Kartik Kailas Venkatesh

Insulin U-500 is a highly concentrated regular insulin that is five times stronger than standard U-100 and is used to treat severe insulin resistance. Glycemic data from continuous glucose monitoring (CGM) in relation to initiation of U-500 insulin in pregnancy with type 2 diabetes are limited. We examined CGM-derived glycemic measures before and after insulin U-500 transition during pregnancy among women with type 2 diabetes. We conducted a case-crossover study evaluating glycemic measures before and after transition to insulin U-500 during pregnancy among women with type 2 diabetes. The case period was from prenatal care to insulin U-500 transition, and the control period was after insulin U-500 transition to delivery. Outcomes included CGM metrics (time in range [TIR; 65–140 mg/dL], time above range [TAR], and time below range), mean glucose and standard deviation, estimated A1c per glucose management indicator, coefficient of variation, and number of hypoglycemic episodes and were compared pre versus post insulin U-500 transition. Adjusted linear mixed models were used. Among 21 women with type 2 diabetes, the median gestational age at prenatal care initiation was 11.1 weeks, at insulin U-500 transition was 25.4 weeks, and at delivery was 37.1 weeks. The insulin U-500 dose at initiation was 300 units/day and at delivery was 422.5 units/day. The TIR was higher, and TAR and mean glucose were lower post versus pre insulin U-500 transition (p < 0.05). In this cohort of pregnant women with type 2 diabetes, transition to insulin U-500 was associated with a modest improvement in some CGM-derived glycemic measures.

Background: Social determinants of health (SDOH) influence maternal cardiovascular health (CVH), but the extent to which SDOH in early pregnancy may explain racial and ethnic differences in post-pregnancy CVH has not been defined. Methods: This secondary analysis used data from the prospective multisite Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be Heart Health Study. CVH was assessed in early pregnancy and 2-7 years after delivery using the American Heart Association's Life's Essential 8 (LE8) framework. We used the Oaxaca-Blinder decomposition to quantify the statistical contributions of differences in early pregnancy CVH, SDOH, psychosocial factors, and demographic covariates to racial and ethnic differences in post-pregnancy CVH between the two largest minoritized racial and ethnic groups (non-Hispanic [NH] Black and Hispanic) compared with NH White women. Results: Among 4,088 women (14.4% Black, 17.6% Hispanic, and 68.0% White), the mean (SD) post-pregnancy LE8 score was lower in Black (70.1 [14.1]) and Hispanic (77.8 [12.7]) women compared with White women (82.4 [12.7]) (all p<0.01). Independent of early pregnancy CVH, maternal age, and nativity, differences in SDOH were associated with 4.5 (95% CI, 2.8-6.2) points of the Black-White gap (37% of the observed post-pregnancy CVH difference) and 3.2 (95% CI, 1.1-5.3) points of the Hispanic-White gap (70% of the observed post-pregnancy CVH difference), respectively. Conclusions: Most racial and ethnic differences in post-pregnancy CVH 2 to 7 years after a first birth were explained by differences in early pregnancy CVH and SDOH. Independent of early pregnancy CVH, SDOH remained the largest measured contributor to the residual difference.

Objective: Pregnant women with type 1 diabetes (T1D) increasingly utilize hybrid closed‐loop (HCL) pumps, but pregnancy‐specific algorithms in many countries including the United States are not available. We compared pregnancy and glycemic outcomes between those intending to use off‐label automated HCL versus manual sensor‐augmented pump therapy (SAPT). Methods: We conducted a single‐center retrospective study from 2022 to 2025. The exposure was intent to use HCL using non‐pregnancy algorithms versus SAPT (reference) at the start of pregnancy. Outcomes included pregnancy outcomes (cesarean delivery, preeclampsia, preterm birth, small‐ and large‐for‐gestational‐age, neonatal intensive care unit admission, neonatal hypoglycemia, neonatal hyperbilirubinemia, and respiratory distress syndrome) and glycemic measures the week before delivery (hemoglobin A1c and continuous glucose monitor metrics including time in range within a pregnancy‐specific range [63–140 mg/dL], time above and below range, standard deviation, and mean glucose). An Inverse‐Probability‐of‐Treatment Weighting analytic approach was used. Results: Among 154 women with T1D, 68.2% intended to use HCL and 31.8% SAPT when initiating prenatal care (median gestational age of 8.0 weeks [interquartile range {IQR}, 7.3, 9.3]). In adjusted analyses, women using HCL had neonates with a higher birthweight (3640 vs. 3430 g; adj. beta, 271.98; 95% CI, 0.31, 543.65) and mean sensor glucose the week prior to delivery (150.0 vs. 145.0 mg/dL; adj. beta, 13.36; 95% CI, 0.79, 25.93) and lower time below range compared with those using SAPT (2.0 vs. 4.0%; adj. beta, −3.73; 95% CI, −6.52, −0.93). Other pregnancy and glycemic outcomes did not differ between groups. Conclusion: Among a US cohort with T1D enrolled in a prenatal and diabetes care program, pregnancy and glycemic outcomes were similar between those using off‐label HCL versus SAPT. Evaluating how HCL with pregnancy‐specific algorithms can be used to promote maternal and child health could be most helpful for pregnant women with T1D and should be a research priority.

Introduction: Pregestational diabetes is one of the most frequent medical conditions in pregnancy. Nutrition insecurity is a non-medical, health-related social need and affects glycaemic management and pregnancy outcomes for women with both type 1 and type 2 pregestational diabetes. Collaborative healthcare-community partnerships to enhance food access, facilitate culinary medicine, diabetes self-management education and support (DSMES) and address unmet social needs for pregnant women with pregestational diabetes remain to be evaluated. Methods and analysis: In a two-arm randomised controlled trial, we will examine the combined effects of a tripartite NOURISH intervention ((1) produce home delivery, (2) culinary medicine with DSMES and (3) community health worker-led social needs assessment and support) versus the current standard of diabetes and prenatal care. We will recruit and enrol 174 pregnant women (87 NOURISH, 87 standard care) ≤22+6 weeks of gestation with pregestational diabetes, inadequate glycaemic management (haemoglobin A1c≥6.5%) and self-reported risk of food insecurity from a diabetes and prenatal care programme at a tertiary care academic health system located in the USA. We will measure the primary outcome of glycaemic management by delivery (haemoglobin A1c<6.5%), and secondarily, adverse pregnancy outcomes (gestational weight gain and composite neonatal morbidity) and patient-reported outcomes (nutrition security). We will also use cost-effectiveness analysis to assess the intervention’s value relative to standard care and use process evaluation to characterise intervention and contextual factors influencing uptake, effectiveness and sustainability. Ethics and dissemination: The Institutional Review Board at The Ohio State University approved this study (IRB: STUDY20260307; date: 23 April 2026). We plan to submit results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings. Trial registration number: NCT07560813 .

OBJECTIVE: The association of gestational diabetes mellitus (GDM) subtypes with maternal cardiometabolic health is not known. We examined whether GDM subtypes were differentially associated with cardiometabolic health 10–14 years after delivery. RESEARCH DESIGN AND METHODS: We used data from the prospective Hyperglycemia and Adverse Pregnancy Outcome Follow-Up Study. The exposure was GDM subtype (insulin deficient, insulin resistant, mixed defect, unclassified). The outcomes were prediabetes or diabetes and, secondarily, hypertension, dyslipidemia, metabolic syndrome, and predicted cardiovascular disease. RESULTS: Of 4,693 women, 3.0% had insulin-deficient, 9.0% insulin-resistant, 1.6% mixed-defect, and 0.7% unclassified GDM. Compared with no GDM, all GDM subtypes except unclassified were associated with higher risk of prediabetes or diabetes (adjusted risk ratios 2.14–2.88), metabolic syndrome, and predicted cardiovascular disease. Only insulin-resistant GDM was associated with dyslipidemia. CONCLUSIONS: All GDM subtypes were associated with an increased risk of prediabetes or diabetes, metabolic syndrome, and high predicted cardiovascular disease 10–14 years after delivery.

OBJECTIVE: To examine the intersectionality of three frequently measured neighborhood social determinants during pregnancy—socioeconomic disadvantage, food access, and walkability—and their collective association with nulliparous term, singleton, vertex (NTSV) cesarean delivery. METHODS: This was a secondary analysis of data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-To-Be observational cohort. Home addresses in the first trimester were geocoded at the census-tract level to define three adverse neighborhood measures: 1) socioeconomic disadvantage by the Area Deprivation Index (in tertiles), 2) low food access by the U.S. Department of Agriculture Food Access Research Atlas (yes/no), and 3) low walkability by the Environmental Protection Agency National Walkability Score (yes/no). The exposure was the number of neighborhood adverse social determinants and was assessed by number (0, 1, 2 or more) and specific combinations. The outcome was NTSV cesarean delivery. Multivariable modified Poisson regression with robust error variance was used. We secondarily assessed the distribution of clinical indications for cesarean delivery and whether associations between neighborhood social determinants and cesarean delivery varied by self-reported race and ethnicity. RESULTS: Among 8,010 nulliparous individuals with NTSV deliveries, 27.3% lived in a neighborhood in the top tertile of socioeconomic disadvantage, 24.5% with low food access, and 66.4% with low walkability. The risk of NTSV cesarean delivery was higher only among individuals living in neighborhoods with low walkability (adjusted relative risk [RR] 1.17, 95% CI, 1.06–1.28). Individuals exposed to one (adjusted RR 1.14, 95% CI, 1.01–1.27) or two or more (adjusted RR 1.19, 95% CI, 1.06–1.34) compared with no adverse neighborhood social determinants had a higher risk of cesarean delivery. Individuals living in neighborhoods with low walkability and high socioeconomic disadvantage (adjusted RR 1.21, 95% CI, 1.03–1.41) or low walkability and low food access (adjusted RR 1.20, 95% CI, 1.05–1.37) had a higher risk of cesarean delivery. The frequency of all three adverse neighborhood social determinants was higher for non-Hispanic Black and Hispanic individuals compared with non-Hispanic White individuals ( P <.05), but the above association between neighborhood social determinants and cesarean delivery did not vary by self-reported race and ethnicity (adjusted interaction P =.6). CONCLUSION: In a prospective U.S. cohort, living in a neighborhood with low walkability, alone and in combination with socioeconomic disadvantage and food access, was associated with an increased risk of NTSV cesarean delivery.

1. Young-onset type 2 diabetes mellitus (YOT2D) is generally defined as a diagnosis of type 2 diabetes (T2D) at under 40 years of age (albeit earlier age cutoffs of 30 and 35 years have been used i...

We examined the association between fetal sex and the risk of maternal prediabetes or diabetes 10 to 14 years after delivery. Secondarily, we assessed whether this association varied by gestational diabetes mellitus (GDM) status and whether measures of maternal insulin sensitivity and resistance varied by fetal sex. This is a secondary analysis from the prospective, international Hyperglycemia and Adverse Pregnancy Outcome Follow-Up Study (HAPO FUS). The exposure was assigned fetal sex at birth (female as the reference). The primary outcome was prediabetes or diabetes assessed 10 to 14 years after the index pregnancy. The effect modifier was GDM per the International Association of Diabetes and Pregnancy Study Group criteria. Modified Poisson regression models were used and adjusted for baseline covariates at enrollment and time from enrollment to follow-up. We secondarily assessed whether the association between fetal sex and prediabetes or diabetes varied by GDM and whether maternal insulin sensitivity at pregnancy enrollment and insulin resistance at 10- to 14-year follow-up differed by fetal sex. Of 4,609 individuals in the analytic sample, 48.9% of infants were assigned female sex at birth, which was 47.1% with GDM and 49.2% without GDM (p = 0.3). At a median of 11.6 years after delivery, 22.4% postpartum individuals developed prediabetes, and 2.9% developed diabetes. The risk of prediabetes or diabetes did not differ by fetal sex (female vs. male: 24.7 vs. 24.6%; adjusted risk ratio: 1.00, 95% CI: 0.89, 1.12). This association was similar regardless of GDM status (interaction p = 0.6). There was no association between fetal sex and insulin sensitivity at enrollment or insulin resistance at follow-up. In the prospective HAPO FUS cohort, there was no association between fetal sex and the risk of maternal prediabetes or diabetes 10 to 14 years after delivery. Further research is needed to better understand the possible impact of fetal sex on peripartum glucose homeostasis.

Objective: To refine a pre‐existing predictive model (“the original calculator”) for postpartum readmission for hypertensive disorders of pregnancy (HDP), and to assess whether model performance is further enhanced by adding neighborhood‐level social determinants of health (SDOH). Design: We conducted a retrospective cohort study of deliveries and readmissions from 2019 to 2022. Setting: Two hospital systems in the southwestern United States. Site‐stratified analysis was planned due to differences in patient demographics at each hospital. Participants: Participants included any person 18 years of age or older who delivered a live‐ or stillborn singleton neonate at 20 weeks or greater during the study period. Only the first pregnancy was included for those patients who had more than one delivery in the study period. Methods: Postpartum readmission for HDP included inpatient stays with a diagnostic code of HDP occurring 1–42 days postdelivery discharge. Each hospital cohort's data were input to the original calculator to externally validate that model. Predictive model recalibration was then performed individually for each hospital's cohort. Model performance was measured using the concordance statistic (c‐statistic), Akaike Information Criterion (AIC), and calibration curves. The census tract‐level Social Vulnerability Index (SVI) score was added as a variable to the recalibrated calculators. Incremental prognostic information added by the SVI variable was measured in recalibrated models. The study received human subjects approval from our institutional review board. Results: The frequency of readmission at Ben Taub Hospital (BTH) was 0.5% (48 readmissions/8646 deliveries) and at Texas Children's Hospital Pavilion for Women (PFW) was 0.7% (163 readmissions/22,966 deliveries). The median SVI score among readmitted patients was 0.84 (interquartile range [IQR] 0.71, 0.96) and 0.46 (IQR 0.18, 0.70) at BTH and PFW, respectively. Model discrimination for each of our cohorts using the original calculator was satisfactory, albeit with lower discriminative ability (c‐statistics were 0.71 and 0.61 for BTH and PFW, respectively), compared with the original calculator's cohort (c‐statistic 0.80). Model recalibration and re‐estimation were done for the existing variable coefficients. This recalibration demonstrated improved discriminative ability (c‐statistics for BTH and PFW were 0.84 and 0.74, respectively). Decision curve analyses showed a net benefit to using the recalibrated calculators when the average risk of readmission was between 0% and 3% (or three times the average rate). Addition of SVI to the model improved overall model fit for BTH (AIC 555 vs. 523) and for PFW (AIC 1850 vs. 1533). SVI added 2.0% to 3.4% additional prognostic information to BTH's model, and 36% to 50% additional prognostic information to PFW's model. Conclusions and relevance: Refitting a pre‐existing risk prediction model on our hospital cohorts showed improved model performance compared with using the original calculator as published. Our models’ performances were slightly improved with the addition of the SVI variable. We highlight important risk factors to consider in calculators in development at other institutions, and emphasize that for postpartum HDP readmission, calculators should be context‐specific and require local recalibration for optimal use.

Metformin is increasingly being used to treat gestational diabetes mellitus (GDM). But pharmacotherapy with metformin frequently requires insulin supplementation to achieve glucose control, and this remains poorly characterized. We identified factors associated with insulin supplementation of metformin versus receipt of metformin alone, and then examined whether these two groups differed in the frequency of adverse pregnancy outcomes (APOs) among individuals with GDM.We conducted a retrospective analysis of a U.S. GDM care program from 2018 to 2021, which first initiated metformin. Modified Poisson regression was used to identify risk factors associated with later insulin supplementation after initial metformin treatment, and stepwise regression was used to identify the most predictive factors. A propensity matched analysis was used to examine the association between metformin with insulin supplementation versus metformin alone (reference) with APOs (hypertensive disorders of pregnancy [HDP], preterm birth [PTB], small for gestational age [SGA], large for gestational age [LGA], and neonatal intensive care unit [NICU] admission). Among 399 deliveries with GDM that initiated metformin, 28.8% required insulin supplementation. Factors associated with an increased risk of insulin supplementation were older age, private insurance, and a higher mean screening glucose tolerance test; factors associated with a decreased risk were later GDM diagnosis and Black and Hispanic race and ethnicity. Individuals who required metformin with insulin supplementation had a higher risk of LGA birth (28.6 vs. 13.9%; adjusted risk ratio [aRR]: 1.89; 95% CI: 1.18, 3.02) and NICU admission (25.8 vs. 13.5%; aRR: 1.79; 95% CI: 1.11, 2.88). Multiple patient characteristics were associated with insulin supplementation after starting metformin to treat GDM. Pregnant individuals with GDM who required insulin supplementation of metformin had a higher risk of LGA and NICU admission.