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3.
N Engl J Med ; 387(16): 1477-1487, 2022 10 20.
Artigo em Inglês | MEDLINE | ID: mdl-36198143

RESUMO

BACKGROUND: In persons with type 1 diabetes and high glycated hemoglobin levels, the benefits of intermittently scanned continuous glucose monitoring with optional alarms for high and low blood glucose levels are uncertain. METHODS: In a parallel-group, multicenter, randomized, controlled trial involving participants with type 1 diabetes and glycated hemoglobin levels between 7.5% and 11.0%, we investigated the efficacy of intermittently scanned continuous glucose monitoring as compared with participant monitoring of blood glucose levels with fingerstick testing. The primary outcome was the glycated hemoglobin level at 24 weeks, analyzed according to the intention-to-treat principle. Key secondary outcomes included sensor data, participant-reported outcome measures, and safety. RESULTS: A total of 156 participants were randomly assigned, in a 1:1 ratio, to undergo intermittently scanned continuous glucose monitoring (the intervention group, 78 participants) or to monitor their own blood glucose levels with fingerstick testing (the usual-care group, 78 participants). At baseline, the mean (±SD) age of the participants was 44±15 years, and the mean duration of diabetes was 21±13 years; 44% of the participants were women. The mean baseline glycated hemoglobin level was 8.7±0.9% in the intervention group and 8.5±0.8% in the usual-care group; these levels decreased to 7.9±0.8% and 8.3±0.9%, respectively, at 24 weeks (adjusted mean between-group difference, -0.5 percentage points; 95% confidence interval [CI], -0.7 to -0.3; P<0.001). The time per day that the glucose level was in the target range was 9.0 percentage points (95% CI, 4.7 to 13.3) higher or 130 minutes (95% CI, 68 to 192) longer in the intervention group than in the usual-care group, and the time spent in a hypoglycemic state (blood glucose level, <70 mg per deciliter [<3.9 mmol per liter]) was 3.0 percentage points (95% CI, 1.4 to 4.5) lower or 43 minutes (95% CI, 20 to 65) shorter in the intervention group. Two participants in the usual-care group had an episode of severe hypoglycemia, and 1 participant in the intervention group had a skin reaction to the sensor. CONCLUSIONS: Among participants with type 1 diabetes and high glycated hemoglobin levels, the use of intermittently scanned continuous glucose monitoring with optional alarms for high and low blood glucose levels resulted in significantly lower glycated hemoglobin levels than levels monitored by fingerstick testing. (Funded by Diabetes UK and others; FLASH-UK ClinicalTrials.gov number, NCT03815006.).


Assuntos
Automonitorização da Glicemia , Diabetes Mellitus Tipo 1 , Hemoglobina A Glicada , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hemoglobina A Glicada/análise , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem
6.
N Engl J Med ; 387(13): 1161-1172, 2022 09 29.
Artigo em Inglês | MEDLINE | ID: mdl-36170500

RESUMO

BACKGROUND: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS: A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, -0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P = 0.39). No episodes of diabetic ketoacidosis occurred in either group. CONCLUSIONS: In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT04200313.).


Assuntos
Diabetes Mellitus Tipo 1 , Hipoglicemiantes , Insulina Aspart , Sistemas de Infusão de Insulina , Insulina Lispro , Adolescente , Adulto , Idoso , Biônica/instrumentação , Glicemia/análise , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/métodos , Criança , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hemoglobina A Glicada/análise , Humanos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/uso terapêutico , Insulina/administração & dosagem , Insulina/efeitos adversos , Insulina/uso terapêutico , Insulina Aspart/administração & dosagem , Insulina Aspart/efeitos adversos , Insulina Aspart/uso terapêutico , Sistemas de Infusão de Insulina/efeitos adversos , Insulina Lispro/administração & dosagem , Insulina Lispro/efeitos adversos , Insulina Lispro/uso terapêutico , Pessoa de Meia-Idade , Adulto Jovem
7.
N Engl J Med ; 387(10): 869-881, 2022 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-36069869

RESUMO

BACKGROUND: Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system. METHODS: In this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age). The AID system was a modified version of AndroidAPS 2.8 (with a standard OpenAPS 0.7.0 algorithm) paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, which has an Android smartphone application as the user interface. The primary outcome was the percentage of time in the target glucose range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) between days 155 and 168 (the final 2 weeks of the trial). RESULTS: A total of 97 patients (48 children and 49 adults) underwent randomization (44 to open-source AID and 53 to the control group). At 24 weeks, the mean (±SD) time in the target range increased from 61.2±12.3% to 71.2±12.1% in the AID group and decreased from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points; 95% confidence interval, 9.2 to 18.8; P<0.001), with no treatment effect according to age (P = 0.56). Patients in the AID group spent 3 hours 21 minutes more in the target range per day than those in the control group. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. Two patients in the AID group withdrew from the trial owing to connectivity issues. CONCLUSIONS: In children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks. (Supported by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12620000034932.).


Assuntos
Glicemia , Diabetes Mellitus Tipo 1 , Hipoglicemiantes , Bombas de Infusão , Insulina , Adolescente , Adulto , Idoso , Austrália , Glicemia/análise , Criança , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Pessoa de Meia-Idade , Adulto Jovem
8.
J Med Life ; 15(6): 792-796, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35928354

RESUMO

Serum creatinine level begins to increase after a decrease in glomerular filtration rate (GFR) by 50% and more, so the question emerged about a more accurate method of determining GFR. The study aimed to determine the role of renal damage markers in the diagnosis of early-stage renal disease in patients with latent autoimmune diabetes in adults (LADA). We included 84 patients with diabetes mellitus (DM) and chronic kidney disease (CKD) caused by diabetic kidney disease (DKD), as well as 25 representatives of the control group. Patients were divided into three groups - 43 people with LADA, 21 with type 1 diabetes mellitus (T1DM), and 20 patients with type 2 diabetes mellitus (T2DM). GFR was assessed using six formulas after establishing the category of GFR and albuminuria. The GFR rate estimated by the CKD-EPI formula in patients with LADA and DKD did not significantly differ from that of CKD-EPI cysC, slightly different from MDRD GFR (10.6% higher, respectively) but 21.9% lower compared to CG formula. In patients with LADA and T1DM, GFR was higher in cases with existing albuminuria, regardless of the formulas used. Thus, the non albuminuria phenotype is accompanied by a greater degree of renal impairment, which indicates the need to determine serum cystatin C in the early stages of LADA. Cystatin C levels are the most accurate, early, and independent predictor of the development and progression of CKD in patients with DM, including LADA.


Assuntos
Cistatina C , Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Diabetes Autoimune Latente em Adultos , Insuficiência Renal Crônica , Biomarcadores/sangue , Creatinina/sangue , Cistatina C/sangue , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Taxa de Filtração Glomerular , Humanos , Rim , Diabetes Autoimune Latente em Adultos/sangue , Diabetes Autoimune Latente em Adultos/complicações , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/complicações
9.
J Trop Pediatr ; 68(4)2022 06 06.
Artigo em Inglês | MEDLINE | ID: mdl-35920158

RESUMO

OBJECTIVE: The studies evaluating cases with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) in the adult population reported hyperreactive platelets and increased activation of prothrombotic factors, resulting in an increased risk of thrombosis. The aim of this study was to evaluate the effects of poor glycemic control and the duration of diabetes on platelet parameters in pediatric population. METHODS: The study included 366 children, out of which 144 (39.3%) were included in the T1DM group and 222 (60.6%) in the healthy control group. The platelet count, mean platelet volume (MPV), platelet distribution width and plateletcrit values were recorded. The children with T1DM were divided into three groups as per their glycated hemoglobin (HbA1c) levels, good (<7.5%), moderate (7.5-9%) and poor metabolic control (>9%). RESULTS: No significant difference in the MPV level between the T1DM (7.41 ± 1.49 fl) and control (7.15 ± 1.23 fl) groups was observed. However, the MPV levels were significantly higher in the poor glycemic control group than in the healthy control group (p = 0.026). Furthermore, as the duration of diabetes and HbA1c levels increased, the MPV levels also increased (p < 0.001, p = 0.441). CONCLUSION: This study suggested as the duration of diabetes and HbA1c levels increased, the MPV levels also increases. Evaluation of hematological parameters can be a cheap and useful method in the evaluation of diabetes regulation in patients with diabetes.


Assuntos
Diabetes Mellitus Tipo 1 , Controle Glicêmico , Volume Plaquetário Médio , Ativação Plaquetária , Criança , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hemoglobina A Glicada , Humanos
10.
Front Endocrinol (Lausanne) ; 13: 884219, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35592786

RESUMO

Despite advances in the characterization of partial clinical remission (PR) of type 1 diabetes, an accurate definition of PR remains problematic. Two recent studies in children with new-onset T1D demonstrated serious limitations of the present gold standard definition of PR, a stimulated C-peptide (SCP) concentration of >300 pmol/L. The first study employed the concept of insulin sensitivity score (ISS) to show that 55% of subjects with new-onset T1D and a detectable SCP level of >300 pmol/L had low insulin sensitivity (IS) and thus might not be in remission when assessed by insulin-dose adjusted A1c (IDAA1c), an acceptable clinical marker of PR. The second study, a randomized controlled trial of vitamin D (ergocalciferol) administration in children and adolescents with new-onset T1D, demonstrated no significant difference in SCP between the ergocalciferol and placebo groups, but showed a significant blunting of the temporal trend in both A1c and IDAA1c in the ergocalciferol group. These two recent studies indicate the poor specificity and sensitivity of SCP to adequately characterize PR and thus call for a re-examination of current approaches to the definition of PR. They demonstrate the limited sensitivity of SCP, a static biochemical test, to detect the complex physiological changes that occur during PR such as changes in insulin sensitivity, insulin requirements, body weight, and physical activity. These shortcomings call for a broader definition of PR using a combination of functional markers such as IDAA1c and ISS to provide a valid assessment of PR that reaches beyond the static changes in SCP alone.


Assuntos
Diabetes Mellitus Tipo 1 , Hemoglobina A Glicada , Hipoglicemiantes , Resistência à Insulina , Insulina , Adolescente , Biomarcadores/análise , Peso Corporal/fisiologia , Peptídeo C/sangue , Criança , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/fisiopatologia , Ergocalciferóis/uso terapêutico , Exercício Físico/fisiologia , Hemoglobina A Glicada/análise , Indicadores Básicos de Saúde , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Resistência à Insulina/fisiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão
11.
Diabetologia ; 65(8): 1302-1314, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35546211

RESUMO

AIMS/HYPOTHESIS: The aim of this study was to assess whether the addition of intermittently scanned continuous glucose monitoring (isCGM) to standard care (self-monitoring of blood glucose [SMBG] alone) improves glycaemic control and pregnancy outcomes in women with type 1 diabetes and multiple daily injections. METHODS: This was a multicentre observational cohort study of 300 pregnant women with type 1 diabetes in Spain, including 168 women using SMBG (standard care) and 132 women using isCGM in addition to standard care. In addition to HbA1c, the time in range (TIR), time below range (TBR) and time above range (TAR) with regard to the pregnancy glucose target range (3.5-7.8 mmol/l) were also evaluated in women using isCGM. Logistic regression models were performed for adverse pregnancy outcomes adjusted for baseline maternal characteristics and centre. RESULTS: The isCGM group had a lower median HbA1c in the second trimester than the SMBG group (41.0 [IQR 35.5-46.4] vs 43.2 [IQR 37.7-47.5] mmol/mol, 5.9% [IQR 5.4-6.4%] vs 6.1% [IQR 5.6-6.5%]; p=0.034), with no differences between the groups in the other trimesters (SMBG vs isCGM: first trimester 47.5 [IQR 42.1-54.1] vs 45.9 [IQR 39.9-51.9] mmol/mol, 6.5% [IQR 6.0-7.1%] vs 6.4% [IQR 5.8-6.9%]; third trimester 43.2 [IQR 39.9-47.5] vs 43.2 [IQR 39.9-47.5] mmol/mol, 6.1% [IQR 5.8-6.5%] vs 6.1% [IQR 5.7-6.5%]). The whole cohort showed a slight increase in HbA1c from the second to the third trimester, with a significantly higher rise in the isCGM group than in the SMBG group (median difference 2.2 vs 1.1 mmol/mol [0.2% vs 0.1%]; p=0.033). Regarding neonatal outcomes, newborns of women using isCGM were more likely to have neonatal hypoglycaemia than newborns of non-sensor users (27.4% vs 19.1%; ORadjusted 2.20 [95% CI 1.14, 4.30]), whereas there were no differences between the groups in large-for-gestational-age (LGA) infants (40.6% vs 45.1%; ORadjusted 0.73 [95% CI 0.42, 1.25]), Caesarean section (57.6% vs 48.8%; ORadjusted 1.33 [95% CI 0.78, 2.27]) or prematurity (27.3% vs 24.8%; ORadjusted 1.05 [95% CI 0.55, 1.99]) in the adjusted models. A sensitivity analysis in pregnancies without LGA infants or prematurity also showed that the use of isCGM was associated with a higher risk of neonatal hypoglycaemia (non-LGA: ORadjusted 2.63 [95% CI 1.01, 6.91]; non-prematurity: ORadjusted 2.52 [95% CI 1.12, 5.67]). For isCGM users, the risk of delivering an LGA infant was associated with TIR, TAR and TBR in the second trimester in the logistic regression analysis. CONCLUSIONS/INTERPRETATION: isCGM use provided an initial improvement in glycaemic control that was not sustained. Furthermore, offspring of isCGM users were more likely to have neonatal hypoglycaemia, with similar rates of macrosomia and prematurity to those of women receiving standard care.


Assuntos
Automonitorização da Glicemia , Diabetes Mellitus Tipo 1 , Controle Glicêmico , Resultado da Gravidez , Gravidez em Diabéticas , Glicemia , Automonitorização da Glicemia/métodos , Cesárea , Estudos de Coortes , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Macrossomia Fetal/epidemiologia , Hemoglobina A Glicada/análise , Humanos , Hipoglicemia/epidemiologia , Recém-Nascido , Gravidez , Gravidez em Diabéticas/sangue , Gravidez em Diabéticas/tratamento farmacológico , Aumento de Peso
12.
Pediatr Diabetes ; 23(4): 516-526, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35297136

RESUMO

OBJECTIVE: To assess the relationship between mindfulness and glycemia among adolescents with type 1 diabetes (T1D) with suboptimal glycemia, and evaluate the potential mediation by ingestive behaviors, including disordered eating, and impulsivity. RESEARCH DESIGN AND METHODS: We used linear mixed models for hemoglobin A1c (HbA1c) and linear regression for continuous glucose monitoring (CGM) to study the relationship of mindfulness [Child and Adolescent Mindfulness Measure (CAMM)] and glycemia in adolescents with T1D from the 18-month Flexible Lifestyles Empowering Change (FLEX) trial. We tested for mediation of the mindfulness-glycemia relationship by ingestive behaviors, including disordered eating (Diabetes Eating Problem Survey-Revised), restrained eating, and emotional eating (Dutch Eating Behavior Questionnaire); and impulsivity (total, attentional, and motor, Barrett Impulsiveness Scale). RESULTS: At baseline, participants (n = 152) had a mean age of 14.9 ± 1.1 years and HbA1c of 9.4 ± 1.2% [79 ± 13 mmol/mol]. The majority of adolescents were non-Hispanic white (83.6%), 50.7% were female, and 73.0% used insulin pumps. From adjusted mixed models, a 5-point increase in mindfulness scores was associated with a -0.19% (95%CI -0.29, -0.08, p = 0.0006) reduction in HbA1c. We did not find statistically significant associations between mindfulness and CGM metrics. Mediation of the relationship between mindfulness and HbA1c by ingestive behaviors and impulsivity was not found to be statistically significant. CONCLUSIONS: Among adolescents with T1D and suboptimal glycemia, increased mindfulness was associated with lower HbA1c levels. Future studies may consider mindfulness-based interventions as a component of treatment for improving glycemia among adolescents with T1D, though more data are needed to assess feasibility and efficacy.


Assuntos
Glicemia , Diabetes Mellitus Tipo 1 , Atenção Plena , Adolescente , Glicemia/análise , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/psicologia , Diabetes Mellitus Tipo 1/terapia , Transtornos da Alimentação e da Ingestão de Alimentos/sangue , Transtornos da Alimentação e da Ingestão de Alimentos/psicologia , Feminino , Hemoglobina A Glicada/análise , Humanos , Comportamento Impulsivo , Estilo de Vida , Masculino , Poder Psicológico , Resultado do Tratamento
14.
PLoS One ; 17(2): e0263511, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35120182

RESUMO

BACKGROUND: Increasing global diabetes incidence has profound implications for health systems and for people living with diabetes. Guidelines have established clinical targets but there may be variation in clinical outcomes including HbA1c, based on location and practice size. Investigating this variation may help identify factors amenable to systemic improvement interventions. The aims of this study were to identify centre-specific and patient-specific factors associated with variation in HbA1c levels and to determine how these associations contribute to variation in performance across diabetes centres. METHODS: This cross-sectional study analysed data for 5,872 people with type 1 (n = 1,729) or type 2 (n = 4,143) diabetes mellitus collected through the Australian National Diabetes Audit (ANDA). A linear mixed-effects model examined centre-level and patient-level factors associated with variation in HbA1c levels. RESULTS: Mean age was: 43±17 years (type 1), 64±13 (type 2); median disease duration: 18 years (10,29) (type 1), 12 years (6,20) (type 2); female: 52% (type 1), 45% (type 2). For people with type 1 diabetes, volume of patients was associated with increases in HbA1c (p = 0.019). For people with type 2 diabetes, type of centre was associated with reduction in HbA1c (p <0.001), but location and patient volume were not. Associated patient-level factors associated with increases in HbA1c included past hyperglycaemic emergencies (type 1 and type 2, p<0.001) and Aboriginal and Torres Strait Islander status (type 2, p<0.001). Being a non-smoker was associated with reductions in HbA1c (type 1 and type 2, p<0.001). CONCLUSIONS: Centre-level and patient-level factors were associated with variation in HbA1c, but patient-level factors had greater impact. Interventions targeting patient-level factors conducted at a centre level including sick-day management, smoking cessation programs and culturally appropriate diabetes education for and Aboriginal and Torres Strait Islander peoples may be more important for improving glycaemic control than targeting factors related to the Centre itself.


Assuntos
Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Hemoglobina A Glicada/biossíntese , Adulto , Idoso , Austrália , Estudos Transversais , Atenção à Saúde , Feminino , Serviços de Saúde do Indígena/normas , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Reprodutibilidade dos Testes , Fumar , Abandono do Hábito de Fumar
15.
Biosensors (Basel) ; 12(2)2022 Feb 09.
Artigo em Inglês | MEDLINE | ID: mdl-35200366

RESUMO

The aim of this study was to evaluate the accuracy and usability of a novel continuous glucose monitoring (CGM) system designed for needle-free insertion and reduced environmental impact. We assessed the sensor performance of two GlucoMen® Day CGM systems worn simultaneously by eight participants with type 1 diabetes. Self-monitoring of blood glucose (SMBG) was performed regularly over 14 days at home. Participants underwent two standardized, 5-h meal challenges at the research center with frequent plasma glucose (PG) measurements using a laboratory reference (YSI) instrument. When comparing CGM to PG, the overall mean absolute relative difference (MARD) was 9.7 [2.6-14.6]%. The overall MARD for CGM vs. SMBG was 13.1 [3.5-18.6]%. The consensus error grid (CEG) analysis showed 98% of both CGM/PG and CGM/SMBG pairs in the clinically acceptable zones A and B. The analysis confirmed that GlucoMen® Day CGM meets the clinical requirements for state-of-the-art CGM. In addition, the needle-free insertion technology is well tolerated by users and reduces medical waste compared to conventional CGM systems.


Assuntos
Automonitorização da Glicemia , Glicemia/metabolismo , Diabetes Mellitus Tipo 1 , Glicemia/química , Automonitorização da Glicemia/instrumentação , Diabetes Mellitus Tipo 1/sangue , Humanos , Projetos Piloto , Reprodutibilidade dos Testes , Tecnologia
16.
Nat Commun ; 13(1): 942, 2022 02 17.
Artigo em Inglês | MEDLINE | ID: mdl-35177603

RESUMO

Insulin analogs have been developed to treat diabetes with focus primarily on improving the time action profile without affecting ligand-receptor interaction or functional selectivity. As a result, inherent liabilities (e.g. hypoglycemia) of injectable insulin continue to limit the true therapeutic potential of related agents. Insulin dimers were synthesized to investigate whether partial agonism of the insulin receptor (IR) tyrosine kinase is achievable, and to explore the potential for tissue-selective systemic insulin pharmacology. The insulin dimers induced distinct IR conformational changes compared to native monomeric insulin and substrate phosphorylation assays demonstrated partial agonism. Structurally distinct dimers with differences in conjugation sites and linkers were prepared to deliver desirable IR partial agonist (IRPA). Systemic infusions of a B29-B29 dimer in vivo revealed sharp differences compared to native insulin. Suppression of hepatic glucose production and lipolysis were like that attained with regular insulin, albeit with a distinctly shallower dose-response. In contrast, there was highly attenuated stimulation of glucose uptake into muscle. Mechanistic studies indicated that IRPAs exploit tissue differences in receptor density and have additional distinctions pertaining to drug clearance and distribution. The hepato-adipose selective action of IRPAs is a potentially safer approach for treatment of diabetes.


Assuntos
Diabetes Mellitus Experimental/tratamento farmacológico , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/farmacologia , Insulina/farmacologia , Receptor de Insulina/agonistas , Tecido Adiposo/efeitos dos fármacos , Tecido Adiposo/metabolismo , Aloxano/administração & dosagem , Aloxano/toxicidade , Animais , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Células CHO , Cricetulus , Diabetes Mellitus Experimental/sangue , Diabetes Mellitus Experimental/induzido quimicamente , Diabetes Mellitus Experimental/metabolismo , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/induzido quimicamente , Diabetes Mellitus Tipo 1/metabolismo , Células HEK293 , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Lipólise/efeitos dos fármacos , Fígado/efeitos dos fármacos , Fígado/metabolismo , Masculino , Camundongos , Ratos , Proteínas Recombinantes/farmacologia , Proteínas Recombinantes/uso terapêutico , Transdução de Sinais/efeitos dos fármacos , Suínos , Porco Miniatura
17.
PLoS One ; 17(2): e0263774, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35192641

RESUMO

INTRODUCTION: Fibroblast growth factor (FGF) 21 is an important regulator of glycemic control, but the association between circulating FGF21 and diabetic complications is poorly understood. Moreover, basal FGF21 secretion, especially in response to insulin dose, in patients with type 1 diabetes mellitus (T1DM), has not been well examined. Therefore, this study aimed to determine the association of circulating FGF21 levels with diabetic complications and insulin dosage in middle-aged and elderly patients with T1DM. MATERIALS AND METHODS: A total of 127 middle-aged and elderly patients with T1DM, including 68 patients with diabetic complications, and 106 non-diabetic individuals were analyzed in this cross-sectional study. Information on demographic characteristics and T1DM was extracted from their electronic medical records. Serum FGF21 levels were determined using ELISA. RESULTS: Serum FGF21 levels were significantly lower in T1DM patients (75.2 [37.4-135.1] pg/mL) than in non-diabetic participants (151.6 [92.0-224.6] pg/mL; P < 0.001). No diabetic complications were associated with serum FGF21 concentrations. Both basal and bolus insulin doses were significantly and positively correlated with serum FGF21 levels (P < 0.05). Stepwise multiple regression analysis showed that FGF21 level was associated with age and body mass index (P < 0.05), while the basal insulin dose was an independent positive predictor of serum FGF21 levels (ß = 0.197, P = 0.032). CONCLUSIONS: Circulating FGF21 levels are reduced in patients with T1DM; however, they are not associated with diabetic complications. In addition, aging, obesity, and insulin dosage are positive determinants of circulating FGF21.


Assuntos
Diabetes Mellitus Tipo 1/sangue , Nefropatias Diabéticas/epidemiologia , Neuropatias Diabéticas/epidemiologia , Retinopatia Diabética/epidemiologia , Fatores de Crescimento de Fibroblastos/sangue , Insulina/administração & dosagem , Adulto , Idoso , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Humanos , Insulina/sangue , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade
18.
BMC Endocr Disord ; 22(1): 7, 2022 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-34986830

RESUMO

OBJECTIVE: The aim of this study was to determine the differences in biochemical parameters and diabetic ketoacidosis (DKA) severity in adult patients with type 1 and type 2 diabetes and utilization of serum BHB as a biomarker for DKA resolution was also evaluated. MATERIALS AND METHODS: This prospective observational study of type 1 or type 2 diabetes mellitus who were diagnosed with DKA between 01 October 2018 and 30 September 2020. The correlations between serum BHB, measured by the Ranbut assay, and pH, bicarbonate, and anion gap were examined. RESULTS: A total of 99 diabetes patients were diagnosed with DKA (mean age 39.4 years, 63.4% female, 53.6% T2DM). while infection was the most common precipitating factor in T2DM (43.4%), non-compliance with treatment was the most common precipitating factor in T1DM (43.5%). T1DM patients had more severe DKA more hypokalemia during treatment. However, there was no significant difference in mortality between type1 and type2 diabetes. The initial laboratories evaluation of patients did not significant differ between type1 and type2 diabetes. Serum BHB during treatment of DKA was significantly correlated with changes in serum bicarbonate (r = - 0.64), serum anion gap (r = 0.84), and venous pH (r = - 0.6). The serum BHB levels corresponding to HCO3 levels for DKA severity were 4.5, 5.7, and 5.9 mmol/L in mild, moderate, and severe DKA, respectively. The serum BHB level of < 1 mmol/L had 73.7% sensitivity and 100% specificity to predict DKA resolution. Median time to resolution of DKA was 12 h with an optimized BHB cut-off value of < 1 mmol/L. There were no significant difference in time to resolution of DKA in the patients with type 1 and type 2 diabetes. CONCLUSIONS: There are no differences in DKA-related biochemical parameters between type 1 and type 2 diabetes patients. The present findings suggest that DKA should be assessed and treated similarly, regardless of its occurrence in type 1 or type 2 diabetes patients.


Assuntos
Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Cetoacidose Diabética/sangue , Adulto , Biomarcadores/sangue , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Cetoacidose Diabética/etiologia , Humanos , Pessoa de Meia-Idade , Gravidade do Paciente , Estudos Prospectivos , Adulto Jovem
19.
Pediatr Diabetes ; 23(2): 228-236, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34779090

RESUMO

AIM: A majority of youth with type 1 diabetes do not meet recommended hemoglobin A1c (HbA1c) targets. The SWEET diabetes registry is a multi-national registry of youth with diabetes. We used data from this registry to identify characteristics associated with glycemic control. METHODS: Patients in the SWEET diabetes registry with at least one HbA1c value within 10 days of diagnosis and three follow up measurements in the first 18 months of diagnosis were included (~10% of the SWEET diabetes registry). Locally weighted scatterplot smoothing was used to generate curves of HbA1c. Wilcoxon, Kruskal-Wallis, or χ2-tests were used to calculate differences between groups. RESULTS: The mean HbA1c of youth in the SWEET diabetes registry is highest at diagnosis and lowest between months 4 and 5 post-diabetes diagnosis. HbA1c continues to increase steadily through the first 18 months of diagnosis. There are no differences in HbA1c trajectories based on sex or use of diabetes technology. Youth in North America/Australia/New Zealand had the highest HbA1c throughout the first 18 months of diagnosis. The trajectory of youth from countries with nationalized health insurance was lower than those countries without nationalized health insurance. Youth from countries with the highest gross domestic product (GDP) had the highest HbA1c throughout the first 18 months of diagnosis. CONCLUSIONS: In this subset of patients, the trajectory of youth from countries with nationalized health insurance was lower than those countries without nationalized health insurance. High GDP and high use of technology did not seem to protect from a higher trajectory.


Assuntos
Diabetes Mellitus Tipo 1/sangue , Hemoglobina A Glicada/análise , Fatores de Tempo , Criança , Pré-Escolar , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Alemanha , Humanos , Hipoglicemiantes/farmacologia , Hipoglicemiantes/uso terapêutico , Masculino , Estudos Prospectivos , Sistema de Registros/estatística & dados numéricos
20.
Pediatr Diabetes ; 23(1): 84-89, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34888998

RESUMO

BACKGROUND: Glucose management indicator (GMI) is a useful metric for the clinical management of diabetic patients using continuous glucose monitoring (CGM). In adults, a marked discordance between HbA1c and GMI has been reported. To date, no studies have evaluated this discordance in children/adolescents with type 1 diabetes (T1D). METHODS: HbA1c and real-life CGM data of the 12 weeks preceding HbA1c measurement were collected from 805 children/adolescents. The absolute difference between HbA1c and GMI was calculated for both the 12-week and 4-week periods preceding HbA1c measurement and the proportion of discordant patients was defined according to specific thresholds in the entire study population and in subjects stratified by type of CGM, insulin therapy, gender, age and puberty. Regression analyses were performed with HbA1c-GMI discordance as dependent variable and patients' characteristics as independent ones. A new GMI equation for children and adolescent was derived from the linear regression analysis between mean glucose and HbA1c. RESULTS: HbA1c-GMI discordance calculated on the 12-week period was <0.1, ≥0.5 and ≥1.0 in 24.8, 33.9 and 9.2% of the subjects, respectively. No significant differences in the proportion of discordant patients were found comparing patients stratified by type of CGM, insulin therapy, gender, age and puberty. GMI-HbA1c discordance was not significantly explained by age, gender, BMI, type of CGM, insulin therapy, hemoglobin, anemia and autoimmune diseases (R2  = 0.012, p = 0.409). HbA1c-GMI discordance calculated on the 4-week period was comparable. GMI (%) equation derived for this cohort was: 3.74 + 0.022x (mean glucose in mg/dl). CONCLUSIONS: GMI could be meaningfully discordant respect to HbA1c in more than a third of children/adolescents with T1D. This discrepancy should be taken into careful consideration when the two indices are directly compared in daily clinical practice.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 1/terapia , Hemoglobina A Glicada/análise , Adolescente , Automonitorização da Glicemia/métodos , Automonitorização da Glicemia/estatística & dados numéricos , Criança , Pré-Escolar , Estudos de Coortes , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/epidemiologia , Feminino , Humanos , Insulina/uso terapêutico , Itália/epidemiologia , Masculino
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