Diabetes Care
· 2026 Jun · PMID 42319764
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OBJECTIVE: To describe trends in the prevalence of gestational diabetes mellitus (GDM), pregestational diabetes mellitus (type 1 and type 2), and severe maternal morbidity (SMM) in the U.S., and to examine associations b...OBJECTIVE: To describe trends in the prevalence of gestational diabetes mellitus (GDM), pregestational diabetes mellitus (type 1 and type 2), and severe maternal morbidity (SMM) in the U.S., and to examine associations between diabetes status and type with SMM. RESEARCH DESIGN AND METHODS: This retrospective study used 2016-2022 data from the Healthcare Cost and Utilization Project National Inpatient Sample. Delivery hospitalizations among women ages 12-55 years were identified. Modified Poisson regression models were used to estimate relative risks (RRs) for overall and nontransfusion SMM, adjusting for sociodemographic and clinical characteristics. RESULTS: Among 25,138,817 delivery hospitalizations, the prevalence of GDM increased from 7.1 to 9.5 per 100 deliveries, pregestational diabetes mellitus type 2 increased from 0.8 to 1.1 per 100 deliveries, and pregestational diabetes mellitus type 1 remained stable at 0.3 per 100 deliveries from 2016 to 2022. Overall SMM increased from 160.0 to 220.3 per 10,000 deliveries; nontransfusion SMM increased from 72.0 to 93.0 per 10,000 deliveries. In sociodemographic-adjusted models, compared with women without diabetes, type 1 diabetes was associated with the highest risk of nontransfusion SMM (RR 4.94; 95% CI 4.55-5.35), followed by type 2 diabetes (RR 2.58; 95% CI 2.43-2.74) and GDM (RR 1.12; 95% CI 1.08-1.15). CONCLUSIONS: From 2016 to 2022, GDM and pregestational diabetes mellitus type 2 rose in parallel with increasing SMM. While GDM was the most prevalent, pregestational diabetes mellitus, particularly type 1, was associated with a higher risk of SMM. The increased risk for SMM associated with all forms of diabetes in pregnancy highlights the importance of cardiometabolic risk management and the need for comprehensive, multidisciplinary care during pregnancy and delivery.
Reaven PD, Macwan SA, McConeghy K
… +4 more, Norman GJ, Conlin PR, Miller DR, Zhou JJ
Diabetes Care
· 2026 Jun · PMID 42319755
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OBJECTIVE: Use of continuous glucose monitors (CGM) improves glucose control and reduces hypoglycemia, but data are lacking for its possible role in reducing other serious clinical events. RESEARCH DESIGN AND METHODS: We...OBJECTIVE: Use of continuous glucose monitors (CGM) improves glucose control and reduces hypoglycemia, but data are lacking for its possible role in reducing other serious clinical events. RESEARCH DESIGN AND METHODS: We conducted a target trial emulation (TTE) analysis in patients with type 1 diabetes (T1D) comparing all-cause mortality between CGM users and non-CGM users using observational health records from the Veterans Health Administration. Participants included adult T1D patients who had their second endocrine visit (time zero) during years 2017-2020. Each patient was cloned to both treatment strategies but was censored if observed care deviated from the assigned strategy (artificial censoring) during the 6-month grace period. Inverse probability weights accounted for artificial censoring, and negative outcomes examined residual confounding. RESULTS: Of the 8,423 individuals initially assigned to both treatment groups, 1,039 were prescribed CGM devices, while 7,399 were not censored or assigned CGM during the grace period. Mortality was lower with CGM initiation, yielding adjusted risk ratios of 0.90 (95% CI 0.71-0.97) to 0.84 (CI 0.72-0.97) over 1-4 years of follow-up. Similar risk ratios were seen with different grace periods (3 or 9 months). Those age >65 years or not on insulin pumps appeared to have greater benefit, but effects did not vary by HbA1c, race or ethnicity, or frailty. Risk ratios did not differ between groups for incident nondiabetes outcomes, including outpatient or inpatient musculoskeletal or gastrointestinal conditions. CONCLUSIONS: In this large TTE of CGM initiation in older T1D patients, CGM use was associated with reduced risk for all-cause mortality.
Ruelas V, Bernstein M, Flores Garcia J
… +2 more, Topalis K, Peters AL
Diabetes Care
· 2026 Jun · PMID 42312902
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OBJECTIVE: Because of a computer-based prior authorization (PA) centralized system failure, Medi-Cal authorities temporarily suspended PA requirements for continuous glucose monitoring (CGM) and insulin pumps, including...OBJECTIVE: Because of a computer-based prior authorization (PA) centralized system failure, Medi-Cal authorities temporarily suspended PA requirements for continuous glucose monitoring (CGM) and insulin pumps, including automated insulin delivery systems, for 18 months. We assessed whether this PA-free period improved access to diabetes technology or impacted glycemic control. RESEARCH DESIGN AND METHODS: We conducted a retrospective chart review of 105 adults with type 1 diabetes in a safety net clinic across two sequential policy periods: PA-required and PA-free. Observational outcomes included device prescriptions, delays, denials, device receipt, and HbA1c. Paired t tests (α = 0.05) assessed HbA1c changes; descriptive statistics summarized access. Definitions for delay and access outcomes were standardized a priori. RESULTS: During the PA-required period, 32 CGM prescriptions were written; 46% were delayed (mean: 82 days), and 21% were denied. During the PA-free period, 27 new CGM prescriptions were written; approvals increased, and mean delay decreased to 40 days, although delays persisted. CGM use increased from 36.2% to 81.0%, and pump use increased from 16 to 25 patients. Mean HbA1c decreased from 9.1%, 76 mmol/mol (SD = 2.16), to 8.5%, 69 mmol/mol (SD = 1.89) (P = 0.032). CONCLUSIONS: Removal of PA requirements was associated with improved access to diabetes technology and clinically meaningful HbA1c reductions. Residual barriers highlight persistent structural inequities. Findings support policies that reduce administrative burden for clinically indicated populations.
Güdemann LM, Angwin C, Holman RR
… +8 more, Sattar N, Pearson ER, Murray Leech J, Patel KA, Hattersley AT, Dennis JM, Shields BM, Jones AG
Diabetes Care
· 2026 Jun · PMID 42312889
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OBJECTIVE: Different precision treatment approaches have been proposed for type 2 diabetes, but robust comparisons are lacking. We compared the utility of proposed approaches targeting glucose-lowering therapy in the Tri...OBJECTIVE: Different precision treatment approaches have been proposed for type 2 diabetes, but robust comparisons are lacking. We compared the utility of proposed approaches targeting glucose-lowering therapy in the TriMaster three-way crossover trial. RESEARCH DESIGN AND METHODS: We evaluated four previously reported precision treatment strategies for their ability to predict overall 4-month HbA1c response and within-person differential response to sitagliptin, canagliflozin, and pioglitazone in 309 adults with type 2 diabetes who received all three medications. Approaches included allocation to clusters based on routine features and HOMA, direct outcome prediction using a routine-features treatment-selection model, type 2 diabetes cluster-specific partitioned polygenic scores (PPSs), and a model based on discriminative dimensionality reduction tree (DDRTree) analysis. RESULTS: The routine-features model and cluster approach were both strongly associated with overall and differential HbA1c responses (P < 0.0001). The routine-features model identified the most effective therapy with significant benefit across all drug comparisons, whereas clinical clusters showed benefit for only one cluster-drug comparison (severe insulin-resistant diabetes: SGLT2i vs. thiazolidinedione [TZD], P = 0.005). DDRTree was not associated with treatment response. Of eight PPSs, only two showed modest association with differential response (lipodystrophy PPS had a greater response to SGLT2 vs. TZD; and β-cell dysfunction, negative proinsulin PPS had a greater response to TZD vs. dipeptidyl peptidase 4 inhibitor). Treatment allocation based on the routine-features model resulted in greater HbA1c reduction than cluster-based allocation (0.27% [95% CI 0.18, 0.35], 2.9 mmol/mol [95% CI 2.0, 3.8] vs. 0.16% [95% CI 0.07, 0.25], 1.7 mmol/mol [95% CI 0.8, 2.7]). CONCLUSIONS: Clinical features are more strongly associated with differential glycemic response than PPS, and direct outcome prediction outperforms data-driven subgrouping for optimizing short-term HbA1c reduction.
Rodríguez de Vera Gómez P, Mayoral E, Rodríguez Jiménez B
… +3 more, Gomez-Peralta F, Umpierrez GE, Martínez-Brocca MA
Diabetes Care
· 2026 Jun · PMID 42301188
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OBJECTIVE: To assess the effect of a population-wide implementation of intermittently scanned continuous glucose monitoring (isCGM) on hospitalization rates and trends, length of stay, and inpatient health care costs amo...OBJECTIVE: To assess the effect of a population-wide implementation of intermittently scanned continuous glucose monitoring (isCGM) on hospitalization rates and trends, length of stay, and inpatient health care costs among adults with insulin-treated type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: This population-based, longitudinal, quasi-experimental cohort study included adults with T2D taking multiple daily insulin injections who initiated publicly funded isCGM between April 2022 and December 2023. Hospitalizations for acute diabetes-related complications (diabetic ketoacidosis, hyperglycemic hyperosmolar state, simple hyperglycemia, and hypoglycemia) and cardiovascular complications (myocardial infarction, stroke, and major lower-extremity amputation) were identified using ICD-10 codes. Incidence rates and rate ratios (RRs) were estimated using Poisson models. Interrupted time series analyses were used to estimate counterfactual trends. RESULTS: Among 15,413 participants, the mean follow-up was 22.5 ± 4.6 months before and 19.1 ± 4.4 months after isCGM initiation. Mean HbA1c decreased from 8.09 to 7.65% (mean difference -0.44 [95% CI -0.47 to -0.42]). Diabetes-related hospitalization rates decreased from 74.6 to 27.5 per 10,000 person-years (RR 0.37 [95% CI 0.28-0.49]). Cardiovascular hospitalization rates remained stable (228.8 vs. 215.8 per 10,000 person-years; RR 0.94 [0.84-1.06]). Interrupted time series analyses showed a change in cardiovascular admission rates after isCGM initiation relative to the preintervention trend. Median length of stay decreased from 4 (interquartile range 5) to 3 (4) days. Total inpatient costs decreased by $3,806,776.90 (-$955,186.70 per 10,000 person-years). CONCLUSIONS: In this real-world study, implementation of isCGM among insulin-treated adults with T2D was associated with substantial reductions in acute diabetes-related hospitalizations, shorter hospital stays, lower health care costs, and changes in cardiovascular hospitalization trends.
Diabetes Care
· 2026 Jun · PMID 42301155
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OBJECTIVE: To examine national trends in out-of-pocket (OOP) costs for glucose-lowering medications among U.S. adults with diabetes from 2000 to 2022. RESEARCH DESIGN AND METHODS: We analyzed Medical Expenditure Panel Su...OBJECTIVE: To examine national trends in out-of-pocket (OOP) costs for glucose-lowering medications among U.S. adults with diabetes from 2000 to 2022. RESEARCH DESIGN AND METHODS: We analyzed Medical Expenditure Panel Survey data, linked to pharmacy-verified records, for adults with self-reported diabetes. OOP costs were evaluated per user by medication category and at the population level. Trends were assessed using inflation-adjusted annual estimates and joinpoint regression, with subgroup analyses by income, race/ethnicity, age, insurance, insulin use, and cardiovascular disease status. RESULTS: Population-average OOP costs declined 46%, driven by sharp per-user OOP cost reductions for older oral agents and decreasing use of human insulin. OOP costs for newer agents and analog insulin remained higher, with surging uptake. Declines occurred across all subgroups, but differences between subgroups were still observed. CONCLUSIONS: Despite substantial reductions in overall OOP costs, high-cost newer therapies continue to impose financial burdens that may limit equitable access.
Cook DA, Perna-Barrull D, Murillo M
… +1 more, Vives-Pi M
Diabetes Care
· 2026 Jun · PMID 42284195
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Type 1 diabetes is a chronic autoimmune disease driven by immune-mediated destruction of pancreatic β-cells. While technological advances in insulin delivery and glucose monitoring have improved glycemic management, they...Type 1 diabetes is a chronic autoimmune disease driven by immune-mediated destruction of pancreatic β-cells. While technological advances in insulin delivery and glucose monitoring have improved glycemic management, they do not address the underlying autoimmune process. Identifying low-risk adjunct strategies that can modulate immune dysfunction therefore remains a clinical and translational priority. Physical exercise is a cornerstone of type 1 diabetes management for its metabolic benefits, yet its potential role as an immunomodulatory intervention has received comparatively little attention. This review critically examines current evidence on exercise-induced immune modulation in type 1 diabetes. We first summarize the effects of exercise on innate and adaptive immunity, including changes in immune-cell phenotypes, cytokine and chemokine profiles, and muscle-derived mediators. We then synthesize preclinical data from rodent models and human β-cell systems showing that exercise reduces islet inflammation, limits immune-cell infiltration, protects β-cells from cytokine-induced injury, and induces anti-inflammatory exerkines such as meteorin-like protein and irisin. Finally, we review available clinical evidence in individuals with type 1 diabetes, including observational and interventional studies linking higher levels of physical activity to longer partial remission, reduced progression of islet autoimmunity, and anti-inflammatory immune signatures. Overall, although direct clinical evidence remains limited, converging preclinical and early human data support a biologically plausible immunoregulatory role for exercise in type 1 diabetes. We discuss therapeutic perspectives where structured exercise may act as a low-risk cotherapy, particularly early after diagnosis or in combination with emerging immunotherapies, and highlight key priorities for future clinical trials.
Jacobsen LM, Cuthbertson D, Felton J
… +11 more, Sherr JL, Simmons KM, Hosford J, Ismail HM, Greenbaum CJ, Wherrett DK, Pinckney A, Sanda S, DiMeglio LA, Higdon LE, Evans-Molina C
Diabetes Care
· 2026 Jun · PMID 42283716
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OBJECTIVE: Long-term side effect surveillance after immunotherapy clinical trial participation in individuals with or at risk of type 1 diabetes is needed. RESEARCH DESIGN AND METHODS: Participants from 14 randomized con...OBJECTIVE: Long-term side effect surveillance after immunotherapy clinical trial participation in individuals with or at risk of type 1 diabetes is needed. RESEARCH DESIGN AND METHODS: Participants from 14 randomized controlled trials (47%) joined the Long-term Investigative Follow-up in Type 1 Diabetes TrialNet or Immune Tolerance Network Type 1 Diabetes Extension Study, and 98% answered at least one health-related outcomes question. RESULTS: Participants were observed for a median of 1.78 (interquartile range 0.89-4.04) years after original trial completion and, in some, up to 18 years. There were no differences in the frequency of self-reported health outcomes, including moderate to severe hypoglycemia events, hospitalizations, serious infections (including COVID-19 infection), new allergic reactions, autoimmune disease, and cancer incidence, between those receiving active and placebo therapy (n = 209-473 responses per question; P > 0.05 for all). CONCLUSIONS: We observed no differences in self-reported health outcomes between those who received active immunotherapy versus placebo. Continued long-term follow-up of immunotherapy trial participants is essential.
Kähkönen O, Kuusela S, Laiho JE
… +9 more, Eurén A, Kallio L, Huhtala H, Aitokari L, Sundell M, Hämäläinen I, Kivelä L, Palmu S, Kurppa K
Diabetes Care
· 2026 Jun · PMID 42274414
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OBJECTIVE: Interest in screening for type 1 diabetes (T1D) is increasing, but studies assessing outcomes during the treatment period among individuals identified through population-based genetic screening and prospective...OBJECTIVE: Interest in screening for type 1 diabetes (T1D) is increasing, but studies assessing outcomes during the treatment period among individuals identified through population-based genetic screening and prospective follow-up remain limited. RESEARCH DESIGN AND METHODS: Characteristics at T1D diagnosis and 1-year treatment outcomes were compared between 126 at-risk children followed in the Type 1 Diabetes Prediction and Prevention (DIPP) study and 440 children diagnosed outside the screening program. RESULTS: DIPP participants had significantly less frequent (P < 0.05) ketoacidosis (5.6% vs. 23.6%), dehydration, electrolyte imbalances, and need for intensive care, and shorter inpatient stays, than non-DIPP children. They showed lower median HbA1c levels (46 vs. 99 mmol/mol [6.4 vs. 11.2%]) and insulin requirements (0.11 vs. 0.74 units/kg/day) both at diagnosis and 1 year later (55 vs. 61 mmol/mol [7.2 vs. 7.7%]; 0.57 vs. 0.70 units/kg/day). CONCLUSIONS: DIPP participants had a milder clinical presentation at T1D diagnosis, with lower HbA1c levels and lower insulin requirements during the first year.
Mellor JC, Blackbourn LAK, McGurnaghan SJ
… +7 more, McKeigue PM, Zaccai J, Guenther O, Ridolfi A, Mahieu A, Bonnemaire M, Colhoun HM
Diabetes Care
· 2026 Jun · PMID 42274395
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OBJECTIVE: To characterize associations of C-peptide measurements with type 1 diabetes (T1D) complications across long-term clinical follow-up in a large representative population cohort (Scottish Diabetes Research Netwo...OBJECTIVE: To characterize associations of C-peptide measurements with type 1 diabetes (T1D) complications across long-term clinical follow-up in a large representative population cohort (Scottish Diabetes Research Network Type 1 Bioresource [SDRNT1BIO]). RESEARCH DESIGN AND METHODS: SDRNT1BIO includes people with a clinical diagnosis of T1D who are aged 16 years or older at enrollment. Their median diabetes duration is 21 (interquartile range = 11-31) years. C-peptide was measured in an untimed blood sample using the Roche immunoassay with a lower limit of detection of 3 pmol/L. Incident events and continuous outcomes were captured through electronic health record linkage across follow-up. Associations were studied using Poisson generalized linear models and linear mixed models adjusted for sex, age, time-updated T1D duration, year of entry, and age/T1D duration interaction. RESULTS: Participants (n = 5,630) were followed for a median of 10.8 years. Inverse associations were found between baseline C-peptide level and diabetic ketoacidosis (DKA) (P < 0.0001; no. of events = 1,015), severe hospitalized hypoglycemia (SHH) (P = 0.0055; n = 539), and incident retinopathy (P < 0.0001; n = 1,172). These associations persisted when adjusted for time-updated glycosylated hemoglobin. No associations were found between baseline C-peptide levels and cardiovascular disease (P = 0.9; n = 714) or death (P = 0.8; n = 566). In a subset of participants (n = 407) with serial C-peptide measures, follow-up C-peptide level was inversely associated with risk for DKA (P < 0.001; n = 92) and there was a borderline association with SHH (P = 0.015; n = 28). CONCLUSIONS: These data demonstrate the importance of C-peptide level and its maintenance for glycemic control and avoidance of acute and chronic complications of T1D.
Cleland CR, Bascaran C, Makupa WU
… +12 more, Shilio B, Tufail A, Egan C, Fajtl J, Olvera-Barrios A, Rudnicka AR, Owen CG, Wallis C, Cartwright E, Bastawrous A, Macleod D, Burton MJ
Diabetes Care
· 2026 Jun · PMID 42267948
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OBJECTIVE: Comparative evaluations of commercially available artificial intelligence (AI) systems for use in diabetic retinopathy (DR) screening, particularly studies that identify systems by name, are limited, constrain...OBJECTIVE: Comparative evaluations of commercially available artificial intelligence (AI) systems for use in diabetic retinopathy (DR) screening, particularly studies that identify systems by name, are limited, constraining procurement and implementation. This study aimed to identify commercially available AI systems potentially suitable for DR screening in a low-resource Tanzanian setting and compare their accuracy in detecting referable DR. RESEARCH DESIGN AND METHODS: Through a scoping review and expert consultation, we identified AI systems potentially suitable for implementation. Systems confirmed as suitable, and whose developers agreed to participate, were evaluated. Performance was assessed on a data set of retinal images collected from a Tanzanian DR screening program. The primary outcomes were sensitivity and specificity in detecting referable DR. Additional implementation data, including regulatory approval, referral thresholds, and additional product features, were also collected. RESULTS: Four commercially available AI systems (Medios AI/Remidio, MONA, Ophtai, and SELENA+) were evaluated. Among 689 people included in the test data set, 379 (55.0%) had referable DR and 93 (13.5%) had proliferative DR. Sensitivity in detecting referable DR ranged from 83.9% to 93.7%, with lower specificity ranging from 70.3% to 79.0%. Sensitivity in detecting proliferative DR exceeded 98% in all four AI systems. All the evaluated AI systems were Conformité Européenne-marked medical devices; one system (Medios AI/Remidio) functions offline as standard. CONCLUSIONS: Several commercially available AI systems demonstrated high sensitivity in detecting referable and proliferative DR, supporting their potential implementation. Consensus on minimum performance thresholds and consideration of implementation factors such as regulatory approval and offline functionality are needed.
Johnsen E, Bengtsson J, Halasa T
… +4 more, Lotfi A, Miller CP, Sustarsic RK, Sattar N
Diabetes Care
· 2026 Jun · PMID 42258754
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OBJECTIVE: This study aimed to evaluate whether achieving a minimum of 15% weight loss early after type 2 diabetes diagnosis was associated with subsequent lower risks of developing macrovascular and microvascular compli...OBJECTIVE: This study aimed to evaluate whether achieving a minimum of 15% weight loss early after type 2 diabetes diagnosis was associated with subsequent lower risks of developing macrovascular and microvascular complications. RESEARCH DESIGN AND METHODS: Using U.K. primary care data from Clinical Practice Research Datalink Aurum linked to hospital and mortality data, we conducted a cohort study (2000-2024) of adults with obesity and type 2 diabetes. Individuals with ≥15% weight loss within 2 years of type 2 diabetes diagnosis were propensity score matched 1:4 to control subjects maintaining a stable weight (<2% weight change). Cumulative incidence rates were determined, and time to first macrovascular (myocardial infarction, stroke, angina, peripheral arterial disease) and microvascular (chronic kidney disease, retinopathy, neuropathy) events was analyzed using Cox proportional hazards regression. RESULTS: The matched cohort included 14,496 individuals with ≥15% weight loss and 57,984 control subjects. Compared with control subjects, the weight loss group had significantly lower risk of first macrovascular (hazard ratio 0.86, 95% CI 0.81-0.91) and microvascular (hazard ratio 0.90, 95% CI 0.86-0.94) events. Individually, significantly lower risks were observed for myocardial infarction, angina, chronic kidney disease, and retinopathy. The weight loss group also demonstrated better glycemic and blood pressure levels, despite fewer medications. CONCLUSIONS: Achieving ≥15% weight loss early in type 2 diabetes was associated with clinically meaningful lower risks for macro- and microvascular complications and better glycemic control compared with stable weight. These real-world findings support prioritizing early, substantial weight reduction as a core therapeutic strategy to improve glycemic control and prevent end-organ damage.
Beernink JM, Heerspink HJL, Birkenfeld AL
… +21 more, Cherney DZI, Colhoun HM, Groop PH, Ji L, Mathieu C, Rosas SE, Tuttle KR, Skyler JS, Amor AJ, Caramori ML, Fiorina P, Jongs N, Pagotto U, Setola E, Brinker M, Lawatscheck R, Russel J, Schloemer P, McGill JB, Rossing P, FINE-ONE investigators*
Diabetes Care
· 2026 Jun · PMID 42258447
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OBJECTIVE: To evaluate whether the efficacy and safety of finerenone varied by baseline hemoglobin A1c (HbA1c) level, a proxy of glycemic control, and diabetes duration in people with type 1 diabetes and chronic kidney d...OBJECTIVE: To evaluate whether the efficacy and safety of finerenone varied by baseline hemoglobin A1c (HbA1c) level, a proxy of glycemic control, and diabetes duration in people with type 1 diabetes and chronic kidney disease (CKD). RESEARCH DESIGN AND METHODS: Adults with type 1 diabetes, urinary albumin-to-creatinine ratio (UACR) 200 to <5,000 mg/g, and estimated glomerular filtration rate (eGFR) 25 to <90 mL/min/1.73 m2 were randomly assigned (one to one) to finerenone or placebo. UACR change from baseline over 6 months by baseline HbA1c and diabetes duration was analyzed. RESULTS: Baseline HbA1c was available for 240 of 242 participants; mean (SD) HbA1c, diabetes duration, and eGFR were 7.6% (1.1%; 60 [12] mmol/mol), 32.0 (14.2) years, and 58.9 (19.2) mL/min/1.73 m2, respectively. At 6 months, HbA1c (95% CI) remained unchanged (finerenone +0.03% [-0.14%, 0.20%]; placebo 0.00% [-0.12%, 0.11%]; between-group difference +0.04% [-0.17%, 0.24%]; P = 0.74). Over 6 months, median UACR decreased from 574.6 to 373.5 mg/g with finerenone and from 506.4 to 475.6 mg/g with placebo, corresponding to a -25% placebo-corrected change (95% CI -35%, -13%; P = 0.0001). Treatment effects were consistent across HbA1c tertiles (<7.1%, ≥7.1% to ≤8.1%, and >8.1%), with placebo-corrected UACR changes (95% CIs) of -17% (-40%, 13%), -18% (-39%, 10%), and -37% (-55%, -13%), respectively (P interaction = 0.41). Effects were similarly consistent across diabetes duration tertiles (P interaction = 0.70). Overall safety and incidence of hyperkalemia were similar across HbA1c tertiles. CONCLUSIONS: In adults with type 1 diabetes and CKD, finerenone reduced UACR and was well tolerated irrespective of HbA1c level or diabetes duration.
Strohhofer C, Eberhard K, Obermayer-Pietsch B
… +11 more, Stadler D, Herzog P, Schwegel N, Santner V, Niedrist T, Herrmann M, von Lewinski D, Zirlik A, Sourij H, Verheyen N, Pieber TR
Diabetes Care
· 2026 Jun · PMID 42257650
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OBJECTIVE: We investigated whether fasting 2-hydroxybutyrate (2-HB), measured by a novel enzymatic assay (XpressGT), can provide incremental discrimination of dysglycemia beyond routine fasting measures. RESEARCH DESIGN...OBJECTIVE: We investigated whether fasting 2-hydroxybutyrate (2-HB), measured by a novel enzymatic assay (XpressGT), can provide incremental discrimination of dysglycemia beyond routine fasting measures. RESEARCH DESIGN AND METHODS: Associations of 2-HB with dysglycemia were assessed in the total Biomarkers of Personalized Medicine cohort and in the prespecified subcohort with fasting plasma glucose (FPG) <110 mg/dL and HbA1c <39 mmol/mol (5.7%). RESULTS: Among 772 individuals, 2-HB increased from normoglycemia (39.0 µmol/L) to prediabetes (51.9 µmol/L) and type 2 diabetes (57.0 µmol/L). In 534 individuals with normal FPG and HbA1c, 2-HB yielded the area under the receiver operating characteristic curve of 0.79 for postprandial dysglycemia (2-h glucose >140 mg/dL during oral glucose tolerance testing). A sensitivity of 90% was achieved at 39 µmol/L, with a negative predictive value of 98.9%. Each 1-SD increase in 2-HB was independently associated with dysglycemia (odds ratio 2.23; P < 0.001). CONCLUSIONS: Enzymatic 2-HB measurement may serve as a screening biomarker to rule out postprandial dysglycemia in individuals with normal FPG and HbA1c.
Diabetes Care
· 2026 Jun · PMID 42257619
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OBJECTIVE: Glycated hemoglobin (HbA1c) and average glucose (AG) can show discordance due to personal variations in red blood cell (RBC) physiology, creating management difficulties. Our aims were to understand the size o...OBJECTIVE: Glycated hemoglobin (HbA1c) and average glucose (AG) can show discordance due to personal variations in red blood cell (RBC) physiology, creating management difficulties. Our aims were to understand the size of the problem and refine this glycemic metric by adjusting for personal differences in RBC characteristics. RESEARCH AND DESIGN AND METHODS: A 26-week prospective study was conducted in individuals with type 1 diabetes (T1D) or type 2 diabetes across four racial groups with HbA1c collected every 2 weeks and continuous glucose monitoring (CGM) used throughout. Personal glycation ratio (PGR) was derived from HbA1c and AG data (weeks 0-12), allowing calculation of personalized HbA1c (pA1C) and subsequent testing (weeks 20-26). The relationship between AG and HbA1c or pA1C was then analyzed, documenting a clinically meaningful discordance of ≥0.5%. In addition, we used real-world data sets to further validate the accuracy of pA1C at reflecting glucose exposure. RESULTS: Of 257 participants (19% T1D) with complete CGM and HbA1c data sets, mean age (±SD) was 53 ± 14 years (45% females). The racial background was 35% Asian, 30% White, 22% Black, and 14% other/mixed. Of the total study population, 33% showed ≥0.5% HbA1c-AG discordance, with the Black population affected most (41% discordance). Use of pA1C reduced the discordance in the whole population to 14% (58% reduction), while this was reduced in the Black population to 12% (71% reduction). CONCLUSIONS: HbA1c-AG discordance is common, particularly in the Black population, with pA1C improving alignment with glucose levels, potentially helping to optimize clinical management and reduce health disparities.
Diabetes Care
· 2026 Jun · PMID 42251767
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OBJECTIVE: We evaluated whether early pregnancy oral glucose tolerance testing (OGTT) or continuous glucose monitoring (CGM) improves gestational diabetes mellitus (GDM) or large for gestational age (LGA) birth predictio...OBJECTIVE: We evaluated whether early pregnancy oral glucose tolerance testing (OGTT) or continuous glucose monitoring (CGM) improves gestational diabetes mellitus (GDM) or large for gestational age (LGA) birth prediction over clinical factors alone. RESEARCH DESIGN AND METHODS: In the Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs) study, a prospective observational study at nine U.S. sites (2021-2025), participants with singleton gestation and without preexisting diabetes underwent blinded 75-g OGTT and CGM at 10-14 weeks' gestation. Predictive models for GDM at 24-28 weeks' and LGA were developed using these data and clinical factors (maternal age, BMI, GDM or macrosomia history). New glycemic criteria maximized the area under the receiver operating characteristic curve in training data from four sites and were validated in five. Models incorporating OGTT or CGM criteria versus clinical factors alone compared positive predictive value (PPV) at a prespecified negative predictive value (NPV) at a reported 8.3% national GDM prevalence and 10% for LGA. RESULTS: Of 2,178 participants, 93.3% who were pregnant at 24-28 weeks completed OGTTs (15.4% GDM), and 98.1% with live births had data to determine LGA (11.2% LGA). At NPV ≥96% and 8.3% GDM prevalence, PPV for GDM was 12.2% (95% CI 11.0-13.3%) for clinical factors alone, 26.5% (23.1-30.3%) for OGTT plus clinical factors, and 19.8% (17.2-22.5%) for CGM plus clinical factors. For LGA, neither glycemic model improved PPV. Validation confirmed findings. CONCLUSIONS: In a U.S.-representative population, adding 10-14-week OGTT or CGM criteria to clinical factors improved GDM but not LGA prediction. Future studies should determine whether predicting GDM in the first trimester facilitates interventions that improve GDM-related pregnancy outcomes.
Leiter LA, Giugliano RP, Marston NA
… +22 more, De Ferrari G, Nicolau JC, Bhatia AK, Cyrille M, Park JG, Kuder JF, Murphy SA, Liu L, Walsh E, Wang H, Džupina A, Ferreira J, Gouni-Berthold I, Jensen HK, Kuusisto J, Pella D, Sattar N, Tsioufis KP, Vinereanu D, Paiva da Silva Lima G, Sabatine MS, Bohula EA
Diabetes Care
· 2026 Jun · PMID 42251764
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OBJECTIVE: This prespecified analysis of Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV) evaluated the efficacy of the PCSK9 inhibitor evolocumab f...OBJECTIVE: This prespecified analysis of Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV) evaluated the efficacy of the PCSK9 inhibitor evolocumab for preventing first cardiovascular events in patients with high-risk diabetes. RESEARCH DESIGN AND METHODS: VESALIUS-CV randomized patients with high-risk diabetes (microvascular disease, insulin use, or duration ≥10 years) or qualifying atherosclerosis, but no prior myocardial infarction (MI) or stroke, and LDL cholesterol (LDL-C) ≥90 mg/dL to evolocumab 140 mg or matching placebo every 2 weeks. The dual primary end points were a composite of coronary heart disease death, MI or ischemic stroke (three-point major adverse cardiovascular event [3P-MACE]) and 3P-MACE plus ischemia-driven arterial revascularization (four-point [4P]-MACE). RESULTS: Of the 6,002 patients with high-risk diabetes, 67% were on a high-intensity statin and 24% were on an sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a glucagon-like peptide 1 receptor agonist (GLP-1RA) at baseline. The median LDL-C at 48 weeks was 47 mg/dL and 109 mg/dL in the evolocumab and placebo arms, respectively (P < 0.0001). After a median follow-up of 4.6 years, evolocumab decreased the relative rates of 3P-MACE and 4P-MACE by 29% (hazard ratio [HR] 0.71; 95% CI 0.59, 0.86; P = 0.0004) and 21% (HR 0.79; 95% CI 0.69, 0.91; P = 0.0013), respectively. These findings were consistent regardless of the presence or absence of qualifying atherosclerosis, baseline LDL-C, statin intensity, and SGLT2i or GLP-1RA use (Pint > 0.05 for each). The porportion of patients with all-cause death was 8.8% vs. 11.0% in the evolocumab versus placebo arms (HR 0.79; 95% CI 0.67, 0.93). CONCLUSIONS: Evolocumab reduced the rate of cardiovascular events in patients with high-risk diabetes, regardless of the presence or absence of qualifying atherosclerosis and background use of other cardioprotective agents.