Maya Spaur, Marta Galvez-Fernandez, Qixuan Chen, Melissa A. Lombard, Benjamin C. Bostick, Pam Factor-Litvak, Amanda M. Fretts, Steven J. Shea, Ana Navas-Acien, Anne E. Nigra
OBJECTIVE We examined the association of arsenic in federally regulated community water systems (CWSs) and unregulated private wells with type 2 diabetes (T2D) incidence in the Strong Heart Family Study (SHFS), a prospective study of American Indian communities, and the Multi-Ethnic Study of Atherosclerosis (MESA), a prospective study of racially and ethnically diverse urban U.S. communities. RESEARCH DESIGN AND METHODS We evaluated 1,791 participants from SHFS and 5,777 participants from MESA who had water arsenic estimates available and were free of T2D at baseline (2001–2003 and 2000–2002, respectively). Participants were followed for incident T2D until 2010 (SHFS cohort) or 2019 (MESA cohort). We used Cox proportional hazards mixed-effects models to account for clustering by family and residential zip code, with adjustment for sex, baseline age, BMI, smoking status, and education. RESULTS T2D incidence was 24.4 cases per 1,000 person-years (mean follow-up, 5.6 years) in SHFS and 11.2 per 1,000 person-years (mean follow-up, 14.0 years) in MESA. In a meta-analysis across the SHFS and MESA cohorts, the hazard ratio (95% CI) per doubling in CWS arsenic was 1.10 (1.02, 1.18). The corresponding hazard ratio was 1.09 (0.95, 1.26) in the SHFS group and 1.10 (1.01, 1.20) in the MESA group. The corresponding hazard ratio (95% CI) for arsenic in private wells and incident T2D in SHFS was 1.05 (0.95, 1.16). We observed statistical interaction and larger magnitude hazard ratios for participants with BMI <25 kg/m2 and female participants. CONCLUSIONS Low to moderate water arsenic levels (<10 µg/L) were associated with T2D incidence in the SHFS and MESA cohorts.
{"title":"Association of Water Arsenic With Incident Diabetes in U.S. Adults: The Multi-Ethnic Study of Atherosclerosis and the Strong Heart Study","authors":"Maya Spaur, Marta Galvez-Fernandez, Qixuan Chen, Melissa A. Lombard, Benjamin C. Bostick, Pam Factor-Litvak, Amanda M. Fretts, Steven J. Shea, Ana Navas-Acien, Anne E. Nigra","doi":"10.2337/dc23-2231","DOIUrl":"https://doi.org/10.2337/dc23-2231","url":null,"abstract":"OBJECTIVE We examined the association of arsenic in federally regulated community water systems (CWSs) and unregulated private wells with type 2 diabetes (T2D) incidence in the Strong Heart Family Study (SHFS), a prospective study of American Indian communities, and the Multi-Ethnic Study of Atherosclerosis (MESA), a prospective study of racially and ethnically diverse urban U.S. communities. RESEARCH DESIGN AND METHODS We evaluated 1,791 participants from SHFS and 5,777 participants from MESA who had water arsenic estimates available and were free of T2D at baseline (2001–2003 and 2000–2002, respectively). Participants were followed for incident T2D until 2010 (SHFS cohort) or 2019 (MESA cohort). We used Cox proportional hazards mixed-effects models to account for clustering by family and residential zip code, with adjustment for sex, baseline age, BMI, smoking status, and education. RESULTS T2D incidence was 24.4 cases per 1,000 person-years (mean follow-up, 5.6 years) in SHFS and 11.2 per 1,000 person-years (mean follow-up, 14.0 years) in MESA. In a meta-analysis across the SHFS and MESA cohorts, the hazard ratio (95% CI) per doubling in CWS arsenic was 1.10 (1.02, 1.18). The corresponding hazard ratio was 1.09 (0.95, 1.26) in the SHFS group and 1.10 (1.01, 1.20) in the MESA group. The corresponding hazard ratio (95% CI) for arsenic in private wells and incident T2D in SHFS was 1.05 (0.95, 1.16). We observed statistical interaction and larger magnitude hazard ratios for participants with BMI &lt;25 kg/m2 and female participants. CONCLUSIONS Low to moderate water arsenic levels (&lt;10 µg/L) were associated with T2D incidence in the SHFS and MESA cohorts.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"28 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140642181","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}
Hongwei Ji, Joseph E. Ebinger, Alan C. Kwan, Karen Reue, Jennifer C. Sullivan, John Shyy, Susan Cheng
OBJECTIVE To investigate whether the sex disparities in type 2 diabetes–associated cardiovascular disease (CVD) risks may be related to early-onset hypertension that could benefit from intensive blood pressure (BP) control. RESEARCH DESIGN AND METHODS We analyzed intensive versus standard BP control in relation to incident CVD events in women and men with type 2 diabetes, based on their age of hypertension diagnosis. RESULTS Among 3,792 adults with type 2 diabetes (49% women), multivariable-adjusted CVD risk was increased per decade earlier age at hypertension diagnosis (hazard ratio 1.11 [1.03–1.21], P = 0.006). Excess risk associated with early-diagnosed hypertension was attenuated in the presence of intensive versus standard antihypertensive therapy in women (P = 0.036) but not men (P = 0.76). CONCLUSIONS Women with type 2 diabetes and early-onset hypertension may represent a higher-risk subpopulation that not only contributes to the female excess in diabetes-related CVD risk but may benefit from intensive BP control.
{"title":"Early-Onset Hypertension and Sex-Specific Residual Risk for Cardiovascular Disease in Type 2 Diabetes","authors":"Hongwei Ji, Joseph E. Ebinger, Alan C. Kwan, Karen Reue, Jennifer C. Sullivan, John Shyy, Susan Cheng","doi":"10.2337/dc23-2275","DOIUrl":"https://doi.org/10.2337/dc23-2275","url":null,"abstract":"OBJECTIVE To investigate whether the sex disparities in type 2 diabetes–associated cardiovascular disease (CVD) risks may be related to early-onset hypertension that could benefit from intensive blood pressure (BP) control. RESEARCH DESIGN AND METHODS We analyzed intensive versus standard BP control in relation to incident CVD events in women and men with type 2 diabetes, based on their age of hypertension diagnosis. RESULTS Among 3,792 adults with type 2 diabetes (49% women), multivariable-adjusted CVD risk was increased per decade earlier age at hypertension diagnosis (hazard ratio 1.11 [1.03–1.21], P = 0.006). Excess risk associated with early-diagnosed hypertension was attenuated in the presence of intensive versus standard antihypertensive therapy in women (P = 0.036) but not men (P = 0.76). CONCLUSIONS Women with type 2 diabetes and early-onset hypertension may represent a higher-risk subpopulation that not only contributes to the female excess in diabetes-related CVD risk but may benefit from intensive BP control.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"18 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140642247","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}
Giuseppe Daniele, Andrea Tura, Alex Brocchi, Alessandro Saba, Beatrice Campi, Veronica Sancho-Bornez, Angela Dardano, Stefano Del Prato
OBJECTIVE To explore the complementary effects of a combination of dipeptidyl peptidase 4 and sodium–glucose cotransporter 2 inhibitors added to metformin on hormonal and metabolic responses to meal ingestion. RESEARCH DESIGN AND METHODS Forty-five patients (age 58 ± 8 years; HbA1c 58 ± 6 mmol/mol; BMI 30.7 ± 3.2 kg/m2) with type 2 diabetes uncontrolled with metformin were evaluated at baseline and 3 and 28 days after 5 mg saxagliptin (SAXA), 10 mg dapagliflozin (DAPA), or 5 mg saxagliptin plus 10 mg dapagliflozin (SAXA+DAPA) using a mixed-meal tolerance test (MMTT) spiked with dual-tracer glucose to assess glucose metabolism, insulin secretion, and sensitivity. RESULTS At day 3, fasting and mean MMTT glucose levels were lower with SAXA+DAPA (−31.1 ± 1.6 and −91.5 ± 12.4 mg/dL) than with SAXA (−7.1 ± 2.1 and −53 ± 10.5 mg/dL) or DAPA (−17.0 ± 1.1 and −42.6 ± 10.0 mg/dL, respectively; P < 0.001). Insulin secretion rate (SAXA+DAPA +75%; SAXA +11%; DAPA 3%) and insulin sensitivity (+2.2 ± 1.7, +0.4 ± 0.7, and +0.4 ± 0.4 mg ⋅ kg−1⋅ min−1, respectively) improved with SAXA+DAPA (P < 0.007). Mean glucagon-like peptide 1 (GLP-1) was higher with SAXA+DAPA than with SAXA or DAPA. Fasting glucagon increased with DAPA and SAXA+DAPA but not with SAXA. Fasting endogenous glucose production (EGP) increased with SAXA+DAPA and DAPA. During MMTT, EGP suppression was greater (48%) with SAXA+DAPA (vs. SAXA 44%; P = 0.02 or DAPA 34%; P = 0.2). Metabolic clearance rate of glucose (MCRglu) increased more with SAXA+DAPA. At week 4, insulin secretion rate, β-cell glucose sensitivity, and insulin sensitivity had further increased in the SAXA+DAPA group (P = 0.02), with no additional changes in GLP-1, glucagon, fasting or MMTT EGP, or MCRglu. CONCLUSIONS SAXA+DAPA provided superior glycemic control compared with DAPA or SAXA, with improved β-cell function, insulin sensitivity, GLP-1 availability, and glucose clearance.
{"title":"β-Cell Function, Incretin Effect, and Glucose Kinetics in Response to a Mixed Meal in Patients With Type 2 Diabetes Treated With Dapagliflozin Plus Saxagliptin","authors":"Giuseppe Daniele, Andrea Tura, Alex Brocchi, Alessandro Saba, Beatrice Campi, Veronica Sancho-Bornez, Angela Dardano, Stefano Del Prato","doi":"10.2337/dc23-2051","DOIUrl":"https://doi.org/10.2337/dc23-2051","url":null,"abstract":"OBJECTIVE To explore the complementary effects of a combination of dipeptidyl peptidase 4 and sodium–glucose cotransporter 2 inhibitors added to metformin on hormonal and metabolic responses to meal ingestion. RESEARCH DESIGN AND METHODS Forty-five patients (age 58 ± 8 years; HbA1c 58 ± 6 mmol/mol; BMI 30.7 ± 3.2 kg/m2) with type 2 diabetes uncontrolled with metformin were evaluated at baseline and 3 and 28 days after 5 mg saxagliptin (SAXA), 10 mg dapagliflozin (DAPA), or 5 mg saxagliptin plus 10 mg dapagliflozin (SAXA+DAPA) using a mixed-meal tolerance test (MMTT) spiked with dual-tracer glucose to assess glucose metabolism, insulin secretion, and sensitivity. RESULTS At day 3, fasting and mean MMTT glucose levels were lower with SAXA+DAPA (−31.1 ± 1.6 and −91.5 ± 12.4 mg/dL) than with SAXA (−7.1 ± 2.1 and −53 ± 10.5 mg/dL) or DAPA (−17.0 ± 1.1 and −42.6 ± 10.0 mg/dL, respectively; P &lt; 0.001). Insulin secretion rate (SAXA+DAPA +75%; SAXA +11%; DAPA 3%) and insulin sensitivity (+2.2 ± 1.7, +0.4 ± 0.7, and +0.4 ± 0.4 mg ⋅ kg−1⋅ min−1, respectively) improved with SAXA+DAPA (P &lt; 0.007). Mean glucagon-like peptide 1 (GLP-1) was higher with SAXA+DAPA than with SAXA or DAPA. Fasting glucagon increased with DAPA and SAXA+DAPA but not with SAXA. Fasting endogenous glucose production (EGP) increased with SAXA+DAPA and DAPA. During MMTT, EGP suppression was greater (48%) with SAXA+DAPA (vs. SAXA 44%; P = 0.02 or DAPA 34%; P = 0.2). Metabolic clearance rate of glucose (MCRglu) increased more with SAXA+DAPA. At week 4, insulin secretion rate, β-cell glucose sensitivity, and insulin sensitivity had further increased in the SAXA+DAPA group (P = 0.02), with no additional changes in GLP-1, glucagon, fasting or MMTT EGP, or MCRglu. CONCLUSIONS SAXA+DAPA provided superior glycemic control compared with DAPA or SAXA, with improved β-cell function, insulin sensitivity, GLP-1 availability, and glucose clearance.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"53 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140640255","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}
Heiko Bratke, Eva Biringer, Anastasia Ushakova, Hanna D. Margeirsdottir, Siv Janne Kummernes, Pål R. Njølstad, Torild Skrivarhaug
OBJECTIVE To evaluate, from 2013 to 2022, how HbA1c, the incidence of acute complications, and use of diabetes technology changed at the national level in Norway and how glycemic control was associated with use of diabetes technology, carbohydrate counting, or participation in a quality improvement project. RESEARCH DESIGN AND METHODS This longitudinal observational study was based on 27,214 annual registrations of 6,775 children from the Norwegian Childhood Diabetes Registry from 2013 to 2022. Individuals aged >18 years, those with diabetes other than type 1, and those without HbA1c measurements were excluded. The outcome measure was HbA1c. The predictor variables in the adjusted linear mixed-effects model were 1) the use of diabetes technology, 2) the use of carbohydrate counting for meal bolusing, and 3) whether the patient’s diabetes team participated in a quality improvement project. RESULTS Mean HbA1c decreased from 8.2% (2013) to 7.2% (2021), and the proportion of youth reaching an HbA1c <7.0% increased from 13% (2013) to 43% (2022). Insulin pump use increased from 65% (2013) to 91% (2022). Continuous glucose monitoring (CGM) use increased from 34% (first recorded in 2016) to 97% (2022). Insulin pump, CGM, and carbohydrate counting were associated with lower HbA1c and higher achievement of glycemic targets. Girls had a higher mean HbA1c than boys. Mean HbA1c levels were lower in clinics that participated in a quality improvement project for the following 4 years after the project. CONCLUSIONS Diabetes technology, carbohydrate counting, and systematic quality improvement in pediatric departments led to improved glycemic control.
{"title":"Ten Years of Improving Glycemic Control in Pediatric Diabetes Care: Data From the Norwegian Childhood Diabetes Registry","authors":"Heiko Bratke, Eva Biringer, Anastasia Ushakova, Hanna D. Margeirsdottir, Siv Janne Kummernes, Pål R. Njølstad, Torild Skrivarhaug","doi":"10.2337/dc24-0086","DOIUrl":"https://doi.org/10.2337/dc24-0086","url":null,"abstract":"OBJECTIVE To evaluate, from 2013 to 2022, how HbA1c, the incidence of acute complications, and use of diabetes technology changed at the national level in Norway and how glycemic control was associated with use of diabetes technology, carbohydrate counting, or participation in a quality improvement project. RESEARCH DESIGN AND METHODS This longitudinal observational study was based on 27,214 annual registrations of 6,775 children from the Norwegian Childhood Diabetes Registry from 2013 to 2022. Individuals aged &gt;18 years, those with diabetes other than type 1, and those without HbA1c measurements were excluded. The outcome measure was HbA1c. The predictor variables in the adjusted linear mixed-effects model were 1) the use of diabetes technology, 2) the use of carbohydrate counting for meal bolusing, and 3) whether the patient’s diabetes team participated in a quality improvement project. RESULTS Mean HbA1c decreased from 8.2% (2013) to 7.2% (2021), and the proportion of youth reaching an HbA1c &lt;7.0% increased from 13% (2013) to 43% (2022). Insulin pump use increased from 65% (2013) to 91% (2022). Continuous glucose monitoring (CGM) use increased from 34% (first recorded in 2016) to 97% (2022). Insulin pump, CGM, and carbohydrate counting were associated with lower HbA1c and higher achievement of glycemic targets. Girls had a higher mean HbA1c than boys. Mean HbA1c levels were lower in clinics that participated in a quality improvement project for the following 4 years after the project. CONCLUSIONS Diabetes technology, carbohydrate counting, and systematic quality improvement in pediatric departments led to improved glycemic control.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"8 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140636154","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}
Philip Zeitler, Rodolfo J. Galindo, Melanie J. Davies, Brandon K. Bergman, Vivian T. Thieu, Claudia Nicolay, Sheryl Allen, Robert J. Heine, Clare J. Lee
OBJECTIVE We evaluated baseline characteristics of participants with early-onset type 2 diabetes (T2D) from the SURPASS program and tirzepatide’s effects on glycemic control, body weight (BW), and cardiometabolic markers. RESEARCH DESIGN AND METHODS This post hoc analysis compared baseline characteristics and changes in mean HbA1c, BW, waist circumference (WC), lipids, and blood pressure (BP) in 3,792 participants with early-onset versus later-onset T2D at week 40 (A Study of Tirzepatide [LY3298176] in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone [SURPASS-1], A Study of Tirzepatide [LY3298176] Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes [SURPASS-2]) or week 52 (A Study of Tirzepatide [LY3298176] Versus Insulin Degludec in Participants With Type 2 Diabetes [SURPASS-3]). Analyses were performed by study on data from participants while on assigned treatment without rescue medication in case of persistent hyperglycemia. RESULTS At baseline in SURPASS-2, participants with early-onset versus later-onset T2D were younger with longer diabetes duration (9 vs. 7 years, P < 0.001) higher glycemic levels (8.5% vs. 8.2%, P < 0.001), higher BW (97 vs. 93 kg, P < 0.001) and BMI (35 vs. 34 kg/m2, P < 0.001), and a similarly abnormal lipid profile (e.g., triglycerides 167 vs. 156 mg/dL). At week 40, similar improvements in HbA1c (−2.6% vs. −2.4%), BW (−14 vs. −13 kg), WC (−10 vs. −10 cm), triglycerides (−26% vs. −24%), HDL (7% vs. 7%), and systolic BP (−6 vs. −7 mmHg) were observed in both subgroups with tirzepatide. CONCLUSIONS Despite younger age, participants with early-onset T2D from the SURPASS program had higher glycemic levels and worse overall metabolic health at baseline versus those with later-onset T2D. In this post hoc analysis, similar improvements in HbA1c, BW, and cardiometabolic markers were observed with tirzepatide, irrespective of age at T2D diagnosis. Future studies are needed to determine long-term outcomes of tirzepatide in early-onset T2D.
目的 我们评估了 SURPASS 计划中早发 2 型糖尿病 (T2D) 参与者的基线特征以及替扎帕肽对血糖控制、体重 (BW) 和心脏代谢指标的影响。研究设计与方法 本项事后分析比较了 3792 名早发与晚发 T2D 参与者在第 40 周时的基线特征以及平均 HbA1c、体重、腰围 (WC)、血脂和血压 (BP) 的变化（单靠饮食和运动无法控制血糖的 2 型糖尿病患者服用替扎帕肽 [LY3298176] 的研究 [SURPASS-1]）、2型糖尿病患者二甲双胍附加疗法中替唑帕肽[LY3298176]与塞马鲁肽每周一次的比较研究[SURPASS-2]）或第52周（2型糖尿病患者中替唑帕肽[LY3298176]与德格鲁德胰岛素的比较研究[SURPASS-3]）。研究分析了参与者在接受指定治疗期间的数据，在出现持续高血糖时未使用抢救药物。结果 在 SURPASS-2 的基线研究中，早发与晚发 T2D 患者的年龄更小，糖尿病病程更长（9 年 vs. 7 年，P < 0.001），血糖水平更高（8.5% vs. 8.2%，P < 0.001）。5% vs. 8.2%，Pamp;lt; 0.001），体重（97 kg vs. 93 kg，Pamp;lt; 0.001）和体重指数（35 kg/m2 vs. 34 kg/m2，Pamp;lt; 0.001）较高，血脂也同样异常（如甘油三酯 167 vs. 甘油三酯 167 vs. 甘油三酯 34 kg/m2，Pamp;lt; 0.001）、甘油三酯 167 vs. 156 mg/dL）。第 40 周时，观察到两个亚组的 HbA1c（-2.6% vs. -2.4%）、体重（-14 kg vs. -13kg）、腹围（-10 cm vs. -10cm）、甘油三酯（-26% vs. -24%）、高密度脂蛋白（7% vs. 7%）和收缩压（-6 mmHg vs. -7mmHg）在使用替扎帕肽后均有类似改善。结论 尽管 SURPASS 计划的早发性 T2D 参与者年龄较小，但与晚发性 T2D 参与者相比，他们的血糖水平较高，整体代谢健康状况较差。在这项事后分析中，无论确诊 T2D 时的年龄如何，使用替扎帕肽对 HbA1c、体重和心脏代谢指标都有类似的改善。未来还需要进行研究，以确定替扎帕肽对早发性 T2D 的长期疗效。
{"title":"Early-Onset Type 2 Diabetes and Tirzepatide Treatment: A Post Hoc Analysis From the SURPASS Clinical Trial Program","authors":"Philip Zeitler, Rodolfo J. Galindo, Melanie J. Davies, Brandon K. Bergman, Vivian T. Thieu, Claudia Nicolay, Sheryl Allen, Robert J. Heine, Clare J. Lee","doi":"10.2337/dc23-2356","DOIUrl":"https://doi.org/10.2337/dc23-2356","url":null,"abstract":"OBJECTIVE We evaluated baseline characteristics of participants with early-onset type 2 diabetes (T2D) from the SURPASS program and tirzepatide’s effects on glycemic control, body weight (BW), and cardiometabolic markers. RESEARCH DESIGN AND METHODS This post hoc analysis compared baseline characteristics and changes in mean HbA1c, BW, waist circumference (WC), lipids, and blood pressure (BP) in 3,792 participants with early-onset versus later-onset T2D at week 40 (A Study of Tirzepatide [LY3298176] in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone [SURPASS-1], A Study of Tirzepatide [LY3298176] Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes [SURPASS-2]) or week 52 (A Study of Tirzepatide [LY3298176] Versus Insulin Degludec in Participants With Type 2 Diabetes [SURPASS-3]). Analyses were performed by study on data from participants while on assigned treatment without rescue medication in case of persistent hyperglycemia. RESULTS At baseline in SURPASS-2, participants with early-onset versus later-onset T2D were younger with longer diabetes duration (9 vs. 7 years, P &lt; 0.001) higher glycemic levels (8.5% vs. 8.2%, P &lt; 0.001), higher BW (97 vs. 93 kg, P &lt; 0.001) and BMI (35 vs. 34 kg/m2, P &lt; 0.001), and a similarly abnormal lipid profile (e.g., triglycerides 167 vs. 156 mg/dL). At week 40, similar improvements in HbA1c (−2.6% vs. −2.4%), BW (−14 vs. −13 kg), WC (−10 vs. −10 cm), triglycerides (−26% vs. −24%), HDL (7% vs. 7%), and systolic BP (−6 vs. −7 mmHg) were observed in both subgroups with tirzepatide. CONCLUSIONS Despite younger age, participants with early-onset T2D from the SURPASS program had higher glycemic levels and worse overall metabolic health at baseline versus those with later-onset T2D. In this post hoc analysis, similar improvements in HbA1c, BW, and cardiometabolic markers were observed with tirzepatide, irrespective of age at T2D diagnosis. Future studies are needed to determine long-term outcomes of tirzepatide in early-onset T2D.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"15 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140621612","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}
Stine H. Scheuer, Gregers S. Andersen, Bendix Carstensen, Lars Diaz, Vanja Kosjerina, Nanna Lindekilde, Sarah H. Wild, Caroline A. Jackson, Frans Pouwer, Michael E. Benros, Marit E. Jørgensen
OBJECTIVE To examine trends in incidence of acute diabetes complications in individuals with type 1 or type 2 diabetes with and without severe mental illness (SMI) in Denmark by age and calendar year. RESEARCH DESIGN AND METHODS We conducted a cohort study using nationwide registers from 1996 to 2020 to identify individuals with diabetes, ascertain SMI status (namely, schizophrenia, bipolar disorder, or major depression) and identify the outcomes: hospitalization for hypoglycemia and diabetic ketoacidosis (DKA). We used Poisson regression to estimate incidence rates (IRs) and incidence rate ratios (IRRs) of recurrent hypoglycemia and DKA events by SMI, age, and calendar year, accounting for sex, diabetes duration, education, and country of origin. RESULTS Among 433,609 individuals with diabetes, 8% had SMI. Risk of (first and subsequent) hypoglycemia events was higher for individuals with SMI than for those without SMI (for first hypoglycemia event, IRR: type 1 diabetes, 1.77 [95% CI 1.56–2.00]; type 2 diabetes, 1.64 [95% CI 1.55–1.74]). Individuals with schizophrenia were particularly at risk for recurrent hypoglycemia events. The risk of first DKA event was higher in individuals with SMI (for first DKA event, IRR: type 1 diabetes, 1.78 [95% CI 1.50–2.11]; type 2 diabetes, 1.85 [95% CI 1.64–2.09]). Except for DKA in the type 2 diabetes group, IR differences between individuals with and without SMI were highest in younger individuals (<50 years old) but stable across the calendar year. CONCLUSIONS SMI is an important risk factor for acute diabetes complication and effective prevention is needed in this population, especially among the younger population and those with schizophrenia.
{"title":"Trends in Incidence of Hospitalization for Hypoglycemia and Diabetic Ketoacidosis in Individuals With Type 1 or Type 2 Diabetes With and Without Severe Mental Illness in Denmark From 1996 to 2020: A Nationwide Study","authors":"Stine H. Scheuer, Gregers S. Andersen, Bendix Carstensen, Lars Diaz, Vanja Kosjerina, Nanna Lindekilde, Sarah H. Wild, Caroline A. Jackson, Frans Pouwer, Michael E. Benros, Marit E. Jørgensen","doi":"10.2337/dc23-2394","DOIUrl":"https://doi.org/10.2337/dc23-2394","url":null,"abstract":"OBJECTIVE To examine trends in incidence of acute diabetes complications in individuals with type 1 or type 2 diabetes with and without severe mental illness (SMI) in Denmark by age and calendar year. RESEARCH DESIGN AND METHODS We conducted a cohort study using nationwide registers from 1996 to 2020 to identify individuals with diabetes, ascertain SMI status (namely, schizophrenia, bipolar disorder, or major depression) and identify the outcomes: hospitalization for hypoglycemia and diabetic ketoacidosis (DKA). We used Poisson regression to estimate incidence rates (IRs) and incidence rate ratios (IRRs) of recurrent hypoglycemia and DKA events by SMI, age, and calendar year, accounting for sex, diabetes duration, education, and country of origin. RESULTS Among 433,609 individuals with diabetes, 8% had SMI. Risk of (first and subsequent) hypoglycemia events was higher for individuals with SMI than for those without SMI (for first hypoglycemia event, IRR: type 1 diabetes, 1.77 [95% CI 1.56–2.00]; type 2 diabetes, 1.64 [95% CI 1.55–1.74]). Individuals with schizophrenia were particularly at risk for recurrent hypoglycemia events. The risk of first DKA event was higher in individuals with SMI (for first DKA event, IRR: type 1 diabetes, 1.78 [95% CI 1.50–2.11]; type 2 diabetes, 1.85 [95% CI 1.64–2.09]). Except for DKA in the type 2 diabetes group, IR differences between individuals with and without SMI were highest in younger individuals (&lt;50 years old) but stable across the calendar year. CONCLUSIONS SMI is an important risk factor for acute diabetes complication and effective prevention is needed in this population, especially among the younger population and those with schizophrenia.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"17 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140621587","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}
Mian Li, Jie Li, Yu Xu, Jinli Gao, Qiuyu Cao, Yi Ding, Zhuojun Xin, Ming Lu, Xiaoting Li, Haihong Song, Jue Shen, Tianzhichao Hou, Ruixin He, Ling Li, Zhiyun Zhao, Min Xu, Jieli Lu, Tiange Wang, Shuangyuan Wang, Hong Lin, Ruizhi Zheng, Jie Zheng, Callum John Baker, Shenghan Lai, Nathan Anthony Johnson, Guang Ning, Stephen Morris Twigg, Weiqing Wang, Yan Liu, Yufang Bi
OBJECTIVE We aimed to examine the effects of a 5:2 regimens diet (2 days per week of energy restriction by formula diet) or an exercise (2 days per week of high-intensity interval training and resistance training) intervention compared with routine lifestyle education (control) on glycemic control and cardiometabolic health among adults with overweight/obesity and type 2 diabetes. RESEARCH DESIGN AND METHODS This two-center, open-label, three-arm, parallel-group, randomized controlled trial recruited 326 participants with overweight/obesity and type 2 diabetes and randomized them into 12 weeks of diet intervention (n = 109), exercise intervention (n = 108), or lifestyle education (control) (n = 109). The primary outcome was the change of glycemic control measured as glycated hemoglobin (HbA1c) between the diet or exercise intervention groups and the control group after the 12-week intervention. RESULTS The diet intervention significantly reduced HbA1c level (%) after the 12-week intervention (−0.72, 95% CI −0.95 to −0.48) compared with the control group (−0.37, 95% CI −0.60 to −0.15) (diet vs. control −0.34, 95% CI −0.58 to −0.11, P = 0.007). The reduction in HbA1c level in the exercise intervention group (−0.46, 95% CI −0.70 to −0.23) did not significantly differ from the control group (exercise vs. control −0.09, 95% CI −0.32 to 0.15, P = 0.47). The exercise intervention group was superior in maintaining lean body mass. Both diet and exercise interventions induced improvements in adiposity and hepatic steatosis. CONCLUSIONS These findings suggest that the medically supervised 5:2 energy-restricted diet could provide an alternative strategy for improving glycemic control and that the exercise regimen could improve body composition, although it inadequately improved glycemic control.
目的 我们旨在研究 5:2 饮食方案（每周 2 天通过配方饮食限制能量）或运动（每周 2 天高强度间歇训练和阻力训练）干预与常规生活方式教育（对照组）相比，对超重/肥胖和 2 型糖尿病成人血糖控制和心脏代谢健康的影响。研究设计与方法 这项双中心、开放标签、三臂、平行分组的随机对照试验招募了 326 名超重/肥胖和 2 型糖尿病患者，并随机安排他们接受为期 12 周的饮食干预（109 人）、运动干预（108 人）或生活方式教育（对照组）（109 人）。主要结果是饮食或运动干预组与对照组在 12 周干预后以糖化血红蛋白（HbA1c）衡量的血糖控制变化。结果 与对照组（-0.37，95% CI -0.60至-0.15）相比，饮食干预组在 12 周干预后的 HbA1c 水平（%）明显降低（-0.72，95% CI -0.95至-0.48）（饮食组与对照组相比-0.34，95% CI -0.58至-0.11，P = 0.007）。运动干预组的 HbA1c 水平降幅（-0.46，95% CI -0.70至-0.23）与对照组没有显著差异（运动与对照组相比-0.09，95% CI -0.32至0.15，P = 0.47）。运动干预组在保持瘦体重方面更胜一筹。饮食和运动干预都能改善脂肪含量和肝脏脂肪变性。结论 这些研究结果表明，医学监督下的 5:2 限能饮食可为改善血糖控制提供另一种策略，而运动疗法可改善身体成分，但对血糖控制的改善作用不足。
{"title":"Effect of 5:2 Regimens: Energy-Restricted Diet or Low-Volume High-Intensity Interval Training Combined With Resistance Exercise on Glycemic Control and Cardiometabolic Health in Adults With Overweight/Obesity and Type 2 Diabetes—A Three-Arm Randomized Controlled Trial","authors":"Mian Li, Jie Li, Yu Xu, Jinli Gao, Qiuyu Cao, Yi Ding, Zhuojun Xin, Ming Lu, Xiaoting Li, Haihong Song, Jue Shen, Tianzhichao Hou, Ruixin He, Ling Li, Zhiyun Zhao, Min Xu, Jieli Lu, Tiange Wang, Shuangyuan Wang, Hong Lin, Ruizhi Zheng, Jie Zheng, Callum John Baker, Shenghan Lai, Nathan Anthony Johnson, Guang Ning, Stephen Morris Twigg, Weiqing Wang, Yan Liu, Yufang Bi","doi":"10.2337/dc24-0241","DOIUrl":"https://doi.org/10.2337/dc24-0241","url":null,"abstract":"OBJECTIVE We aimed to examine the effects of a 5:2 regimens diet (2 days per week of energy restriction by formula diet) or an exercise (2 days per week of high-intensity interval training and resistance training) intervention compared with routine lifestyle education (control) on glycemic control and cardiometabolic health among adults with overweight/obesity and type 2 diabetes. RESEARCH DESIGN AND METHODS This two-center, open-label, three-arm, parallel-group, randomized controlled trial recruited 326 participants with overweight/obesity and type 2 diabetes and randomized them into 12 weeks of diet intervention (n = 109), exercise intervention (n = 108), or lifestyle education (control) (n = 109). The primary outcome was the change of glycemic control measured as glycated hemoglobin (HbA1c) between the diet or exercise intervention groups and the control group after the 12-week intervention. RESULTS The diet intervention significantly reduced HbA1c level (%) after the 12-week intervention (−0.72, 95% CI −0.95 to −0.48) compared with the control group (−0.37, 95% CI −0.60 to −0.15) (diet vs. control −0.34, 95% CI −0.58 to −0.11, P = 0.007). The reduction in HbA1c level in the exercise intervention group (−0.46, 95% CI −0.70 to −0.23) did not significantly differ from the control group (exercise vs. control −0.09, 95% CI −0.32 to 0.15, P = 0.47). The exercise intervention group was superior in maintaining lean body mass. Both diet and exercise interventions induced improvements in adiposity and hepatic steatosis. CONCLUSIONS These findings suggest that the medically supervised 5:2 energy-restricted diet could provide an alternative strategy for improving glycemic control and that the exercise regimen could improve body composition, although it inadequately improved glycemic control.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"72 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140620476","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}
Shuxiao Shi, Ying Dong, Sujing Wang, Xihao Du, Nannan Feng, Lan Xu, Victor W. Zhong
OBJECTIVE Whether genetic susceptibility to disease and dietary cholesterol (DC) absorption contribute to inconsistent associations of DC consumption with diabetes and cardiovascular disease (CVD) remains unclear. RESEARCH DESIGN AND METHODS DC consumption was assessed by repeated 24-h dietary recalls in the UK Biobank. A polygenetic risk score (PRS) for DC absorption was constructed using genetic variants in the Niemann-Pick C1-Like 1 and ATP Binding Cassettes G5 and G8 genes. PRSs for diabetes, coronary artery disease, and stroke were also created. The associations of DC consumption with incident diabetes (n = 96,826) and CVD (n = 94,536) in the overall sample and by PRS subgroups were evaluated using adjusted Cox models. RESULTS Each additional 300 mg/day of DC consumption was associated with incident diabetes (hazard ratio [HR], 1.17 [95% CI, 1.07–1.27]) and CVD (HR, 1.09 [95% CI, 1.03–1.17]), but further adjusting for BMI nullified these associations (HR for diabetes, 0.99 [95% CI, 0.90–1.09]; HR for CVD, 1.04 [95% CI, 0.98–1.12]). Genetic susceptibility to the diseases did not modify these associations (P for interaction ≥0.06). The DC-CVD association appeared to be stronger in people with greater genetic susceptibility to cholesterol absorption assessed by the non-high-density lipoprotein cholesterol-related PRS (P for interaction = 0.04), but the stratum-level association estimates were not statistically significant. CONCLUSIONS DC consumption was not associated with incident diabetes and CVD, after adjusting for BMI, in the overall sample and in subgroups stratified by genetic predisposition to cholesterol absorption and the diseases. Nevertheless, whether genetic predisposition to cholesterol absorption modifies the DC-CVD association requires further investigation.
{"title":"Associations of Dietary Cholesterol Consumption With Incident Diabetes and Cardiovascular Disease: The Role of Genetic Variability in Cholesterol Absorption and Disease Predisposition","authors":"Shuxiao Shi, Ying Dong, Sujing Wang, Xihao Du, Nannan Feng, Lan Xu, Victor W. Zhong","doi":"10.2337/dc23-2336","DOIUrl":"https://doi.org/10.2337/dc23-2336","url":null,"abstract":"OBJECTIVE Whether genetic susceptibility to disease and dietary cholesterol (DC) absorption contribute to inconsistent associations of DC consumption with diabetes and cardiovascular disease (CVD) remains unclear. RESEARCH DESIGN AND METHODS DC consumption was assessed by repeated 24-h dietary recalls in the UK Biobank. A polygenetic risk score (PRS) for DC absorption was constructed using genetic variants in the Niemann-Pick C1-Like 1 and ATP Binding Cassettes G5 and G8 genes. PRSs for diabetes, coronary artery disease, and stroke were also created. The associations of DC consumption with incident diabetes (n = 96,826) and CVD (n = 94,536) in the overall sample and by PRS subgroups were evaluated using adjusted Cox models. RESULTS Each additional 300 mg/day of DC consumption was associated with incident diabetes (hazard ratio [HR], 1.17 [95% CI, 1.07–1.27]) and CVD (HR, 1.09 [95% CI, 1.03–1.17]), but further adjusting for BMI nullified these associations (HR for diabetes, 0.99 [95% CI, 0.90–1.09]; HR for CVD, 1.04 [95% CI, 0.98–1.12]). Genetic susceptibility to the diseases did not modify these associations (P for interaction ≥0.06). The DC-CVD association appeared to be stronger in people with greater genetic susceptibility to cholesterol absorption assessed by the non-high-density lipoprotein cholesterol-related PRS (P for interaction = 0.04), but the stratum-level association estimates were not statistically significant. CONCLUSIONS DC consumption was not associated with incident diabetes and CVD, after adjusting for BMI, in the overall sample and in subgroups stratified by genetic predisposition to cholesterol absorption and the diseases. Nevertheless, whether genetic predisposition to cholesterol absorption modifies the DC-CVD association requires further investigation.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"31 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140541505","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}
Angelo Sabag, Matthew N. Ahmadi, Monique E. Francois, Svetlana Postnova, Peter A. Cistulli, Luigi Fontana, Emmanuel Stamatakis
OBJECTIVE To assess the association between timing of aerobic moderate to vigorous physical activity (MVPA) and risk of cardiovascular disease (CVD), microvascular disease (MVD), and all-cause mortality in adults with obesity and a subset with obesity and type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS Participants included adults with obesity (BMI ≥30 kg/m2) and a subset of those with T2D from the UK Biobank accelerometry substudy. Aerobic MVPA was defined as bouts of MVPA lasting ≥3 continuous minutes. Participants were categorized into morning, afternoon, or evening MVPA based on when they undertook the majority of their aerobic MVPA. The reference group included participants with an average of less than one aerobic MVPA bout per day. Analyses were adjusted for established and potential confounders. RESULTS The core sample included 29,836 adults with obesity, with a mean age of 62.2 (SD 7.7) years. Over a mean follow-up period of 7.9 (SD 0.8) years, 1,425 deaths, 3,980 CVD events, and 2,162 MVD events occurred. Compared with activity in the reference group, evening MVPA was associated with the lowest risk of mortality (hazard ratio [HR] 0.39; 95% CI 0.27, 0.55), whereas afternoon (HR 0.60; 95% CI 0.51, 0.71) and morning MVPA (HR 0.67; 95% CI 0.56, 0.79) demonstrated significant but weaker associations. Similar patterns were observed for CVD and MVD incidence, with evening MVPA associated with the lowest risk of CVD (HR 0.64; 95% CI 0.54, 0.75) and MVD (HR 0.76; 95% CI 0.63, 0.92). Findings were similar in the T2D subset (n = 2,995). CONCLUSIONS Aerobic MVPA bouts undertaken in the evening were associated with the lowest risk of mortality, CVD, and MVD. Timing of physical activity may play a role in the future of obesity and T2D management.
{"title":"Timing of Moderate to Vigorous Physical Activity, Mortality, Cardiovascular Disease, and Microvascular Disease in Adults With Obesity","authors":"Angelo Sabag, Matthew N. Ahmadi, Monique E. Francois, Svetlana Postnova, Peter A. Cistulli, Luigi Fontana, Emmanuel Stamatakis","doi":"10.2337/dc23-2448","DOIUrl":"https://doi.org/10.2337/dc23-2448","url":null,"abstract":"OBJECTIVE To assess the association between timing of aerobic moderate to vigorous physical activity (MVPA) and risk of cardiovascular disease (CVD), microvascular disease (MVD), and all-cause mortality in adults with obesity and a subset with obesity and type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS Participants included adults with obesity (BMI ≥30 kg/m2) and a subset of those with T2D from the UK Biobank accelerometry substudy. Aerobic MVPA was defined as bouts of MVPA lasting ≥3 continuous minutes. Participants were categorized into morning, afternoon, or evening MVPA based on when they undertook the majority of their aerobic MVPA. The reference group included participants with an average of less than one aerobic MVPA bout per day. Analyses were adjusted for established and potential confounders. RESULTS The core sample included 29,836 adults with obesity, with a mean age of 62.2 (SD 7.7) years. Over a mean follow-up period of 7.9 (SD 0.8) years, 1,425 deaths, 3,980 CVD events, and 2,162 MVD events occurred. Compared with activity in the reference group, evening MVPA was associated with the lowest risk of mortality (hazard ratio [HR] 0.39; 95% CI 0.27, 0.55), whereas afternoon (HR 0.60; 95% CI 0.51, 0.71) and morning MVPA (HR 0.67; 95% CI 0.56, 0.79) demonstrated significant but weaker associations. Similar patterns were observed for CVD and MVD incidence, with evening MVPA associated with the lowest risk of CVD (HR 0.64; 95% CI 0.54, 0.75) and MVD (HR 0.76; 95% CI 0.63, 0.92). Findings were similar in the T2D subset (n = 2,995). CONCLUSIONS Aerobic MVPA bouts undertaken in the evening were associated with the lowest risk of mortality, CVD, and MVD. Timing of physical activity may play a role in the future of obesity and T2D management.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"263 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140541422","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}
Thomas Danne, Michael Joubert, Niels Væver Hartvig, Anne Kaas, Nikoline Nygård Knudsen, Julia K. Mader
OBJECTIVE To evaluate the association of insulin injection adherence, smart insulin pen engagement, and glycemic control using real-world data from 16 countries from adults self-administering basal insulin degludec and bolus insulin with a smart insulin pen (NovoPen 6 or NovoPen Echo Plus) alongside continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS Data were aggregated over 14-day periods. Treatment adherence was defined according to the number of missed basal and missed bolus insulin doses and smart pen engagement according to the number of days with data uploads. RESULTS Data from 3,945 adults, including 25,157 14-day periods with ≥70% CGM coverage, were analyzed. On average, 0.2 basal and 6.0 bolus insulin doses were missed over 14 days. The estimated probability of missing at least one basal insulin dose over a 14-day period was 17.6% (95% CI 16.5, 18.7). Missing one basal or bolus insulin dose per 14 days was associated with a significant decrease in percentage of time with glucose levels in range (TIR) (3.9–10.0 mmol/L), of −2.8% (95% CI −3.7, −1.8) and −1.7% (−1.8, −1.6), respectively; therefore, missing two basal or four bolus doses would decrease TIR by >5%. Smart pen engagement was associated positively with glycemic outcomes. CONCLUSIONS This combined analysis of real-world smart pen and CGM data showed that missing two basal or four bolus insulin doses over a 14-day period would be associated with a clinically relevant decrease in TIR. Smart insulin pens provide valuable insights into treatment injection behaviors.
{"title":"Association Between Treatment Adherence and Continuous Glucose Monitoring Outcomes in People With Diabetes Using Smart Insulin Pens in a Real-World Setting","authors":"Thomas Danne, Michael Joubert, Niels Væver Hartvig, Anne Kaas, Nikoline Nygård Knudsen, Julia K. Mader","doi":"10.2337/dc23-2176","DOIUrl":"https://doi.org/10.2337/dc23-2176","url":null,"abstract":"OBJECTIVE To evaluate the association of insulin injection adherence, smart insulin pen engagement, and glycemic control using real-world data from 16 countries from adults self-administering basal insulin degludec and bolus insulin with a smart insulin pen (NovoPen 6 or NovoPen Echo Plus) alongside continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS Data were aggregated over 14-day periods. Treatment adherence was defined according to the number of missed basal and missed bolus insulin doses and smart pen engagement according to the number of days with data uploads. RESULTS Data from 3,945 adults, including 25,157 14-day periods with ≥70% CGM coverage, were analyzed. On average, 0.2 basal and 6.0 bolus insulin doses were missed over 14 days. The estimated probability of missing at least one basal insulin dose over a 14-day period was 17.6% (95% CI 16.5, 18.7). Missing one basal or bolus insulin dose per 14 days was associated with a significant decrease in percentage of time with glucose levels in range (TIR) (3.9–10.0 mmol/L), of −2.8% (95% CI −3.7, −1.8) and −1.7% (−1.8, −1.6), respectively; therefore, missing two basal or four bolus doses would decrease TIR by &gt;5%. Smart pen engagement was associated positively with glycemic outcomes. CONCLUSIONS This combined analysis of real-world smart pen and CGM data showed that missing two basal or four bolus insulin doses over a 14-day period would be associated with a clinically relevant decrease in TIR. Smart insulin pens provide valuable insights into treatment injection behaviors.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"46 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140346026","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}
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