Diabetes Care最新文献

{"title":"Diabetes Care in the School Setting: A Statement of the American Diabetes Association","authors":"Fran Cogen, Henry Rodriguez, Christine A. March, Cynthia E. Muñoz, Jacqueline McManemin, Margaret Pellizzari, Janet Rodriguez, Leah Wycoff, Alan L. Yatvin, Torie Atkinson, Nuha A. ElSayed, Raveendhara R. Bannuru, Elizabeth J. Pekas, Crystal Woodward, Jennifer Sherman","doi":"10.2337/dci24-0082","DOIUrl":"https://doi.org/10.2337/dci24-0082","url":null,"abstract":"Diabetes is a prevalent chronic disease in school-age children. To keep students with diabetes safe at school, support their long-term health, prevent complications, and ensure full participation in all school activities, proper monitoring of and response to glucose levels must be attended to throughout the school day and during all school-sponsored activities. Care coordination among the family, school, and diabetes health care professionals is critical. With proper planning, including the education and training of school staff, children and youth with diabetes can fully and safely participate in school. In this statement, we review the legal framework for diabetes care in schools, the core components of school-based diabetes care, the responsibilities of various stakeholders, and special circumstances.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":null,"pages":null},"PeriodicalIF":16.2,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142489741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Consensus Considerations and Good Practice Points for Use of Continuous Glucose Monitoring Systems in Hospital Settings","authors":"Julie L.V. Shaw, Raveendhara R. Bannuru, Lori Beach, Nuha A. ElSayed, Guido Freckmann, Anna K. Füzéry, Angela W.S. Fung, Jeremy Gilbert, Yun Huang, Nichole Korpi-Steiner, Samantha Logan, Rebecca Longo, Dylan MacKay, Lisa Maks, Stefan Pleus, Kendall Rogers, Jane Jeffrie Seley, Zachary Taxin, Fiona Thompson-Hutchison, Nicole V. Tolan, Nam K. Tran, Guillermo E. Umpierrez, Allison A. Venner","doi":"10.2337/dci24-0073","DOIUrl":"https://doi.org/10.2337/dci24-0073","url":null,"abstract":"Continuous glucose monitoring (CGM) systems provide frequent glucose measurements in interstitial fluid and have been used widely in ambulatory settings for diabetes management. During the coronavirus disease 2019 (COVID-19) pandemic, regulators in the U.S. and Canada temporarily allowed for CGM systems to be used in hospitals with the aim of reducing health care professional COVID-19 exposure and limiting use of personal protective equipment. As such, studies on hospital CGM system use have been possible. With improved sensor accuracy, there is increased interest in CGM usage for diabetes management in hospitals. Laboratorians and health care professionals must determine how to integrate CGM usage into practice. The aim of this consensus guidance document is to provide an update on the application of CGM systems in hospital, with insights and opinions from laboratory medicine, endocrinology, and nursing.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":null,"pages":null},"PeriodicalIF":16.2,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142489739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Relationship of Plasma Apolipoprotein C-I Truncation With Risk of Diabetes in the Multi-Ethnic Study of Atherosclerosis and the Actos Now for the Prevention of Diabetes Study","authors":"Juraj Koska, Yueming Hu, Jeremy Furtado, Dean Billheimer, Dobrin Nedelkov, Dawn Schwenke, Matthew J. Budoff, Alain G. Bertoni, Robyn L. McClelland, Peter D. Reaven","doi":"10.2337/dc24-1462","DOIUrl":"https://doi.org/10.2337/dc24-1462","url":null,"abstract":"OBJECTIVE Higher truncated-to-native apolipoprotein (apo) C-I proteoform ratios (C-I′/C-I) are associated with favorable cardiometabolic risk profiles, but their relationship with longitudinal changes in insulin resistance (IR) and incident diabetes is unknown. RESEARCH DESIGN AND METHODS Plasma apoC-I proteoforms were measured by mass spectrometry immunoassay at baseline in 4,742 nondiabetic participants in the Multi-Ethnic Study of Atherosclerosis (MESA) and 524 participants with prediabetes in the Actos Now for Prevention of Diabetes (ACT NOW) study. The primary outcome was incident diabetes (fasting glucose [FG] ≥7.0 mmol/L or hypoglycemic medication use in MESA; FG ≥7.0 mmol/L or 2-h glucose ≥11.1 mmol/L in an oral glucose tolerance test [OGTT] in ACT NOW). Secondary outcomes were changes in FG and HOMA-IR in MESA, and OGTT-glucose area under the curve (AUCglucose) and Matsuda insulin sensitivity index (ISI) in ACT NOW. RESULTS In MESA, a higher C-I′/C-I was associated with lower risk of diabetes (n = 564 events; HR 0.87 [95% CI 0.79, 0.95] per SD; P = 0.0036; median follow-up, 9 years), and smaller increases (follow-up adjusted for baseline) in FG (−0.5%; P < 0.0001) and HOMA-IR (−2.9%; P = 0.011) after adjusting for baseline clinical and demographic covariates, including plasma triglycerides and HDL cholesterol. Total apoC-I concentrations were not associated with changes in FG, HOMA-IR, or incident diabetes. In ACT NOW, higher C-I′/C-I was associated with smaller increases in AUCglucose (−1.8%; P = 0.0052), greater increases in ISI (7.2%; P = 0.0095), and lower risk of diabetes (n = 59 events; 0.66 [95% CI 0.48, 0.91]; P = 0.004; median follow-up, 2.5 years) after adjusting for treatment group and diabetes risk factors, including plasma lipids. CONCLUSIONS Our results indicate that apoC-I truncation may contribute to changes in glucose levels, IR, and risk of diabetes.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":null,"pages":null},"PeriodicalIF":16.2,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142490432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of Infection in Older Adults With Type 2 Diabetes With Relaxed Glycemic Control","authors":"Kasia J. Lipska, Lisa K. Gilliam, Catherine Lee, Jennifer Y. Liu, Vincent X. Liu, Howard H. Moffet, Melissa M. Parker, Heidi Zapata, Andrew J. Karter","doi":"10.2337/dc24-1612","DOIUrl":"https://doi.org/10.2337/dc24-1612","url":null,"abstract":"OBJECTIVE To compare the risk of hospitalization for infection among patients who achieve intensive versus relaxed glycemic control. RESEARCH DESIGN AND METHODS This retrospective cohort study included adults age ≥65 years with type 2 diabetes from an integrated health care delivery system. Negative binomial models were used to estimate incidence rates and relative risk (RR) of hospitalization for infections (respiratory; genitourinary; skin, soft tissue, and bone; and sepsis), comparing two levels of relaxed (hemoglobin A1c [HbA1c] 7% to <8% and 8% to <9%) with intensive (HbA1c 6% to <7%) glycemic control from 1 January 2019 to 1 March 2020. RESULTS Among 103,242 older patients (48.5% with HbA1c 6% to <7%, 35.3% with HbA1c 7% to <8%, and 16.1% with HbA1c 8% to <9%), the rate of hospitalization for infections was 51.3 per 1,000 person-years. Compared with HbA1c 6% to <7%, unadjusted risk of hospitalization for infections was significantly elevated among patients with HbA1c 8% to <9% (RR 1.25; 95% CI 1.13, 1.39) but not among patients with HbA1c 7% to <8% (RR 0.99; 95% CI 0.91, 1.08), and the difference became nonsignificant after adjustment. Across categories of infections, the adjusted RR of hospitalization was significantly higher among patients with HbA1c 8% to <9% only for skin, soft tissue, and bone infection (RR 1.33; 95% CI 1.05, 1.69). CONCLUSIONS Older patients with type 2 diabetes who achieve relaxed glycemic control levels endorsed by clinical guidelines are not at significantly increased risk of hospitalization for most infections, but HbA1c 8% to <9% is associated with an increased risk of hospitalization for skin, soft tissue, and bone infections.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":null,"pages":null},"PeriodicalIF":16.2,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142487502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incremental Prognostic Value of a Coronary Heart Disease Polygenic Risk Score in Type 2 Diabetes","authors":"Ify R. Mordi, Ivy Li, Gittu George, Rory J. McCrimmon, Colin N. Palmer, Ewan R. Pearson, Chim C. Lang, Alex S. Doney","doi":"10.2337/dc24-1489","DOIUrl":"https://doi.org/10.2337/dc24-1489","url":null,"abstract":"OBJECTIVE The recent availability of cardiovascular risk-reducing type 2 diabetes (T2D) therapies makes it imperative to optimally identify individuals who could derive benefit. Current clinical risk prediction may misclassify individuals as low risk and could be improved. Our aim was to determine the incremental prognostic value of a coronary heart disease (CHD) genome-wide polygenic risk score (PRS) to a clinical risk score in prediction of major adverse cardiovascular events (MACE) in patients with T2D. RESEARCH DESIGN AND METHODS We evaluated 10,556 individuals with T2D aged 40–79 without a prior cardiovascular hospitalization. We calculated 10-year clinical cardiovascular risk at the date of recruitment using the Pooled Cohort Equation (PCE Risk) and constructed a CHD PRS. The primary outcome was time to first MACE incidence, and we assessed the additional incremental predictive value of the CHD PRS to the PCE risk. RESULTS At 10 years, there were 1,477 MACE. After adjustment for clinical risk, the CHD PRS was significantly associated with MACE (hazard ratio [HR] 1.69 per SD increase, 95% CI 1.60–1.79). Individuals with PCE Risk <7.5% but in the top quintile of CHD PRS had a significantly increased likelihood of MACE (HR 10.69, 95% CI 5.07–22.55) compared with those in the lowest. The addition of the PRS to the clinical risk score led to significant improvements in risk prediction, particularly in those at low clinical risk. CONCLUSIONS The addition of a CHD PRS to clinical assessment improved MACE prediction in T2D individuals without prior cardiovascular disease, particularly in those at low clinical risk.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":null,"pages":null},"PeriodicalIF":16.2,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142443875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Maternal Glycemic Status and Longitudinal Fetal Body Composition and Organ Volumes Based on Three-Dimensional Ultrasonography","authors":"Kathryn A. Wagner, Jessica L. Gleason, Zhen Chen, Cuilin Zhang, Stefanie N. Hinkle, Dian He, Wesley Lee, Roger B. Newman, John Owen, Daniel W. Skupski, William A. Grobman, Seth Sherman, Fasil Tekola-Ayele, Jagteshwar Grewal, Katherine L. Grantz","doi":"10.2337/dc24-1068","DOIUrl":"https://doi.org/10.2337/dc24-1068","url":null,"abstract":"OBJECTIVE Gestational diabetes mellitus (GDM) increases the risk of fetal overgrowth as measured by two-dimensional ultrasonography. Whether fetal three-dimensional (3D) soft tissue and organ volumes provide additional insight into fetal overgrowth is unknown. RESEARCH DESIGN AND METHODS We prospectively evaluated longitudinal 3D fetal body composition and organ volumes in a diverse US singleton pregnancy cohort (2015–2019). Women were diagnosed with GDM, impaired glucose tolerance (IGT), or normal glucose tolerance (NGT). Up to five 3D ultrasound scans measured fetal body composition and organ volumes; trajectories were modeled using linear mixed models. Overall and weekly mean differences in fetal 3D trajectories were tested across glycemic status, adjusted for covariates. RESULTS In this sample (n = 2,427), 5.2% of women had GDM, and 3.0% had IGT. Fetuses of women who developed GDM compared with NGT had larger fractional arm and fractional fat arm volumes from 26 to 35 weeks, smaller fractional lean arm volume from 17 to 22 weeks, and larger abdominal area from 24 to 40 weeks. Fetuses of women with IGT had similar growth patterns, which manifested later in gestation and with larger magnitudes, and had larger fractional lean arm volume. No overall differences were observed among thigh or organ volumes across glycemic status. CONCLUSIONS Body composition differed in fetuses of GDM-complicated pregnancies, including larger arm and abdominal measures across the second and third trimesters. Patterns were similar in IGT-complicated pregnancies except that they occurred later in gestation and with larger magnitudes. Future research should explore how lifestyle and medication may alter fetal fat accumulation trajectories among hyperglycemic pregnancies.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":null,"pages":null},"PeriodicalIF":16.2,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142443853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Syringe and Needle Reuse on the Clinical Outcomes of Patients With Type 2 Diabetes: A 12-Week Randomized Clinical Trial","authors":"Gabriela Berlanda, Gabriela H. Telo, Agnes Nogueira Gossenheimer, Andrea Auler, Eduardo Sturmer da Silva, Paula Godinho Rodrigues, Ana Carolina Krum dos Santos, Sandro Campos Amico, Beatriz D. Schaan","doi":"10.2337/dc24-0157","DOIUrl":"https://doi.org/10.2337/dc24-0157","url":null,"abstract":"OBJECTIVE To evaluate the clinical and laboratory outcomes of patients with type 2 diabetes by comparing the no reuse or reuse of syringes and needles for insulin injection. RESEARCH DESIGN AND METHODS Adults with type 2 diabetes who had reused syringes and needles at least three times were randomly instructed either to not reuse or to reuse insulin syringes and needles five times. The primary outcomes assessed were glycemic control, pain scores, and skin complications (ecchymosis, lipohypertrophy, nodules, infection) at baseline and 4, 8, and 12 weeks after the intervention. Secondary outcomes included treatment adherence, quality of life, microbiological contamination of syringes and needles, needle quality, and insulin injection technique. RESULTS Among the 71 participants (mean ± SD age 59.7 ± 8.8 years), 59% were women with a median duration of diabetes of 18 years (interquartile range 10–25 years) and a mean BMI of 31.7 ± 6.7 kg/m2. The group that reused syringes and needles experienced an increase in lipohypertrophy/nodules (0.16 ± 0.08, P = 0.040) but did not experience worsening pain or glycemic control, even when the syringes and needles were inserted into the skin with great effort. There was no difference in the total number of skin complications, quality of life, or microbiological contamination. Both groups improved treatment adherence, with a greater increase in the reuse group. CONCLUSIONS The reuse of syringes and needles is associated with a modest increase in lipohypertrophy/nodules but does not have a short-term impact on glycemic control in patients with type 2 diabetes.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":null,"pages":null},"PeriodicalIF":16.2,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142440215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Adopting Preventive Drug Lists on Medication Costs and Disparities by Income Over 2 Years: A Natural Experiment for Translation in Diabetes (NEXT-D) Study","authors":"Christine Y. Lu, Stephanie Argetsinger, Matthew Lakoma, Fang Zhang, J. Frank Wharam, Dennis Ross-Degnan","doi":"10.2337/dc24-0361","DOIUrl":"https://doi.org/10.2337/dc24-0361","url":null,"abstract":"OBJECTIVE To examine the association between preventive drug lists (PDLs) and changes in medication costs among patients with diabetes insured in commercial health plans over 2 follow-up years. RESEARCH DESIGN AND METHODS We conducted a quasiexperimental study using the Optum deidentified Clinformatics Data Mart Database (January 2003 to December 2017). The intervention group included 5,582 patients with diabetes age 12–64 years switched by employers to PDL coverage; the control group included 5,582 matched patients whose employers offered no PDL. Outcomes included out-of-pocket costs, standardized costs, and 30-day fills for all medications because PDL-associated savings could be used to pay for medicines in other classes and for five therapeutic classes covered by the PDLs (oral diabetic medications, insulins, test strips, antihypertensive drugs, and lipid-lowering drugs). RESULTS Pre– to post–out-of-pocket spending for all medications declined by 29.7% in follow-up year 2 (95% CI −36.0, −23.4%) among PDL members relative to controls. Higher-income and lower-income PDL members experienced significant reductions in out-of-pocket spending for all medications in year 2 (30%) and for key therapeutic classes (range −23 to −67%). We found significant increases in use of key therapeutic classes in the overall population (range 8–15%) and in higher-income and lower-income PDL members (range 9–50%). CONCLUSIONS PDLs offer an effective strategy for employers and insurers to lower member cost sharing and encourage increased use of important medications to prevent or manage chronic illnesses. For patients with diabetes, especially those with lower incomes, PDL coverage resulted in substantial and persistent reductions in out-of-pocket medication costs, medication use increases, and some increased use of more expensive products.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":null,"pages":null},"PeriodicalIF":16.2,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142385617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of Energy Intake and Dietary Glycemic Load in Different Time Periods With Cardiovascular Disease Mortality Among U.S. Adults With Type 2 Diabetes","authors":"Jin Dai, Roch Nianogo, Tannaz Moin, Nathan D. Wong, Qibin Qi, Daniela Sotres-Alvarez, Liwei Chen","doi":"10.2337/dc24-1345","DOIUrl":"https://doi.org/10.2337/dc24-1345","url":null,"abstract":"OBJECTIVE To examine the associations of energy intake and glycemic load (GL) in different time periods during the day with cardiovascular disease (CVD) mortality risk in adults with type 2 diabetes. RESEARCH DESIGN AND METHODS This cohort study included 2,911 adults with diabetes from who were part of the U.S. National Health and Nutrition Examination Survey 2003–2014 (baseline), and CVD mortality data obtained by linkage to the National Death Index through 2019. Energy intake and GL in early morning (6:00–7:59 a.m.), late morning (8:00–10:59 a.m.), afternoon (11:00 a.m.–5:59 p.m.), evening (6:00–11:59 p.m.), and night (0:00–5:59 a.m.) were derived from two 24-h dietary recalls at baseline. Cox models were used to estimate hazard ratios (HRs) for CVD mortality, adjusted for total energy intake, diet quality, sociodemographic and lifestyle characteristics, and medical conditions. RESULTS At baseline, the study population (51.8% female, 62.3% non-Hispanic White) had a mean age of 57.4 (SE, 0.4) years. Over a median follow-up of 9.3 (interquartile range = 6.8, 12.1) years, 190 CVD deaths were documented. Energy intake and GL in late morning were inversely associated with CVD mortality risk (per 100-kcal energy intake increment, HR 0.90 [95% CI 0.83–0.98]; per 10-unit GL increment, HR 0.86 [95% CI 0.77–0.95]). In contrast, energy intake and GL at night were positively associated with CVD mortality risk (per 100-kcal energy intake increment, HR 1.22 [95% CI 1.07–1.40]; per 10-unit GL increment, HR 1.44 [95% CI 1.17–1.77]). CONCLUSIONS For adults with type 2 diabetes, late morning may be a protective eating time against CVD mortality, whereas night may be a detrimental eating time.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":null,"pages":null},"PeriodicalIF":16.2,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142385158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advanced Hybrid Closed-Loop Therapy Compared With Standard Insulin Therapy Intrapartum and Early Postpartum in Women With Type 1 Diabetes: A Secondary Observational Analysis From the CRISTAL Randomized Controlled Trial","authors":"Kaat Beunen, Pieter Gillard, Nancy Van Wilder, Dominique Ballaux, Gerd Vanhaverbeke, Youri Taes, Xavier-Philippe Aers, Frank Nobels, Liesbeth Van Huffel, Joke Marlier, Dahae Lee, Joke Cuypers, Vanessa Preumont, Sarah E. Siegelaar, Rebecca C. Painter, Annouschka Laenen, Chantal Mathieu, Katrien Benhalima","doi":"10.2337/dc24-1320","DOIUrl":"https://doi.org/10.2337/dc24-1320","url":null,"abstract":"OBJECTIVE To determine efficacy and safety of intrapartum and early postpartum advanced hybrid closed-loop (AHCL) therapy compared with standard insulin therapy in pregnant women with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS CRISTAL was a double-arm, open-label, randomized controlled trial performed in Belgium and the Netherlands that assigned 95 pregnant participants with T1D 1:1 to a MiniMed 780G AHCL system (n = 46) or standard insulin therapy (n = 49). This prespecified, secondary observational analysis focused on differences in glycemic control and safety outcomes between participants from the original AHCL group who continued AHCL intrapartum (n = 27) and/or early postpartum (n = 37, until hospital discharge) and those from the original standard insulin therapy group using standard insulin therapy intrapartum (n = 45) and/or early postpartum (n = 34). RESULTS Of the 43 and 46 participants in the AHCL and standard insulin therapy groups, respectively, completing the trial, 27 (62.8%) in the AHCL group continued AHCL and 45 in the standard insulin therapy group (97.8%) continued standard insulin therapy intrapartum. Compared with standard insulin therapy, intrapartum AHCL was associated with more time in range 3.5–7.8 mmol/L (71.5 ± 17.7% vs. 63.1 ± 17.0%, P = 0.030) and numerically lower time above range >7.8 mmol/L (27.3 ± 17.4% vs. 35.3 ± 17.5%, P = 0.054), without increases in time below range <3.5 mmol/L (1.1 ± 2.4% vs. 1.5 ± 2.3%, P = 0.146). Early postpartum, 37 (86.0%) participants randomized to AHCL continued AHCL, with a median increase in insulin-to-carbohydrate ratios of 67% (interquartile range −14 to 126). Similar tight glycemic control (3.9–10.0 mmol/L: 86.8 ± 6.7% vs. 83.8 ± 8.1%, P = 0.124) was observed with AHCL versus standard insulin therapy. No severe hypoglycemia or diabetic ketoacidosis was reported in either group. CONCLUSIONS AHCL is effective in maintaining tight glycemic control intrapartum and early postpartum and can be safely continued during periods of rapidly changing insulin requirements.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":null,"pages":null},"PeriodicalIF":16.2,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142328683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}