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BACKGROUND: Digital therapeutics, an emerging type of medical approach, is defined as evidence-based therapeutic interventions through qualified software programs that help prevent, manage, or treat chronic diseases such as type 2 diabetes mellitus (T2DM), which has high social and economic burden. Klivo, a startup certified by the Brazilian Society of Diabetes, developed the first digital therapeutic product for managing T2DM in Brazil, reaching 21 of 24 states. Klivo has continuously been improving its model of behavior change on the basis of an intensive lifestyle intervention method that addresses individuals' needs-the Klivo Intervention Program for T2DM (KIPDM). To test the most recent version of the KIPDM, we will evaluate the ongoing management of daily life habits in patients with T2DM by measuring clinically significant outcomes. To improve the transparency of further results, here we will present the study protocol and detail the plan for the research project, including the study design and the analysis strategies. METHODS: The KIPDM will be sponsored by health plans and healthcare provider organizations and will be free for patients (adults aged ≥ 18 years and <65 years; and glycated hemoglobin ≥ 7%). The program will be based on a 6-month management process that will supervise patients remotely. The program will include educational classes via the Klivo app, text messages, or e-mails. Evaluation will include objectively assessing clinical, laboratory, and behavioral outcomes such as health-related quality of life, mental health, medication adherence, and healthcare utilization. For this, validated electronic questionnaires will be available through the Klivo app. The primary outcome will be glycated hemoglobin (HbA1c) values. The secondary outcome will be time in target blood glucose range (TIR) estimated by capillary glycemia. Other outcomes of interest will be evaluated at baseline and stipulated time points (3 and 6 months after the start of the program). EXPECTED OUTCOMES: KIPDM patients should present improved HbA1c and TIR along the intervention as compared to baseline values. Findings from this study will provide insights into the health improvement of T2DM and other cardiometabolic conditions such as hypertension, dyslipidemia, and obesity by using a digital therapeutic strategy. By analyzing the patient's health over time, this study will also contribute to understanding comorbidities associated with this chronic condition in the Brazilian population.

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INTRODUCTION: For individuals diagnosed with diabetes mellitus, the practice of properly oriented physical exercises brings significant benefits to the individual's health and is considered an indispensable tool for metabolic management. The individualization of exercise routines is an essential aspect for therapeutic success, despite the need to consider some general recommendations. This review is an authorized literal translation of the Brazilian Society of Diabetes (SBD) Guidelines 2021-2022, which is based on scientific evidence and provides guidance on physical activities and exercises aimed at individuals with type 1 and 2 diabetes. METHODS: SBD designated 9 specialists from its "Department of Diabetes, Exercise & Sports" to author chapters on physical activities and exercises directed to individuals with type 1 and 2 diabetes. The aim of these chapters was to highlight recommendations in accordance with Evidence Levels, based on what is described in the literature. These chapters were analyzed by the SBD Central Committee, which is also responsible for the SBD 2021-2022 guidelines. Main clinical inquiries were selected to perform a narrated review by using MEDLINE via PubMed. Top available evidence, such as high-quality clinical trials, large observational studies and meta-analyses related to physical activity and exercise advisory, were analyzed. The adopted MeSh terms were [diabetes], [type 1 diabetes], [type 2 diabetes], [physical activity] [physical exercise]. RESULTS: 17 recommendations were defined by the members. For this review, it was considered different Evidence Levels, as well as different Classes of Recommendations. As to Evidence Levels, the following levels were contemplated: Level A) More than one randomized clinical trial or a randomized clinical trial meta-analysis with low heterogeneity. Level B) Meta analysis with observational studies, one randomized clinical trial, sizeable observational studies and sub-groups analysis. Level C) Small non-randomized studies, cross-sectional studies, case control studies, guidelines or experts' opinions. In respect to Recommendation Classes, the following criteria were adopted: I. "Recommended": Meaning there was a consent of more than 90% of the panel; IIa. "Must be considered": meaning there is a general preference of the panel which 70-90% agrees; IIb. "Can be considered". 50-70% agrees; III Not recommended: There is a consensus that the intervention should not be performed. CONCLUSION: Physical exercise aids on the glycemic control of type 2 diabetes individuals while also decreasing cardiovascular risk in individuals with type 1 and 2 diabetes. Individuals diagnosed with diabetes should perform combined aerobic and resistance exercises in order to manage the disease. In addition, exercises focusing on flexibility and balance should be specially addressed on elderly individuals. Diabetes individuals using insulin as therapeutic treatment should properly monitor glycemia levels before, during and after exercise sessions to minimize health incidents, such as hypoglycemia.

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Abstract Objective To evaluate the effect of the carbohydrate counting method (CCM) on glycemic control,maternal, and perinatal outcomes of pregnant women with pregestational diabetes mellitus (DM). Methods Nonrandomized controlled clinical trial performed with 89 pregnant women who had pregestational DMand received prenatal care in a public hospital in Rio de Janeiro, state of Rio de Janeiro, Brazil, between 2009 and 2014, subdivided into historic control group and intervention group, not simultaneous. The intervention group (n=51) received nutritional guidance from the carbohydrate counting method (CCM), and the historical control group (n=38), was guided by the traditionalmethod (TM). The Mann-Whitney test or the Wilcoxon test were used to compare intra- and intergroup outcomes andanalysis of variance (ANOVA) for repeated measures, corrected by the Bonferroni post-hoc test,was used to assess postprandial blood glucose. Results Only the CCM group showed a reduction in fasting blood glucose. Postprandial blood glucose decreased in the 2nd (p=0.00) and 3rd (p=0.00) gestational trimester in the CCM group, while in the TM group the reduction occurred only in the 2nd trimester (p=0.015). For perinatal outcomes and hypertensive disorders of pregnancy, there were no differences between groups. Cesarean delivery was performed in 82% of the pregnant women and was associated with hypertensive disorders (gestational hypertension or pre-eclampsia; p=0.047). Conclusion Both methods of nutritional guidance contributed to the reduction of postprandial glycemia of women and no differences were observed for maternal and perinatal outcomes. However, CCM had a better effect on postprandial glycemia and only this method contributed to reducing fasting blood glucose throughout the intervention. ReBEC Clinical Trials Database The present study was registered in the ReBEC Clinical Trials Database (Registro Brasileiro de Ensaios Clínicos, number RBR-524z9n).

Resumo Objetivo Avaliar o efeito do método de contagem de carboidratos no controle glicêmico, desfechos maternos e perinatais de gestantes com diabetes mellitus (DM) pré-gestacional. Métodos Ensaio clínico controlado não randomizado realizado com 89 gestantes com DM pré-gestacional atendidas em hospital público do Rio de Janeiro, RJ, Brasil, entre 2009 e 2014, divididas emgrupo controle histórico e grupo intervenção. O grupo intervenção (n=51) recebeu orientação nutricional combase nométodo de contagem de carboidratos (CCM) e o grupo controle histórico (n=38) foi orientado pelo método tradicional (MT). Os testes de Mann-Whitney ou de Wilcoxon foram usados para comparar os desfechos intra- e intergrupos e, para avaliar a glicemia pós-prandial, análise de variância (ANOVA, na sigla em inglês) para medidas repetidas foi usada. Resultados Somente o grupo com método CCM apresentou redução da glicemia de jejum. A glicemia pós-prandial diminuiu no 2° (p=0,00) e 3° (p=0,00) trimestres gestacionais no grupo com método CCM, e no grupo com método tradicional, a redução ocorreu apenas no 2° trimestre (p=0,015). Para os resultados perinatais e distúrbios hipertensivos da gravidez, não houve diferenças entre os grupos. O parto cirúrgico foi realizado em 82% das gestantes e esteve associado a distúrbios hipertensivos gestacionais (p=0,047). Conclusão Ambos osmétodos de orientação nutricional contribuírampara a redução da glicemia pós-prandial e não foram observadas diferenças para os resultados maternos e perinatais. No entanto, o método CCM apresentou melhor efeito sobre a glicemia pós-prandial e foi o único que induziu redução da glicemia de jejum.

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OBJECTIVE: To evaluate the effect of the carbohydrate counting method (CCM) on glycemic control, maternal, and perinatal outcomes of pregnant women with pregestational diabetes mellitus (DM). METHODS: Nonrandomized controlled clinical trial performed with 89 pregnant women who had pregestational DM and received prenatal care in a public hospital in Rio de Janeiro, state of Rio de Janeiro, Brazil, between 2009 and 2014, subdivided into historic control group and intervention group, not simultaneous. The intervention group (n = 51) received nutritional guidance from the carbohydrate counting method (CCM), and the historical control group (n = 38), was guided by the traditional method (TM). The Mann-Whitney test or the Wilcoxon test were used to compare intra- and intergroup outcomes and analysis of variance (ANOVA) for repeated measures, corrected by the Bonferroni post-hoc test, was used to assess postprandial blood glucose. RESULTS: Only the CCM group showed a reduction in fasting blood glucose. Postprandial blood glucose decreased in the 2nd (p = 0.00) and 3rd (p = 0.00) gestational trimester in the CCM group, while in the TM group the reduction occurred only in the 2nd trimester (p = 0.015). For perinatal outcomes and hypertensive disorders of pregnancy, there were no differences between groups. Cesarean delivery was performed in 82% of the pregnant women and was associated with hypertensive disorders (gestational hypertension or pre-eclampsia; p = 0.047). CONCLUSION: Both methods of nutritional guidance contributed to the reduction of postprandial glycemia of women and no differences were observed for maternal and perinatal outcomes. However, CCM had a better effect on postprandial glycemia and only this method contributed to reducing fasting blood glucose throughout the intervention. REBEC CLINICAL TRIALS DATABASE: The present study was registered in the ReBEC Clinical Trials Database (Registro Brasileiro de Ensaios Clínicos, number RBR-524z9n).

OBJETIVO: Avaliar o efeito do método de contagem de carboidratos no controle glicêmico, desfechos maternos e perinatais de gestantes com diabetes mellitus (DM) pré-gestacional. MéTODOS: Ensaio clínico controlado não randomizado realizado com 89 gestantes com DM pré-gestacional atendidas em hospital público do Rio de Janeiro, RJ, Brasil, entre 2009 e 2014, divididas em grupo controle histórico e grupo intervenção. O grupo intervenção (n = 51) recebeu orientação nutricional com base no método de contagem de carboidratos (CCM) e o grupo controle histórico (n = 38) foi orientado pelo método tradicional (MT). Os testes de Mann-Whitney ou de Wilcoxon foram usados para comparar os desfechos intra- e intergrupos e, para avaliar a glicemia pós-prandial, análise de variância (ANOVA, na sigla em inglês) para medidas repetidas foi usada. RESULTADOS: Somente o grupo com método CCM apresentou redução da glicemia de jejum. A glicemia pós-prandial diminuiu no 2° (p = 0,00) e 3° (p = 0,00) trimestres gestacionais no grupo com método CCM, e no grupo com método tradicional, a redução ocorreu apenas no 2° trimestre (p = 0,015). Para os resultados perinatais e distúrbios hipertensivos da gravidez, não houve diferenças entre os grupos. O parto cirúrgico foi realizado em 82% das gestantes e esteve associado a distúrbios hipertensivos gestacionais (p = 0,047). CONCLUSãO: Ambos os métodos de orientação nutricional contribuíram para a redução da glicemia pós-prandial e não foram observadas diferenças para os resultados maternos e perinatais. No entanto, o método CCM apresentou melhor efeito sobre a glicemia pós-prandial e foi o único que induziu redução da glicemia de jejum.

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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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BACKGROUND: Dunnigan type Familial Partial Lipodystrophy (FPLD) is characterized by loss of subcutaneous fat from the limbs and excessive accumulation on the visceral adipose tissue (VAT). Affected individuals have insulin resistance (IR), diabetes, dyslipidemia and early cardiovascular (CV) events, due to their imbalanced distribution of total body fat (TBF). Epicardial adipose tissue (EAT) is correlated with VAT. Hence, EAT could be a new index of cardiac and visceral adiposity with great potential as a marker of CV risk in FPLD. OBJECTIVE: Compare EAT in FPLD patients versus healthy controls. Moreover, we aimed to verify if EFT is related to anthropometrical (ATPM) and Dual-Energy X-ray Absorptiometry (DEXA) measures, as well as laboratory blood findings. We postulated that FPLD patients have enlarged EAT. METHODS: This is an observational, cross-sectional study. Six patients with a confirmed mutation in the LMNA gene for FPLD were enrolled in the study. Six sex, age and BMI-matched healthy controls were also selected. EFT was measured by transthoracic echocardiography (ECHO). All participants had body fat distribution evaluated by ATPM and by DEXA measures. Fasting blood samples were obtained for biochemical profiles and also for leptin measurements. RESULTS: Median EFT was significantly higher in the FPLD group than in matched controls (6.0 ± 3.6 mm vs. 0.0 ± 2.04 mm; p = 0.0306). Additionally, FPLD patients had lower leptin values. There was no significant correlation between EAT and ATPM and DEXA measurements, nor laboratory findings. CONCLUSIONS: This study demonstrates, for the first time, that EAT measured by ECHO is increased in FPLD patients, compared to healthy controls. However, it failed to prove a significant relation neither between EAT and DEXA, ATPM or laboratory variables analyzed.

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Desde a sua descrição em 1988 até os dias atuais a síndrome metabólica (SM) vem sendo reavaliada, tando em relação aos critérios diagnósticos como em relação à utilidade clínica. O objetivo do presente artigo é apresentar os critérios de diagnóstico atuais de acordo com as principais instituições representativas de classe e rever resumidamente as evidências científicas atuais, conceitos de fisiopatologia, prós e contras de sua utilização na prática clínica

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