Listening to Women: Experiences of Using Closed-Loop in Type 1 Diabetes Pregnancy.

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.

Comprehensive Management of Type 2 Diabetes During Pregnancy.

This JAMA Insights Clinical Update discusses a comprehensive approach to treating pregnant patients with type 2 diabetes to reduce adverse perinatal and neonatal outcomes.

Association of community walkability and glycemic control among pregnant individuals with pregestational diabetes mellitus.

BACKGROUND: Neighborhood walkability is a community-level social determinant of health that measures whether people who live in a neighborhood walk as a mode of transportation. Whether neighborhood walkability is associated with glycemic control among pregnant individuals with pregestational diabetes remains to be defined. OBJECTIVE: This study aimed to evaluate the association between community-level neighborhood walkability and glycemic control as measured by hemoglobin A1c (A1C) among pregnant individuals with pregestational diabetes. STUDY DESIGN: This was a retrospective analysis of pregnant individuals with pregestational diabetes enrolled in an integrated prenatal and diabetes care program from 2012 to 2016. Participant addresses were geocoded and linked at the census-tract level. The exposure was community walkability, defined by the US Environmental Protection Agency National Walkability Index (score range 1-20), which incorporates intersection density (design), proximity to transit stops (distance), and a mix of employment and household types (diversity). Individuals from neighborhoods that were the most walkable (score, 15.26-20.0) were compared with those from neighborhoods that were less walkable (score <15.26), as defined per national Environmental Protection Agency recommendations. The outcomes were glycemic control, including A1C <6.0% and <6.5%, measured both in early and late pregnancy, and mean change in A1C across pregnancy. Modified Poisson regression and linear regression were used, respectively, and adjusted for maternal age, body mass index at delivery, parity, race and ethnicity as a social determinant of health, insurance status, baseline A1C, gestational age at A1C measurement in early and late pregnancy, and diabetes type. RESULTS: Among 417 pregnant individuals (33% type 1, 67% type 2 diabetes mellitus), 10% were living in the most walkable communities. All 417 individuals underwent A1C assessment in early pregnancy (median gestational age, 9.7 weeks; interquartile range, 7.4-14.1), and 376 underwent another A1C assessment in late pregnancy (median gestational age, 30.4 weeks; interquartile range, 27.8-33.6). Pregnant individuals living in the most walkable communities were more likely to have an A1C <6.0% in early pregnancy (15% vs 8%; adjusted relative risk, 1.46; 95% confidence interval, 1.00-2.16), and an A1C <6.5% in late pregnancy compared with those living in less walkable communities (13% vs 9%; adjusted relative risk, 1.33; 95% confidence interval, 1.08-1.63). For individuals living in the most walkable communities, the median A1C was 7.5 (interquartile range, 6.0-9.4) in early pregnancy and 5.9 (interquartile range, 5.4-6.4) in late pregnancy. For those living in less walkable communities, the median A1C was 7.3 (interquartile range, 6.2-9.2) in early pregnancy and 6.2 (interquartile range, 5.6-7.1) in late pregnancy. Change in A1C across pregnancy was not associated with walkability. CONCLUSION: Pregnant individuals with pregestational diabetes mellitus living in more walkable communities had better glycemic control in both early and late pregnancy. Whether community-level interventions to enhance neighborhood walkability can improve glycemic control in pregnancy requires further study.

Management of Diabetic Ketoacidosis in Pregnancy.

Diabetic ketoacidosis (DKA) is a rare, but potentially life-threatening complication of diabetes. Certain physiological changes during pregnancy predispose pregnant individuals to developing DKA. Early recognition and aggressive treatment are essential to avoid maternal and fetal morbidity and mortality. Although laboratory values can help to support, pregnant patients with DKA may not meet the usual criteria and the diagnosis can be made clinically. The key components to treatment include volume replacement, insulin infusion, correction of serum potassium, and fetal monitoring. With appropriate treatment, maternal mortality is low. After recovery, steps should be taken to avoid recurrence.

Diabetic Embryopathies.

Diabetic embryopathy is defined as congenital anomalies that are linked to maternal diabetes. The association between diabetes and fetal, neonatal, and long-term complications is well-established. These complications include organ or structural maldevelopment, fetal growth abnormalities, and learning/psychiatric comorbidities. Recent studies have elucidated the pathophysiology behind these conditions and outlined new management approaches. Caudal regression syndrome, also known as sacral agenesis, is a well-known but less described complication of maternal diabetes. The purpose of this review is to summarize existing research on common neonatal morbidities in infants of mothers with diabetes with a focus on caudal regression syndrome and its long-term associations.

Congenital Abnormalities in the Infant of a Diabetic Mother.

Diabetes mellitus is among the most common chronic diseases worldwide. Infants of diabetic mothers are at increased risk of having congenital abnormalities. Tremendous progress has been achieved in the pregnancy care of diabetic women; however, the risk of birth defects associated with maternal diabetes still exists. These anomalies might arise in many organs and systems of the developing fetus. Many mechanisms have been implicated in the teratogenicity of maternal diabetes and it is critical to achieve good glycemic control before conception in women with diabetes. Neonatal clinicians must be able to identify patients at risk and recognize the signs of diabetic embryopathy. This article presents a review of congenital anomalies associated with maternal diabetes.

Identification and management of GCK-MODY complicating pregnancy in Chinese patients with gestational diabetes.

Precise differentiation of glucokinase (GCK) monogenic diabetes from gestational diabetes mellitus (GDM) is critical for accurate management of the pregnancy outcome. We screened GCK-MODY complicating pregnancies in Chinese GDM patients, explored the pathogenesis of novel GCK mutations, and evaluated the patients' pregnancy outcome and management. The GCK gene from 411 GDM patients was screened with PCR-direct sequencing and multiplex ligation-dependent probe amplification (MLPA) and 15 GCK mutations were identified. We also retrospectively analyzed a total of 65 pregnancies from 21 GCK-MODY families, wherein 41 were from 15 maternal families and 24 were from six paternal families. Bioinformatic analysis and biochemical functional study were conducted to identify novel GCK mutations. In total, we identified 21 GCK mutations: 15 from the 411 GDM patients and six from 24 fathers. Of th Asp78Asn (GAC → AAC), Met87Arg (ATG → AGG), Leu451Val (CTT → GTT), Leu451Pro (CTG → CCG) and 1019 + 20G > A e mutations, five, i.e., were novel and deleterious, with markedly decreased enzyme activity and thermal stability. The unaffected offspring of GCK mutation-affected mothers were heavier than affected offspring (p < 0.001). Of 21 insulin-treated affected mothers, 10 had maternal hypoglycemia (47.6%) and seven had perinatal complications (33.3%), and the affected offspring of the insulin-treated affected mothers had significantly lower birth weights than that of the 20 diet-control affected mothers (p = 0.031). In this study, the prevalence of GCK-MODY complicating pregnancy in Chinese GDM patients was 3.6% (15/411). The defective GCK may contribute to the hyperglycemia in GCK-MODY. Insulin therapy is not beneficial for GCK-MODY complicating pregnancy and therefore should not be recommended.

Pilot Randomized Controlled Trial of Diabetes Group Prenatal Care.

OBJECTIVE: This study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities. STUDY DESIGN: A pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle. RESULTS: Of 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0-0.7] vs. 0.5 lbs/week [interquartile range: 0.2-0.9]; p = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4-8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms. CONCLUSION: Diabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes. KEY POINTS: · Women with gestational diabetes in group care were 3.5 times more likely to return for postpartum glucose tolerance testing.. · Women with gestational diabetes in group care had less gestational weight gain during the study period.. · Diabetes Group Prenatal Care is a promising intervention to improve outcomes for women with diabetes in pregnancy..

Diabetic ketoacidosis in pregnancy - Case series, pathophysiology, and review of the literature.

OBJECTIVE: Diabetic ketoacidosis (DKA) during pregnancy is a life-threatening emergency for both the mother and the fetus. The pathophysiology of DKA in pregnancy has its own characteristics due to multiple factors, such as insulin resistance, accelerated starvation and respiratory alkalosis, thus creating ketosis-prone state, with DKA occurring at milder degrees of hyperglycemia, even in normoglycemic levels, which can result in delayed diagnosis and treatment with potential for adverse metabolic consequences. STUDY DESIGN: In this article, we presented 8 clinical cases of DKA during pregnancy. We discuss the spectrum of the clinical picture, the entity of euglycemic DKA vs hyperglycemic DKA, the period of pregnancy in appearance of episode of DKA and triggers of DKA. CONCLUSION: The treatment of DKA in pregnant women must be started immediately and must be accentuated on intravenous fluids, insulin and electrolyte replacement. DKA in pregnancy may be euglycemic. Prevention, early recognition, immediate hospitalization, and aggressive management remain the cornerstones in DKA management in pregnancy.

Management of pregestational diabetes mellitus: a comparison of guidelines.

BACKGROUND: Pregestational diabetes is associated with adverse maternal and neonatal outcomes. The aim of this study was to summarize and compare evidence-based recommendations on pregestational diabetes and to focus especially on issues related to the management of this entity. MATERIALS AND METHODS: A descriptive review of three recently published national guidelines on pregestational diabetes was conducted: the American Diabetes Association on "Diabetes in Pregnancy: Standards of Medical Care in Diabetes - 2019," the National Institute for Health and Care Excellence on "Diabetes in pregnancy: management from preconception to the postnatal period" and the American College of Obstetricians and Gynecologists on "Pregestational Diabetes Mellitus." These guidelines were compared according to recommendations on management, during the preconception, antenatal, intrapartum and postpartum period. RESULTS: There were many similar recommendations regarding the preconception counseling, the antepartum assessment by specialists, the glycemic control target levels, the pharmacologic treatment and the postpartum period among the three guidelines. On the other hand, the American Diabetes Association makes no recommendations regarding fetal monitoring and obstetric management during pregnancy and the intrapartum period, while there are several similarities between the other two guidelines. CONCLUSIONS: The adoption of an international consensus based on evidence - based guidelines will increase the awareness of the healthcare professionals on the management of pregestational diabetes, leading that way to more favorable perinatal outcomes.

Glycaemic control and novel technology management strategies in pregestational diabetes mellitus.

Introduction: Pregestational diabetes (PGDM) is an increasingly common and complex condition that infers risk to both mother and infant. To prevent serious morbidity, strict glycaemic control is essential. The aim of this review is to review the glucose sensing and insulin delivering technologies currently available for women with PGDM. Methods: We reviewed online databases for articles relating to technology use in pregnancy using a combination of keywords and MeSH headings. Relevant articles are included below. Results: A number of technological advancements have improved care and outcomes for women with PGDM. Real time continuous glucose monitoring (rtCGM) offers clear advantages in terms of infants size and neonatal intensive care unit admissions; and further benefits are seen when combined with continuous subcutaneous insulin delivery (insulin pump) and algorithms which continuously adjust insulin levels to glucose targets (hybrid closed loop). Other advancements including flash or intermittent scanning CGM (isCGM) and stand-alone insulin pumps do not confer as many advantages for women and their infants, however they are increasingly used outside of pregnancy and many women enter pregnancy already using these devices. Discussion: This article offers a discussion of the most commonly used technologies in pregnancy and evaluates their current and future roles.

Maternal and Fetal Outcomes in Women with Diabetes in Pregnancy Treated before and after the Introduction of a Standardized Multidisciplinary Management Protocol.

BACKGROUND: Diabetes in pregnancy is associated with an increased risk to the woman and to the developing fetus. Currently, there is no consensus on the optimal management strategies for the follow-up and the timing of delivery of pregnancies affected by gestational and pregestational diabetes, with different international guidelines suggesting different management options. MATERIALS AND METHODS: We conducted a retrospective cohort study from January 2017 to January 2021, to compare maternal and neonatal outcomes of pregnancies complicated by gestational and pregestational diabetes, followed-up and delivered in a third level referral center before and after the introduction of a standardized multidisciplinary management protocol including diagnostic, screening, and management criteria. RESULTS: Of the 131 women included, 55 were managed before the introduction of the multidisciplinary management protocol and included in group 1 (preprotocol), while 76 were managed according to the newly introduced multidisciplinary protocol and included in group 2 (after protocol). We observed an increase in the rates of vaginal delivery, rising from 32.7% to 64.5% (<0.001), and the rate of successful induction of labor improved from 28.6% to 86.2% (P < 0.001). No differences were found in neonatal outcomes, and the only significant difference was demonstrated for the rates of fetal macrosomia (20% versus 5.3%, P: 0.012). Therefore, the improvements observed in the maternal outcomes did not impact negatively on fetal and neonatal outcomes. CONCLUSION: The introduction of a standardized multidisciplinary management protocol led to an improvement in the rates of vaginal delivery and in the rate of successful induction of labor in our center. A strong cooperation between obstetricians, diabetologists, and neonatologists is crucial to obtain a successful outcome in women with diabetes in pregnancy.

Gestational diabetes mellitus - A metabolic and reproductive disorder.

Maternal health associated with Gestational Diabetes Mellitus (GDM) has been gaining significant research attention due to its severe risk and adverse health effects. GDM is the leading health disease in pregnant women. It is the most common metabolic disease and it can affect up to 25% of women during pregnancy. Pregnancy is a sensitive period that impacts both pregnant women and their unborn children's long-term health. It is a well-known fact that the leading causes of disease and mortality worldwide are diabetes mellitus and cancer, and specifically, women with diabetes mellitus are at a higher risk of developing breast cancer (BC). Women who have diabetes are equally vulnerable to reproductive diseases. Reproductive dysfunctions with diabetes are mainly attributed to coexisting polycystic ovarian syndrome (PCOS), obesity, and hyperinsulinemia, etc. Moreover, India has long been recognized as the world's diabetic capital, and it is widely acknowledged that particularly pregnant and lactating women are among the most affected by diabetes. In India, one-third (33%) of women with GDM had a history of maternal diabetes. Nevertheless, the latest research suggests that gestational diabetes is also a risk factor for cardiometabolic diseases of the mother and offspring. Therefore, in the 21st century, GDM imposes a major challenge for healthcare professionals. We intend to explore the role of diabetes on female reproductive function throughout various stages of life in the perspective of the changing prognosis, prevalence, and prevention of GDM.

COVID-19 vaccination in pregnant and lactating diabetic women.

AIM: To discuss available information on the opportunity for pregnant women affected by diabetes/obesity to receive COVID-19 vaccine. DATA SYNTHESIS: Pregnant women with SARS-CoV-2 (COVID-19) infection are at high risk for severe acute respiratory syndrome and adverse outcomes. Pregnant women with severe COVID-19 present increased rates of preterm delivery (<37 gestational weeks), cesarean delivery and neonatal admissions to the intensive care unit. Comorbidity such as diabetes (pregestational or gestational) or obesity further increased maternal and fetal complications. It is known that diabetic or obese patients with COVID-19 present an unfavorable course and a worse prognosis, with a direct association between worse outcome and suboptimal glycol-metabolic control or body mass index (BMI) levels. Critical COVID-19 infection prevention is important for both mother and fetus. Vaccination during pregnancy is a common practice. Vaccines against COVID-19 are distributed across the world with some population considered to have a priority. Since pregnant women are excluded from clinical trials very little information are available on safety and efficacy of COVD-19 vaccines during pregnancy. However, it is well known the concept of passive immunization of the newborn obtained with transplacental passage of protective antibodies into the fetal/neonatal circulation after maternal infection or vaccination. Moreover, it has been reported that COVID-19 vaccine-induced IgG pass to the neonates through breastmilk. Therefore, maternal vaccination can protect mother, fetus and baby. CONCLUSIONS: After an individual risk/benefit evaluation pregnant and lactating women should be counselled to receive COVID-19 vaccines.

Use of Virtual Care for Glycemic Management in People With Types 1 and 2 Diabetes and Diabetes in Pregnancy: A Rapid Review.

Our objective in this study was to answer the main research question: In patients with diabetes, does virtual care vs face-to-face care provide different clinical, patient and practitioner experience or quality outcomes? Articles (2012 to 2020) describing interventions using virtual care with the capability for 2-way, individualized interactions compared with usual care were included. Studies involving any patients with diabetes and outcomes of glycated hemoglobin (A1C), quality of care and/or patient or health-care practitioner experience were included. Systematic reviews, randomized controlled studies, quasi-experimental trials, implementation trials, observational studies and qualitative analyses were reviewed. MEDLINE and McMaster Health Evidence databases searched in June 2020 identified 59 articles. Virtual care, in particular telemonitoring, combined with a means of 2-way communications provided improvement in A1C similar or superior to usual care, with the strongest evidence for type 2 diabetes. Virtual care was generally acceptable to patients, who expressed satisfaction with their care. Health-care providers recognized benefits but raised issues of technical support, workflow and compensation.

Clinical Effectiveness of Different Technologies for Diabetes in Pregnancy: Systematic Literature Review.

BACKGROUND: Hyperglycemia in pregnancy occurs worldwide and is closely associated with health issues in women and their offspring, such as pregnancy and birth complications, respectively, as well as comorbidities, such as metabolic and cardiovascular diseases. To optimize the management of diabetic pregnancies, sustainable strategies are urgently needed. Investigation of constantly evolving technologies for diabetes that help to manage pregnancy and health is required. OBJECTIVE: We aimed to conduct a systematic review to assess the clinical effectiveness of technologies for diabetes in pregnancy. METHODS: Relevant databases including MEDLINE (PubMed), Cochrane Library, Embase, CINAHL, and Web of Science Core Collection were searched in September 2020 for clinical studies (2008-2020). Findings were organized by type of diabetes, type of technology, and outcomes (glycemic control, pregnancy- and birth-related outcomes, and neonatal outcomes). Study quality was assessed using Effective Public Health Practice Project criteria. RESULTS: We identified 15 randomized controlled trials, 3 randomized crossover trials, 2 cohort studies, and 2 controlled clinical trials. Overall, 9 studies focused on type 1 diabetes, 0 studies focused on gestational diabetes, and 3 studies focused on both type 1 diabetes and type 2 diabetes. We found that 9 studies were strong quality, 11 were moderate quality, and 2 were weak quality. Technologies for diabetes seemed to have particularly positive effects on glycemic control in all types of diabetes, shown by some strong and moderate quality studies. Positive trends in pregnancy-related, birth-related, and neonatal outcomes were observed. CONCLUSIONS: Technologies have the potential to effectively improve the management of diabetes during pregnancy. Further research on the clinical effectiveness of these technologies is needed, especially in pregnant women with type 2 diabetes.