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Browsing by Subject "Glycated hemoglobin"
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Item Effect of Tight Glycemic Control on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial(American Medical Association, 2023) McVean, Jennifer; Forlenza, Gregory P.; Beck, Roy W.; Bauza, Colleen; Bailey, Ryan; Buckingham, Bruce; DiMeglio, Linda A.; Sherr, Jennifer L.; Clements, Mark; Neyman, Anna; Evans-Molina, Carmella; Sims, Emily K.; Messer, Laurel H.; Ekhlaspour, Laya; McDonough, Ryan; Van Name, Michelle; Rojas, Diana; Beasley, Shannon; DuBose, Stephanie; Kollman, Craig; Moran, Antoinette; CLVer Study Group; Pediatrics, School of MedicineImportance: Near normalization of glucose levels instituted immediately after diagnosis of type 1 diabetes has been postulated to preserve pancreatic beta cell function by reducing glucotoxicity. Previous studies have been hampered by an inability to achieve tight glycemic goals. Objective: To determine the effectiveness of intensive diabetes management to achieve near normalization of glucose levels on preservation of pancreatic beta cell function in youth with newly diagnosed type 1 diabetes. Design, setting, and participants: This randomized, double-blind, clinical trial was conducted at 6 centers in the US (randomizations from July 20, 2020, to October 13, 2021; follow-up completed September 15, 2022) and included youths with newly diagnosed type 1 diabetes aged 7 to 17 years. Interventions: Random assignment to intensive diabetes management, which included use of an automated insulin delivery system (n = 61), or standard care, which included use of a continuous glucose monitor (n = 52), as part of a factorial design in which participants weighing 30 kg or more also were assigned to receive either oral verapamil or placebo. Main outcomes and measures: The primary outcome was mixed-meal tolerance test-stimulated C-peptide area under the curve (a measure of pancreatic beta cell function) 52 weeks from diagnosis. Results: Among 113 participants (mean [SD] age, 11.8 [2.8] years; 49 females [43%]; mean [SD] time from diagnosis to randomization, 24 [5] days), 108 (96%) completed the trial. The mean C-peptide area under the curve decreased from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks in the intensive management group, and from 0.60 to 0.50 pmol/mL in the standard care group (treatment group difference, -0.01 [95% CI, -0.11 to 0.10]; P = .89). The mean time in the target range of 70 to 180 mg/dL, measured with continuous glucose monitoring, at 52 weeks was 78% in the intensive management group vs 64% in the standard care group (adjusted difference, 16% [95% CI, 10% to 22%]). One severe hypoglycemia event and 1 diabetic ketoacidosis event occurred in each group. Conclusions and relevance: In youths with newly diagnosed type 1 diabetes, intensive diabetes management, which included automated insulin delivery, achieved excellent glucose control but did not affect the decline in pancreatic C-peptide secretion at 52 weeks.Item The Evolution of Hemoglobin A1c Targets for Youth With Type 1 Diabetes: Rationale and Supporting Evidence(American Diabetes Association, 2021) Redondo, Maria J.; Libman, Ingrid; Maahs, David M.; Lyons, Sarah K.; Saraco, Mindy; Reusch, Jane; Rodriguez, Henry; DiMeglio, Linda A.; Pediatrics, School of MedicineThe American Diabetes Association 2020 Standards of Medical Care in Diabetes (Standards of Care) recommends a hemoglobin A1c (A1C) of <7% (53 mmol/mol) for many children with type 1 diabetes (T1D), with an emphasis on target personalization. A higher A1C target of <7.5% may be more suitable for youth who cannot articulate symptoms of hypoglycemia or have hypoglycemia unawareness and for those who do not have access to analog insulins or advanced diabetes technologies or who cannot monitor blood glucose regularly. Even less stringent A1C targets (e.g., <8%) may be warranted for children with a history of severe hypoglycemia, severe morbidities, or short life expectancy. During the "honeymoon" period and in situations where lower mean glycemia is achievable without excessive hypoglycemia or reduced quality of life, an A1C <6.5% may be safe and effective. Here, we provide a historical perspective of A1C targets in pediatrics and highlight evidence demonstrating detrimental effects of hyperglycemia in children and adolescents, including increased likelihood of brain structure and neurocognitive abnormalities, microvascular and macrovascular complications, long-term effects, and increased mortality. We also review data supporting a decrease over time in overall severe hypoglycemia risk for youth with T1D, partly associated with the use of newer insulins and devices, and weakened association between lower A1C and severe hypoglycemia risk. We present common barriers to achieving glycemic targets in pediatric diabetes and discuss some strategies to address them. We aim to raise awareness within the community on Standards of Care updates that impact this crucial goal in pediatric diabetes management.Item Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study(American Diabetes Association, 2022) Rossing, Peter; Burgess, Ellen; Agarwal, Rajiv; Anker, Stefan D.; Filippatos, Gerasimos; Pitt, Bertram; Ruilope, Luis M.; Gillard, Pieter; MacIsaac, Richard J.; Wainstein, Julio; Joseph, Amer; Brinker, Meike; Roessig, Lothar; Scott, Charlie; Bakris, George L.; FIDELIO-DKD Investigators; Medicine, School of MedicineObjective: Finerenone significantly improved cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease trial. We explored whether baseline HbA1c level and insulin treatment influenced outcomes. Research design and methods: Patients with T2D, urine albumin-to-creatinine ratio (UACR) of 30-5,000 mg/g, estimated glomerular filtration rate (eGFR) of 25 to <75 mL/min/1.73 m2, and treated with optimized renin-angiotensin system blockade were randomly assigned to receive finerenone or placebo. Efficacy outcomes included kidney (kidney failure, sustained decrease ≥40% in eGFR from baseline, or renal death) and cardiovascular (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) composite endpoints. Patients were analyzed by baseline insulin use and by baseline HbA1c <7.5% (58 mmol/mol) or ≥7.5%. Results: Of 5,674 patients, 3,637 (64.1%) received insulin at baseline. Overall, 5,663 patients were included in the analysis for HbA1c; 2,794 (49.3%) had baseline HbA1c <7.5% (58 mmol/mol). Finerenone significantly reduced risk of the kidney composite outcome independent of baseline HbA1c level and insulin use (Pinteraction = 0.41 and 0.56, respectively). Cardiovascular composite outcome incidence was reduced with finerenone irrespective of baseline HbA1c level and insulin use (Pinteraction = 0.70 and 0.33, respectively). Although baseline HbA1c level did not affect kidney event risk, cardiovascular risk increased with higher HbA1c level. UACR reduction was consistent across subgroups. Adverse events were similar between groups regardless of baseline HbA1c level and insulin use; few finerenone-treated patients discontinued treatment because of hyperkalemia. Conclusions: Finerenone reduces kidney and cardiovascular outcome risk in patients with CKD and T2D, and risks appear consistent irrespective of HbA1c levels or insulin use.Item Impact of community health workers on diabetes management in an urban United States Community with high diabetes burden through the COVID pandemic(Elsevier, 2024-02-09) Hansotte, Elinor; Andrea, Sarah B.; Weathers, Tess D.; Stone, Cynthia; Jessup, Alisha; Staten, Lisa K.; Global Health, School of Public HealthObjective: Community Health Worker (CHW) interventions are promising approaches to increasing access to health care, garnering better health outcomes, and decreasing health inequities for historically marginalized populations. This study examines the impact of a health system-based CHW program embedded in the Diabetes Impact Project - Indianapolis Neighborhoods (DIP-IN), a large, place-based, multi-year intervention to reduce diabetes burden. We assessed the CHW program's effectiveness in managing glucose control and reducing diabetes-associated complications across the COVID timeline. Methods: We examined the association between the CHW intervention and diabetes management in 454 CHW patients and 1,020 propensity score-matched comparison patients. Using electronic medical records for encounters between January 1, 2017, and March 31, 2022, we estimated the CHW program effect using a difference-in-difference approach through generalized linear mixed models. Results: Participation was associated with a significant reduction (-0.54-unit (95 % CI: -0.73, -0.35) in glycosylated hemoglobin (A1C) on average over time that was beyond the change observed among comparison patients, higher odds of having ≥ 2 A1C measures in a year (OR = 2.32, 95 % CI: 1.79, 3.00), lower odds of ED visits (OR: 0.88; 95 % CI: 0.73, 1.05), and lower odds of hospital admission (OR: 0.81; 95 % CI: 0.60,1.09). When analyses were restricted to a pre-pandemic timeframe, the pattern of results were similar. Conclusion: This program was effective in improving diabetes management among patients living in diabetes-burdened communities, and the effects were persistent throughout the pandemic timeline. CHW programs offer crucial reinforcement for diabetes management during periods when routine healthcare access is constrained.