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ABSTRACT Objective: The objective of this study was to verify the impact of carbohydrate counting (CC) on glycemic control and body weight variation (primary and secondary outcomes, respectively) between consultations in patients with diabetes mellitus (T1D) followed at a tertiary hospital in southern Brazil in a public health system environment. We also sought to investigate CC adherence. Materials and methods: This retrospective cohort study included 232 patients with T1D who underwent nutritional monitoring at a referral hospital for diabetes care between 2014 and 2018. To assess primary and secondary outcomes, data from 229 patients, 49 of whom underwent CC during this period and 180 individuals who used fixed doses of insulin, were analyzed. The impact of CC on glycemic control was assessed with the mean glycated hemoglobin (HbA1c) level at all consultations during the follow-up period. Results: In the model adjusted for the most confounders (except pregnancy), the mean HbA1c was better in the CC group (8.66 ± 0.4% vs. 9.36 ± 0.39%; p = 0.016), and body weight variation was lower (0.13 ± 0.28 kg vs. 0.53 ± 0.24 kg; p = 0.024). Adherence to CC was reported in 69.2% of consultations. Conclusion: CC optimized the glycemic control of individuals with T1D, resulting in less weight variation than in the fixed insulin dose group, which indicates that CC is an important care strategy for these patients.
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Objective: The objective of this study was to verify the impact of carbohydrate counting (CC) on glycemic control and body weight variation (primary and secondary outcomes, respectively) between consultations in patients with diabetes mellitus (T1D) followed at a tertiary hospital in southern Brazil in a public health system environment. We also sought to investigate CC adherence. Materials and methods: This retrospective cohort study included 232 patients with T1D who underwent nutritional monitoring at a referral hospital for diabetes care between 2014 and 2018. To assess primary and secondary outcomes, data from 229 patients, 49 of whom underwent CC during this period and 180 individuals who used fixed doses of insulin, were analyzed. The impact of CC on glycemic control was assessed with the mean glycated hemoglobin (HbA1c) level at all consultations during the follow-up period. Results: In the model adjusted for the most confounders (except pregnancy), the mean HbA1c was better in the CC group (8.66 ± 0.4% vs. 9.36 ± 0.39%; p = 0.016), and body weight variation was lower (0.13 ± 0.28 kg vs. 0.53 ± 0.24 kg; p = 0.024). Adherence to CC was reported in 69.2% of consultations. Conclusion: CC optimized the glycemic control of individuals with T1D, resulting in less weight variation than in the fixed insulin dose group, which indicates that CC is an important care strategy for these patients.
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Diabetes Mellitus Tipo 1 , Feminino , Gravidez , Humanos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hemoglobinas Glicadas , Glicemia , Estudos Retrospectivos , Controle Glicêmico , Insulina/uso terapêutico , Peso Corporal , Hipoglicemiantes/uso terapêuticoRESUMO
BACKGROUND AND AIMS: Diabetes mellitus (DM) is one of the most prevalent chronic noncommunicable diseases globally, and the only way to reduce its complications is good glycaemic control. Insulin remains the only approved treatment for type 1 DM (T1DM) and is used by many with type 2 DM (T2DM). Carbohydrate counting is considered the ideal way to calculate meal-related insulin doses as it allows greater flexibility in diet and could, in some people, reduce the burden of the disease. The primary objective of this systematic review was to assess carbohydrate counting efficacy in reducing glycated haemoglobin (HbA1c ) levels and safety by not increasing hypoglycaemia risk, inducing an increase in body weight or blood lipids, or reducing the quality of life of people with T1DM. METHODS: We included randomised controlled clinical trials with a parallel-group design comparing any carbohydrate counting forms with standard care or other forms of dietary advice or insulin dose calculation in people with T1DM with a follow up period of at least 3 months and with no restrictions in language, age or settings. As a primary outcome, we consider the change of HbA1c levels within at least 3 months. Secondary outcomes were hypoglycaemia events, body weight changes, blood lipids levels, and the total daily insulin dose. We also evaluated health-related quality-of-life changes and questionnaires on satisfaction with treatment of diabetes. RESULTS: Data from 11 studies with 899 patients were retrieved with a mean follow-up of 52 ± 35.5 weeks. Carbohydrate counting is not better in reducing HbA1c levels (SMD-0.24%, 95% CI -0.68 to 0.21) than all dietary advice forms. However, this finding was highly heterogeneous. We identified three studies that account for most of the heterogeneity using clustering algorithms. A second analysis excluding these studies shows a meaningful reduction in HbA1c levels (SMD-0.52%, 95% CI -0.82 to -0.23) with low heterogeneity. In the subgroup analysis, carbohydrate counting significantly reduces HbA1c levels compared with usual diabetes education. Carbohydrate counting does not relate to any substantial change in blood lipids, body weight, hypoglycaemia risk or daily insulin dose. Finally, we analysed the effect of trial duration on reduction in HbA1c levels and found no significant change related to time. CONCLUSIONS: Carbohydrate counting is an efficacious technique to safely reduce the levels of HbA1c in adults and children compared with standard diabetes education, and its effect does not appear to change with prolonged time. Standardisation in reporting important outcomes such as hypoglycaemia and quality of life are vital to produce comparable evidence in carbohydrate counting clinical trials. This systematic review was registered in PROSPERO under code: CRD42020218499.
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Diabetes Mellitus Tipo 1 , Hipoglicemia , Adulto , Criança , Humanos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Qualidade de Vida , Hemoglobinas Glicadas/análise , Hipoglicemia/prevenção & controle , Insulina/efeitos adversos , Peso Corporal , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Either under standard basal-bolus treatment or hybrid closed-loop control, subjects with type 1 diabetes are required to count carbohydrates (CHOs). However, CHO counting is not only burdensome but also prone to errors. Recently, an artificial pancreas algorithm that does not require premeal insulin boluses-the so-called automatic regulation of glucose (ARG)-was introduced. In its first pilot clinical study, although the exact CHO counting was not required, subjects still needed to announce the meal time and classify the meal size. METHOD: An automatic switching signal generator (SSG) is proposed in this work to remove the manual mealtime announcement from the control strategy. The SSG is based on a Kalman filter and works with continuous glucose monitoring readings only. RESULTS: The ARG algorithm with unannounced meals (ARGum) was tested in silico under the effect of different types of mixed meals and intrapatient variability, and contrasted with the ARG algorithm with announced meals (ARGam). Simulations reveal that, for slow-absorbing meals, the time in the euglycemic range, [70-180] mg/dL, increases using the unannounced strategy (ARGam: 78.1 [68.6-80.2]% (median [IQR]) and ARGum: 87.8 [84.5-90.6]%), while similar results were found with fast-absorbing meals (ARGam: 87.4 [86.0-88.9]% and ARGum: 87.6 [86.1-88.8]%). On the other hand, when intrapatient variability is considered, time in euglycemia is also comparable (ARGam: 81.4 [75.4-83.5]% and ARGum: 80.9 [77.0-85.1]%). CONCLUSION: In silico results indicate that it is feasible to perform an in vivo evaluation of the ARG algorithm with unannounced meals.
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Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Refeições , Pâncreas Artificial , Algoritmos , Automonitorização da Glicemia , Simulação por Computador , Diabetes Mellitus Tipo 1/sangue , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Período Pós-PrandialRESUMO
AIM: To evaluate the predictive factors of glycemic control in children and adolescents with type 1 diabetes mellitus (T1DM). METHODS: Cross-sectional study at a referral service in Rio de Janeiro, Brazil. Sociodemographic, anthropometric, clinical, and dietary factors were evaluated. Food consumption was evaluated by 24â¯h dietary recall and the NOVA system was adopted for classifying the foods according to the extent and purpose of industrial processing. The predictive factors were evaluated by multivariate linear regression, adopting pâ¯<â¯0.05. RESULTS: One hundred and twenty children and adolescents participated, with a mean age of 11.74â¯years (±2.88) and HbA1c of 8.13% (±1.26). The mean diabetes duration was 6.68â¯years (±3.33) and the insulin used was 1.05 units per kilogram of ideal weight (IU/kg of ideal weight; ±0.46) About 80% (nâ¯=â¯96) used carbohydrate counting and it was verified that 24.27% (±17.89) of the participants' total calories came from ultraprocessed foods. For each year of diagnosis with T1DM and for each IU/kg of weight used, HbA1c increased by 0.087% (ßâ¯=â¯0.087, pâ¯=â¯0.007) and 0.651%, respectively (ßâ¯=â¯0.651; pâ¯=â¯<0.001). Use of carbohydrate counting was associated with a 1.058% reduction in HbA1c (ßâ¯=â¯-1.058; pâ¯=â¯0.001). CONCLUSION: Disease duration and insulin dose were directly reflected in HbA1c concentrations, while carbohydrate counting showed an inverse association.
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Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hemoglobinas Glicadas/análise , Hiperglicemia/diagnóstico , Hipoglicemia/diagnóstico , Insulina/administração & dosagem , Encaminhamento e Consulta , Adolescente , Peso Corporal , Brasil/epidemiologia , Criança , Estudos Transversais , Diabetes Mellitus Tipo 1/fisiopatologia , Ingestão de Energia , Feminino , Humanos , Hiperglicemia/epidemiologia , Hiperglicemia/prevenção & controle , Hipoglicemia/epidemiologia , Hipoglicemia/prevenção & controle , Masculino , Valor Preditivo dos Testes , PrevalênciaRESUMO
The aim of the study was to evaluate the food intake of pregnant women with gestational diabetes mellitus (GDM) according to two methods of dietary guidance. A randomised controlled clinical trial was conducted by appointment with a nutritionist and by using data from hospital records (2011-2014). The study population comprised adult women diagnosed with GDM treated in a public maternity hospital in Rio de Janeiro, Brazil. The control group (CG) received nutritional advice by the traditional method and the intervention group (IG) were instructed on carbohydrate counting. The analysis of food intake and the consumption of processed foods (PF) and ultra-processed foods (UPF) were evaluated in the second and third trimester. A total of 286 pregnant women were initially assessed (145 in the CG and 141 in the IG). It was observed that 89/120 (74·2 %) and 183/229 (79·9 %) consumed PF daily in the second and third trimesters, respectively, whereas 117/120 (97·5 %) and 225/231 (97·4 %) consumed UPF daily in the second and third trimesters, respectively. When analysing the intake of macronutrients (%) by quartiles, women who had fat intake in the third quartile had the highest average postprandial blood glucose compared with those who consumed fat in the second quartile (P=0·02). The consumption of PF and UPF was high and dietary intake was similar in both groups, regardless of dietary guidance method deployed, suggesting that both methods tested in the study can be used for monitoring the nutritional status of pregnant women with GDM.
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Diabetes Gestacional/dietoterapia , Ingestão de Alimentos , Terapia Nutricional/métodos , Adulto , Brasil , Aconselhamento , Dieta , Carboidratos da Dieta/administração & dosagem , Feminino , Idade Gestacional , Humanos , Avaliação Nutricional , Gravidez , Método Simples-CegoRESUMO
BACKGROUND: Emerging therapies such as closed-loop (CL) glucose control, also known as artificial pancreas (AP) systems, have shown significant improvement in type 1 diabetes mellitus (T1DM) management. However, demanding patient intervention is still required, particularly at meal times. To reduce treatment burden, the automatic regulation of glucose (ARG) algorithm mitigates postprandial glucose excursions without feedforward insulin boluses. This work assesses feasibility of this new strategy in a clinical trial. METHODS: A 36-hour pilot study was performed on five T1DM subjects to validate the ARG algorithm. Subjects wore a subcutaneous continuous glucose monitor (CGM) and an insulin pump. Insulin delivery was solely commanded by the ARG algorithm, without premeal insulin boluses. This was the first clinical trial in Latin America to validate an AP controller. RESULTS: For the total 36-hour period, results were as follows: average time of CGM readings in range 70-250 mg/dl: 88.6%, in range 70-180 mg/dl: 74.7%, <70 mg/dl: 5.8%, and <50 mg/dl: 0.8%. Results improved analyzing the final 15-hour period of this trial. In that case, the time spent in range was 70-250 mg/dl: 94.7%, in range 70-180 mg/dl: 82.6%, <70 mg/dl: 4.1%, and <50 mg/dl: 0.2%. During the last night the time spent in range was 70-250 mg/dl: 95%, in range 70-180 mg/dl: 87.7%, <70 mg/dl: 5.0%, and <50 mg/dl: 0.0%. No severe hypoglycemia occurred. No serious adverse events were reported. CONCLUSIONS: The ARG algorithm was successfully validated in a pilot clinical trial, encouraging further tests with a larger number of patients and in outpatient settings.
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Algoritmos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Pâncreas Artificial , Adulto , Automonitorização da Glicemia , Feminino , Humanos , Sistemas de Infusão de Insulina , América Latina , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Período Pós-PrandialRESUMO
Abstract Objective: This study aimed to evaluate the effectiveness and safety of carbohydrate counting (CHOC) in the treatment of adult patients with type 1 diabetes mellitus (DM1). Materials and methods: We performed a systematic review of randomized studies that compared CHOC with general dietary advice in adult patients with DM1. The primary outcomes were changes in glycated hemoglobin (HbA1c), quality of life, and episodes of severe hypoglycemia. We searched the following electronic databases: Embase, PubMed, Lilacs, and the Cochrane Central Register of Controlled Trials. The quality of evidence was analyzed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results: A total of 3,190 articles were identified, and two reviewers independently screened the titles and abstracts. From the 15 potentially eligible studies, five were included, and 10 were excluded because of the lack of randomization or different control/intervention groups. Meta-analysis showed that the final HbA1c was significantly lower in the CHOC group than in the control group (mean difference, random, 95% CI: −0.49 (-0.85, −0.13), p = 0.006). The meta-analysis of severe hypoglycemia and quality of life did not show any significant differences between the groups. According to the GRADE, the quality of evidence for severe hypoglycemia, quality of life, and change in HbA1c was low, very low, and moderate, respectively. Conclusion: The meta-analysis showed evidence favoring the use of CHOC in the management of DM1. However, this benefit was limited to final HbA1c, which was significantly lower in the CHOC than in the control group.
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Humanos , Adulto , Diabetes Mellitus Tipo 1/dietoterapia , Dieta com Restrição de Carboidratos , Qualidade de Vida , Hemoglobinas Glicadas/análise , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Hipoglicemia/etiologiaRESUMO
BACKGROUND/AIMS: Carbohydrate counting (CC) is a helpful strategy for the treatment of type 1 diabetes mellitus (T1DM) and the main parameters used in this method are the insulin to carbohydrate ratio (ICR) and the sensitivity factor (SF). Throughout pregnancy, a state of insulin resistance develops. Therefore, we hypothesized that ICR and SF change and our aim was to describe the pattern of modification of these parameters in pregnant women with T1DM on CC. METHODS: This study followed 21 women with T1DM throughout pregnancy. Starting ICR was 1:15 and SF was calculated using the formula: 1,500/total daily insulin dose (TDID; for regular insulin) or 1,800/TDID (for ultra-rapid analogs). ICR was adjusted every 1-2 weeks according to self-monitoring of blood glucose. SF was recalculated every 1-2 weeks. RESULTS: Throughout gestation there was a mean decrease in the ICR in breakfast, lunch and dinner of 8.2 (p < 0.0001), 7.7 (p = 0.003) and 7 (p = 0.005) grams per international units (g/IU), respectively. Mean SF reduction from first to third trimester was 10 mg/dL per IU (mg/dL/IU; p < 0.0001). CONCLUSIONS: Women with T1DM in CC during pregnancy evolve with a progressive reduction in the ICR at every meal (mean of 8.2 g/IU for breakfast, 7.7 g/IU for lunch and 7 g/IU for dinner) and also in the SF (10 mg/dL/IU).
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Diabetes Mellitus Tipo 1/sangue , Carboidratos da Dieta/administração & dosagem , Adolescente , Adulto , Glicemia/metabolismo , Índice de Massa Corporal , Diabetes Mellitus Tipo 1/dietoterapia , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Hemoglobinas Glicadas/metabolismo , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/sangue , Insulina/uso terapêutico , Resistência à Insulina , Gravidez , Estudos Prospectivos , Adulto JovemRESUMO
OBJECTIVE: To test the hypothesis that lower basal insulin doses may be paradoxically associated with better diabetic control, we assessed the association between the basal insulin dose and hemoglobin A1c (HbA1c) level in a group of children and young adults with type 1 diabetes. STUDY DESIGN: This was a retrospective study of 89 patients with type 1 diabetes (mean age, 14.67 ± 4.8 years; range, 3-29 years) treated in a single outpatient clinic. Forty-six of the 89 patients were treated with continuous subcutaneous insulin infusion, and the other 43 were treated with multiple daily injections (glargine as basal insulin). The daily basal insulin dose was taken either as downloaded from the insulin pump or as registered in the chart at the most recent clinic visit. Glucose data were taken from computerized registration of downloaded patient glucometers. The mean time between data download and HbA1c determination was 0.9 ± 0.78 months. HbA1c level and basal insulin dose were entered with other variables in a multivariable linear regression model. RESULTS: There was a significant correlation between injection of less total daily basal insulin and lower HbA1c level (Pearson correlation, 0.441; P < .001). Optimal HbA1c level was associated with use of 0.28 ± 0.08 U/kg/day of basal insulin (35 ± 10% basal/total). CONCLUSION: With lower basal insulin levels, lower HbA1C was achieved despite the same total bolus dose. The optimal basal dose as determined by this study is similar to that found in fasting individuals of similar age.