One abnormal value in oral glucose tolerance test during pregnancy and type 2 diabetes risk: Insights from a 5-Year Follow-Up study.

OBJECTIVES: To evaluate the risk of type 2 diabetes(T2D) following one abnormal value(OAbV) in an oral glucose tolerance test(oGTT) performed during pregnancy. STUDY DESIGN: A retrospective analysis of parturients between 01.01.2017 and 31.12.2020 with 5 years of follow-up after delivery. Glucose levels during pregnancy were extracted from the computerized laboratory system of Meuhedet HMO and cross-tabulated with the Israeli National Registry of Diabetes. Women with multiple gestations or pregestational diabetes were excluded. Maternal characteristics and risk of T2D were stratified and compared between 3 groups: normal glucose status, OAbV in oGTT, and gestational diabetes. Statistical analysis included univariate analysis followed by survival analysis. Further analysis was stratified to women with and without obesity. RESULTS: 58,693 women entered the analysis. Following an adjustment to maternal age, obesity, hypertension, and hyperlipidemia, OAbV in oGTT was associated with a 1.8-fold increased risk of T2D in a 5-year follow-up compared to normal glucose status. When stratified by obesity, OAbV was associated with a 3.7-fold increase in T2D in women without obesity, however, was no longer a statistically significant predictor of T2D among women with obesity. CONCLUSIONS: Women with OAbV oGTT during pregnancy are at increased risk for developing T2D over 5 years of follow-up.

Oral Glucose Tolerance Test Performed after 28 Gestational Weeks and Risk for Future Diabetes-A 5-Year Cohort Study.

Gestational diabetes mellitus (GDM) is diagnosed by an oral glucose tolerance test (oGTT), preferably performed at 24 + 0-28 + 6 gestational weeks, and is considered a risk factor for type 2 diabetes (T2DM). In this study, we aimed to evaluate the risk of T2DM associated with abnormal oGTT performed after 28 weeks. We conducted a retrospective cohort study that included parturients with available glucose levels during pregnancy and up to 5 years of follow-up after pregnancy. Data were extracted from the computerized laboratory system of Meuhedet HMO and cross-tabulated with the Israeli National Registry of Diabetes (INRD). The women were stratified into two groups: late oGTT (performed after 28 + 6 weeks) and on-time oGTT (performed at 24 + 0-28 + 6 weeks). The incidence of T2DM was evaluated and compared using univariate analysis followed by survival analysis adjusted to confounders. Overall, 78,326 parturients entered the analysis. Of them, 6195 (7.9%) performed on-time oGTT and 5288 (6.8%) performed late oGTT. The rest-66,846 (85.3%)-had normal glucose tolerance. Women who performed late oGTT had lower rates of GDM and T2DM. However, once GDM was diagnosed, regardless of oGTT timing, the risk of T2DM was increased (2.93 (1.69-5.1) vs. 3.64 (2.44-5.44), aHR (95% CI), late vs. on-time oGTT, p < 0.001 for both). Unlike in oGTT performed on time, one single abnormal value in late oGTT was not associated with an increased risk for T2DM.

Does Iodine Intake Modify the Effect of Maternal Dysglycemia on Birth Weight in Mild-to-Moderate Iodine-Deficient Populations? A Mother-Newborn Prospective Cohort Study.

It is unclear how maternal glycemic status and maternal iodine status influence birth weight among individuals with mild-to-moderate iodine deficiency (ID). We studied the association between birth weight and both maternal glucose levels and iodine intake among pregnant women with mild-to-moderate ID. Glucose values were assessed using a glucose challenge test (GCT) and non-fasting glucose levels that were determined before delivery; individuals' iodine statuses were assessed using an iodine food frequency questionnaire; and serum thyroglobulin (Tg) and urinary iodine concentrations (UIC) were used to assess each group's iodine status. Thyroid antibodies and free thyroxine (FT4) levels were measured. Obstetric and anthropometric data were also collected. Large-for-gestational age (LGA) status was predicted using a Cox proportional hazards model with multiple confounders. Tg > 13 g/L was independently associated with LGA (adjusted hazard ratio = 3.4, 95% CI: 1.4-10.2, p = 0.001). Estimated iodine intake correlated with FT4 among participants who reported consuming iodine-containing supplements (ICS) after adjusting for confounders (ß = 0.4, 95% CI: 0.0002-0.0008, p = 0.001). Newborn weight percentiles were inversely correlated with maternal FT4 values (ß = -0.2 95% CI:-0.08--56.49, p = 0.049). We conclude that in mild-to-moderate ID regions, insufficient maternal iodine status may increase LGA risk. Iodine status and ICS intake may modify the effect that maternal dysglycemia has on offspring weight.

Flat maternal glucose response curve and adverse pregnancy outcome.

OBJECTIVE: The significance of a flat oral glucose tolerance test (OGTT) response curve in pregnancy remains unclear. We investigated the association of a flat curve with pregnancy outcomes. STUDY DESIGN: Retrospective cohort study. Flat OGTT curve was defined by an area under the curve below the 10th percentile. Pregnancy outcomes were compared between flat and normal curve. RESULTS: Of the 2673 eligible women, 269 had a flat response curve. Compared with the normal-response group, the flat-curve group had a lower mean birthweight (3363 ± 547 g vs. 3459 ± 519 g, p < 0.005), higher probability of small for gestational age (SGA) (19% vs. 12%, p < 0.005, aOR = 1.75, 95% CI 1.24-2.47), and 5-min Apgar score < 7 (1.12% vs. 0.29%, p < 0.05, aOR = 3.95, 95% CI 1.01-15.5). There were no differences in obstetric or maternal outcomes. CONCLUSIONS: Flat OGTT is associated with lower birthweight, higher rates of SGA, and low Apgar scores. Detecting this previously unrecognized risk group, could potentially reduce these complications.

Autoimmune thyroid diseases as a cost of physiological autoimmune surveillance.

Graves' disease (GD) and Hashimoto's thyroiditis (HT) are common autoimmune diseases of the thyroid gland, causing hyperthyroidism and hypothyroidism, respectively. Despite their opposing clinical manifestation, they have several enigmatic links. Here, we propose that GD and HT have the same fundamental origin: both diseases are the cost of a beneficial physiological process called autoimmune surveillance of hypersecreting mutants. Autoreactive T cells selectively eliminate mutant cells that hypersecrete the hormones and threaten to become toxic nodules. These T cells can trigger a humoral response in susceptible individuals, leading to the production of antibodies against thyroid antigens. This shared origin can explain similarities in incidence and risk factors between HT and GD, despite their opposite clinical phenotypes.

Greater risk of type 2 diabetes progression in multifetal gestations with gestational diabetes: the impact of obesity.

BACKGROUND: The relationship between gestational diabetes mellitus and adverse outcomes in multifetal pregnancies is complex and controversial. Moreover, limited research has focused on the risk of gestational diabetes mellitus progression to type 2 diabetes mellitus specifically in multifetal pregnancies, resulting in conflicting results from existing studies. OBJECTIVE: This study aimed to assess the risk of gestational diabetes mellitus progression to type 2 diabetes mellitus between singleton and multifetal pregnancies in a large cohort of parturients with a 5-year follow-up. STUDY DESIGN: A retrospective study was conducted on a prospective cohort of pregnant individuals with pregnancies between January 1, 2017, and December 31, 2020, followed up to 5 years after delivery. Glucose levels during pregnancy were obtained from the Meuhedet Health Maintenance Organization laboratory system and cross-linked with the Israeli National Diabetes Registry. The cohort was divided into 4 groups: singleton pregnancy without gestational diabetes mellitus, singleton pregnancy with gestational diabetes mellitus, multifetal pregnancy without gestational diabetes mellitus, and multifetal pregnancy with gestational diabetes mellitus. Gestational diabetes mellitus was defined according to the American Diabetes Association criteria using the 2-step strategy. Univariate analyses, followed by survival analysis that included Kaplan-Meier hazard curves and Cox proportional-hazards models, were used to assess differences between groups and calculate the adjusted hazard ratios with 95% confidence intervals for progression to type 2 diabetes mellitus. RESULTS: Among 88,611 parturients, 61,891 cases met the inclusion criteria. The prevalence of type 2 diabetes mellitus was 6.5% in the singleton pregnancy with gestational diabetes mellitus group and 9.4% in the multifetal pregnancy with gestational diabetes mellitus group. Parturients with gestational diabetes mellitus, regardless of plurality, were older and had higher fasting plasma glucose levels in the first trimester of pregnancy. The rates of increased body mass index, hypertension, and earlier gestational age at delivery were significantly higher in the gestational diabetes mellitus group among patients with singleton pregnancies but not among patients with multifetal pregnancies. Survival analysis demonstrated that gestational diabetes mellitus was associated with adjusted hazard ratios of type 2 diabetes mellitus of 4.62 (95% confidence interval, 3.69-5.78) in singleton pregnancies and 9.26 (95% confidence interval, 2.67-32.01) in multifetal pregnancies (P<.001 for both). Stratified analysis based on obesity status revealed that, in parturients without obesity, gestational diabetes mellitus in singleton pregnancies increased the risk of type 2 diabetes mellitus by 10.24 (95% confidence interval, 6.79-15.44; P<.001) compared with a nonsignificant risk in multifetal pregnancies (adjusted hazard ratio, 9.15; 95% confidence interval, 0.92-90.22; P=.059). Among parturients with obesity, gestational diabetes mellitus was associated with an increased risk of type 2 diabetes mellitus for both singleton and multifetal pregnancies (adjusted hazard ratio, 3.66; [95% confidence interval, 2.81-4.67; P<.001] and 9.31 [95% confidence interval, 2.12-40.76; P=.003], respectively). CONCLUSION: Compared with gestational diabetes mellitus in singleton pregnancies, gestational diabetes mellitus in multifetal pregnancies doubles the risk of progression to type 2 diabetes mellitus. This effect is primarily observed in patients with obesity. Our findings underscore the importance of providing special attention and postpartum follow-up for patients with multifetal pregnancies and gestational diabetes mellitus, especially those with obesity, to enable early diagnosis and intervention for type 2 diabetes mellitus.

Dynamics of thyroid diseases and thyroid-axis gland masses.

Thyroid disorders are common and often require lifelong hormone replacement. Treating thyroid disorders involves a fascinating and troublesome delay, in which it takes many weeks for serum thyroid-stimulating hormone (TSH) concentration to normalize after thyroid hormones return to normal. This delay challenges attempts to stabilize thyroid hormones in millions of patients. Despite its importance, the physiological mechanism for the delay is unclear. Here, we present data on hormone delays from Israeli medical records spanning 46 million life-years and develop a mathematical model for dynamic compensation in the thyroid axis, which explains the delays. The delays are due to a feedback mechanism in which peripheral thyroid hormones and TSH control the growth of the thyroid and pituitary glands; enlarged or atrophied glands take many weeks to recover upon treatment due to the slow turnover of the tissues. The model explains why thyroid disorders such as Hashimoto's thyroiditis and Graves' disease have both subclinical and clinical states and explains the complex inverse relation between TSH and thyroid hormones. The present model may guide approaches to dynamically adjust the treatment of thyroid disorders.

Relationship among chrononutrition, sleep, and glycemic control in women with gestational diabetes mellitus: a randomized controlled trial.

BACKGROUND: Gestational diabetes mellitus is associated with an increased risk of maternal, fetal, and neonatal morbidities. Chronobiological disorders have recently been identified as risk factors for those morbidities. The disorders include chrononutritional disorders related to meal frequency and content according to the sleep-wake cycle, sleep disorders related to sleep quality, and chrono-obesity disorders, such as abnormal weight gain because of sleep deprivation and time of eating. OBJECTIVE: This study aimed to assess whether a chrononutritional and sleep hygiene intervention can improve maternal glycemic control and reduce the proportion of large-for-gestational-age newborns among women with gestational diabetes mellitus. STUDY DESIGN: This randomized controlled trial included 103 women with gestational diabetes mellitus who were carrying a singleton fetus and assigned to either the intervention group (n=33) or the control group (n=70). The intervention group was assigned to a chrononutrition and sleep hygiene program, in addition to the usual care for gestational diabetes mellitus, from the time of diabetes mellitus diagnosis to birth, whereas the control group received the usual gestational diabetes mellitus care. RESULTS: The chrononutritional and sleep hygiene intervention significantly reduced the proportion of women with suboptimal glycemic control (<80% of the plasma glucose values at target), after adjustment for maternal age, prepregnancy body mass index, gravidity, history of gestational diabetes mellitus, and large for gestational age (relative risk, 0.28; 95% confidence interval, 0.18-0.81). The effect of the intervention on balancing maternal glycemic control was mainly because of the decreased carbohydrate intake in the evening interval of the day (relative risk, 0.8; 95% confidence interval, 0.64-0.99). However, the intervention had no effect on the proportion of large-for-gestational-age newborns. CONCLUSION: The chrononutritional and sleep hygiene intervention can improve maternal glycemic control.

Comparison of Insulin Dose Adjustments Made by Artificial Intelligence-Based Decision Support Systems and by Physicians in People with Type 1 Diabetes Using Multiple Daily Injections Therapy.

Objective: Artificial intelligence-based decision support systems (DSS) need to provide decisions that are not inferior to those given by experts in the field. Recommended insulin dose adjustments on the same individual data set were compared among multinational physicians, and with recommendations made by automated Endo.Digital DSS (ED-DSS). Research Design and Methods: This was a noninterventional study surveying 20 physicians from multinational academic centers. The survey included 17 data cases of individuals with type 1 diabetes who are treated with multiple daily insulin injections. Participating physicians were asked to recommend insulin dose adjustments based on glucose and insulin data. Insulin dose adjustments recommendations were compared among physicians and with the automated ED-DSS. The primary endpoints were the percentage of comparison points for which there was agreement on the trend of insulin dose adjustments. Results: The proportion of agreement and disagreement in the direction of insulin dose adjustment among physicians was statistically noninferior to the proportion of agreement and disagreement observed between ED-DSS and physicians for basal rate, carbohydrate-to insulin ratio, and correction factor (P < 0.001 and P ≤ 0.004 for all three parameters for agreement and disagreement, respectively). The ED-DSS magnitude of insulin dose change was consistently lower than that proposed by the physicians. Conclusions: Recommendations for insulin dose adjustments made by automatization did not differ significantly from recommendations given by expert physicians regarding the direction of change. These results highlight the potential utilization of ED-DSS as a useful clinical tool to manage insulin titration and dose adjustments.

Flash Glucose Monitoring in Israel: Understanding Real-World Associations between Self-Monitoring Frequency and Metrics of Glycemic Control.

OBJECTIVE: Flash glucose monitoring has been widely used in Israel for diabetes treatment and since 2018, the cost is reimbursed for all people with type 1 diabetes nationally. In the current study, we present the daily scanning behavior for FreeStyle Libre users in Israel and how this was associated with a range of metrics for glycemic assessment. METHODS: Deidentified data from FreeStyle Libre readers were collected between September 2014 and October 2020. Scan-rate data from Israel was extracted and sorted into 10 equal-sized groups based on scan frequency. The glucose parameters derived for each group were: estimated HbA1c (eA1c), time in range (TIR) between 70 and 180 mg/dL, and time with glucose levels of <70 mg/dL, <54 mg/dL, and >180 mg/dL. RESULTS: The data set for Israel included 12 370 readers, with data from 131 639 separate glucose sensors representing 152 million automatically recorded individual glucose readings. Users performed an average of 15 daily glucose scans, ranging from a mean of 4.1 scans per day (lowest, 10%), rising to a mean of 38.7 scans/day (highest, 10%) (median, 12; IQR, 8-18 for all readers). As the scan rates increased, the eA1c decreased from 7.6% to 6.7% (P < .001). Mean TIR increased from 56.9% to 70.0% with increasing scan rates (P < .001). Concordantly, time with glucose levels of >180 mg/dL and <54 mg/dL decreased from 37.2% to 23.6% (P < .001) and from 2.23% to 1.99%, respectively, as scan frequency increased. CONCLUSION: In Israel, people with diabetes under real-world conditions record higher rates of FreeStyle Libre scanning. These are associated with improvements in TIR, eA1c, and reduced time with glucose levels of >180 mg/dL or <54 mg/dL.

Pharmacological therapy in gestational diabetes - a comparison between insulin and oral therapy.

BACKGROUND: The appropriate medical treatment for gestational diabetes mellitus (GDM) is controversial and recommendations vary between different organizations. OBJECTIVE: To compare the safety and efficacy of glyburide and insulin as treatments for GDM. METHODS: Retrospective analysis of all pregnant women diagnosed with GDM and treated with either glyburide or insulin. Demographic features, clinical characteristics, maternal and neonatal outcomes were compared according to type of pharmacological treatment. RESULTS: Included in the study were 323 women, of whom 269 (83.28%) were treated with glyburide and 54 (16.72%) with insulin. There were no significant differences between the groups, apart from a higher one-hour oral glucose tolerance test (OGTT) value (191.80 mg/dl in the glyburide group, 204.33 in the insulin group, p = .01). Optimal glucose control was achieved in 130 women in the glyburide group (48.32%) and 15 in the insulin group (27.77%), p = .007. This difference remained significant after adjustment for age, BMI, and fasting glucose during OGTT (aOR = 2.22). Mean gestational weight gain was lower in the glyburide group vs. insulin group (10.01 vs. 11.99 kg, p = .048). Apart from higher maternal hypoglycemia rate (12.64% in glyburide group vs. 1.85% in insulin group, p = .016), there were no other differences in maternal and neonatal outcomes between the groups. Glyburide failure rate was 13.38%, and associated with higher fasting OGTT value (100.70 mg/dl in glyburide failure group vs. 94.67 mg/dl in the glyburide treatment until delivery group, p = .041). CONCLUSIONS: Glyburide is at least as safe and effective as insulin except for higher rates of maternal hypoglycemia. Considering its advantages compared to insulin (ease of use and storage, increased patient responsiveness, and lower cost), it may be considered as first line treatment in GDM, especially when fasting OGTT value is not high.

Characterization of women with gestational diabetes who failed to achieve glycemic control by lifestyle modifications.

PURPOSE: To identify specific characteristics of women diagnosed with gestational diabetes who failed to achieve good glycemic control by lifestyle modifications only. METHODS: Retrospective analysis of women carrying a singleton pregnancy diagnosed with gestational diabetes. The cohort included 314 women who achieved good glycemic control by lifestyle modifications and 328 women who required anti-diabetic medications. Lifestyle modifications included medical nutrition therapy and physical exercise recommendations. Anti-diabetic medications included either oral treatment with metformin or glyburide and\or insulin. RESULTS: Women in the lifestyle modifications group were younger (32.87 vs. 33.79 years, p = 0.012) and had lower pre-pregnancy body-mass-index (25.86 vs. 27.93 kg/m2, p < 0.001). Glucose challenge test (GCT) was significantly lower in the lifestyle modifications group (158.31 vs. 171.04 mg/dL in the anti-diabetic treatment group, p < 0.001). Moreover, fasting oral-glucose-tolerance-test (fOGTT) results were significantly lower in the lifestyle modifications group (88.22 vs. 96.34 mg/dL in the anti-diabetic treatment group, p < 0.001). In a receiver-operator-curve analysis, GCT + 4*fOGTT, was the best model to predict lifestyle modifications failure with an area under the curve of 0.7419. Higher rates of vaginal delivery and lower rates of maternal hypoglycemia in the lifestyle modifications group were observed. CONCLUSIONS: Maternal baseline characteristics and diabetes diagnostic parameters may predict which women will fail to achieve good glycemic control solely by lifestyle modifications.

Foetal Sonographic Anogenital Distance Is Longer in Polycystic Ovary Syndrome Mothers.

Anogenital distance (AGD) is a biomarker for the prenatal hormonal environment. Androgen excess is a key element in polycystic ovary syndrome (PCOS). The aim of this study was to assess the sonographic foetal AGD in a population of PCOS mothers in comparison to the general population. Foetal AGD was measured prospectively by 2D ultrasound in PCOS mothers and compared to prenatal AGD nomograms. The results were interpreted regarding maternal and foetal characteristics. The mean sonographic foetal AGD centile measurement in PCOS mothers was significantly longer in comparison to the general population (86.04% ± 18.22; p < 0.001). Estimated foetal weight and birthweight were appropriate for gestational age and did not correlate with AGD. Sonographic foetal AGD was significantly longer in PCOS diabetic mothers and in those who conceived following assisted reproduction treatments when compared to the general population (p < 0.001). Our results support the role of AGD as a biomarker of the prenatal hormonal environment and provide evidence for the hyperandrogenic effect in PCOS pregnancies on foetal androgenic status and genitalia development.

Hypoglycaemia and its management in primary care setting.

Hypoglycaemia is common in patients with type 1 diabetes and type 2 diabetes and constitutes a major limiting factor in achieving glycaemic control among people with diabetes. While hypoglycaemia is defined as a blood glucose level under 70 mg/dL (3.9 mmol/L), symptoms may occur at higher blood glucose levels in individuals with poor glycaemic control. Severe hypoglycaemia is defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions to assure neurologic recovery. Hypoglycaemia is the most important safety outcome in clinical studies of glucose lowering agents. The American Diabetes Association Standards of Medical Care recommends that a management protocol for hypoglycaemia should be designed and implemented by every hospital, along with a clear prevention and treatment plan. A tailored approach, using clinical and pathophysiologic disease stratification, can help individualize glycaemic goals and promote new therapies to improve quality of life of patients. Data from recent large clinical trials reported low risk of hypoglycaemic events with the use of newer anti-diabetic drugs. Increased hypoglycaemia risk is observed with the use of insulin and/or sulphonylureas. Vulnerable patients with T2D at dual risk of severe hypoglycaemia and cardiovascular outcomes show features of "frailty." Many of such patients may be better treated by the use of GLP-1 receptor agonists or SGLT2 inhibitors rather than insulin. Continuous glucose monitoring (CGM) should be considered for all individuals with increased risk for hypoglycaemia, impaired hypoglycaemia awareness, frequent nocturnal hypoglycaemia and with history of severe hypoglycaemia. Patients with impaired awareness of hypoglycaemia benefit from real-time CGM. The diabetes educator is an invaluable resource and can devote the time needed to thoroughly educate the individual to reduce the risk of hypoglycaemia and integrate the information within the entire construct of diabetes self-management. Conversations about hypoglycaemia facilitated by a healthcare professional may reduce the burden and fear of hypoglycaemia among patients with diabetes and their family members. Optimizing insulin doses and carbohydrate intake, in addition to a short warm up before or after the physical activity sessions may help avoiding hypoglycaemia. Several therapeutic considerations are important to reduce hypoglycaemia risk during pregnancy including administration of rapid-acting insulin analogues rather than human insulin, pre-conception initiation of insulin analogues, and immediate postpartum insulin dose reduction.

Perinatal outcome in gestational diabetes according to different diagnostic criteria.

Objectives To evaluate whether gestational diabetes mellitus (GDM) diagnosed by different criteria impacts perinatal outcome. Methods This was a retrospective study of deliveries with a diagnosis of GDM (2014-2016). Perinatal outcomes were compared between patients with: (1) GDM diagnosed according to a single abnormal value on the 100-g oral glucose tolerance test (OGTT); (2) two or more abnormal OGTT values; and (3) a 50-g glucose challenge test (GCT) value ≥200 mg/dL. Results A total of 1163 women met the inclusion criteria, of whom 441 (37.9%) were diagnosed according to a single abnormal OGTT value, 627 (53.9%) had two or more abnormal OGTT values and 95 (8.17%) had a GCT value ≥200 mg/dL. Diet-only treatment was significantly higher in the single abnormal value group (70.3% vs. 65.1% vs. 50.5%) and rates of medical treatment were significantly higher in the GCT ≥ 200 mg/dL group (P < 0.05). Women in the GCT ≥ 200 mg/dL group had higher rates of neonatal intensive care unit (NICU) admission (10.5% vs. 2.7% vs. 2.8%, P < 0.001) and neonatal hypoglycemia (5.3% vs. 0.5% vs. 0.8%, P < 0.001). On multivariate logistic regression, GCT ≥ 200 mg/dL was no longer associated with higher rates of NICU admission and neonatal hypoglycemia (P > 0.05). Conclusion No difference was noted in the perinatal outcome amongst the different methods used for diagnosing GDM.

First trimester glycosylated hemoglobin as a predictor of gestational diabetes mellitus.

OBJECTIVE: To evaluate the potential role of glycosylated haemoglobin (HbA1C) as an early biomarker for gestational diabetes. METHODS: In a retrospective analysis, healthy women who went on to give birth to a singleton newborn in a tertiary medical center in Petach Tikva, Israel, underwent measurement of HbA1C in the first trimester (up to 12 weeks of pregnancy) between August 1, 2007, and December 31, 2014. Women with type 1 or type 2 diabetes, HbA1C ≥6.5%, and/or fasting plasma glucose ≥126 mg/dL were excluded, as were women whose glucose levels had already been tested before 24 weeks of pregnancy. Data were extracted from a maternal and neonatal database. The primary outcome measure was the association between first trimester HbA1C and adverse pregnancy outcome, primarily, gestational diabetes. RESULTS: The cohort included 142 women. HbA1C concentration was linearly and inversely correlated to length of gestation (r=-0.317, P<0.001). Higher HbA1C was associated with gestational diabetes. An HbA1C concentration of ≥5.45% predicted gestational diabetes with 83.3% sensitivity, 69% specificity, and gave positive and negative predictive values of 53% and 90.8%, respectively. CONCLUSION: Early pregnancy HbA1C could serve as a predictor of gestational diabetes. Ideally, HbA1C should be considered in multi-parameter prediction models to enhance accuracy.

Noninvasive, continuous, real-time glucose measurements compared to reference laboratory venous plasma glucose values.

Purpose: Current modalities for glucose monitoring are invasive and inconvenient. The search for a noninvasive technique is still ongoing, without a clinically viable product. The aim of our study was to evaluate the safety and accuracy of a novel non-invasive continuous glucometer - the Wizmi™ device. Methods: Prospective, observational, controlled clinical trial. We included healthy pregnant women designated to undergo a 3-hour oral glucose tolerance test. Each participant underwent synchronous and simultaneous glucose measurement by venous sampling of plasma glucose and non-invasive glucose by Wizmi device. Primary outcome was the accuracy of the Wizmi device as assessed by comparing between paired measurements, i.e. non-invasive glucose measurements by Wizmi versus standard plasma glucose levels, which were taken at the exact same time. Results: Thirty-two women underwent oral glucose tolerance test (OGTT), contributing 224 paired glucose measurements. Of the 224 paired measurements, all were within the clinically appropriate zones of the Clarke error grid analysis zones -208 (93%) in Zone A and 16 (7%) in zone B. Mean absolute relative difference of the Wizmi non-invasive glucose versus plasma glucose laboratory reference was 7.23% or 9.66 mg/dl. Overall, for all 224 paired measurements, across all Wizmi glucose ranges, the agreement was 86.6, 92.0, 97.8 and 99.5% for deviations within ±15, 20, 30, 40% (if glucose >80 mg/dl) or mg/dl (if glucose ≤80 mg/dl). Conclusions: Wizmi device is novel non-invasive continuous glucose monitor, safe to use, with overall high accuracy compared to a gold standard reference of plasma glucose.