Diabetes Care最新文献

{"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":"46 1","pages":""},"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":"71 1","pages":""},"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":"12 1","pages":""},"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":"30 1","pages":""},"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}

{"title":"Continuous Glucose Monitoring With Geriatric Principles in Older Adults With Type 1 Diabetes and Hypoglycemia: A Randomized Controlled Trial","authors":"Medha N. Munshi, Christine Slyne, Atif Adam, Colin Conery, Adeolu Oladunjoye, Simon Neuwahl, David Wypij, Elena Toschi","doi":"10.2337/dc24-1069","DOIUrl":"https://doi.org/10.2337/dc24-1069","url":null,"abstract":"OBJECTIVE Continuous glucose monitoring (CGM) use in older adults with type 1 diabetes (T1D) has shown benefits. However, the impact of CGM use, coupled with simplified treatment regimens and personalized glycemic goals that are better suited for older patients with multiple comorbidities and hypoglycemia, is not known. RESEARCH DESIGN AND METHODS Older adults (≥65 years) with T1D with hypoglycemia (two or more episodes of hypoglycemia [blood glucose <70 mg/dL for ≥20 min over 2 weeks]) who were CGM naïve or CGM users were randomized to intervention and control groups. The intervention consisted of the combined use of CGM with geriatric principles (i.e., adjusting goals based on overall health, and simplification of regimens based on CGM patterns and clinical characteristics) over 6 months. The control group received usual care by their endocrinologist. The primary end point was change in time when blood glucose was <70 mg/dL from baseline to 6 months. Cost-effectiveness was calculated using a health care sector perspective. RESULTS We randomized 131 participants (aged 71 ± 5 years; 21% ≥75 years old) to the intervention (n = 68; CGM users = 33) or the control (n = 63; CGM users = 40) group. The median change in hypoglycemia from baseline to 6 months was −2·6% in the intervention group and −0.3% in the control group (median difference, −2.3% [95% CI −3.7%, −1.3%]; P < 0.001). This improvement was seen in both CGM naïve (−2.8%; 95% CI −5.6%, −0.8%) and CGM users (−1.2%; 95% CI −2.7%, −0.1%). The HbA1c did not differ between the groups (7.5% vs 7.3%). The intervention was cost-effective (incremental cost-effectiveness ratio $71,623 per quality adjusted life-year). CONCLUSIONS In older adults with T1D and high risk of hypoglycemia, CGM use enhanced by geriatric principles can lower hypoglycemia without worsening glycemic control in a cost-effective fashion.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"24 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142324928","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":"A Glycemic Threshold Above Which the Improvement of β-Cell Function and Glycemia in Response to Insulin Therapy Is Amplified in Early Type 2 Diabetes: The Reversal of Glucotoxicity","authors":"Ravi Retnakaran, Jiajie Pu, Chang Ye, Alexandra Emery, Stewart B. Harris, Sonja M. Reichert, Hertzel C. Gerstein, Natalia McInnes, Caroline K. Kramer, Bernard Zinman","doi":"10.2337/dc24-1375","DOIUrl":"https://doi.org/10.2337/dc24-1375","url":null,"abstract":"OBJECTIVE Alleviation of unrecognized glucotoxicity, with resultant recovery of β-cell function, could amplify the glucose-lowering effect of pharmacotherapy and contribute to the variable therapeutic response observed among patients with type 2 diabetes (T2D). However, clinical evidence supporting this concept is lacking. Short-term intensive insulin therapy (IIT) can ameliorate glucotoxicity and improve β-cell function in early T2D. Thus, for evidence of recovery of glucotoxicity-associated β-cell dysfunction, we sought to determine whether there exists a baseline fasting glucose threshold above which the post-IIT improvement in both β-cell function and glycemia is amplified. RESEARCH DESIGN AND METHODS IIT (glargine, lispro) was administered for 3 weeks to 108 adults with T2D (mean duration 1.8 ± 1.4 years). Oral glucose tolerance tests before and after IIT enabled assessment of β-cell function by Insulin Secretion-Sensitivity Index-2 and insulinogenic index/HOMA-insulin resistance. For each level of baseline fasting glycemia from 6.0 to 10.5 mmol/L, we modeled the difference in IIT-induced percentage change in β-cell function between those at/above the indicated glucose level and those below it. RESULTS The relationship between baseline fasting glucose and the differential change in β-cell function was nonlinear. Instead, this relationship was best fit by a cubic regression model with inflection (amplification) at fasting glucose at 9.3 mmol/L. Moreover, baseline fasting glucose at 9.3 mmol/L also identified the inflection point at which nonlinear reductions in fasting glucose and 2-h glucose, respectively, were both amplified. CONCLUSIONS The respective improvements in β-cell function and glycemia in response to short-term IIT are amplified in those in whom baseline fasting glucose exceeds a defined threshold, consistent with reversal of glucotoxicity.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"19 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142275869","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":"Family History of Diabetes and Clinical Characteristics in Children at Diagnosis of Type 1 Diabetes—A Swedish Population-Based Study","authors":"Emma Hedlund, Jasaman Tojjar, Lisa Lilja, Helena Elding Larsson, Gun Forsander, Johnny Ludvigsson, Claude Marcus, Fredrik Norström, Martina Persson, Annelie Carlsson","doi":"10.2337/dc24-0534","DOIUrl":"https://doi.org/10.2337/dc24-0534","url":null,"abstract":"OBJECTIVE To compare the prevalence of parental diabetes between children with and without type 1 diabetes (T1D), and to compare clinical characteristics at diagnosis of T1D in children with, versus without, a family history of diabetes. RESEARCH DESIGN AND METHODS Parental diabetes among children with T1D was compared with a general population cohort. Clinical characteristics were compared by family history of diabetes in parents and grandparents of 3,603 children with T1D using relative risk (RR) and ANOVA. RESULTS Children with T1D more often had parents with type 2 diabetes (T2D) (RR 1.88; P < 0.001) than did children without diabetes. Children with T1D and a family history of T2D were more likely to be overweight or obese (P = 0.002). CONCLUSIONS A family history of T2D and being overweight may contribute to increased risk of T1D.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"11 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142275876","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":"The Supporting Emerging Adults With Diabetes (SEAD) Program: An Adult-Based Real-World Clinical Model That Improves Hospitalizations, Diabetes Technology Uptake, and Glycemic Outcomes in Underserved Young Adults With Type 1 Diabetes","authors":"Shivani Agarwal, Priyanka Mathias, Clyde Schechter, Molly Finnan, Michael Greenberg, Stephanie L. Leung, Sharon Movsas, Judith A. Long","doi":"10.2337/dc24-1346","DOIUrl":"https://doi.org/10.2337/dc24-1346","url":null,"abstract":"OBJECTIVE Underserved young adults (YA) with type 1 diabetes (T1D) experience the worst outcomes across the life span. We developed and integrated the Supporting Emerging Adults with Diabetes (SEAD) program into routine endocrinology care to address unmet social and medical challenges. RESEARCH DESIGN AND METHODS This study was designed as a longitudinal cohort study, with prospective data collection over 4 years on YA in SEAD compared with usual endocrine care. We used propensity-weighted analysis to account for differences in baseline characteristics, and multivariate regression and Cox proportional hazard models to evaluate change in outcomes over time. Primary outcomes included incidence of hospitalizations, diabetes technology uptake, and annual change in HbA1c levels. RESULTS We included 497 YA with T1D in SEAD (n = 332) and usual endocrine care (n = 165); mean age 25 years, 27% non-Hispanic Black, 46% Hispanic, 49% public insurance, mean HbA1c 9.2%. Comparing YA in SEAD versus usual care, 1) incidence of hospitalizations was reduced by 64% for baseline HbA1c >9% (HR 0.36 [0.13, 0.98]) and 74% for publicly insured (HR 0.26 [0.07, 0.90]); 2) automated insulin delivery uptake was 1.5-times higher (HR 1.51 [0.83, 2.77]); and 3) HbA1c improvement was greater (SEAD, −0.37% per year [−0.59, −0.15]; usual care, −0.26% per year [−0.58, 0.05]). CONCLUSIONS SEAD meaningfully improves clinical outcomes in underserved YA with T1D, especially for publicly insured and high baseline HbA1c levels. Early intervention for at-risk YA with T1D as they enter adult care could reduce inequity in short and long-term outcomes.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"5 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142236374","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":"Accelerated Longitudinal Glycemic Changes in Relation to Urinary Toxic/Essential Metals and Metal Mixtures Among Mexican Americans Living in Starr County, Texas","authors":"Margaret C. Weiss, Jiehuan Sun, Brian P. Jackson, Mary E. Turyk, Luyu Wang, Eric L. Brown, David Aguilar, Sharon A. Brown, Craig L. Hanis, Maria Argos, Robert M. Sargis","doi":"10.2337/dc24-0646","DOIUrl":"https://doi.org/10.2337/dc24-0646","url":null,"abstract":"OBJECTIVE Metal and metalloid exposures (hereafter \"metals\") are associated with adverse health outcomes, including type 2 diabetes; however, previous studies were largely cross- sectional or underpowered. Furthermore, underserved racial/ethnic groups are underrepresented in environmental health research despite having higher rates of type 2 diabetes and a greater risk of metal exposures. Consequently, we evaluated continuous glycemic traits in relation to baseline urinary toxic metal, essential metal, and metal mixtures in a cohort of Mexican American adults. RESEARCH DESIGN AND METHODS A total of 510 participants were selected based upon self-reported diabetes status and followed over 3 years. Urinary metals were assessed at baseline. Linear mixed-effects models were used to estimate per-month changes in hemoglobin A1c, fasting plasma glucose, and postload glucose in relation to urinary metal levels. Multiple statistical approaches were used to assess the associations between glycemic traits and metal mixtures. RESULTS After adjustment, higher urinary levels of arsenic, selenium, copper, molybdenum, nickel, and tin were associated with faster increases in measures of glycemia. The toxic metal mixture composed of arsenic, lead, cadmium, nickel, and tin was associated with faster increases in postload glucose. Using postload glucose criteria, highest versus lowest arsenic was predicted to accelerate conversion of normoglycemia to prediabetes and diabetes by 23 and 65 months, respectively. CONCLUSIONS In this underrepresented, high-risk Mexican American population, exposure to toxic metals and alterations in essential metal homeostasis were associated with faster increases in glycemia over time that may accelerate type 2 diabetes development.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"31 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142234432","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":"Glycemic and Psychosocial Outcomes of Advanced Hybrid Closed Loop Therapy in Youth With High HbA1c: A Randomized Clinical Trial","authors":"Mary B. Abraham, Grant J. Smith, Julie Dart, Antony Clarke, Keely Bebbington, Janice M. Fairchild, Geoffrey R. Ambler, Fergus J. Cameron, Elizabeth A. Davis, Timothy W. Jones","doi":"10.2337/dc24-0276","DOIUrl":"https://doi.org/10.2337/dc24-0276","url":null,"abstract":"OBJECTIVE To determine the efficacy of advanced hybrid closed loop (AHCL) therapy in a high-risk cohort of youth on continuous subcutaneous insulin infusion (CSII) ± continuous glucose monitoring (CGM) with suboptimal glycemia. RESEARCH DESIGN AND METHODS In a 6-month multicenter clinical trial, youth with type 1 diabetes with mean and most recent HbA1c > 8.5% (65 mmol/mol) were randomly assigned 1:1 to AHCL or treatment as usual (CSII ± CGM). The primary outcome was the 24-week between-group difference in HbA1c. Secondary outcomes included CGM metrics from masked CGM and psychological measures (youth-reported problem areas in diabetes [PAID], quality of life, anxiety, depression, and hypoglycemia fear) assessed using validated questionnaires. RESULTS A total of 42 participants were randomized (mean [SD] age 16.2 [2.5] years, HbA1c 9.8 [1.1]% or 84 [12] mmol/mol, PAID score 50.3 [19.8]). At study end, the mean (SD) HbA1c was 8.8 (1.1)% or 73 (12) mmol/mol with AHCL and 9.9 (1.2)% or 85 (13.1) mmol/mol with CSII ± CGM, with mean adjusted group difference of −0.77% (95% CI −1.45 to −0.09) or −8.4 mmol/mol (−15.8 to −1.0); P = 0.027. AHCL increased time in range 70–180 mg/dL (difference 19.1%; 95% CI 11.1 to 27.1), reduced time >180 mg/dL (difference −17.7%; 95% CI −26.6 to −8.8), with no increase in time spent <70 mg/dL (difference −0.8%; 95% CI −2.7 to 0.6). There was no evidence for difference in psychosocial outcomes between the two groups at study end. CONCLUSIONS AHCL should be encouraged in youth with suboptimal glycemia, as AHCL improves glycemia. However, psychological support remains vital, as technology alone may not be able to reduce the burden of diabetes care in this subgroup.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"324 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142231405","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}