Body image and psychosocial outcomes in youth and young adults with differences of sex development: a multi-method study.

OBJECTIVE: Differences of sex development (DSD) can affect the physical health, appearance, and psychosocial functioning of affected individuals, but little is known about how subjective appearance perceptions (body image) impact psychosocial outcomes. This study evaluated body image and its associations with psychosocial outcomes including quality of life, resilience, and psychosocial adjustment. METHODS: This cross-sectional, multi-method study assessed body image and psychosocial outcomes including quality of life, adjustment, and resilience in 97 youth and young adults with DSD (mean age = 17 ± 3.7 years; 56% assigned female in infancy) using psychometrically sound instruments. A subsample (n = 40) completed qualitative interviews. RESULTS: Quantitative results indicated that overall, participants were satisfied with their physical appearance, although less so with their primary sex characteristics. Body image dissatisfaction was associated with poorer psychosocial adjustment, quality of life, and resilience. Qualitatively, youth and young adults reported a variety of perceptions, both positive and negative, related to their body image and the impact of living with a DSD condition. Themes identified included appearance management; effects of DSD on body image; diagnostic factors and features; attitudes about diagnosis; and treatment. CONCLUSIONS: Body image is significantly associated with psychosocial outcomes in youth and young adults with DSD, with qualitative findings highlighting both positive and negative body image experiences. Results have implications for clinical care including screening for appearance concerns, normalization of appearance variations, and intervention development to better support healthy body image and psychosocial functioning in youth and young adults with DSD.

Transition From Pediatric to Adult Care for Individuals With Type 1 Diabetes: Opportunities and Challenges.

OBJECTIVES: Type 1 diabetes (T1D) is a chronic disease with patients across the age spectrum that has high potential for morbidity and mortality. Unfortunately, patients transitioning from pediatric to adult care continue to demonstrate worsened glycemic control in part due to lack of understanding of transition of care best practices. METHODS: This review highlights the impact of existing transition of care interventions, assessment tools, and other recently published strategies for providers to consider to improve care of adolescent and young adult (AYA) patients with T1D in both hospital- and clinic-based settings. RESULTS: Many barriers impact patients with T1D during the transition period and disparities by race, sex, insurance status, and comorbid illness persist. As diabetic care continues to evolve and the prevalence of adolescents and young adults living with T1D increases, an intentional approach to transition of care is more pressing than ever. While current literature on transition of care models is limited, many show promise in improving clinic attendance and decreasing hospitalization. There are critical discussions that providers should lead with AYA patients to improve their outcomes and increase diabetes self-management, such as re-addressing carbohydrate counseling, sleep hygiene, and reproductive planning. CONCLUSION: While further research on transition of care is needed, many care models offer the promise of improved T1D outcomes, enhancements in our approach to care, and increased value for our health care system at large.

CGM in the Hospital: Is It Ready for Prime Time?

PURPOSE OF REVIEW: The use of continuous glucose monitoring (CGM) in the hospital setting is growing with more patients using these devices at home and when admitted to the hospital, especially during the COVID-19 pandemic. RECENT FINDINGS: Historically, most evidence for CGM use in the inpatient setting was limited to small studies utilizing outdated CGM technology and analyzing accuracy of sensor measurements. Previous studies have shown reduced sensor accuracy during extreme hypo- or hyperglycemia, rapid fluctuations of glucose, compression of the sensor itself, and in those who are critically ill. Studies that are more recent have shown CGM to have adequate accuracy and may be effective in reducing hypoglycemia in hospitalized patients; some studies have also showed improvement in time in target glycemic range. Furthermore, CGM may reduce nursing workload, cost of inpatient care, and use of personal protective equipment and face-to-face patient care especially for patients during the COVID-19 pandemic. This review will describe the evidence for use of CGM in hospitalized critically ill or non-critically ill patients, address accuracy and safety considerations, and outline paths for future implementation.

Differences in Hemoglobin A1c during Pregnancy between Non-Hispanic Black versus White Women with Prepregnancy Diabetes.

OBJECTIVE: The objective of this was to determine whether the change in hemoglobin A1c (HbA1c) from early to late pregnancy differs between non-Hispanic Black and White women with prepregnancy diabetes. STUDY DESIGN: A retrospective analysis was performed from an integrated prenatal and diabetes care program from 2012 to 2016. We compared HbA1c as a continuous measure and secondarily, HbA1c <6.5%, cross-sectionally, and longitudinally in early (approximately 10 weeks) and late (approximately 31 weeks) pregnancies. Linear and logistic regression were used and adjusted for age, body mass index, White diabetes class, medication use, diabetes type, gestational age at baseline HbA1c measurement, and baseline hemoglobin. RESULTS: Among 296 non-Hispanic Black (35%) and White pregnant women (65%) with prepregnancy diabetes (39% type 1 and 61% type 2), Black women were more likely to experience increased community-level social determinants of health as measured by the Social Vulnerability Index (SVI) and were less likely to have type 1 diabetes and have more severe diabetes versus White women (p < 0.05). Black women had higher mean HbA1c (7.8 vs. 7.4%; beta: 0.75; 95% confidence interval [CI]: 0.30-1.19) and were less likely to have HbA1c < 6.5% at 10 weeks compared with White women (24 vs. 35%; adjusted odds ratio: 0.45; 95% CI: 0.24-0.81) but not after adjusting for SVI. At 31 weeks, both groups had similar mean HbA1c (both 6.5%) and were equally as likely to have HbA1c < 6.5% (57 vs. 54%). From early to late pregnancy, Black women had a higher percentage decrease in HbA1c (1.3 vs. 0.9%; beta = 0.63; 95% CI: 0.27-0.99) and were equally as likely to have an improvement or stable HbA1C < 6.5% from 10 to 31 weeks, with both groups having a similar mean HbA1c (6.5%) at 31 weeks. CONCLUSION: Despite experiencing greater community-level social determinants of health, Black women with pregestational diabetes had a larger reduction in HbA1c and were able to equally achieve the target of HbA1c < 6.5% by late pregnancy compared with White women as part of an integrated diabetes and prenatal care program. KEY POINTS: · An integrated diabetes and pregnancy care program may decrease racial and ethnic disparities in glycemic control.. · Black women had a larger reduction in HbA1c versus White women.. · Black women were able to equally achieve the target of HbA1c < 6.5% by late pregnancy versus White women..

Facilitators and Barriers to Nursing Implementation of Continuous Glucose Monitoring (CGM) in Critically Ill Patients With COVID-19.

OBJECTIVE: We describe our implementation of a continuous glucose monitoring (CGM) guideline to support intravenous insulin administration and reduce point of care (POC) glucose monitoring frequency in the coronavirus disease 2019 medical intensive care unit (MICU) and evaluate nurses' experience with implementation of CGM and hybrid POC + CGM protocol using the Promoting Action on Research in Health Services framework. METHODS: A multidisciplinary team created a guideline providing criteria for establishing initial sensor-meter agreement within each individual patient followed by hybrid use of CGM and POC. POC measures were obtained hourly during initial validation, then every 6 hours. We conducted a focus group among MICU nurses to evaluate initial implementation efforts with content areas focused on initial assessment of evidence, context, and facilitation to identify barriers and facilitators. The focus group was analyzed using a qualitative descriptive approach. RESULTS: The protocol was integrated through a rapid cycle review process and ultimately disseminated nationally. The Diabetes Consult Service performed device set-up and nurses received just-in-time training. The majority of barriers centered on contextual factors, including limitations of the physical environment, complex device set-up, hospital firewalls, need for training, and CGM documentation. Nurses' perceived device accuracy and utility were exceptionally high. Solutions were devised to maximize facilitation and sustainability for nurses while maintaining patient safety. CONCLUSION: Outpatient CGM systems can be implemented in the MICU using a hybrid protocol implementation science approach. These efforts hold tremendous potential to reduce healthcare worker exposure while maintaining glucose control during the COVID-19 pandemic.

The Accuracy and Cost-Effectiveness of Selective Fetal Echocardiography for the Diagnosis of Congenital Heart Disease in Patients with Pregestational Diabetes Stratified by Hemoglobin A1c.

OBJECTIVE: To evaluate the accuracy of antenatal diagnosis of congenital heart disease (CHD) using screening methods including a combination of elevated hemoglobin A1c, detailed anatomy ultrasound, and fetal echocardiography. STUDY DESIGN: This is a retrospective cohort study of all pregnancies complicated by pregestational diabetes from January 2012 to December 2016. The sensitivity, specificity, positive predictive value, and negative predictive value were calculated for each screening regimen. The incremental cost-effectiveness ratio (ICER) was calculated for each regimen with effectiveness defined as additional CHD diagnosed. RESULTS: A total of 378 patients met inclusion criteria with an overall prevalence of CHD of 4.0% (n = 15). When compared with a detailed ultrasound, fetal echocardiography had a higher sensitivity (73.3 vs. 40.0%). However, all cases of major CHD were detected by detailed ultrasound (n = 6). Using an elevated early A1c > 7.7% and a detailed ultrasound resulted in a sensitivity and specificity of 60.0 and 99.4%, respectively. The use of selective fetal echocardiography for an A1c > 7.7% or abnormal detailed anatomy ultrasound would result in a 63.3% reduction in cost per each additional minor CHD diagnosed (ICER: $18,290.52 vs. $28,875.67). CONCLUSION: Fetal echocardiography appears to have limited diagnostic value in women with pregestational diabetes. However, these results may not be generalizable outside of a high-volume academic setting.

Using oral agents to manage gestational diabetes: what have we learned?

Insulin has been the mainstay of treatment of diabetes during pregnancy for decades. Although glyburide and metformin are classified as category B during pregnancy, recent research has suggested that these oral agents alone or in conjunction with insulin may be safe for the treatment of gestational diabetes (GDM). This paper summarizes the data on the use of glyburide and metformin for treatment of GDM.

Randomized Trial of Assisted Hybrid Closed-Loop Therapy Versus Sensor-Augmented Pump Therapy in Pregnancy.

Objective: Examine gestational safety, glycemic and health outcomes, of a hybrid closed-loop (HCL) system without pregnancy-specific glucose targets. Research Design: This was a pilot feasibility investigator-initiated, two-site, single-blind, randomized controlled trial of sensor-augmented pump therapy (SAPT) versus HCL therapy in type 1 diabetes pregnancies. Participants were enrolled in the first trimester and randomized at 14-18 weeks of gestation and used SAPT or HCL until 4-6 weeks postpartum. We compared continuous glucose monitoring (CGM) metrics, severe hypoglycemia (SH), diabetic ketoacidosis (DKA), adverse skin reactions, and pregnancy outcomes between groups. Results: Baseline characteristics were similar between groups (n = 11 HCL and n = 12 SAPT). There was no SH or DKA episode after randomization. Time spent <54 mg/dL did not differ between groups. Time spent <63 mg/dL decreased in both groups, significantly in the HCL group (3.5% [1.3% standard error] second trimester and 2.8% [1.3%] third trimester vs. 7.9% [1.3%] run-in phase, P < 0.05 for both). Mean sensor glucose was lower with SAPT compared to HCL therapy in the third trimester (119 [4] mg/dL SAPT vs. 132 [4] mg/dL HCL, P < 0.05). Third trimester time-in-range (TIR; 63-140 mg/dL) increased with SAPT (68.2% [3.1%] vs. 64.3% [3.1%] run-in phase, P < 0.05). Gestational health outcomes did not differ between groups. The HCL group used assistive techniques, such as fake carbohydrate boluses and exiting HCL overnight. Conclusions: CGM within group differences were seen for time <63 mg/dL favoring HCL therapy and TIR favoring SAPT (third trimester vs. baseline). Safety and adverse pregnancy outcomes were similar between groups.

Tandem T:Slim X2 Insulin Pump Use in Clinical Practice Among Pregnant Individuals With Type 1 Diabetes: A Retrospective Observational Cohort Study.

BACKGROUND: Insulin pump use is increasing in frequency among pregnant individuals with type 1 diabetes (T1D). Automated insulin delivery (AID) technologies have not been studied extensively in pregnancy. METHOD: We present a retrospective case series of eight individuals with T1D who used the Tandem t:slim X2 insulin pump (Tandem Diabetes Care, Inc., CA, USA) during pregnancy. Weekly continuous glucose monitor and insulin pump data were analyzed from electronic medical records and data-sharing portals. Safety, glycemic control, and pregnancy outcomes were examined with both the control IQ (CIQ) and basal IQ (BIQ) algorithms. RESULTS: Six CIQ and two BIQ users were studied. The mean glycated hemoglobin (A1C) during pregnancy was 6.1%, and the average time in pregnancy-recommended glycemic range (TIR; 63-140mg/dL) was 67.9%. There were no instances of diabetic ketoacidosis or severe hypoglycemia. CIQ users had a higher mean sensor glucose (127.6 mg/dL) compared to BIQ participants (118.4 mg/dL). However, the average time below range (<63 mg/dL) was 6.1% in BIQ participants compared to 1.5% in CIQ participants. CIQ participants used several strategies to achieve glycemic targets, including daytime use of sleep activity. An increased basal-to-bolus insulin ratio was negatively correlated with TIR (r=-0.415). CONCLUSIONS: Tandem t:slim X2 insulin pumps were safely used during pregnancy in eight individuals with T1D, with variable success in achieving recommended glycemic targets. Further research is needed to understand differences in CIQ and BIQ use in pregnancy. AID device manufacturers must additionally develop further methods to target lower glucose for pregnant users.

Expert Guidance on Off-Label Use of Hybrid Closed-Loop Therapy in Pregnancies Complicated by Diabetes.

Automated insulin delivery (AID) systems have established benefits in terms of glycemic control, health outcomes, and quality of life and are strongly recommended for people with type 1 diabetes outside of pregnancy. While evidence for use of investigational AID systems during pregnancy is promising, data and guidance are still needed regarding use of commercially available systems during pregnancy. Unfortunately, none of the hybrid closed-loop (HCL) systems that are currently available in the United States have glucose targets that are as aggressive as pregnancy glycemic targets, none have a pregnancy-specific algorithm, and none are approved for use during pregnancy. As such, any use of these systems during pregnancy is considered off-label in the United States and would be "assisted" by provider/user techniques. Despite these limitations, many women conceive while using clinically available HCL systems and may be hesitant to cease use during pregnancy. Achievement of strict pregnancy glycemic targets can be difficult, and it is conceivable that selective off-label use of clinically available HCL systems in some women could lead to improved glycemia. We herein offer expert guidance based on clinical experience and available case reports on how to identify appropriate candidates for HCL therapy in pregnancy, how to counsel pregnant women with diabetes on the potential risks and benefits of HCL therapy during pregnancy, and how to manage commercially available systems off-label throughout gestation in an assisted HCL approach.

Disparities in Continuous Glucose Monitoring Use Among Women of Reproductive Age with Type 1 Diabetes in the T1D Exchange.

We identified characteristics associated with continuous glucose monitoring (CGM) use in women of reproductive age with type 1 diabetes (T1D) in the T1D Exchange clinic registry from 2015 to 2018. Among 6643 assessed women, the frequency of CGM increased from 2015 to 2018 (20.6% vs. 30.0%; adjusted odds ratios [aOR]: 1.72; confidence interval [95% CI]: 1.51-1.95) and was more likely with recent pregnancy (45.3% vs. 25.8%; aOR: 1.63; 95% CI: 1.23-2.16). Non-Hispanic Black and Hispanic race and ethnicity, younger age, lower educational attainment, lower income, and Medicaid insurance were associated with lower odds of CGM. The use of CGM was associated with lower odds of diabetic ketoacidosis and lower hemoglobin A1c without any difference in the odds of symptomatic severe hypoglycemia. In conclusion, although CGM use was associated with better glycemic control, the majority of reproductive-age women still did not use it. Those who did not use CGM were more likely to be those at greatest risk of adverse pregnancy outcomes.

Management of type 1 diabetes in pregnancy: update on lifestyle, pharmacological treatment, and novel technologies for achieving glycaemic targets.

Glucose concentrations within target, appropriate gestational weight gain, adequate lifestyle, and, if necessary, antihypertensive treatment and low-dose aspirin reduces the risk of pre-eclampsia, preterm delivery, and other adverse pregnancy and neonatal outcomes in pregnancies complicated by type 1 diabetes. Despite the increasing use of diabetes technology (ie, continuous glucose monitoring and insulin pumps), the target of more than 70% time in range in pregnancy (TIRp 3·5-7·8 mmol/L) is often reached only in the final weeks of pregnancy, which is too late for beneficial effects on pregnancy outcomes. Hybrid closed-loop (HCL) insulin delivery systems are emerging as promising treatment options in pregnancy. In this Review, we discuss the latest evidence on pre-pregnancy care, management of diabetes-related complications, lifestyle recommendations, gestational weight gain, antihypertensive treatment, aspirin prophylaxis, and the use of novel technologies for achieving and maintaining glycaemic targets during pregnancy in women with type 1 diabetes. In addition, the importance of effective clinical and psychosocial support for pregnant women with type 1 diabetes is also highlighted. We also discuss the contemporary studies examining HCL systems in type 1 diabetes during pregnancies.

Influence of Literacy, Self-Efficacy, and Social Support on Diabetes-Related Outcomes Following Hospital Discharge.

Objective: To evaluate the relationship between health literacy, social support, and self-efficacy as predictors of change in A1c and readmission among hospitalized patients with type 2 diabetes (T2D). Methods: This is a secondary analysis of patients with T2D (A1c >8.5%) enrolled in a randomized trial in which health literacy (Newest Vital Sign), social support (Multidimensional Scale of Perceived Social Support), and empowerment (Diabetes Empowerment Scale-Short Form) was assessed at baseline. Multivariable models evaluated whether these concepts were associated with A1c reduction at 12 weeks (absolute change, % with >1% reduction, % reaching individualized target) and readmission (14 and 30 days). Results: A1c (N=108) decreased >1% in 60%, while individualized A1c target was achieved in 31%. After adjustment for baseline A1c and potential confounders, health literacy was associated with significant reduction in A1c (Estimate -0.21, 95% CI -0.40, -0.01, p=0.041) and >1% decrease in A1c (OR 1.37, 95% CI 1.08, 1.73, p=0.009). However, higher social support was associated with greater adjusted odds of reaching the individualized A1c target (OR 1.63, 95% CI 1.04, 2.55, p=0.32). Both higher empowerment (OR 0.23, 95% CI 0.08, 0.64, p=0.005) and social support (OR 0.57, 95% CI 0.36, 0.91, p=0.018) were associated with fewer readmissions by 14 days, but not 30 days. Conclusion: The study indicates that health literacy and social support may be important predictors of A1c reduction post-discharge among hospitalized patients with T2D. Social support and diabetes self-management skills should be addressed and early follow-up may be critical for avoiding readmissions. Clinical Trial: NCT03455985.

Association Between Social Vulnerability and Achieving Glycemic Control Among Pregnant Individuals With Pregestational Diabetes.

OBJECTIVE: To evaluate the association between community-level social vulnerability and achieving glycemic control (defined as hemoglobin A1c [Hb A1c] less than 6.0% or less than 6.5%) among individuals with pregestational diabetes. METHODS: We conducted a retrospective cohort of individuals with pregestational diabetes with singleton gestations from 2012 to 2016 at a tertiary care center. Addresses were geocoded using ArcGIS and then linked at the census tract to the Centers for Disease Control and Prevention's 2018 SVI (Social Vulnerability Index), which incorporates 15 Census variables to produce a composite score and four scores across thematic domains (socioeconomic status, household composition and disability, minority status and language, and housing type and transportation). Scores range from 0 to 1, with higher values indicating greater community-level social vulnerability. The primary outcome was Hb A1c less than 6.0%, and, secondarily, Hb A1c less than 6.5%, in the second or third trimesters. Multivariable Poisson regression with robust error variance was used to evaluate the association between SVI score as a continuous measure and target Hb A1c. RESULTS: Among 418 assessed pregnant individuals (33.0% type 1; 67.0% type 2 diabetes), 41.4% (173/418) achieved Hb A1c less than 6.0%, and 56.7% (237/418) Hb A1c less than 6.5% at a mean gestational age of 29.5 weeks (SD 5.78). Pregnant individuals with a higher SVI score were less likely to achieve Hb A1c less than 6.0% compared with those with a lower SVI score. For each 0.1-unit increase in SVI score, the risk of achieving Hb A1c less than 6.0% decreased by nearly 50% (adjusted risk ratio [aRR] 0.53; 95% CI 0.36-0.77), and by more than 30% for Hb A1c less than 6.5% (adjusted odds ratio 0.67; 95% CI 0.51-0.88). With regard to specific SVI domains, those who scored higher on socioeconomic status (aRR 0.50; 95% CI 0.35-0.71) as well as on household composition and disability (aRR 0.55; 95% CI 0.38-0.79) were less likely to achieve Hb A1c less than 6.0%. CONCLUSION: Pregnant individuals with pregestational diabetes living in an area with higher social vulnerability were less likely to achieve glycemic control, as measured by HgbA1c levels. Interventions are needed to assess whether addressing social determinants of health can improve glycemic control in pregnancy.

Effectiveness of a Diabetes-Focused Electronic Discharge Order Set and Postdischarge Nursing Support Among Poorly Controlled Hospitalized Patients: Randomized Controlled Trial.

BACKGROUND: Although the use of electronic order sets has become standard practice for inpatient diabetes management, there is limited decision support at discharge. OBJECTIVE: In this study, we assessed whether an electronic discharge order set (DOS) plus nurse follow-up calls improve discharge orders and postdischarge outcomes among hospitalized patients with type 2 diabetes mellitus. METHODS: This was a randomized, open-label, single center study that compared an electronic DOS and nurse phone calls to enhanced standard care (ESC) in hospitalized insulin-requiring patients with type 2 diabetes mellitus. The primary outcome was change in glycated hemoglobin (HbA1c) level at 24 weeks after discharge. The secondary outcomes included the completeness and accuracy of discharge prescriptions related to diabetes. RESULTS: This study was stopped early because of feasibility concerns related to the long-term follow-up. However, 158 participants were enrolled (DOS: n=82; ESC: n=76), of whom 155 had discharge data. The DOS group had a greater frequency of prescriptions for bolus insulin (78% vs 44%; P=.01), needles or syringes (95% vs 63%; P=.03), and glucometers (86% vs 36%; P<.001). The clarity of the orders was similar. HbA1c data were available for 54 participants in each arm at 12 weeks and for 44 and 45 participants in the DOS and ESC arms, respectively, at 24 weeks. The unadjusted difference in change in HbA1c level (DOS - ESC) was -0.6% (SD 0.4%; P=.18) at 12 weeks and -1.1% (SD 0.4%; P=.01) at 24 weeks. The adjusted difference in change in HbA1c level was -0.5% (SD 0.4%; P=.20) at 12 weeks and -0.7% (SD 0.4%; P=.09) at 24 weeks. The achievement of the individualized HbA1c target was greater in the DOS group at 12 weeks but not at 24 weeks. CONCLUSIONS: An intervention that included a DOS plus a postdischarge nurse phone call resulted in more complete discharge prescriptions. The assessment of postdischarge outcomes was limited, owing to the loss of the long-term follow-up, but it suggested a possible benefit in glucose control. TRIAL REGISTRATION: ClinicalTrials.gov NCT03455985; https://clinicaltrials.gov/ct2/show/NCT03455985.

Type 1 Diabetes: Management in Women From Preconception to Postpartum.

CONTEXT: This review presents an up-to-date summary on management of type 1 diabetes mellitus (T1DM) among women of reproductive age and covers the following time periods: preconception, gestation, and postpartum. EVIDENCE ACQUISITION: A systematic search and review of the literature for randomized controlled trials and other studies evaluating management of T1DM before pregnancy, during pregnancy, and postpartum was performed. EVIDENCE SYNTHESIS: Preconception planning should begin early in the reproductive years for young women with T1DM. Preconception and during pregnancy, it is recommended to have near-normal glucose values to prevent adverse maternal and neonatal outcomes, including fetal demise, congenital anomaly, pre-eclampsia, macrosomia, neonatal respiratory distress, neonatal hyperbilirubinemia, and neonatal hypoglycemia. CONCLUSION: Women with T1DM can have healthy, safe pregnancies with preconception planning, optimal glycemic control, and multidisciplinary care.

Exploratory Analysis of Glycemic Control and Variability Over Gestation Among Pregnant Women with Type 1 Diabetes.

In exploratory analyses, we evaluated glycemic variability (GV) and gestational outcomes in pregnant women (n = 28) with type 1 diabetes (T1D). Gestational age at delivery was higher for women with lower glycemic measures, including estimated HbA1c (eHbA1c) (0.14% decrease in HbA1c per 1-week greater gestational age, P = 0.0035), mean sensor glucose (-3.9 mg/dL P = 0.0039), time spent >140 mg/dL (-3.1%, P = 0.0029), and higher time in range (TIR) of 63-140 mg/dL (3.2%, P = 0.0029). Third trimester measured HbA1c was significantly associated with gestational age at delivery (P = 0.0081). Preeclampsia was associated with less TIR in first (50.5% vs. 69.9%, P = 0.0034) and second trimesters (47.1% vs. 66.7%, P = 0.0025), but not with measured HbA1c. There were significant differences in other markers of GV (continuous overall net glycemic action, high blood glucose index, J-index, mean amplitude of glycemic excursions) with infant birth weight and gestational age at delivery. Thus, multiple markers of glycemia and GV were associated with gestational health outcomes in T1D pregnancies in this pilot study. Clinical Trial Registration number: NCT02556554.

Use of Continuous Glucose Monitor in Critically Ill COVID-19 Patients Requiring Insulin Infusion: An Observational Study.

CONTEXT: The coronavirus disease 2019 (COVID-19) pandemic has created a need for remote blood glucose (BG) monitoring in the intensive care unit (ICU). OBJECTIVE: To evaluate feasibility and patient safety of a hybrid monitoring strategy of point-of-care (POC) BG plus continuous glucose monitor (CGM) in the ICU. DESIGN: Retrospective analysis. SETTING: ICU of an academic medical center. PATIENTS: Patients with COVID-19 on IV insulin. INTERVENTION: After meeting initial validation criteria, CGM was used for IV insulin titration and POC BG was performed every 6 hours or as needed. MAIN OUTCOME MEASURES: Outcomes included frequency of POC BG, workflow, safety, and accuracy measures. RESULTS: The study included 19 patients, 18 with CGM data, mean age 58 years, 89% on mechanical ventilation, 37% on vasopressors, and 42% on dialysis. The median time to CGM validation was 137 minutes (interquartile range [IQR] 114-206). During IV insulin, the median number of POC values was 7 (IQR 6-16) on day 1, and declined slightly thereafter (71% reduction compared with standard of 24/day). The median number of CGM values used nonadjunctively to titrate IV insulin was 11.5 (IQR 0, 15) on day 1 and increased thereafter. Time in range 70 to 180 mg/dL was 64 ± 23% on day 1 and 72 ± 16% on days 2 through 7, whereas time <70 mg/dL was 1.5 ± 4.1% on day 1 and <1% on days 2 through 7. CONCLUSIONS: This study provides data to support that CGM using a hybrid protocol is feasible, accurate, safe, and has potential to reduce nursing and staff workload.

The use of longitudinal hemoglobin A1c values to predict adverse obstetric and neonatal outcomes in pregnancies complicated by pregestational diabetes.

BACKGROUND: Although an elevated early pregnancy hemoglobin A1c has been associated with both spontaneous abortion and congenital anomalies, it is unclear whether A1c assessment is of value beyond the first trimester in pregnancies complicated by pregestational diabetes. OBJECTIVE: We sought to investigate the prognostic ability of longitudinal A1c assessment to predict obstetric and neonatal adverse outcomes based on degree of glycemic control in early and late pregnancy. MATERIALS AND METHODS: This was a retrospective cohort study of all pregnancies complicated by pregestational diabetes from January 2012 to December 2016 at The Ohio State University Wexner Medical Center with both an early A1c (<20 weeks' gestation) and late A1c (>26 weeks' gestation) available for analysis. Patients were categorized by good (early and late A1c <6.5%), improved (early A1c >6.5% and late A1c <6.5%) and poor (late A1c >6.5%) glycemic control. A multivariate regression model was used to calculate adjusted odds ratios (aOR) for each identified obstetric and neonatal outcome, controlling for maternal age, body mass index, race/ethnicity, type of diabetes, and gestational age at delivery compared to good control as the referent group. RESULTS: A total of 341 patients met inclusion criteria during the study period. The median A1c values improved from early to late gestation in the good (5.7% [interquartile range [IQR], 5.4-6.1%] versus 5.4%; [IQR 5.2-5.7%]), improved (7.5% [IQR, 6.7-8.5] versus 5.9% [IQR, 5.6-6.1%]) and poor (8.3% [IQR, 7.1-9.6%] versus 7.3% [IQR, 6.8-7.9%]) glycemic control groups. There were no statistically significant differences in the rate of adverse outcomes between the good and improved groups except for an increased rate of neonatal intensive care unit admissions in the improved group (aOR, 3.7; confidence interval [CI], 1.9-7.3). In contrast, the poor control group had an increased rate of shoulder dystocia (aOR, 6.8; CI, 1.4-34.0), preterm delivery (aOR, 3.9; CI, 2.1-7.3), neonatal intensive care unit admission (aOR, 2.8; CI, 1.4-5.3), respiratory distress syndrome (aOR, 3.0; CI, 1.1-8.0), hypoglycemia (aOR, 3.2; CI, 1.5-6.9), large for gestational age weight at birth (aOR, 2.7; CI, 1.5-4.9), neonatal length of stay >4 days (aOR, 3.1; CI, 1.6-6.0) and preeclampsia (aOR, 2.4; CI, 1.2-4.6). There were no differences in rates of cesarean delivery, umbilical artery pH <7.1, or Apgar score <7 at 5 minutes after regression analysis. CONCLUSION: Antenatal hemoglobin A1c values are useful for objective risk stratification of patients with pregestational diabetes. Strict glycemic control throughout pregnancy with a late pregnancy A1c target of <6.5% leads to reduced rates of obstetric and neonatal adverse outcomes independent of early pregnancy glucose control.