Automated Identification of Different Severity Levels of Diabetic Retinopathy Using a Handheld Fundus Camera and Single-Image Protocol.

Purpose: To evaluate the performance of artificial intelligence (AI) systems embedded in a mobile, handheld retinal camera, with a single retinal image protocol, in detecting both diabetic retinopathy (DR) and more-than-mild diabetic retinopathy (mtmDR). Design: Multicenter cross-sectional diagnostic study, conducted at 3 diabetes care and eye care facilities. Participants: A total of 327 individuals with diabetes mellitus (type 1 or type 2) underwent a retinal imaging protocol enabling expert reading and automated analysis. Methods: Participants underwent fundus photographs using a portable retinal camera (Phelcom Eyer). The captured images were automatically analyzed by deep learning algorithms retinal alteration score (RAS) and diabetic retinopathy alteration score (DRAS), consisting of convolutional neural networks trained on EyePACS data sets and fine-tuned using data sets of portable device fundus images. The ground truth was the classification of DR corresponding to adjudicated expert reading, performed by 3 certified ophthalmologists. Main Outcome Measures: Primary outcome measures included the sensitivity and specificity of the AI system in detecting DR and/or mtmDR using a single-field, macula-centered fundus photograph for each eye, compared with a rigorous clinical reference standard comprising the reading center grading of 2-field imaging protocol using the International Classification of Diabetic Retinopathy severity scale. Results: Of 327 analyzed patients (mean age, 57.0 ± 16.8 years; mean diabetes duration, 16.3 ± 9.7 years), 307 completed the study protocol. Sensitivity and specificity of the AI system were high in detecting any DR with DRAS (sensitivity, 90.48% [95% confidence interval (CI), 84.99%-94.46%]; specificity, 90.65% [95% CI, 84.54%-94.93%]) and mtmDR with the combination of RAS and DRAS (sensitivity, 90.23% [95% CI, 83.87%-94.69%]; specificity, 85.06% [95% CI, 78.88%-90.00%]). The area under the receiver operating characteristic curve was 0.95 for any DR and 0.89 for mtmDR. Conclusions: This study showed a high accuracy for the detection of DR in different levels of severity with a single retinal photo per eye in an all-in-one solution, composed of a portable retinal camera powered by AI. Such a strategy holds great potential for increasing coverage rates of screening programs, contributing to prevention of avoidable blindness. Financial Disclosures: F.K.M. is a medical consultant for Phelcom Technologies. J.A.S. is Chief Executive Officer and proprietary of Phelcom Technologies. D.L. is Chief Technology Officer and proprietary of Phelcom Technologies. P.V.P. is an employee at Phelcom Technologies.

Insulin infusion sets associated with adverse events: strategies for improved diabetes education.

Introduction: Insulin Infusion Sets (IIS) play a crucial role in ensuring the safe delivery of insulin through a Continuous Subcutaneous Insulin Infusion (CSII) for individuals with Type 1 Diabetes (T1D). Recent advancements in therapy have highlighted the need to address issues such as unexplained hyperglycemia and IIS occlusion. Objective: To investigate the adverse events (AEs) associated with IIS that impact the treatment of T1D, with a specific focus on promoting effective educational practices. Methods: One hundred and eighteen patients under treatment at the Diabetes Center Insulin Pump Ambulatory, Federal University of São Paulo responded to a semi-structured questionnaire. Over 6 months, a nurse researcher interviewed them via video calls. Results: Catheter-related adverse events (AEs) included catheter knots, folding, and accidental traction. AEs associated with cannula use were mainly related to cannula fixation adhesive, insulin leakage, bleeding episodes, and skin problems. The cannula patch tends to detach easily in hot conditions or when used for more than 3 days, leading to local itching. Adhesive glue can cause redness and pain. Insulin leakage typically occurs after the catheter disconnects from the cannula, accidental cannula traction, or beneath the cannula patch. Bleeding has been reported inside the cannula or at the insertion site, resulting in local pain and, in some cases, obstruction of insulin flow. When accidental cannula traction occurs, it is recommended to replace the entire IIS system. In situations involving bleeding, leakage, insulin odor, or unsuccessful attempts to correct hyperglycemic episodes with a "bolus" of insulin, it is advisable to change the IIS system and evaluate appropriate techniques for handling and infusing the device. Moreover, regular inspections of the device and reservoir/cartridge are essential. Conclusion: Serious AEs can occur even in cases where the occlusion alarm is not activated, leading to interruptions in insulin flow. Conversely, in less severe situations, alarm activation can occur even in the absence of insulin flow interruption. Accidental catheter traction and catheter bending are commonly encountered in everyday situations, while issues related to the cannula directly affect blood glucose levels. AEs related to the IIS cannula often involve insulin leakage into the skin, bleeding, and skin events attributed to adhesive issues with the cannula.

Prolactin does not seem to mediate the improvement on insulin resistance markers and blood glucose levels related to breastfeeding.

Introduction: The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Strategies to decrease this risk should be strongly encouraged. Lactation has been associated, for the mother, with reduction in future T2DM risk in several studies. The mechanisms behind this phenomenon, however, are poorly understood. The aims of this study were, first, to compare blood glucose levels and markers of insulin resistance (MIR) in early postpartum women with overweight/obesity according to their breastfeeding status and, second, to evaluate whether prolactin (PRL) levels could mediate improvements in these parameters. Methods: The prospective study followed 95 women older than 18 years from early pregnancy for up to 60 to 180 days postpartum. All participants had a BMI > 25 kg/m2 and a singleton pregnancy. At each visit, questionnaires and clinical and biochemical evaluations were performed. Participants were divided into two groups according to the breastfeeding status as "yes" for exclusive or predominant breastfeeding, and "no" for not breastfeeding. Results: Breastfeeding women (n = 44) had significantly higher PRL levels [47.8 (29.6-88.2) vs. 20.0 (12.0-33.8), p< 0.001]. They also had significantly lower fasting blood glucose levels [89.0 (8.0) vs. 93.9 (12.6) mg/dl, p = 0.04], triglycerides (TG) [92.2 (37.9) vs. 122.4 (64.4) mg/dl, p = 0.01], TG/HDL ratio [1.8 (0.8) vs. 2.4 (1.6) mg/dl, p = 0.02], TyG index [8.24 (0.4) vs. 8.52 (0.53), p = 0.005], fasting serum insulin [8.9 (6.3-11.6) vs. 11.4 (7.7-17.0), p = 0.048], and HOMA-IR [2.0 (1.3-2.7) vs. 2.6 (1.6-3.9), p = 0.025] in the postpartum period compared to the non-breastfeeding group. Groups were homogeneous in relation to prevalence of GDM, pre-gestational BMI, as well as daily caloric intake, physical activity, and weight loss at postpartum. Linear regression analysis with adjustments for confounders showed a statistically significant association of breastfeeding with fasting blood glucose [-6.37 (-10.91 to -1.83), p = 0.006], HOMA-IR [-0.27 (-0.51 to -0.04), p = 0.024], TyG index [-0.04 (-0.06 to -0.02), p = 0.001], and TG/HDL ratio [-0.25 (-0.48 to -0.01), p = 0.038]. Mediation analysis showed that PRL did not mediate these effects. Sensitivity analyses considering different cutoffs for PRL levels also did not show modification effect in the mediation analyses. Conclusion: Breastfeeding was associated with improvement in glucose metabolism and MIR 60 to 180 days after birth in overweight and obese women, even when adjusted for confounders. PRL levels were not found to mediate the association between breastfeeding and improvement in MIR.

Psycho-Behavioral Characteristics Perceived as Facilitators by Brazilian Adults with Type 1 Diabetes Mellitus in a Public Health Service.

Type 1 diabetes imposes a complex and challenging routine on patients and caregivers. Therefore, considering individual experiences and personal facilitators to promote assertive interventions is crucial. However, no studies have addressed these perspectives in the Brazilian adult population. We aimed to identify psycho-behavioral characteristics perceived as facilitators for coping with the condition. We used a biographical method to conduct semi-structured, face-to-face, in-depth interviews for each participant. Transcripts were analyzed using inductive thematic analysis. Participants (n = 22) were aged 18-57 years (mean: 30.2; standard deviation (SD): 8.7), and the duration since diagnosis was approximately 20.6 years (SD: 4.6). A total of 12 (54.4%) were women, 13 (59.1%) used insulin pumps, 14 (63.6%) had at least a college degree, and 13 (59.1%) had HbA1C (glycated hemoglobin) levels above 58 mmol/mol (7.5%). Five major themes emerged: (1) peer learning, (2) ownership, (3) welcoming experiences, (4) equity, and (5) reframing the path (P.O.W.E.R.). All themes appeared in the lived experiences shared by participants with HbA1C levels below 58 mmol/mol (7.5%). Improved glycemic control can be achieved, and the challenges encountered in diabetes care within similar socioeconomic contexts can be addressed by an interdisciplinary care team that takes P.O.W.E.R. into consideration when providing person-centered care strategies.

Maternal-fetal outcomes of pregnant women with type 1 diabetes treated with continuous subcutaneous insulin infusion or multiple daily injections during pregnancy - A Brazilian health care referral center cohort study.

Objective: Pregnant women with type 1 diabetes (T1D) have an increased risk of maternal-fetal complications. Regarding treatment, continuous subcutaneous insulin infusion (CSII) has advantages compared to multiple daily injections (MDI), but data about the best option during pregnancy are limited. This study's aim was to compare maternal-fetal outcomes among T1D patients treated with CSII or MDI during pregnancy. Subjects and methods: This study evaluated 174 pregnancies of T1D patients. Variables of interest were compared between the groups (CSII versus MDI), and logistic regression analysis was performed (p < 0.05). Results: Of the 174 included pregnancies, CSII was used in 21.3% (37) and MDI were used in 78.7% (137). HbA1c values improved throughout gestation in both groups, with no difference in the first and third trimesters. The frequency of cesarean section was significantly higher in the CSII group [94.1 vs. 75.4%, p = 0.017], but there was no significant difference in the frequency of other complications, such as miscarriage, premature delivery and preeclampsia. The mean birth weight and occurrence of neonatal complications were also similar, except for the proportion of congenital malformations, which was significantly lower in the CSII group [2.9 vs. 15.6%, p = 0.048]. In regression analysis, the association of CSII with cesarean section and malformations lost significance after adjusting for HbA1c and other covariates of interest. Conclusion: In this study, we observed a higher frequency of cesarean section and a lower occurrence of congenital malformations in the CSII group, but the adjusted results might indicate that these associations are influenced by glycemic control.

Clinical validation of a smartphone-based retinal camera for diabetic retinopathy screening.

AIMS: This study aims to compare the performance of a handheld fundus camera (Eyer) and standard tabletop fundus cameras (Visucam 500, Visucam 540, and Canon CR-2) for diabetic retinopathy and diabetic macular edema screening. METHODS: This was a multicenter, cross-sectional study that included images from 327 individuals with diabetes. The participants underwent pharmacological mydriasis and fundus photography in two fields (macula and optic disk centered) with both strategies. All images were acquired by trained healthcare professionals, de-identified, and graded independently by two masked ophthalmologists, with a third senior ophthalmologist adjudicating in discordant cases. The International Classification of Diabetic Retinopathy was used for grading, and demographic data, diabetic retinopathy classification, artifacts, and image quality were compared between devices. The tabletop senior ophthalmologist adjudication label was used as the ground truth for comparative analysis. A univariate and stepwise multivariate logistic regression was performed to determine the relationship of each independent factor in referable diabetic retinopathy. RESULTS: The mean age of participants was 57.03 years (SD 16.82, 9-90 years), and the mean duration of diabetes was 16.35 years (SD 9.69, 1-60 years). Age (P = .005), diabetes duration (P = .004), body mass index (P = .005), and hypertension (P < .001) were statistically different between referable and non-referable patients. Multivariate logistic regression analysis revealed a positive association between male sex (OR 1.687) and hypertension (OR 3.603) with referable diabetic retinopathy. The agreement between devices for diabetic retinopathy classification was 73.18%, with a weighted kappa of 0.808 (almost perfect). The agreement for macular edema was 88.48%, with a kappa of 0.809 (almost perfect). For referable diabetic retinopathy, the agreement was 85.88%, with a kappa of 0.716 (substantial), sensitivity of 0.906, and specificity of 0.808. As for image quality, 84.02% of tabletop fundus camera images were gradable and 85.31% of the Eyer images were gradable. CONCLUSIONS: Our study shows that the handheld retinal camera Eyer performed comparably to standard tabletop fundus cameras for diabetic retinopathy and macular edema screening. The high agreement with tabletop devices, portability, and low costs makes the handheld retinal camera a promising tool for increasing coverage of diabetic retinopathy screening programs, particularly in low-income countries. Early diagnosis and treatment have the potential to prevent avoidable blindness, and the present validation study brings evidence that supports its contribution to diabetic retinopathy early diagnosis and treatment.

Association between HLA Class II Alleles/Haplotypes and Genomic Ancestry in Brazilian Patients with Type 1 Diabetes: A Nationwide Exploratory Study.

We aimed to identify HLA-DRB1, -DQA1, and -DQB1 alleles/haplotypes associated with European, African, or Native American genomic ancestry (GA) in admixed Brazilian patients with type 1 diabetes (T1D). This exploratory nationwide study enrolled 1599 participants. GA percentage was inferred using a panel of 46 ancestry informative marker-insertion/deletion. Receiver operating characteristic curve analysis (ROC) was applied to identify HLA class II alleles related to European, African, or Native American GA, and showed significant (p < 0.05) accuracy for identifying HLA risk alleles related to European GA: for DRB1*03:01, the area under the curve was (AUC) 0.533; for DRB1*04:01 AUC = 0.558, for DRB1*04:02 AUC = 0.545. A better accuracy for identifying African GA was observed for the risk allele DRB1*09:01AUC = 0.679 and for the protective alleles DRB1*03:02 AUC = 0.649, DRB1*11:02 AUC = 0.636, and DRB1*15:03 AUC = 0.690. Higher percentage of European GA was observed in patients with risk haplotypes (p < 0.05). African GA percentage was higher in patients with protective haplotypes (p < 0.05). Risk alleles and haplotypes were related to European GA and protective alleles/haplotypes to African GA. Future studies with other ancestry markers are warranted to fill the gap in knowledge regarding the genetic origin of T1D in highly admixed populations such as that found in Brazil.

Increased risk of death following recurrent ketoacidosis admissions: a Brazilian cohort study of young adults with type 1 diabetes.

BACKGROUND: Recurrent DKA (rDKA) remains an acute type 1 diabetes complication even in post-insulin era. This study aimed to analyze the predictors and effects of rDKA on the mortality of patients with type 1 diabetes. METHODS: Patients hospitalized (n = 231) wih diabetic ketoacidosis (between 2007 and 2018) were included. Laboratorial and clinical variables were collected. Mortality curves were compared in four groups: diabetic ketoacidosis as a new-onset type 1 diabetes (group A), single diabetic ketoacidosis episode after diagnosis of type 1 diabetes (group B), 2-5 diabetic ketoacidosis events (group C), and > 5 diabetic ketoacidosis events during follow-up period (group D). RESULTS: During the follow-up period (approximately 1823 days), the mortality rate was 16.02% (37/231). The median age at death was 38.7 years. In the survival curve analysis, at 1926 days (5 years), the probabilities of death were indicated by ratios of 7.78%, 4.58%, 24.40%, and 26.63% in groups A, B, C, and D, respectively. One diabetic ketoacidosis episode compared with ≥ 2 events had a relative risk of 4.49 (p = 0.004) of death and > 5 events had 5.81 (p = 0.04). Neuropathy (RR 10.04; p < 0.001), retinopathy (relative risk 7.94; p < 0.01), nephropathy (RR 7.10; p < 0.001), mood disorders (RR 3.57; p = 0.002), antidepressant use (RR 3.09; p = 0.004), and statin use (RR 2.81; p = 0.0024) increased the risk of death. CONCLUSIONS: Patients with type 1 diabetes with > 2 diabetic ketoacidosis episodes have four times greater risk of death in 5 years. Microangiopathies, mood disorders, and use of antidepressants and statins were important risk factors for short-term mortality.

Father's weight could contribute to large babies in overweight and obese mothers with and without gestational diabetes.

We evaluated whether there was an association between fathers' nutritional status and children's birth weight (BW) considering weight-matched mothers with and without gestational diabetes mellitus (GDM). In total, 86 trios of women, infants, and fathers were evaluated. BW was not different between the groups of obese and non-obese parents, frequency of maternal obesity, or GDM. The percentage of infants who were large for gestational age (LGA) was 25% in the obese group and 14% in the non-obese group (p = 0.44). There was a borderline significance for higher body mass index (p = 0.09) of the father in the LGA group compared with the adequate for gestational age group. These results corroborate the hypothesis that the father's weight can also be relevant for the occurrence of LGA.

Residual ß-cell function in Brazilian Type 1 diabetes after 3 years of diagnosis: prevalence and association with low presence of nephropathy.

BACKGROUND: Persistence of ß cell-function in Type 1 diabetes (T1D) is associated with glycaemia stability and lower prevalence of microvascular complications. We aimed to assess the prevalence of residual C- peptide secretion in long-term Brazilian childhood onset T1D receiving usual diabetes care and its association to clinical, metabolic variables and microvascular complications. METHODS: A cross-sectional observational study with 138 T1D adults with ≥ 3 years from the diagnosis by routine diabetes care. Clinical, metabolic variables and microvascular complications were compared between positive ultra-sensitive fasting serum C-peptide (FCP +) and negative (FCP-) participants. RESULTS: T1D studied had ≥ 3 yrs. of diagnosis and 60% had FCP > 1.15 pmol/L. FCP + T1D were older at diagnosis (10 vs 8 y.o; p = 0.03) and had less duration of diabetes (11 vs 15 y.o; p = 0.002). There was no association between the FCP + and other clinical and metabolic variable but there was inversely association with microalbuminuria (28.6% vs 13.4%, p = 0.03), regardless of HbA1c. FCP > 47 pmol/L were associated with nephropathy protection but were not related to others microvascular complications. CONCLUSION: Residual insulin secretion is present in 60% of T1D with ≥ 3 years of diagnosis in routine diabetes care. FCP + was positively associated with age of diagnosis and negatively with duration of disease and microalbuminuria, regardless of HbA1c.

Association of parental cardiovascular risk factors with offspring type 1 diabetes mellitus insulin sensitivity.

AIM: This study aimed to determine whether the insulin resistance (IR) and lipid profiles in Type 1 Diabetes (T1D) offspring are associated with IR and other cardiovascular risk factors in their parents. METHODS: This study included 99 T1D patients (19.6 ± 4.0 yrs.), 85 mothers and 60 fathers. Parents' IR was assessed by HOMA-IR, and the insulin sensitivity in T1D patients was assessed by the estimated Glucose Disposal Rate (eGDR). RESULTS: The eGDR in the T1D offspring was negatively related to age (p = 0.023), weight (p = 0.004), LDL (p = 0.026), and microalbuminuria (p = 0.019). Maternal Type 2 Diabetes (p < 0.001) and HOMA-IR (p = 0.029) were negatively related to eGDR in their T1D offspring. The maternal HOMA-IR and the proband's eGDR were positively (p = 0.012) and negatively (p = 0.042) associated with the birth weight of the T1D offspring, respectively. We didn't find an association with the fathers' profiles. CONCLUSIONS: In a cohort of offspring with T1D the insulin sensitivity was related to the IR, lipid profile, and the presence of T2D only in their mothers. Precocious screening and treatment of these risk factors beyond glycemic control will benefit T1D with this background.

Inadequate pregnancy planning in diabetics, and its impact on glycemic control and complications.

INTRODUCTION: To assess the intention of actual pregnancy and its influence on glycated hemoglobin (HbA1c) profile before and during the pregnancy of women with previous diabetes mellitus (DM). METHODS: Prospective cohort study included pregnant women with previous DM assisted from October/2018 to October/2019. Data were collected with standardized questionnaire and from medical records. Comparisons of variables of interest (Student's t test, Mann-Whitney or chi-square test) were performed between the group of women who did or denied report having interest to become pregnant. And a logistic regression analysis were performed considering prematurity or fetal/neonatal complication as dependent variables. RESULTS: Sixty patients were included, with HbA1c mean of pre-pregnancy, first and third trimesters of 9.3, 8.1 and 6.8%, respectively. 7.7% women had HbA1c ≤ 6.5% in pre-pregnancy and 16.7% in first trimester. 83.3% reported having received guidance on the importance of glucose control and contraception before their current pregnancy. Although 28.3% reported the intention to become pregnant, only 28.3% reported regular use of any contraceptive method before it, none of which had HbA1c in the recommended goal for pregnancy. Glycemic control did not differ between groups intending or not to become pregnant. Women with adequate glycemic control in first trimester had a lower frequency of prematurity (p = 0.015) and fetal complications (p = 0.001), and better control at the end of pregnancy. DISCUSSION: Although most of these women reported having had information about the importance of a planned pregnancy, adequate glycemic control of women with diabetes before and during the pregnancy is still not a reality nowadays. It might be necessary to improve medical communication in pregnancy planning.

Maternal-fetal outcomes of pregnant women with type 1 diabetes treated with continuous subcutaneous insulin infusion or multiple daily injections during pregnancy - A Brazilian health care referral center cohort study

ABSTRACT Objective: Pregnant women with type 1 diabetes (T1D) have an increased risk of maternal-fetal complications. Regarding treatment, continuous subcutaneous insulin infusion (CSII) has advantages compared to multiple daily injections (MDI), but data about the best option during pregnancy are limited. This study's aim was to compare maternal-fetal outcomes among T1D patients treated with CSII or MDI during pregnancy. Subjects and methods: This study evaluated 174 pregnancies of T1D patients. Variables of interest were compared between the groups (CSII versus MDI), and logistic regression analysis was performed (p < 0.05). Results: Of the 174 included pregnancies, CSII was used in 21.3% (37) and MDI were used in 78.7% (137). HbA1c values improved throughout gestation in both groups, with no difference in the first and third trimesters. The frequency of cesarean section was significantly higher in the CSII group [94.1 vs. 75.4%, p = 0.017], but there was no significant difference in the frequency of other complications, such as miscarriage, premature delivery and preeclampsia. The mean birth weight and occurrence of neonatal complications were also similar, except for the proportion of congenital malformations, which was significantly lower in the CSII group [2.9 vs. 15.6%, p = 0.048]. In regression analysis, the association of CSII with cesarean section and malformations lost significance after adjusting for HbA1c and other covariates of interest. Conclusion: In this study, we observed a higher frequency of cesarean section and a lower occurrence of congenital malformations in the CSII group, but the adjusted results might indicate that these associations are influenced by glycemic control.

The gut microbiome of obese postpartum women with and without previous gestational diabetes mellitus and the gut microbiota of their babies.

BACKGROUND: The incidence of gestational diabetes mellitus (GDM) is increasing worldwide, and has been associated with some changes in the gut microbiota. Studies have shown that the maternal gut microbiota pattern with hyperglycemia can be transmitted to the offspring. The study aimed to evaluate the gut microbiota of obese postpartum women with and without previous GDM and their offspring. METHODS: We evaluated a total of 84 puerperal women who had (n = 40) or not GDM (n = 44), and their infants were also included. Stool samples were obtained 2-6 months after delivery. The molecular profile of the fecal microbiota was obtained by sequencing V4 region of 16S rRNA gene (Illumina® MiSeq). RESULTS: We found that the gut microbiota structures of the puerperal women and their infants were similar. Stratifying according to the type of delivery, the relative abundance of Victivallis genus was higher in women who had natural delivery. Exposure to exclusive breastfeeding was associated with a greater abundance of Bacteroides and Staphylococcus. The differential abundance test showed correlations to clinical and laboratory parameters. This work showed no difference in the microbiota of obese puerperal women with and without GDM and their offspring. However, breastfeeding contributed to the ecological succession of the intestinal microbiota of the offspring. CONCLUSION: This work can contribute to understanding the potential effects of GDM and early life events on the gut microbiome of mothers and their offspring and its possible role in metabolism later in life.

Gut Microbiota across Normal Gestation and Gestational Diabetes Mellitus: A Cohort Analysis.

The prevalence of gestational diabetes mellitus (GDM) is a global public health concern. The mechanism that leads to glucose tolerance beyond normal physiological levels to pathogenic conditions remains incompletely understood, and it is speculated that the maternal microbiome may play an important role. This study analyzes the gut microbiota composition in each trimester of weight-matched women with and without GDM and examines possible bacterial genera associations with GDM. This study followed 56 pregnant women with GDM and 59 without admitted to the outpatient clinic during their first/second or third trimester of gestation. They were submitted to a standardized questionnaire, dietary recalls, clinical examination, biological sample collection, and molecular profiling of fecal microbiota. Women with GDM were older and had a higher number of pregnancies than normal-tolerant ones. There was no difference in alpha diversity, and the groups did not differ regarding the overall microbiota structure. A higher abundance of Bacteroides in the GDM group was found. A positive correlation between Christensenellaceae and Intestinobacter abundances with one-hour post-challenge plasma glucose and a negative correlation between Enterococcus and two-hour plasma glucose levels were observed. Bifidobacterium and Peptococcus abundances were increased in the third gestational trimester for both groups. The gut microbiota composition was not dependent on the presence of GDM weight-matched women throughout gestation. However, some genera abundances showed associations with glucose metabolism. Our findings may therefore encourage a deeper understanding of physiological and pathophysiological changes in the microbiota throughout pregnancy, which could have further implications for diseases prevention.

Comparison of three insulin bolus calculators to increase time in range of glycemia in a group of poorly controlled adults Type 1 diabetes in a Brazilian public health service.

BACKGROUND: A main factor contributing to insufficient glycemic control, during basal/bolus insulin therapy, is poor self-management bolus. Insulin bolus administration frequency is strongly associated with glycated hemoglobin (A1c) in Type 1 Diabetes (T1D). In the present study, we analyzed the performance of two-bolus calculator's software that could be accessible to T1D patients from a Public Health Service to improve glycemic time in range (TIR) and A1c. METHODS: This prospective, controlled, randomized, parallel intervention clinical trial was carried out with 111 T1D participants on basal/bolus therapy [multiple daily insulin injections (MDI) or subcutaneous infusion pump (CSII)] with basal A1c ≥ 8.5% for 24 weeks. Patients were divided into 3 groups: 2 interventions: COMBO® (bolus calculator) and GLIC (mobile application) and 1 control (CSII group). Anthropometrics and metabolic variables were assessed on basal, 3 and 6 months of follow-up. RESULTS: TIR was increased in 9.42% in COMBO group (29 ± 12% to 38.9 ± 12.7%; p < 0.001) in 8.39% in the GLIC® group (28 ± 15% to 36.6 ± 15.1%; p < 0.001) while remained stable in CSII group (40 ± 11% to 39.3 ± 10.3%). A1c decrease in 1.08% (p < 0.001), 0.64% (p < 0.001) and 0.38% (p = 0.01) at 6 months in relation to basal in the COMBO, GLIC and CSII respectively. Daily basal insulin dose was reduced by 8.8% (p = 0.01) in the COMBO group. CONCLUSION: The COMBO and a mobile applicative (GLIC) bolus calculator had a similar and a good performance to optimize the intensive insulin treatment of T1D in the public health system with increase in the TIR and reduction in A1C without increase hypoglycemia prevalence.