abundance of a migratory species at the continental scale. We apply this novel approach to a harvested bird valued by birders and hunters in North America, the northern pintail duck (Anas acuta), a species well below its population goal. Based on empirical observations from 2007-2016, habitat conservation investments for waterfowl cost $313 M and affected <2% of the pintail's primary breeding area in the Prairie Pothole Region of Canada. Realistic scenarios for harvest and habitat conservation costing an estimated $588 M (2016 USD) led to predicted pintail population sizes <3 M when assuming average parameter values. Accounting for parameter uncertainty, converting 70-100% of these croplands to idle grassland (cost: $35.7B-50B) is required to achieve the continental population goal of 4 M individuals under the current harvest policy. Using our work as a starting point, we propose continued development of modeling approaches that link conservation funding, habitat delivery, and population response to better integrate conservation efforts and harvest management of economically important migratory species.


Assuntos
Migração Animal , Biodiversidade , Aves/fisiologia , Conservação dos Recursos Naturais/métodos , Ecossistema , Dinâmica Populacional , Animais , Geografia , Pradaria , Densidade Demográfica
8.
Anaesthesia ; 74(7): 929-939, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30821852

RESUMO

In the peri-operative period, dexamethasone is widely and effectively used for prophylaxis of postoperative nausea and vomiting. The objective of this meta-analysis was to assess the adverse effects of an incidental steroid load of dexamethasone in adult surgical patients. We searched in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and the Web of Science for randomised controlled trials comparing an incidental steroid load of dexamethasone with a control intervention in adult patients undergoing surgery. Two review authors independently screened studies for eligibility, extracted data and assessed all included studies for bias. Our primary outcomes were postoperative systemic or wound infection, delayed wound healing and glycaemic response within 24 h. We included 37 studies in this meta-analysis. The pooled results found no evidence that dexamethasone increased the risk of a postoperative wound infection, Peto OR (95%CI) 1.01 (0.80-1.27); 4603 participants, 26 studies; I² = 32%; moderate-quality evidence. Whether dexamethasone influenced wound healing was unclear due to the large confidence intervals, Peto OR (95%CI) 0.99 (0.28-3.43); 1072 participants, 8 studies; I² = 0%; low-quality evidence. Dexamethasone produced a mild increase in glucose levels among participants without diabetes during the first 12 h after surgery, mean difference (95%CI) 0.7 mmol.l-1 (0.3-1.2) 10 studies; 595 participants; I² = 50%; low-quality evidence. This article is an abridged version of a Cochrane Review.


Assuntos
Dexametasona/efeitos adversos , Glucocorticoides/efeitos adversos , Complicações Pós-Operatórias/induzido quimicamente , Humanos
10.
Oecologia ; 187(1): 305-318, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29627956

RESUMO

According to theory, habitat selection by organisms should reflect underlying habitat-specific fitness consequences and, in birds, reproductive success has a strong impact on population growth in many species. Understanding processes affecting habitat selection also is critically important for guiding conservation initiatives. Northern pintails (Anas acuta) are migratory, temperate-nesting birds that breed in greatest concentrations in the prairies of North America and their population remains below conservation goals. Habitat loss and changing land use practices may have decoupled formerly reliable fitness cues with respect to nest habitat choices. We used data from 62 waterfowl nesting study sites across prairie Canada (1997-2009) to examine nest survival, a primary fitness metric, at multiple scales, in combination with estimates of habitat selection (i.e., nests versus random points), to test for evidence of adaptive habitat choices. We used the same habitat covariates in both analyses. Pintail nest survival varied with nest initiation date, nest habitat, pintail breeding pair density, landscape composition and annual moisture. Selection of nesting habitat reflected patterns in nest survival in some cases, indicating adaptive selection, but strength of habitat selection varied seasonally and depended on population density and landscape composition. Adaptive selection was most evident late in the breeding season, at low breeding densities and in cropland-dominated landscapes. Strikingly, at high breeding density, habitat choice appears to become maladaptive relative to nest predation. At larger spatial scales, the relative availability of habitats with low versus high nest survival, and changing land use practices, may limit the reproductive potential of pintails.


Assuntos
Ecossistema , Comportamento de Nidação , Animais , Aves , Canadá , América do Norte
11.
Diabetes Obes Metab ; 20(3): 749-752, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-28940961

RESUMO

Historically, metformin was withheld before surgery for fear of metformin-associated lactic acidosis. Currently, however, this risk is deemed to be low and guidelines have moved towards the continuation of metformin. We hypothesized that continuing metformin peri-operatively would lower postoperative serum glucose level without an effect on plasma lactate levels. We performed a single-blind multicentre randomized controlled trial in people with type 2 diabetes mellitus scheduled for non-cardiac surgery and continued (MF+ group) or withheld (MF- group) metformin before surgery. The main outcome measures were the differences in peri-operative plasma glucose and lactate levels. We randomized 70 patients (37 MF+ group and 33 MF- group) with type 2 diabetes mellitus. Postoperative glucose levels were similar in the MF+ and the MF- groups (8.2 ± 1.8 vs 8.3 ± 2.3 mmol/L P = .95) Although preoperative lactate levels were slightly higher in the MF+ group compared with the MF- group (1.5 vs 1.2 mmol/L; P = .02), the postoperative lactate levels were not significantly different (1.2 vs 1.0 mmol/L; P = .18). In conclusion, continuation of metformin during elective non-cardiac surgery does not improve glucose control or raise lactate levels to a clinically relevant degree.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/sangue , Feminino , Humanos , Cuidados Intraoperatórios , Tempo de Internação/estatística & dados numéricos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Método Simples-Cego , Resultado do Tratamento , Adulto Jovem
12.
Anaesthesia ; 73(3): 332-339, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29230803

RESUMO

In this open-label multicentre randomised controlled trial, we investigated three peri-operative treatment strategies to lower glucose and reduce the need for rescue insulin in patients aged 18-75 years with type-2 diabetes mellitus undergoing non-cardiac surgery. Patients were randomly allocated using a web-based randomisation program to premedication with liraglutide (liraglutide group), glucose-insulin-potassium infusion (insulin infusion group) or insulin bolus regimen (insulin bolus group), targeting a glucose < 8.0 mmol.l-1 . The primary outcome was the between group difference in median glucose levels 1 h after surgery. We analysed 150 patients (liraglutide group n = 44, insulin infusion group n = 53, insulin bolus group n = 53) according to the intention-to-treat principle. Median (IQR [range]) plasma glucose 1 h postoperatively was lower in the liraglutide group compared with the insulin infusion and insulin bolus groups (6.6 (5.6-7.7 [4.2-13.5]) mmol.l-1 vs. 7.5 (6.4-8.3 [3.9-16.6]) mmol.l-1 (p = 0.026) and 7.6 (6.4-8.9 [4.7-13.2]) mmol.l-1 ) p = 0.006, respectively). The incidence of hypoglycaemia and postoperative complications did not differ between the groups. Six patients had pre-operative nausea in the liraglutide group, of which two had severe nausea, compared with no patients in the insulin infusion and insulin bolus groups (p = 0.007). The pre-operative administration of liraglutide stabilised peri-operative plasma glucose levels and reduced peri-operative insulin requirements, at the expense of increased pre-operative nausea rates.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/administração & dosagem , Liraglutida/uso terapêutico , Assistência Perioperatória , Idoso , Glicemia/análise , Diabetes Mellitus Tipo 2/sangue , Feminino , Glucose/uso terapêutico , Humanos , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Potássio/uso terapêutico
13.
J Clin Monit Comput ; 32(5): 953-964, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29218549

RESUMO

Subcutaneous continuous glucose monitoring (CGM) may have benefits in achieving glycemic control in critically ill patients. The aim of this study was to assess the accuracy and reliability of the FreeStyle Navigator I in critically ill patients and to assess patient related factors influencing the accuracy and reliability. This study is a retrospective analysis of data from a randomized controlled trial conducted in a 20-bed mixed intensive care unit. Analytical accuracy, clinical accuracy and reliability were assessed against arterial blood glucose samples as reference. Assessment was according to recent consensus recommendations with median absolute relative difference (median ARD), Bland-Altman plots, the ISO system accuracy standards (ISO 15197:2013) and Clarke error grid analysis (CEG). We analyzed 2840 paired measurements from 155 critically ill patients. The median ARD of all paired values was 13.3 [6.9-22.1]%. The median ARD was significantly higher in both the hypoglycemic and the hyperglycemic range (32.4 [12.1-53.4]% and 18.7 [10.7-28.3]% respectively, p < 0.001). The Bland-Altman analysis showed a mean bias of - 0.82 mmol/L with a lower limit of agreement (LOA) of - 3.88 mmol/L and an upper LOA of 2.24 mmol/L. A total of 1626 (57.3%) values met the ISO-2013, standards and 1,334 (47%) CGM values were within 12.5% from the reference value. CEG: 71.0% zone A, 25.8% zone B, 0.5% zone C, 2.5% zone D, 0.3% zone E. The median overall real-time data display time was 94.0 ± 14.9% and in 23% of the patients, the sensor measured < 95% of the time. Additionally, data gaps longer than 30 min were found in 48% of the patients. The analytical accuracy of the FreeStyle Navigator I in critically ill patients was suboptimal. Furthermore, the clinical accuracy, did not meet the required standards. The reliability was satisfactory, however, in almost a quarter of the patients the realtime data display was < 95%. The accuracy was considerably and significantly lower in hyper- and hypoglycemic ranges.


Assuntos
Glicemia/análise , Monitorização Fisiológica/instrumentação , Idoso , Estado Terminal/enfermagem , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica/enfermagem , Monitorização Fisiológica/estatística & dados numéricos , Reprodutibilidade dos Testes , Estudos Retrospectivos
14.
Diabet Med ; 34(11): 1623-1628, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-28703888

RESUMO

AIMS: Individual indicators of socio-economic status have been associated with glycaemic control in people with Type 2 diabetes, but little is known about the association between partner's socio-economic status and HbA1c levels. We therefore examined the cross-sectional association between individual and partner's level of occupation on HbA1c levels in people with Type 2 diabetes in the Netherlands. METHODS: We included people with Type 2 diabetes with a partner who were treated in primary, secondary and tertiary care in the Diabetes Pearl cohort. Occupational level was classified according to International Standard Classification of Occupations (ISCO)-08 skill levels. Linear regression analyses were performed stratified for sex, and corrected for age, recruitment centre and diabetes medication. RESULTS: In total, 3257 participants (59.8% men, mean 62.2±9.4 years) were included. For men, having a partner with an intermediate level of occupation was associated with lower HbA1c levels [e.g. ISCO level 3: -2 mmol/mol (95% CI -4;-1) or -0.2% (95% CI -0.4;-0.1)], compared with having a partner of the highest occupational level (ISCO level 4). In women, having an unemployed partner was associated with higher HbA1c levels [14 mmol/mol (95% CI 6; 22) or 1.3% (95% CI 0.6; 2.0)], compared with having a partner of the highest occupational level. CONCLUSIONS: Partner's occupational status provided additional information on the association between socio-economic status and HbA1c levels in people with Type 2 diabetes. Women seemed to benefit from a partner with a higher occupational status, while men seemed to benefit from a partner with a lower status. Because of the cross-sectional nature of the present study, more research is necessary to explore this association.


Assuntos
Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/epidemiologia , Hemoglobinas Glicadas/análise , Ocupações , Cônjuges , Adulto , Idoso , Idoso de 80 Anos ou mais , Glicemia/análise , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Ocupações/estatística & dados numéricos , Classe Social , Apoio Social , Cônjuges/estatística & dados numéricos , Adulto Jovem
16.
Diabet Med ; 34(2): 262-271, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-27696520

RESUMO

AIM: To assess the impact on fear of hypoglycaemia and treatment satisfaction with an artificial pancreas system used for 2 consecutive months, as well as participant acceptance of the artificial pancreas system. METHODS: In a randomized crossover trial patient-related outcomes associated with an evening-and-night artificial pancreas and sensor-augmented pump therapy were compared. Both intervention periods lasted 8 weeks. The artificial pancreas acceptance questionnaire (range 0-90, higher scores better), Hypoglycaemia Fear Survey II (range 0-72, higher scores worse) and Diabetes Treatment Satisfaction Questionnaire (range 0-36, higher scores better) were completed by 32 participants. Semi-structured interviews were conducted after study completion in a subset of six participants. Outcomes were compared using a repeated-measures anova model or paired t-test when appropriate. RESULTS: The total artificial pancreas acceptance questionnaire score at the end of the artificial pancreas period was 69.1 (sd 14.7; 95% CI 63.5, 74.7), indicating a positive attitude towards the artificial pancreas. No significant differences were found among the scores at baseline, end of sensor-augmented pump therapy period or end of the artificial pancreas period with regard to fear of hypoglycaemia [28.2 (sd 17.5), 23.5 (sd 16.6) and 23.5 (sd 16.7), respectively; P = 0.099] or diabetes treatment satisfaction [29.0 (sd 3.9), 28.2 (sd 5.2) and 28.0 (sd 7.1), respectively; P = 0.43]. Themes frequently mentioned in the interviews were 'positive effects at work', 'improved blood glucose', 'fewer worries about blood glucose', but also 'frequent alarms', 'technological issues' and 'demand for an all-in-one device'. CONCLUSIONS: The psychological outcomes of artificial pancreas and sensor-augmented pump therapy were similar. Current artificial pancreas technology is promising but user concerns should be taken into account to ensure utility of these systems.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Medo/psicologia , Hipoglicemia/psicologia , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Pâncreas Artificial , Satisfação do Paciente , Adulto , Glicemia/metabolismo , Estudos Cross-Over , Diabetes Mellitus Tipo 1/metabolismo , Feminino , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
17.
Diabetes Obes Metab ; 18(7): 671-7, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-26996542

RESUMO

AIMS: To assess the performance and safety of an integrated bihormonal artificial pancreas system consisting of one wearable device and two wireless glucose sensor transmitters during short-term daily use at home. METHODS: Adult patients with type 1 diabetes using an insulin pump were invited to enrol in this randomized crossover study. Treatment with the artificial pancreas started with a day and night in the clinical research centre, followed by 3 days at home. The control period consisted of 4 days of insulin pump therapy at home with blinded continuous glucose monitoring for data collection. Days 2-4 were predefined as the analysis period, with median glucose as the primary outcome. RESULTS: A total of 10 patients completed the study. The median [interquartile range (IQR)] glucose level was similar for the two treatments [7.3 (7.0-7.6) mmol/l for the artificial pancreas vs. 7.7 (7.0-9.0) mmol/l for the control; p = 0.123]. The median (IQR) percentage of time spent in euglycaemia (3.9-10 mmol/l) was longer during use of the artificial pancreas [84.7 (82.2-87.8)% for the artificial pancreas vs. 68.5 (57.9-83.6)% for the control; p = 0.007]. Time in hypoglycaemia was 1.3 (0.2-3.2)% for the artificial pancreas and 2.4 (0.4-10.3)% for the control treatment (p = 0.139). Separate analysis of daytime and night-time showed that the improvements were mainly achieved during the night. CONCLUSIONS: The results of this pilot study suggest that our integrated artificial pancreas provides better glucose control than insulin pump therapy in patients with type 1 diabetes at home and that the treatment is safe.


Assuntos
Diabetes Mellitus Tipo 1/terapia , Pâncreas Artificial , Adolescente , Adulto , Idoso , Glicemia/metabolismo , Estudos Cross-Over , Diabetes Mellitus Tipo 1/sangue , Feminino , Glucagon/administração & dosagem , Glucagon/efeitos adversos , Serviços de Assistência Domiciliar , Humanos , Hiperglicemia/induzido quimicamente , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Sistemas de Infusão de Insulina , Insulinas/administração & dosagem , Insulinas/efeitos adversos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Resultado do Tratamento , Adulto Jovem
18.
Diabetes Obes Metab ; 18(1): 34-9, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26343550

RESUMO

AIMS: To evaluate the pharmacokinetics and pharmacodynamics of different doses of glucagon administered subcutaneously (s.c.) at different blood glucose levels. METHODS: This study was an open-label, randomized, three-period, cross-over experiment in 6 patients with type 1 diabetes. During each of the three periods, different blood glucose levels were established in four consecutive steps (8, 6, 4 and 2.8 mmol/l) and glucagon was given at each blood glucose level in doses from 0.11 to 0.44 mg and 0.33, 0.66 and 1 mg at the lowest glucose concentration. RESULTS: Maximum glucagon concentration and area under the curve increased with increasing glucagon dose. Maximum glucagon concentration was reached after 10-20 min. Glucagon raised blood glucose in a dose-dependent manner at different baseline blood glucose levels. The median glucose excursion ranged from 2.6 to 6.2 mmol/l. Time to maximum glucose concentration was dose-dependent for the glucagon doses at 2.8 mmol/l, with median values from 40 to 80 min. CONCLUSIONS: Glucagon administered s.c. produces a stable pharmacokinetic and pharmacodynamic response at lower doses than the usual rescue dose and across a range of hypo- to hyperglycaemic blood glucose levels. This supports the use of small glucagon doses in the artificial pancreas to correct and prevent hypoglycaemia.


Assuntos
Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Glucagon/farmacocinética , Hipoglicemiantes/farmacocinética , Adulto , Glicemia/análise , Estudos Cross-Over , Relação Dose-Resposta a Droga , Feminino , Fármacos Gastrointestinais/administração & dosagem , Fármacos Gastrointestinais/farmacocinética , Glucagon/administração & dosagem , Técnica Clamp de Glucose , Humanos , Hipoglicemiantes/administração & dosagem , Masculino , Pessoa de Meia-Idade
19.
Atherosclerosis ; 240(2): 318-23, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25864162

RESUMO

AIMS: Intensive glucose control, often involving insulin treatment, failed to improve cardiovascular outcomes in several clinical trials. Observational studies reported an association between insulin use and cardiovascular disease (CVD) risk. It has therefore been suggested that insulin adversely affects CVD risk. To investigate the feasibility of this hypothesis, we studied the association between insulin dose and CVD risk in type 2 diabetes. METHODS: A case-control study was conducted of new users of oral antidiabetics who were prescribed insulin, using the Dutch Pharmo database. Cases were hospitalized for a cardiovascular event (CVE) and matched 1:2 to patients who were not hospitalized for a CVE, by sex, age, duration of diabetes and type of oral antidiabetic. Patients were divided into tertiles according to mean daily insulin dose. Conditional logistic regression analyses were used to explore the association between insulin exposure and CVE risk. RESULTS: We included 836 patients (517 (62%) male, mean age 66 years). After adjusting for available potential confounders, including HbA1c and triglycerides, insulin exposure was positively related to CVE risk (odds ratios for high (≥53.0 U/day) and intermediate (24.3-52.9 U/day) vs. low exposure (≤24.2 U/day): 3.00 [95% confidence interval (CI) 1.70 to 5.28] and 2.03 [95% CI 1.17 to 3.52]. CONCLUSION: Our findings are in line with the suggestion that high-dose insulin therapy adversely affects CVD risk, but need to be interpreted with caution due to the observational nature of the study. The role of particularly high-dose insulin in the progression of CVD warrants further investigation.


Assuntos
Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Idoso , Biomarcadores/sangue , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Doenças Cardiovasculares/diagnóstico , Bases de Dados Factuais , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Hemoglobinas Glicadas/metabolismo , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Países Baixos/epidemiologia , Razão de Chances , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
20.
J Diabetes Sci Technol ; 9(5): 1027-9, 2015 Apr 27.
Artigo em Inglês | MEDLINE | ID: mdl-25917336

RESUMO

In this issue of Journal of Diabetes Science and Technology, Nakamura and Balo report on accuracy and efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System. The authors demonstrate good overall performance of this real-time continuous glucose monitoring (RT-CGM) system, although accuracy data of the next generation RT-CGM system, the G4AP, is already available. Also, now that MARDs seem to move to single-digit numbers, the question comes up how low we need to go with accuracy. Results of the study also showed a reduction in time spent in hypoglycemia, although the clinical relevance should be questioned. To date, few trials have demonstrated a reduction of severe hypoglycemia. Conventional RT-CGM, without threshold suspension or closing the loop, might be insufficient in preventing severe hypoglycemia.


Assuntos
Automonitorização da Glicemia/instrumentação , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Feminino , Humanos , Masculino
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