Search

Norbert Freinkel emphasized the need for “more aggressive therapy with exogenous insulin” during type 1 diabetes (T1D) pregnancy. Recent advances in diabetes technology, continuous glucose monitoring (CGM), and hybrid closed-loop (HCL) insulin delivery systems allow us to revisit Freinkel’s observations from a contemporary perspective. The Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT) led to international recommendations that CGM be offered to all pregnant women with T1D to help them meet their pregnancy glucose targets and improve neonatal outcomes. However, despite CGM use, only 35% of trial participants reached the pregnancy glucose targets by 35 weeks’ gestation, which is too late for optimal obstetric and neonatal outcomes. The constant vigilance to CGM data and insulin dose adjustment, with perpetual worry about the impact of hyperglycemia on the developing fetal structures, leave many pregnant women feeling overwhelmed. HCL systems that can adapt to marked gestational changes in insulin sensitivity and pharmacokinetics may help to bridge the gap between the nonpregnant time in range glycemic targets (70–180 mg/dL) and the substantially more stringent pregnancy-specific targets (TIRp) (63–140 mg/dL) required for optimal obstetric and neonatal outcomes. Use of HCL (CamAPS FX system) was associated with a 10.5% higher TIRp, 10.2% less hyperglycemia, and 12.3% higher overnight TIRp. Clinical benefits were accompanied by 3.7 kg (8 lb) less gestational weight gain and consistently achieved across a representative patient population of insulin pump or injection users, across trial sites, and across maternal HbA1c categories. Working collaboratively, women, HCL technology, and health care teams achieved improved glycemia with less worry, less work, and more positive pregnancy experiences. [ABSTRACT FROM AUTHOR]

Background: Continuous glucose monitoring (CGM) provides the most objective method of assessing glucose in daily life. Although there have been small, short-term physiologic studies of glucose metabolism in 'healthy' pregnant women a comprehensive, longitudinal description of changes in glucose over the course of pregnancy and how glucose dysregulation earlier in pregnancy relates to traditional third trimester screening for gestational diabetes, fetal growth and pregnancy outcomes is lacking. This study aims to characterise longitudinal changes in glycemia across gestation using CGM, in order to understand the evolution of dysglycemia and its relationship to fetal growth. Method/design: A multi-centre, prospective, observational, cohort study of 500 healthy pregnant women, recruited in the first trimester of pregnancy. Masked CGM will be performed for a 14-day period on five occasions across pregnancy at ~ 10–12, 18–20, 26–28, 34–36 weeks gestation and postnatally. Routinely collected anthropometric and sociodemographic information will be recorded at each visit including: weight, height, blood pressure, current medication. Age, parity, ethnicity, smoking will be recorded. Blood samples will be taken at each visit for HbA1c and a sample stored. Details on fetal growth from ultrasound scans and the OGTT results will be recorded. Maternal and neonatal outcomes will be collected. CGM glucose profiling is the exposure of interest, and will be performed using standard summary statistics, functional data analysis and glucotyping. The primary maternal outcome is clinical diagnosis of GDM. The primary neonatal outcome is large for gestational age (LGA) (> 90th centile defined by customised birthweight centile). The relationship of glucose to key secondary maternal and neonatal outcomes will be explored. Discussion: This study will ascertain the relationship of maternal dysglycemia to fetal growth and outcomes. It will explore whether CGM glucose profiling can detect GDM before the OGTT; or indeed whether CGM glucose profiling may be more useful than the OGTT at detecting LGA and other perinatal outcomes. Trial registration: ISRCTN 15,706,303 https://www.isrctn.com/ISRCTN15706303 Registration date: 13th March 2023. [ABSTRACT FROM AUTHOR]

This year's diabetes pregnancy manuscripts, three for each of type 1 diabetes (T1D), type 2 diabetes (T2D), and gestational diabetes mellitus (GDM), were chosen from over 3500 published articles. Data were collected on pregnant women with diabetes (any type) with DKA events (cases) and pregnant women with diabetes without DKA (controls) from 194 maternity units between April 2019 and September 2020. Another concerning finding is the prevalence of diabetic ketoacidosis (DKA) during pregnancy in all types of diabetes. Seventy DKA events (85%) occurred in women with T1D (incidence 16.6/100,000; 95% CI, 13.0-20.9), 5 DKA events (6%) in women with T2D (incidence 1.1/100,000; 95% CI, 0.4-2.5), and 7 (9%) in women diagnosed with GDM. [Extracted from the article]

Objective: To determine gestational weekly changes in continuous glucose monitoring (CGM) metrics and 24-h glucose profiles and their relationship to infant birth weight in pregnant women with type 1 diabetes.Research Design and Methods: An analysis of >10.5 million CGM glucose measures from 386 pregnant women with type 1 diabetes from two international multicenter studies was performed. CGM glucose metrics and 24-h glucose profiles were calculated for each gestational week, and the relationship to normal (10-90th percentile) and large (>90th percentile) for gestational age (LGA) birth weight infants was determined.Results: Mean CGM glucose concentration fell and percentage of time spent in the pregnancy target range of 3.5-7.8 mmol/L (63-140 mg/dL) increased in the first 10 weeks of pregnancy and plateaued until 28 weeks of gestation, before further improvement in mean glucose and percentage of time in range until delivery. Maternal CGM glucose metrics diverged at 10 weeks of gestation, with significantly lower mean CGM glucose concentration (7.1 mmol/L; 95% CI 7.05-7.15 [127.8 mg/dL; 95% CI 126.9-128.7] vs. 7.5 mmol/L; 95% CI 7.45-7.55 [135 mg/dL; 95% CI 134.1-135.9]) and higher percentage of time in range (55%; 95% CI 54-56 vs. 50%; 95% CI 49-51) in women who had normal versus LGA. The 24-h glucose profiles were significantly higher across the day from 10 weeks of gestation in LGA.Conclusions: Normal birth weight is associated with achieving significantly lower mean CGM glucose concentration across the 24-h day and higher CGM time in range from before the end of the first trimester, emphasizing the need for a shift in clinical management, with increased focus on using weekly CGM glucose targets for optimizing maternal glycemia from early pregnancy. [ABSTRACT FROM AUTHOR]

Similarly, in late pregnancy, women with type 2 diabetes were more likely to have anxiety symptoms (31 vs 11%; I P i =0.002) and depressive symptoms (23 vs 4%; I P i =0.002) compared to women without diabetes. Compared to women without diabetes, those with type 2 diabetes were more likely to have both anxiety symptoms (36 vs 6%; I P i <0.001) and depressive symptoms (14 vs 2%; I P i =0.003) in early pregnancy. Conclusions While mean sensor glucose over 24 h and overnight were similar between IS-CGM and RT-CGM, time below range overnight was higher when assessed using IS-CGM compared to masked RT-CGM in early pregnancy. The manuscripts chosen for this yearbook address key controversies in the screening and detection of gestational diabetes mellitus (GDM), glycemic metrics using intermittent and continuous glucose monitoring (CGM) in type 1 diabetes and the theory of beta-cell regeneration. [Extracted from the article]

Compared to women without diabetes, those with type 2 diabetes were more likely to have both anxiety symptoms (36 vs 6%; I P i <0.001) and depressive symptoms (14 vs 2%; I P i =0.003) in early pregnancy. Similarly, in late pregnancy, women with type 2 diabetes were more likely to have anxiety symptoms (31 vs 11%; I P i =0.002) and depressive symptoms (23 vs 4%; I P i =0.002) compared to women without diabetes. Conclusions While mean sensor glucose over 24 h and overnight were similar between IS-CGM and RT-CGM, time below range overnight was higher when assessed using IS-CGM compared to masked RT-CGM in early pregnancy. The manuscripts chosen for this yearbook address key controversies in the screening and detection of gestational diabetes mellitus (GDM), glycemic metrics using intermittent and continuous glucose monitoring (CGM) in type 1 diabetes and the theory of beta-cell regeneration. [Extracted from the article]

Results Case 1 presented at 4-weeks gestation in her second pregnancy, having had a previous miscarriage at 7-weeks gestation. They encompass improvements in our understanding of continuous glucose monitoring (CGM) in pregnancy, early data on the first commercially available closed-loop system used (off-license) during pregnancy, and advancements in our understanding of screening for GDM. As CGM in pregnancy continues to gain more widespread use, identifying these patterns using FDA may not only aid in the understanding of the pathophysiology of various glycemic-related complications but also help diabetes clinicians and women with diabetes identify and target patterns to reduce adverse outcomes. The manuscripts chosen for this year's article on technology and pregnancy demonstrated advances in our understanding of type 1, type 2, and gestational diabetes (GDM) in pregnant women. [Extracted from the article]

The article focuses on the good news for pregnant women with type 1 diabetes and past or current gestational diabetes. Topics discussed include the National Institute for Health and Care Excellence (NICE) reviewed the evidence and updated their recommendations on intermittently scanned and Continuous Glucose Monitoring (CGM) during pregnancy for type 1 diabetes women; and the NICE guidelines recommend offering CGM to all pregnant women with type 1 diabetes.

In recent years, continuous glucose monitoring (CGM) has become increasingly available with the introduction of devices that are specifically approved for use during pregnancy. Evidence in the form of randomized-controlled trials and cohort studies continues to build support for the use of CGM during pregnancy to improve measures of maternal glycemia as well as obstetric and neonatal outcomes. Based on data from the CGM in pregnant women with type 1 diabetes (CONCEPTT) trial alongside a Swedish cohort study of real-world outcomes of pregnant women with type 1 diabetes, the UK National Institute for Health and Clinical Excellence (NICE) guidelines now recommend that real-time CGM be offered to all pregnant women with type 1 diabetes. Based on these guidelines, all pregnant individuals in the United Kingdom with type 1 diabetes will receive government-funded real-time CGM for a 12-month duration. These guidelines are a game-changer and will continue to facilitate more widespread access to CGM use in the United Kingdom and beyond. This review describes the role of CGM in the management of diabetes in pregnancy, discusses contemporary maternal glucose levels and their relationship with outcomes in diabetes pregnancies, and examines the high-quality, randomized-controlled trial and the real-world clinical data evaluating the impact of CGM use. [ABSTRACT FROM AUTHOR]

The authors comment on a study published within the issue which examined the pregnancy outcomes in young women with youth-onset type 2 diabetes (T2D). Topics covered include the characteristics of study participants, factors that contributed to obstetric and neonatal complications in two-thirds of pregnancies, and the strengths and limitations of the study.

Cyclospora cayetanensis is a protozoan parasite that causes foodborne and waterborne diarrheal illness outbreaks worldwide. Most of these outbreaks are associated with the consumption of fresh produce. Sensitive and specific methods to detect C. cayetanensis in agricultural water are needed to identify the parasite in agricultural water used to irrigate crops that have been implicated in outbreaks. In this study, a method to detect C. cayetanensis in water by combining dead-end ultrafiltration (DEUF) with sensitive and specific molecular detection was developed and evaluated. Triplicates of 10-liter agricultural water samples were seeded with 200, 100, 25, 12, and 6 C. cayetanensis oocysts. Surface water samples were also collected in the Mid-Atlantic region. All water samples were processed by DEUF and backflushed from the ultrafilters. DNA was extracted from concentrated samples and analyzed by quantitative PCR (qPCR) targeting the C. cayetanensis 18S rRNA gene. All water samples seeded with 12, 25, 100, and 200 oocysts were positive, and all unseeded samples were negative. Samples seeded with 6 oocysts had a detection rate of 66.6% (8/12). The method was also able to detect C. cayetanensis isolates in surface water samples from different locations of the Chesapeake and Ohio Canal (C&O Canal) in Maryland. This approach could consistently detect C. cayetanensis DNA in 10-liter agricultural water samples contaminated with low levels of oocysts, equivalent to the levels that may be found in naturally incurred environmental water sources. Our data demonstrate the robustness of the method as a useful tool to detect C. cayetanensis from environmental sources. [ABSTRACT FROM AUTHOR]

Background: Pregnant women with diabetes are identified as being more vulnerable to the severe effects of COVID-19 and advised to stringently follow social distancing measures. Here, we review the management of diabetes in pregnancy before and during the lockdown. Methods: Majority of antenatal diabetes and obstetric visits are provided remotely, with pregnant women attending hospital clinics only for essential ultrasound scans and labor and delivery. Online resources for supporting women planning pregnancy and for self-management of pregnant women with type 1 diabetes (T1D) using intermittent or continuous glucose monitoring are provided. Retinal screening procedures, intrapartum care, and the varying impact of lockdown on maternal glycemic control are considered. Alternative screening procedures for diagnosing hyperglycemia during pregnancy and gestational diabetes mellitus (GDM) are discussed. Case histories describe the remote initiation of insulin pump therapy and automated insulin delivery in T1D pregnancy. Results: Initial feedback suggests that video consultations are well received and that the patient experiences for women requiring face-to-face visits are greatly improved. As the pandemic eases, formal evaluation of remote models of diabetes education and technology implementation, including women's views, will be important. Conclusions: Research and audit activities will resume and we will find new ways for supporting pregnant women with diabetes to choose their preferred glucose monitoring and insulin delivery. [ABSTRACT FROM AUTHOR]

The manuscripts chosen for this year's technology and pregnancy article provide new insights into fetal exposure to maternal glucose during pregnancies complicated by gestational diabetes, and type 1 diabetes. Data relating continuous glucose monitoring (CGM) in type 1 diabetes pregnancy to neonatal outcomes are scarce. Healthcare providers and women with diabetes can focus on increasing CGM time in range during the latter half of pregnancy to reduce the risk of neonatal hypoglycemia. Women with gestational diabetes were more likely to develop type 2 diabetes or prediabetes than women without gestational diabetes (adjusted OR 3.44 [95% CI 2.84, 4.14]). [Extracted from the article]

The article discusses research which described longitudinal continuous glucose monitoring (CGM) metrics during healthy pregnancy and following Roux-en-Y gastric bypass (RYGB) in women aged 29 years. The study measured mean CGM glucose levels during the day and overnight throughout pregnancy, glycemic variability, median nocturnal CGM glucose in Bariatric Surgery and Consequences for Mother and Baby in Pregnancy (BAMBI) control participants, target glucose range, and pregnancy outcomes.

The article offers information on some key advances in the field of diabetes technology that is increasingly used in the clinical management of diabetes before and during pregnancy. It mentions the real-world data are becoming increasingly important to health-care providers and regulators; and also mentions metabolomic data from the Great Britain describe the metabolite disturbances in obese women 10 weeks prior to gestational diabetes mellitus (GDM) diagnosis.

Studies from Scotland and Canada confirm large increases in the incidence of pregnancies complicated by pregestational type 1 diabetes (T1D). With this increased antenatal workload comes more specialization and staff expertise, which may be important as diabetes technology use increases. While euglycemia remains elusive and obstetrical intervention (earlier delivery, increased operative deliveries) is increasing, there have been some notable successes in the past 5-10 years. These include a decline in the rates of congenital anomaly (Canada) and stillbirths (U.K.) and substantial reductions in both maternal hypoglycemia (both moderate and severe) across many countries. However, pregnant women with T1D still spend ∼30-45% of the time (8-11 h/day) hyperglycemic during the second and third trimesters. The duration of maternal hyperglycemia appears unchanged in routine clinical care over the past decade. This ongoing fetal exposure to maternal hyperglycemia likely explains the persistent rates of large for gestational age (LGA), neonatal hypoglycemia, and neonatal intensive care unit (NICU) admissions in T1D offspring. The Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT) found that pregnant women using real-time continuous glucose monitoring (CGM) spent 5% less time (1.2 h/day) hyperglycemic during the third trimester, with clinically relevant reductions in LGA, neonatal hypoglycemia, and NICU admissions. This article will review the progress in our understanding of the intensive glycemic treatment of T1D pregnancy, focusing in particular on the recent technological advances in CGM and automated insulin delivery. It suggests that even with advanced diabetes technology, optimal maternal dietary intake is needed to minimize the neonatal complications attributed to postprandial hyperglycemia. [ABSTRACT FROM AUTHOR]

A collaborative validation study was performed to evaluate the performance of a new U.S. Food and Drug Administration method developed for detection of the protozoan parasite, Cyclospora cayetanensis, on cilantro and raspberries. The method includes a sample preparation step in which oocysts are recovered from produce using an enhanced produce washing solution containing 0.1% Alconox and a commercially available method to disrupt the C. cayetanensis oocysts and extract DNA. A real-time PCR assay targeting the C. cayetanensis 18S rDNA gene with an internal amplification control to monitor PCR inhibition provides species-specific identification. Five laboratories blindly analyzed a total of 319 samples consisting of 25 g of cilantro or 50 g of raspberries which were either uninoculated or artificially contaminated with C. cayetanensis oocysts. Detection rates for cilantro inoculated with 200, 10, and 5 oocysts, were 100%, 80%, and 31%, respectively. For raspberries, the detection rates for samples inoculated with 200, 10, and 5 oocysts were 100%, 90% and 50%, respectively. All uninoculated samples, DNA blank extracts, and no-template PCR controls were negative. Reproducibility between laboratories and analysts was high and the method was shown to be an effective analytical tool for detection of C. cayetanensis in produce. [ABSTRACT FROM AUTHOR]

Cyclosporacayetanensis is a protozoan parasite that causes human diarrheal disease associated with the consumption of fresh produce or water contaminated with C. cayetanensis oocysts. In the United States, foodborne outbreaks of cyclosporiasis have been linked to various types of imported fresh produce, including cilantro and raspberries. An improved method was developed for identification of C. cayetanensis in produce at the U.S. Food and Drug Administration. The method relies on a 0.1% Alconox produce wash solution for efficient recovery of oocysts, a commercial kit for DNA template preparation, and an optimized TaqMan real-time PCR assay with an internal amplification control for molecular detection of the parasite. A single laboratory validation study was performed to assess the method's performance and compare the optimized TaqMan real-time PCR assay and a reference nested PCR assay by examining 128 samples. The samples consisted of 25 g of cilantro or 50 g of raspberries seeded with 0, 5, 10, or 200 C. cayetanensis oocysts. Detection rates for cilantro seeded with 5 and 10 oocysts were 50.0 and 87.5%, respectively, with the real-time PCR assay and 43.7 and 94.8%, respectively, with the nested PCR assay. Detection rates for raspberries seeded with 5 and 10 oocysts were 25.0 and 75.0%, respectively, with the real-time PCR assay and 18.8 and 68.8%, respectively, with the nested PCR assay. All unseeded samples were negative, and all samples seeded with 200 oocysts were positive. Detection rates using the two PCR methods were statistically similar, but the real-time PCR assay is less laborious and less prone to amplicon contamination and allows monitoring of amplification and analysis of results, making it more attractive to diagnostic testing laboratories. The improved sample preparation steps and the TaqMan real-time PCR assay provide a robust, streamlined, and rapid analytical procedure for surveillance, outbreak response, and regulatory testing of foods for detection of C. cayetanensis. [ABSTRACT FROM AUTHOR]

Objective: To determine whether fetal overgrowth precedes the diagnosis of gestational diabetes mellitus (GDM) and to quantify the interrelationships among fetal overgrowth, GDM, and maternal obesity.Research Design and Methods: We conducted a prospective cohort study of unselected nulliparous women and performed ultrasonic measurement of the fetal abdominal circumference (AC) and head circumference (HC) at 20 and 28 weeks of gestational age (wkGA). Exposures were diagnosis of GDM ≥28 wkGA and maternal obesity. The risk of AC >90th and HC-to-AC ratio <10th percentile was modeled using log-binomial regression, adjusted for maternal characteristics.Results: Of 4,069 women, 171 (4.2%) were diagnosed with GDM at ≥28 wkGA. There was no association between fetal biometry at 20 wkGA and subsequent maternal diagnosis of GDM. However, at 28 wkGA, there was an increased risk of AC >90th percentile (adjusted relative risk 2.05 [95% CI 1.37-3.07]) and HC-to-AC ratio <10th percentile (1.97 [1.30-2.99]). Maternal obesity showed similar associations at 28 wkGA (2.04 [1.62-2.56] and 1.46 [1.12-1.90], respectively). The combination of GDM and obesity was associated with an approximately fivefold risk of AC >90th (4.52 [2.98-6.85]) and approximately threefold risk of HC-to-AC ratio <10th percentile (2.80 [1.64-4.78]) at 28 wkGA. Fetal AC >90th percentile at 28 weeks was associated with an approximately fourfold risk of being large for gestational age at birth.Conclusions: Diagnosis of GDM is preceded by excessive growth of the fetal AC between 20 and 28 wkGA, and its effects on fetal growth are additive with the effects of maternal obesity. [ABSTRACT FROM AUTHOR]

OBJECTIVE--This study evaluated closed-loop insulin delivery with a model predictive control (MPC) algorithm during early (12-16 weeks) and late gestation (28-32 weeks) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS--Ten women with type 1 diabetes (age 31 years, diabetes duration 19 years, BMI 24.1 kg/m², booking A1C 6.9%) were studied over 24 h during early (14.8 weeks) and late pregnancy (28.0 weeks). A nurse adjusted the basal insulin infusion rate from continuous glucose measurements (CGM), fed into the MPC algorithm every 15 min. Mean glucose and time spent in target (63-140 mg/dL), hyperglycemic (> 140 to ≥ 180 mg/dL), and hypoglycemic (<63 to ≥50 mg/dL) were calculated using plasma and sensor glucose measurements. Linear mixed-effects models were used to compare glucose control during early and late gestation. RESULTS--During closed-loop insulin delivery, median (interquartile range) plasma glucose levels were 117 (100.8-154.8) mg/dL in early and 126 (109.8-140.4) mg/dL in late gestation (P = 0.72). The overnight mean (interquartile range) plasma glucose time in target was 84% (50100%) in early and 100% (94-100%) in late pregnancy (P = 0.09). Overnight mean (interquartile range) time spent hyperglycemic (> 140 mg/dL) was 7% (0-40%) in early and 0% (0-6%) in late pregnancy (P = 0.25) and hypoglycemic (<63 mg/dL) was 0% (0-3%) and 0% (0-0%), respectively (P = 0.18). Postprandial glucose control, glucose variability, insulin infusion rates, and CGM sensor accuracy were no different in early or late pregnancy. CONCLUSIONS--MPC algorithm performance was maintained throughout pregnancy, suggesting that overnight closed-loop insulin delivery could be used safely during pregnancy. More work is needed to achieve optimal postprandial glucose control. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- To implement and evaluate a regional prepregnancy care program in women with type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS -- Prepregnancy care was promoted among patients and health professionals and delivered across 10 regional maternity units. A prospective cohort study of 680 pregnancies in women with type 1 and type 2 diabetes was performed. Primary outcomes were adverse pregnancy outcome (congenital malformation, stillbirth, or neonatal death), congenital malformation, and indicators of pregnancy preparation (5 mg folic acid, gestational age, and A1C). Comparisons were made with a historical cohort (n = 613 pregnancies) from the same units during 1999-2004. RESULTS -- A total of 181 (27%) women attended, and 499 women (73%) did not attend prepregnancy care. Women with prepregnancy care presented earlier (6.7 vs. 7.7 weeks; P < 0.001), were more likely to take 5 mg preconception folic acid (88.2 vs. 26.7%; P < 0.0001) and had lower A1C levels (A1C 6.9 vs. 7.6%; P < 0.0001). They had fewer adverse pregnancy outcomes (1.3 vs. 7.8%; P < 0.009). Multivariate logistic regression confirmed that in addition to glycemic control, lack of prepregnancy care was independently associated with adverse outcome (odds ratio 0.2 [95% CI 0.05-0.89]; P = 0.03). Compared with 1999-2004, folic acid supplementation increased (40.7 vs. 32.5%; P = 0.006) and congenital malformations decreased (4.3 vs. 7.3%; P = 0.04). CONCLUSIONS -- Regional prepregnancy care was associated with improved pregnancy preparation and reduced risk of adverse pregnancy outcome in type 1 and type 2 diabetes. Prepregnancy care had benefits beyond improved glycemic control and was a stronger predictor of pregnancy outcome than maternal obesity, ethnicity, or social disadvantage. [ABSTRACT FROM AUTHOR]

A gap currently exists between our expectations of tight blood glucose control and the reality of safely achieving it before and during pregnancy. Technological and pharmaceutical advances will not in isolation prevent poor pregnancy outcomes without recognising the social, cultural and behavioural context of the women living with diabetes. Neither will behavioural and/or educational programmes completely overcome the fundamentally disordered metabolic pathways and physiological challenges of pregnancy. Improved integration of the technological, behavioural and educational aspects of diabetes care will pave the way for truly personalized, interdisciplinary diabetes management and ultimately improved pregnancy outcomes for women with diabetes and their infants. [ABSTRACT FROM AUTHOR]

Objective To evaluate the effectiveness of continuous glucose monitoring during pregnancy on maternal glycaemic control, infant birth weight, and risk of macrosomia in women with type 1 and type 2 diabetes. Design Prospective, open label randomised controlled trial. Setting Two secondary care multidisciplinar/ obstetric clinics for diabetes in the United Kingdom. Participants 71 women with type 1 diabetes (n=46) ortype 2 diabetes (n=25) allocated to antenatal care plus continuous glucose monitoring (n=38) or to standard antenatal care (n=33). Intervention Continuous glucose monitoring was used as an educational tool to inform shared decision making and future therapeutic changes at intervals of 4-6 weeks during pregnancy. All other aspects of antenatal care were equal between the groups. Main outcome measures The primary outcome was maternal glycaemic control during the second and third trimesters from measurements of HbAlc levels every four weeks. Secondary outcomes were birth weight and risk of macrosomia using birthweight standard deviation scores and customised birthweight centiles. Statistical analyses were done on an intention to treat basis. Results Women randomised to continuous glucose monitoring had lower mean HbAlc levels from 32 to 36 weeks' gestation compared with women randomised to standard antenatal care: 5.8% (SD 0.6) v6A% (SD 0.7). Compared with infants of mothers in the control arm those of mothers in the intervention arm had decreased mean birthweight standard deviation scores (0.9 y 1.6; effect size 0.7 SD, 95% confidence interval 0.0 to 1.3), decreased median customised birthweight centiles (69% v93%), and a reduced risk of macrosomia (odds ratio 0.36, 95% confidence interval 0.13 to 0.98). Conclusion Continuous glucose monitoring during pregnancy is associated with improved glycaemic control in the third trimester, lower birth weight, and reduced risk of macrosomia. Trial registration Current Controlled Trials ISRCTN84461581. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- To examine the changes in glycemic excursions that occur during pregnancy using continuous glucose monitoring and to compare patterns of glycemia in pregnant women with type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS -- An observational data analysis was performed from a prospective randomized study of continuous glucose monitoring in 57 women with pregestational type 1 (n = 40) or type 2 (n = 17) diabetes with 7-day continuous glucose monitoring system profiles during each trimester. Serial glucose measurements were divided into periods of euglycemia (70-140 mg/dl), hyperglycemia (>140 mg/dl), and hypoglycemia (<70 mg/dl). Generalized linear mixed effects models were fitted to the repeated measures data to determine how these glycemic characteristics varied during gestation and by diabetes type. RESULTS -- A total of 180 continuous glucose profiles were examined (140 type 1 diabetes, 40 type 2 diabetes), providing 20,433 h of data for analysis (16,117 h type 1 diabetes, 4,316 type 2 diabetes). Women with type 2 diabetes spend -33% less time hyperglycemic throughout pregnancy than women with type 1 diabetes (P = 0.005), with a significantly more rapid reduction in time spent hyperglycemic in early pregnancy (P = 0.02). Although women with type 2 diabetes spend less overall time hypoglycemic (P = 0.04), their risk of nocturnal hypoglycemia is equivalent to that of women with type 1 diabetes (blood glucose level <70 mg/dl, P = 0.9; blood glucose level <50 mg/dl, P = 0.2). CONCLUSIONS -- Continuous glucose monitoring reveals clear differences in the level of glycemic control that exist in women with type 1 and type 2 diabetes. These data will guide therapeutic interventions aimed at optimizing glycemic control and improving the pregnancy outcomes of both type 1 and type 2 diabetes. [ABSTRACT FROM AUTHOR]

Technological advances in the management of diabetes have been described as a stepping stone in the journey towards a cure. These include continuous glucose monitoring, insulin pumps, computerised mathematical algorithms, and closed-loop artificial pancreas systems. The approaches offer the tantalising promise of near-normal glucose control to people with diabetes. However, as is often the case with human/technological interactions, we have the technology but we do not have all the answers. [Copyright &y& Elsevier]

OBJECTIVE--To evaluate the safety and efficacy of closed-loop insulin delivery in well-controlled pregnant women with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII). RESEARCH DESIGN AND METHODS--A total of 12 women with type 1 diabetes (aged 32.9 years, diabetes duration 17.6 years, BMI 27.1 kg/m², and HbA1c 6.4%) were randomly allocated to closed-loop or conventional CSII. They performed normal daily activities (standardized meals, snacks, and exercise) for 24 h on two occasions at 19 and 23 weeks' gestation. Plasma glucose time in target (63-140 mg/dL) and time spent hypoglycemic were calculated. RESULTS--Plasma glucose time in target was comparable for closed-loop and conventional CSII (median [interquartile range]: 81 [59-87] vs. 81% [54-90]; P = 0.75). Less time was spent hypoglycemic (<45 mg/dL [0.0 vs. 0.3%]; P = 0.04), with a lower low blood glucose index (2.4 [0.9-3.5] vs. 3.3 [1.9-5.1]; P = 0.03), during closed-loop insulin delivery. CONCLUSIONS--Closed-loop insulin delivery was as effective as conventional CSII, with less time spent in extreme hypoglycemia. [ABSTRACT FROM AUTHOR]

Background: Diabetes inpatient specialist services vary across the country, with limited evidence to guide service delivery. Currently, referrals to diabetes inpatient specialists are usually 'reactive' after diabetes-related events have taken place, which are associated with an increased risk of morbidity/mortality and increased length of hospital stay. We propose that a proactive diabetes review model of care, delivered by diabetes inpatient specialist nurses, may contribute to the prevention of such diabetes-related events and result in a reduction in the risk of harm. Method: We will conduct a cluster randomised feasibility study with process evaluation. The proactive diabetes review model (PDRM) is a complex intervention that focuses on the prevention of potentially modifiable diabetes-related harms. All eligible patients will receive a comprehensive, structured diabetes review that aims to identify and prevent potentially modifiable diabetes-related harms through utilising a standardised review structure. Reviews are undertaken by a diabetes inpatient specialist nurse within one working day of admission. This differs from usual care where patients are often only seen after diabetes-related harms have taken place. The trial duration will be approximately 32 weeks, with intervention delivery throughout. There will be an initial 8-week run-in phase, followed by a 24-week data collection phase. Eight wards will be equally randomised to either PDRM or usual care. Adult patients with a known diagnosis of diabetes admitted to an included ward will be eligible. Data collection will be limited to that typically collected as part of usual care. Data collected will include descriptive data at both the ward and patient level and glucose measures, such as frequency and results of capillary glucose testing, ketonaemia and hypoglycaemic events. The analysis aims to determine the fidelity and acceptability of the intervention and the feasibility of a future definitive trial. Whilst this study is primarily about trial feasibility, the findings of the process evaluation may lead to changes to both trial processes and modifications to the intervention. A qualitative process evaluation will be conducted in parallel to the trial. A minimum of 22 patients, nurses, doctors, and managers will be recruited with methods including direct non-participant observation and semi-structured interviews. The feasibility of a future definitive trial will be assessed by evaluating recruitment and randomisation processes, staffing resources and quality of available data. Discussion: The aim of this cluster randomised feasibility trial with a process evaluation is to explore the feasibility of a definitive trial and identify appropriate outcome measures. If a trial is feasible and the effectiveness of PDRM can be evaluated, this could inform the future development of inpatient diabetes services nationally. Trial registration: UK Clinical Research Network, 51,167. ISRCTN, ISRCTN70402110. Registered on 21 February 2022. [ABSTRACT FROM AUTHOR]

Aims: To examine maternal fear of hypoglycaemia, glycaemia and pregnancy outcomes in women with impaired and normal awareness of hypoglycaemia. Methods: A pre‐planned sub‐study of 214 pregnant women with type 1 diabetes who participated in the CONCEPTT trial. Participants completed hypoglycaemia fear surveys (HFS‐II) at baseline. Logistic regression and Poisson regression analyses were used to obtain an adjusted estimate for the rate ratio relating awareness to the number of severe hypoglycaemic episodes, and for several neonatal outcomes in relation to the total HFS‐II score. The role of continuous glucose monitoring (CGM) use was examined. Results: Overall, 30% of participants reported impaired awareness of hypoglycaemia (n = 64). Women with impaired awareness of hypoglycaemia had more episodes of severe hypoglycaemia (mean 0.44 vs. 0.08, p < 0.001) (12–34 weeks gestation) and scored higher on the HFS‐II scale (43.7 vs. 36.0, p 0.008), indicating more fear of hypoglycaemia. They spent more time below range (CGM <3.5 mmol/L) and exhibited more glycaemic variability at 12 weeks gestation. Higher overall HFS‐II scores were associated with a higher risk of maternal severe hypoglycaemia episodes (Rate Ratio 1.78, 95% CI 1.39–2.27). Women with impaired awareness of hypoglycaemia had less maternal weight gain but there were no differences in neonatal outcomes between women with impaired awareness of hypoglycaemia and normal hypoglycaemia awareness. Higher HFS‐II scores were associated with more nephropathy (Odds Ratio 1.91, 95% CI 1.06–3.4). CGM use after 12 weeks was not associated with the number of episodes of severe hypoglycaemia (RR 0.75, 95% CI 0.49–1.15; p = 0.18). Conclusions: In pregnant women with type 1 diabetes, impaired awareness of hypoglycaemia is associated with more maternal severe hypoglycaemia episodes and more fear of hypoglycaemia. Having impaired awareness of hypoglycaemia and/or fear of hypoglycaemia should alert clinicians to this increased risk. Reassuringly, there was no increase in adverse neonatal outcomes. [ABSTRACT FROM AUTHOR]

In this article, the author talks about the healthcare outcomes of pregnant women's suffering with type 1 diabetes, using insulin pump therapy which is associated with improved glucose control and discussed cost implications of such women's.

The article discusses the automated insulin delivery systems in Great Britain. Topics discussed include the home-use crossover study of a bihormonal insulin and glucagon system, manual insulin pump therapy, and patients with hypoglycaemia. Also being discussed are the manual insulin pumps and several daily injections.

Background: Continuous glucose monitoring (CGM) provides far greater detail about fetal exposure to maternal glucose across the 24 hour day, but recommended summary statistics give no dynamic information about the glucose profile across 24 hours. Aim: To examine whether differences in temporal glucose control occur in women with type 1 diabetes who develop large for gestational age infants (LGA). Research Design and Methods: CGM data was available from 200 pregnant women (100 CGM intervention; 100 controls) in the CONCEPTT study, at baseline, 24 and 34 weeks gestation. All women were being treated to tight glycemic targets (mean HbA1c 6.4% at 34 weeks gestation). Functional data analysis (FDA) was applied to determine differences in temporal glucose profiles. LGA was defined as birth weight ≥90th percentile adjusted for infant sex, gestational age, maternal BMI, ethnicity and parity. Results: 122/200 women had a LGA infant (61%). FDA revealed that those women who gave birth to a LGA infant ran a significantly higher glucose (by 9-14mg/dL; 0.5-0.8 mmol/l) for 16.5 hours of the day compared to those women who did not have a LGA infant (see fig). Conclusion: Women who go on to have LGA infants have significantly higher fetal exposure to glucose across the 24 hour day, despite being treated to tight glucose targets. Disclosure: E.M. Scott: Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Abbott, Eli Lilly and Company. H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc. D. Feig: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. G. Law: None. Funding: JDRF; Canadian Clinical Trials Network; National Institute for Health Research [ABSTRACT FROM AUTHOR]

Background: The CONCEPTT randomized trial of CGM in pregnant women with type 1 diabetes showed significant improvement in pregnancy outcomes, but no difference in mean CGM glucose between those allocated to CGM vs. capillary glucose monitoring. Whilst summary statistics are recommended for the reporting of CGM data, they do not give dynamic information about the glucose profile across 24 hours. Aim: To determine, using novel functional data analysis (FDA), if differences in the temporal glucose profile occurred in women randomized to CGM. Methods: CGM data was available from 200 pregnant women (100 CGM intervention; 100 control) in the CONCEPTT study, at baseline, 24 and 34 weeks gestation. FDA was applied to the glucose data to generate functional glucose curves and multivariable statistical analysis applied. Results: Despite having the same mean CGM glucose as those on capillary glucose monitoring alone 121 vs. 126 mg/dL; 6.7 vs. 7.0 mmol/l p=0.14, FDA revealed that pregnant CGM users were in fact running a significantly lower glucose (by 9-14mg/dL; 0.5-0.8 mmol/l) for a total of 8 hours a day (08.30-12.30 and 15.00-19.00). Conclusion: Analysis of temporal glucose profiles gives key information about glucose control, missed by commonly reported CGM metrics. The women allocated to CGM ran a significantly lower glucose for 33% of the day. Disclosure: E.M. Scott: Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Abbott, Eli Lilly and Company. H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc. D. Feig: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. G. Law: None. Funding: JDRF; Canadian Clinical Trials Network; National Institute for Health Research [ABSTRACT FROM AUTHOR]

Aims: To evaluate the cost-effectiveness of continuous glucose monitoring (CGM) in type 1 diabetes (T1D) pregnancy. Methods: Decision analytical models to compare T1D antenatal care with and without use of CGM. Probabilities, maternal health state utilities and healthcare resource utilization were obtained from individual patient-trial data. Costs and neonatal health state utilities were obtained from the literature. Primary outcome of interest was neonatal quality adjusted life years (QALY). The willingness to pay threshold was £30,000/QALY. Results: Direct costs of CGM use were £2,045. From a neonatal perspective, CGM during was cost saving (- £2,613), and effective (75.43 vs. 73.77 QALYs), with an incremental cost effectiveness ratio (ICER) - 1,570.57/QALY (Figure 1). Sensitivity analyses demonstrated robustness of the model across ranges of variables including varying NICU care for preterm and term neonates, and health state utilities. From a maternal perspective, CGM was associated with additional cost (£330), but remained effective; QALYs 61.33 vs. 61.27 and ICER £5,508.00/QALY. CGM remained efficacious and the favored treatment strategy in the sensitivity analyses performed. Conclusions: CGM use during T1D pregnancy is cost saving from a neonatal perspective and associated with improved cost effectiveness for both mother and neonate. Disclosure: H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc. D. Feig: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. N. Patel: None. Funding: JDRF (17-2011-533); JDRF Canadian Clinical Trial Network (80-2010-585) [ABSTRACT FROM AUTHOR]

Objective: To determine the impact of implementing emergency care pathway(s) for screening, diagnosing and managing women with gestational diabetes (GDM) during COVID‐19. Design: Retrospective multicentre cohort. Setting: Nine National Health Service (NHS) Hospital Trusts/Health boards in England and Scotland. Population: 4915 women with GDM pre‐pandemic (1 April 2018 to 31 March 2020), and 3467 women with GDM during the pandemic (1 May 2020 to 31 March 2021). Methods: We examined clinical outcomes for women with GDM prior to and during the pandemic following changes in screening methods, diagnostic testing, glucose thresholds and introduction of virtual care for monitoring of antenatal glycaemia. Main Outcome Measures: Intervention at birth, perinatal mortality, large‐for‐gestational‐age infants and neonatal unit admission. Results: The new diagnostic criteria more often identified GDM women who were multiparous, had higher body mass index (BMI) and greater deprivation, and less frequently had previous GDM (all p < 0.05). During COVID, these women had no differences in the key outcome measures. Of the women, 3% were identified with pre‐existing diabetes at antenatal booking. Where OGTT continued during COVID, but virtual care was introduced, outcomes were also similar pre‐ and during the pandemic. Conclusions: Using HbA1c and fasting glucose identified a higher risk GDM population during the pandemic but this had minimal impact on pregnancy outcomes. The high prevalence of undiagnosed pre‐existing diabetes suggests that women with GDM risk factors should be offered HbA1c screening in early pregnancy. [ABSTRACT FROM AUTHOR]

The article presents comments of the author on technological advances in continuous glucose monitoring (CGM) systems, which have transformed the management of type 1 diabetes. Topics discussed include cardiotocography (CTG) as the established method to monitor the fetal heart rate, moderate correlation between maternal glucose level and fetal heart rate and role of continuous CTG in earlier gestation

Objective: To determine if temporal glucose profiles differed between 1) women who were randomized to real-time continuous glucose monitoring (RT-CGM) or self-monitored blood glucose (SMBG), 2) women who used insulin pumps or multiple daily insulin injections (MDIs), and 3) women whose infants were born large for gestational age (LGA) or not, by assessing CGM data obtained from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT).Research Design and Methods: Standard summary metrics and functional data analysis (FDA) were applied to CGM data from the CONCEPTT trial (RT-CGM, n = 100; SMBG, n = 100) taken at baseline and at 24- and 34-weeks' gestation. Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups.Results: FDA revealed that women using RT-CGM had significantly lower glucose (0.4-0.8 mmol/L [7-14 mg/dL]) for 7 h/day (0800 h to 1200 h and 1600 h to 1900 h) compared with those with SMBG. Women using pumps had significantly higher glucose (0.4-0.9 mmol/L [7-16 mg/dL]) for 12 h/day (0300 h to 0600 h, 1300 h to 1800 h, and 2030 h to 0030 h) at 24 weeks with no difference at 34 weeks compared with MDI. Women who had an LGA infant ran a significantly higher glucose by 0.4-0.7 mmol/L (7-13 mg/dL) for 4.5 h/day at baseline, by 0.4-0.9 mmol/L (7-16 mg/dL) for 16 h/day at 24 weeks, and by 0.4-0.7 mmol/L (7-13 mg/dL) for 14 h/day at 34 weeks.Conclusions: FDA of temporal glucose profiles gives important information about differences in glucose control and its timing, which are undetectable by standard summary metrics. Women using RT-CGM were able to achieve better daytime glucose control, reducing fetal exposure to maternal glucose. [ABSTRACT FROM AUTHOR]

Background: Clinicians mediate access to closed-loop technology for people with diabetes. Consequently, their attitudes regarding appropriate levels of closed-loop usage will play a key role in future adoption processes. This study aimed to explore clinician attitudes toward future mainstream closed-loop usage in England. Materials and Methods: We conducted 36 semistructured interviews with clinicians from a range of professional backgrounds working in outpatient clinics in England. Interview topics included clinicians' views on future pathways for closed-loop use and attitudes toward the predictability of users' technology experiences, a key factor in eligibility decision making. We analyzed transcripts using thematic and framework approaches. Results: Clinicians exhibited a range of opinions regarding future eligibility for closed-loop technology. We identified three key strands of clinician opinion, envisaging (1) tighter access for closed loop (n = 10), citing funding challenges and issues arising from user overconfidence or negative technology attitudes; (2) similar access to closed loop as for current diabetes technologies (n = 15), on the grounds that future funding and access pathways will be similar to current arrangements; and (3) wider access for closed-loop technologies (n = 9), given the potential for significant and widespread benefits arising from closed-loop usage, including downstream cost savings alongside improved glycemic control. Conclusions: Clinicians expressed a range of opinions encompassing continuity with current diabetes technologies, while others envisaged either tighter or more liberal access for closed-loop systems. To optimize technology adoption and equitable uptake, future implementation pathways should consider clinician attitudes toward technology use and access. [ABSTRACT FROM AUTHOR]

Background: Outbreaks of cyclosporiasis, a diarrheal illness caused by Cyclospora cayetanensis, have been a public health issue in the USA since the mid 1990's. In 2018, 2299 domestically acquired cases of cyclosporiasis were reported in the USA as a result of multiple large outbreaks linked to different fresh produce commodities. Outbreak investigations are hindered by the absence of standardized molecular epidemiological tools for C. cayetanensis. For other apicomplexan coccidian parasites, multicopy organellar DNA such as mitochondrial genomes have been used for detection and molecular typing. Methods: We developed a workflow to obtain complete mitochondrial genome sequences from cilantro samples and clinical samples for typing of C. cayetanensis isolates. The 6.3 kb long C. cayetanensis mitochondrial genome was amplified by PCR in four overlapping amplicons from genomic DNA extracted from cilantro, seeded with oocysts, and from stool samples positive for C. cayetanensis by diagnostic methods. DNA sequence libraries of pooled amplicons were prepared and sequenced via next-generation sequencing (NGS). Sequence reads were assembled using a custom bioinformatics pipeline. Results: This approach allowed us to sequence complete mitochondrial genomes from the samples studied. Sequence alterations, such as single nucleotide polymorphism (SNP) profiles and insertion and deletions (InDels), in mitochondrial genomes of 24 stool samples from patients with cyclosporiasis diagnosed in 2014, exhibited discriminatory power. The cluster dendrogram that was created based on distance matrices of the complete mitochondrial genome sequences, indicated distinct strain-level diversity among the 2014 C. cayetanensis outbreak isolates analyzed in this study. Conclusions: Our results suggest that genomic analyses of mitochondrial genome sequences may help to link outbreak cases to the source. [ABSTRACT FROM AUTHOR]

Introduction: Recent high-profile calls have emphasized that women's experiences should be considered in maternity care provisioning. We explored women's experiences of using closed-loop during type 1 diabetes (T1D) pregnancy to inform decision-making about antenatal rollout and guidance and support given to future users. Methods: We interviewed 23 closed-loop participants in the Automated insulin Delivery Among Pregnant women with T1D (AiDAPT) trial after randomization to closed-loop and ∼20 weeks later. Data were analyzed thematically. Results: Women described how closed-loop lessened the physical and mental demands of diabetes management, enabling them to feel more normal and sleep better. By virtue of spending increased time-in-range, women also worried less about risks to their baby and being judged negatively by health care professionals. Most noted that intensive input and support during early pregnancy had been crucial to adjusting to, and developing confidence in, the technology. Women emphasized that attaining pregnancy glucose targets still required ongoing effort from themselves and the health care team. Women described needing education to help them determine when, and how, to intervene and when to allow the closed-loop to operate without interference. All women reported more enjoyable pregnancy experiences as a result of using closed-loop; some also noted being able to remain longer in paid employment. Conclusions: Study findings endorse closed-loop use in T1D pregnancy by highlighting how the technology can facilitate positive pregnancy experiences. To realize fully the benefits of closed-loop, pregnant women would benefit from initial intensive oversight and support together with closed-loop specific education and training. Clinical Trial Registration number: NCT04938557. [ABSTRACT FROM AUTHOR]

Objective: To describe glucose metrics in a high-risk population of women with type 2 diabetes (T2DM) in pregnancy and to explore the associations with neonatal outcomes. Research Design and Methods: Prospective observational study of 57 women. Continuous glucose monitoring (CGM) trajectories were determined from metrics collected in early and late gestation using the first and last two (mean 16 and 35) weeks of Freestyle Libre data. Logistic regression was used to examine associations of CGM metrics with neonatal hypoglycemia (glucose <2.6 mmol/L requiring intravenous dextrose) and large for gestational age (LGA) (>90th percentile for gestational age and sex). Pregnancy-specific target glucose range was 3.5–7.8 mmol/L (63–140 mg/dL). Results: Forty-one women used CGM for 15 weeks (mean age 33 years, 73% Aboriginal or Torres Strait Islander, 32% living remotely). There was limited change in average metrics from early to late pregnancy. For the subgroup with sensor use >50% (n = 29), mean time in range (TIR) increased by 9%, time above range reduced by 12%, average glucose reduced by 1 mmol/L, and time below range increased by 3%. Neonatal hypoglycemia was associated with most CGM metrics, HbA1c and CGM targets, particularly those from late pregnancy. LGA was associated with hyperglycemic metrics from early pregnancy. Each 1% increase TIR was associated with a 4%–5% reduction in risk of neonatal complications. Conclusion: In this high-risk group of women with T2DM, CGM metrics only improved during pregnancy in those with greater sensor use and were associated with LGA in early pregnancy and neonatal hypoglycemia throughout. Culturally appropriate health care strategies are critical for successful use of CGM technology. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This study aimed to evaluate the efficacy of closed-loop insulin delivery postpartum. RESEARCH DESIGN AND METHODS: In this open-label, randomized controlled trial, postpartum individuals with type 1 diabetes were randomized to hybrid closed-loop insulin delivery with the MiniMed 670G/770G system in automode or sensor-augmented pump therapy in the first 12-weeks postpartum followed by a continuation phase with closed-loop insulin delivery for all until 24 weeks postpartum. RESULTS: Eighteen participants (mean ± SD age 32 ± 3.5 years, diabetes duration 22 ± 7.3 years, and early pregnancy HbA1c 52 ± 6.8 mmol/mol [6.9 ± 0.9%]) completed 24 weeks of postpartum follow-up. In the randomized phase, percent time in range 70–180 mg/dL (3.9–10 mmol/L) did not differ between groups (79.2 ± 8.7% vs. 78.2 ± 6.0%; P = 0.41). Participants randomized to closed-loop insulin delivery spent less time <70 mg/dL (3.9 mmol/L) and <54 mg/dL (3.0 mmol/L) (1.7 ± 0.8% vs. 5.5 ± 3.3% [P < 0.001] and 0.3 ± 0.2% vs. 1.1 ± 0.9% [P = 0.008]). Time >180 mg/dL (10 mmol/L) was not different between groups (18.7 ± 8.8% vs. 15.9 ± 7.7%; P = 0.21). In the continuation phase, those initially randomized to sensor-augmented pump therapy had less time <70 mg/dL after initiation of closed-loop insulin delivery (5.5 ± 3.3% vs. 3.3 ± 2.2%; P = 0.039). The closed-loop group maintained similar glycemic metrics in both study phases. There were no episodes of diabetic ketoacidosis or severe hypoglycemia in the randomized or continuation phase in either group. CONCLUSIONS: Women randomized to closed-loop insulin delivery postpartum had less hypoglycemia than those randomized to sensor-augmented pump therapy. There were no safety concerns. These findings are reassuring for use of closed-loop insulin delivery postpartum because of its potential to reduce hypoglycemia. [ABSTRACT FROM AUTHOR]

Aim: To describe the continuous glucose monitoring (CGM) profiles of type 1 diabetes (T1D) offspring in the early neonatal period and its association with maternal intrapartum glucose control.Methods: A prospective observational study of T1D pregnant women and their neonatal offspring. Women had a CGM sensor inserted 2-3 days before delivery. Infants had a masked CGM sensor inserted as soon as possible after delivery. Maternal glycemic outcomes were time-in-target (70-140 mg/dL [3.9-7.8 mmol/L]), hyperglycemia >140 mg/dL (7.8 mmol/L), and mean CGM glucose during the 24 h preceding delivery. Neonatal outcomes included lowest recorded blood glucose concentration, and CGM measures (glucose <47 mg/dL [2.6 mmol/L], time-in-target (47-144 mg/dL [2.6-8.0 mmol/L]), glucose standard deviation [SD]) during the first 72 h of life.Results: Data were available for 16 mother-infant pairs. Mothers had a mean age (SD) 32.3 (4.3) years, T1D duration 17.6 (6.8) years, first antenatal glycated hemoglobin 7.4 (0.8)% (57 [8.5] mmol/mol). In the 24 h preceding delivery, mothers spent mean (SD) 72 (20)% time-in-target (70-140 mg/dL [3.9-7.8 mmol/L]), 19 (15)% time >140 mg/dL (7.8 mmol/L), and 9 (9)% time <70 mg/dL (3.9 mmol/L) with mean (SD) CGM glucose 113 (9) mg/dL (6.3 [0.7] mmol/L). Fifteen infants (93.8%) had ≥1 blood glucose concentration <47 mg/dL (2.6 mmol/L), and five had ≥1 blood glucose concentration <18 mg/dL (1.0 mmol/L). The mean infant CGM glucose on days 1, 2, and 3 of life was 63 (14), 67 (13), 76 (11) mg/dL (3.5 [0.8], 3.7 [0.7], and 4.2 [0.6] mmol/L). Four infants (25%) spent >50% time with CGM glucose levels <47 mg/dL (2.6 mmol/L) on day 1.Conclusions: CGM detected widespread neonatal hypoglycemia, even among mothers with good intrapartum glucose control. [ABSTRACT FROM AUTHOR]

The article discusses research done on intermittent real-time continuous glucose monitoring (CGM) in pregnant women with diabetes. It references a study by A. L. Secher and colleagues, published in the 2013 issue. The researchers focused on the prevention of nocturnal hypoglycemia. They concluded that intermittent use of real-time CGM failed to improve glycemic control or neonatal morbidity.

Aims: The aim of the study was to examine the content and impact of interventions that have been used to increase the uptake of pre‐pregnancy care for women with type 2 diabetes, and their impact on maternal and fetal outcomes. Methods: A systematic search of multiple databases was conducted in November 2021, and updated July 2022, to identify studies assessing interventions to enhance pre‐pregnancy care for women with type 2 diabetes. Over 10% of articles were screened by two reviewers at title and abstract phase, after which all selected full‐text articles were screened by two reviewers. Quality assessment was conducted using the Critical Appraisal Skills Programme checklist for cohort studies. Meta‐analysis was not possible due to study heterogeneity; therefore, narrative synthesis was conducted. Results: Four eligible cohort studies were identified. The conclusions able to be drawn by this review were limited as women with type 2 diabetes (n = 800) were in the minority in all four studies (35%–40%) and none of the interventions were exclusively tailored for them. The uptake of pre‐pregnancy care was lower in women with type 2 diabetes (8%–10%) compared with other participant groups in the studies. Pregnancy preparation indicators generally improved among all groups exposed to pre‐pregnancy care, with varying impact on pregnancy outcomes. Conclusions: This review demonstrates that previous interventions have had a limited impact on pre‐pregnancy care uptake in women with type 2 diabetes. Future studies should focus on tailored interventions for improving pre‐pregnancy care for women with type 2 diabetes, particularly those from ethnic minorities and living in poorer communities. [ABSTRACT FROM AUTHOR]

Background: Interest is growing in how closed‐loop systems can support attainment of within‐target glucose levels amongst pregnant women with type 1 diabetes. We explored healthcare professionals' views about how, and why, pregnant women benefitted from using the CamAPS FX system during the AiDAPT trial. Methods: We interviewed 19 healthcare professionals who supported women using closed‐loop during the trial. Our analysis focused on identifying descriptive and analytical themes relevant to clinical practice. Results: Healthcare professionals highlighted clinical and quality‐of‐life benefits to using closed‐loop in pregnancy; albeit, they attributed some of these to the continuous glucose monitoring component. They emphasised that the closed‐loop was not a panacea and that, to gain maximum benefit, an effective collaboration between themselves, the woman and the closed‐loop was needed. Optimal performance of the technology, as they further noted, also required women to interact with the system sufficiently, but not excessively; a requirement that they felt some women had found challenging. Even where healthcare professionals felt that this balance was not achieved, they suggested that women had still benefitted from using the system. Healthcare professionals reported difficulties predicting how specific women would engage with the technology. In light of their trial experiences, healthcare professionals favoured an inclusive approach to closed‐loop rollout in routine clinical care. Conclusions: Healthcare professionals recommended that closed‐loop systems be offered to all pregnant women with type 1 diabetes in the future. Presenting closed‐loop systems to pregnant women and healthcare teams as one pillar of a three‐party collaboration may help promote optimal use. [ABSTRACT FROM AUTHOR]