Pub Date : 2024-10-01Epub Date: 2024-04-05DOI: 10.1089/dia.2024.0125
Gregory P Forlenza, Jennifer L Sherr
{"title":"Response to: MiniMed 780G System Outperforms Other Automated Insulin Systems Due to Algorithm Design, Not Bias-Response to Inaccurate Allegations.","authors":"Gregory P Forlenza, Jennifer L Sherr","doi":"10.1089/dia.2024.0125","DOIUrl":"10.1089/dia.2024.0125","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"785-786"},"PeriodicalIF":5.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140184016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-06-07DOI: 10.1089/dia.2024.0096
Seema Meighan, Julia L Douvas, Andrew Rearson, Robert Squaresky, Andrea Kelly, Brynn E Marks
Background: Youth starting Omnipod 5 (OP5) can onboard with a diabetes educator or self-start with support from online, industry-provided educational modules. We compared glycemic control and pump interaction by training type among youth initiating OP5. Methods: This retrospective review included 297 youth with type 1 diabetes (T1D) aged <22 years initiating OP5. We analyzed baseline continuous glucose monitor (CGM) data and pump and CGM data from the first 90 days of OP5 use. Multilevel mixed-effects regression assessed for changes in time in range (TIR) from baseline to 90 days by training type. Results: Of youth initiating OP5, 42.4% trained with a diabetes educator and 57.6% self-started. At baseline, self-starters had a longer T1D duration (5.0 (2.6,7.9) vs. 2.5 (1.3, 5.5) years, P = 0.001), more time <54 mg/dL (0.3% (0.1,1) vs. 0.15% (0,1), P = 0.01), and a higher coefficient of variation (40.2% (37, 44.4) vs. 38.7% (34.4, 42.4), P = 0.004). After 90 days of OP5 use, groups did not differ in time in automated mode or boluses per day. In a longitudinal model, after adjusting for baseline TIR and T1D duration, 90-day TIR was 10.5%-points higher (CI: 9.2-11.8, P < 0.0001), positively associated with baseline TIR (β = 0.82, CI: 0.78-0.85, P < 0.0001), and 1.1%-points greater among self-starters (CI: 0.06-2.2; P = 0.04). Conclusions: After 90 days of OP5 use, glycemic control and pump interactions were minimally different between youth who self-started and those who trained with a diabetes educator. For youth at a tertiary care center previously using an Omnipod system, online educational modules offered by industry provide sufficient training for use.
{"title":"The Type of Patient Training Does Not Impact Outcomes in the First 90 Days of Automated Insulin Delivery Use.","authors":"Seema Meighan, Julia L Douvas, Andrew Rearson, Robert Squaresky, Andrea Kelly, Brynn E Marks","doi":"10.1089/dia.2024.0096","DOIUrl":"10.1089/dia.2024.0096","url":null,"abstract":"<p><p><b><i>Background:</i></b> Youth starting Omnipod 5 (OP5) can onboard with a diabetes educator or self-start with support from online, industry-provided educational modules. We compared glycemic control and pump interaction by training type among youth initiating OP5. <b><i>Methods:</i></b> This retrospective review included 297 youth with type 1 diabetes (T1D) aged <22 years initiating OP5. We analyzed baseline continuous glucose monitor (CGM) data and pump and CGM data from the first 90 days of OP5 use. Multilevel mixed-effects regression assessed for changes in time in range (TIR) from baseline to 90 days by training type. <b><i>Results:</i></b> Of youth initiating OP5, 42.4% trained with a diabetes educator and 57.6% self-started. At baseline, self-starters had a longer T1D duration (5.0 (2.6,7.9) vs. 2.5 (1.3, 5.5) years, <i>P</i> = 0.001), more time <54 mg/dL (0.3% (0.1,1) vs. 0.15% (0,1), <i>P</i> = 0.01), and a higher coefficient of variation (40.2% (37, 44.4) vs. 38.7% (34.4, 42.4), <i>P</i> = 0.004). After 90 days of OP5 use, groups did not differ in time in automated mode or boluses per day. In a longitudinal model, after adjusting for baseline TIR and T1D duration, 90-day TIR was 10.5%-points higher (CI: 9.2-11.8, <i>P</i> < 0.0001), positively associated with baseline TIR (β = 0.82, CI: 0.78-0.85, <i>P</i> < 0.0001), and 1.1%-points greater among self-starters (CI: 0.06-2.2; <i>P</i> = 0.04). <b><i>Conclusions:</i></b> After 90 days of OP5 use, glycemic control and pump interactions were minimally different between youth who self-started and those who trained with a diabetes educator. For youth at a tertiary care center previously using an Omnipod system, online educational modules offered by industry provide sufficient training for use.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"773-779"},"PeriodicalIF":5.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141161189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-05-13DOI: 10.1089/dia.2023.0612
Taylor L Clark, William H Polonsky, Emily C Soriano
Background: Despite the known glycemic benefits of continuous glucose monitoring (CGM) for adults with type 2 diabetes (T2D), the attitudinal and behavioral changes underlying these glycemic improvements remain understudied. This study aimed to qualitatively explore these changes among a sample of adults with T2D. Methods: In-depth, semistructured interviews were conducted with adults with T2D who had been using CGM for 3-6 months as part of a larger community project in Ohio. Thematic analysis was used to identify themes across participants' experiences. Results: A total of 34 participants provided insights into their experiences with CGM. Six primary themes emerged: (1) Making the Invisible Visible, highlighting the newfound awareness of T2D in daily life. (2) Effective Decision-Making, emphasizing the use of real-time glucose data for immediate and long-term choices. (3) Enhanced Self-Efficacy, describing a renewed sense of control and motivation. (4) Diabetes-Related Diet Modifications. (5) Changes in Physical Activity. (6) Changes in Medication Taking. Conclusions: Participants reported a far-reaching impact of CGM on their daily lives, with many stating that CGM fostered a greater understanding of diabetes and prompted positive behavior changes. The observed attitudinal and behavioral shifts likely contributed synergistically to the significant glycemic benefits observed over the study period. This study highlights the technology's potential to bring about meaningful attitudinal and behavioral changes.
{"title":"The Potential Impact of Continuous Glucose Monitoring Use on Diabetes-Related Attitudes and Behaviors in Adults with Type 2 Diabetes: A Qualitative Investigation of the Patient Experience.","authors":"Taylor L Clark, William H Polonsky, Emily C Soriano","doi":"10.1089/dia.2023.0612","DOIUrl":"10.1089/dia.2023.0612","url":null,"abstract":"<p><p><b><i>Background:</i></b> Despite the known glycemic benefits of continuous glucose monitoring (CGM) for adults with type 2 diabetes (T2D), the attitudinal and behavioral changes underlying these glycemic improvements remain understudied. This study aimed to qualitatively explore these changes among a sample of adults with T2D. <b><i>Methods:</i></b> In-depth, semistructured interviews were conducted with adults with T2D who had been using CGM for 3-6 months as part of a larger community project in Ohio. Thematic analysis was used to identify themes across participants' experiences. <b><i>Results:</i></b> A total of 34 participants provided insights into their experiences with CGM. Six primary themes emerged: (1) Making the Invisible Visible, highlighting the newfound awareness of T2D in daily life. (2) Effective Decision-Making, emphasizing the use of real-time glucose data for immediate and long-term choices. (3) Enhanced Self-Efficacy, describing a renewed sense of control and motivation. (4) Diabetes-Related Diet Modifications. (5) Changes in Physical Activity. (6) Changes in Medication Taking. <b><i>Conclusions:</i></b> Participants reported a far-reaching impact of CGM on their daily lives, with many stating that CGM fostered a greater understanding of diabetes and prompted positive behavior changes. The observed attitudinal and behavioral shifts likely contributed synergistically to the significant glycemic benefits observed over the study period. This study highlights the technology's potential to bring about meaningful attitudinal and behavioral changes.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"700-708"},"PeriodicalIF":5.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140206476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-05-24DOI: 10.1089/dia.2023.0528
Emilia Fushimi, Eleonora M Aiello, Sunghyun Cho, Michael C Riddell, Robin L Gal, Corby K Martin, Susana R Patton, Michael R Rickels, Francis J Doyle
Background: Managing exercise in type 1 diabetes is challenging, in part, because different types of exercises can have diverging effects on glycemia. The aim of this work was to develop a classification model that can classify an exercise event (structured or unstructured) as aerobic, interval, or resistance for the purpose of incorporation into an automated insulin delivery (AID) system. Methods: A long short-term memory network model was developed with real-world data from 30-min structured sessions of at-home exercise (aerobic, resistance, or mixed) using triaxial accelerometer, heart rate, and activity duration information. The detection algorithm was used to classify 15 common free-living and unstructured activities and relate each to exercise-associated change in glucose. Results: A total of 1610 structured exercise sessions were used to train, validate, and test the model. The accuracy for the structured exercise sessions in the testing set was 72% for aerobic, 65% for interval, and 77% for resistance. In addition, we tested the classifier on 3328 unstructured sessions. We validated the session-associated change in glucose against the expected change during exercise for each type. Mean and standard deviation of the change in glucose of -20.8 (40.3) mg/dL were achieved for sessions classified as aerobic, -16.2 (39.0) mg/dL for sessions classified as interval, and -11.6 (38.8) mg/dL for sessions classified as resistance. Conclusions: The proposed algorithm reliably identified physical activity associated with expected change in glucose, which could be integrated into an AID system to manage the exercise disturbance in glycemia according to the predicted class.
{"title":"Online Classification of Unstructured Free-Living Exercise Sessions in People with Type 1 Diabetes.","authors":"Emilia Fushimi, Eleonora M Aiello, Sunghyun Cho, Michael C Riddell, Robin L Gal, Corby K Martin, Susana R Patton, Michael R Rickels, Francis J Doyle","doi":"10.1089/dia.2023.0528","DOIUrl":"10.1089/dia.2023.0528","url":null,"abstract":"<p><p><b><i>Background:</i></b> Managing exercise in type 1 diabetes is challenging, in part, because different types of exercises can have diverging effects on glycemia. The aim of this work was to develop a classification model that can classify an exercise event (structured or unstructured) as aerobic, interval, or resistance for the purpose of incorporation into an automated insulin delivery (AID) system. <b><i>Methods:</i></b> A long short-term memory network model was developed with real-world data from 30-min structured sessions of at-home exercise (aerobic, resistance, or mixed) using triaxial accelerometer, heart rate, and activity duration information. The detection algorithm was used to classify 15 common free-living and unstructured activities and relate each to exercise-associated change in glucose. <b><i>Results:</i></b> A total of 1610 structured exercise sessions were used to train, validate, and test the model. The accuracy for the structured exercise sessions in the testing set was 72% for <i>aerobic</i>, 65% for <i>interval</i>, and 77% for <i>resistance</i>. In addition, we tested the classifier on 3328 unstructured sessions. We validated the session-associated change in glucose against the expected change during exercise for each type. Mean and standard deviation of the change in glucose of -20.8 (40.3) mg/dL were achieved for sessions classified as <i>aerobic</i>, -16.2 (39.0) mg/dL for sessions classified as <i>interval</i>, and -11.6 (38.8) mg/dL for sessions classified as <i>resistance</i>. <b><i>Conclusions:</i></b> The proposed algorithm reliably identified physical activity associated with expected change in glucose, which could be integrated into an AID system to manage the exercise disturbance in glycemia according to the predicted class.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"709-719"},"PeriodicalIF":5.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-05-31DOI: 10.1089/dia.2024.0035
Ola Friman, Navid Soltani, Marcus Lind, Pia Zetterqvist, Anca Balintescu, Anders Perner, Anders Oldner, Olav Rooyackers, Johan Mårtensson
Background: Subcutaneous continuous glucose monitoring (CGM) may facilitate glucose control in the ICU. We aimed to assess the accuracy of CGM (Dexcom G6) against arterial blood glucose (ABG) in adult critically ill patients receiving intravenous insulin infusion and vasopressor therapy. We also aimed to assess feasibility and tolerability of CGM in this setting. Methods: We included ICU patients receiving mechanical ventilation, insulin, and vasopressor therapy. Numerical accuracy was assessed by the mean absolute relative difference (MARD), overall, across arterial glucose strata, over different noradrenaline equivalent infusion rates, and over time since CGM start. MARD <14% was considered acceptable. Clinical accuracy was assessed using Clarke Error Grid (CEG) analysis. Feasibility outcome included number and duration of interrupted sensor readings due to signal loss. Tolerability outcome included skin reactions related to sensor insertion or sensor adhesives. Results: We obtained 2946 paired samples from 40 patients (18 with type 2 diabetes) receiving a median (IQR) maximum noradrenaline equivalent infusion rate of 0.18 (0.08-0.33) µg/kg/min during CGM. Overall, MARD was 12.7% (95% CI 10.7-15.3), and 99.8% of CGM readings were within CEG zones A and B. MARD values ≥14% were observed when ABG was outside target range (6-10 mmol/L [108-180 mg/dL]) and with noradrenaline equivalent infusion rates above 0.10 µg/kg/min. Accuracy improved with time after CGM start, reaching MARD values <14% after 36 h. We observed four episodes of interrupted sensor readings due to signal loss, ranging from 5 to 20 min. We observed no skin reaction related to sensor insertion or sensor adhesives. Conclusions: In our ICU cohort of patients receiving vasopressor infusion, subcutaneous CGM demonstrated acceptable overall numerical and clinical accuracy. However, suboptimal accuracy may occur outside glucose ranges of 6-10 mmol/L (108-180 mg/dL), during higher dose vasopressor infusion, and during the first 36 h after CGM start.
{"title":"Performance of Subcutaneous Continuous Glucose Monitoring in Adult Critically Ill Patients Receiving Vasopressor Therapy.","authors":"Ola Friman, Navid Soltani, Marcus Lind, Pia Zetterqvist, Anca Balintescu, Anders Perner, Anders Oldner, Olav Rooyackers, Johan Mårtensson","doi":"10.1089/dia.2024.0035","DOIUrl":"10.1089/dia.2024.0035","url":null,"abstract":"<p><p><b><i>Background:</i></b> Subcutaneous continuous glucose monitoring (CGM) may facilitate glucose control in the ICU. We aimed to assess the accuracy of CGM (Dexcom G6) against arterial blood glucose (ABG) in adult critically ill patients receiving intravenous insulin infusion and vasopressor therapy. We also aimed to assess feasibility and tolerability of CGM in this setting. <b><i>Methods:</i></b> We included ICU patients receiving mechanical ventilation, insulin, and vasopressor therapy. Numerical accuracy was assessed by the mean absolute relative difference (MARD), overall, across arterial glucose strata, over different noradrenaline equivalent infusion rates, and over time since CGM start. MARD <14% was considered acceptable. Clinical accuracy was assessed using Clarke Error Grid (CEG) analysis. Feasibility outcome included number and duration of interrupted sensor readings due to signal loss. Tolerability outcome included skin reactions related to sensor insertion or sensor adhesives. <b><i>Results:</i></b> We obtained 2946 paired samples from 40 patients (18 with type 2 diabetes) receiving a median (IQR) maximum noradrenaline equivalent infusion rate of 0.18 (0.08-0.33) µg/kg/min during CGM. Overall, MARD was 12.7% (95% CI 10.7-15.3), and 99.8% of CGM readings were within CEG zones A and B. MARD values ≥14% were observed when ABG was outside target range (6-10 mmol/L [108-180 mg/dL]) and with noradrenaline equivalent infusion rates above 0.10 µg/kg/min. Accuracy improved with time after CGM start, reaching MARD values <14% after 36 h. We observed four episodes of interrupted sensor readings due to signal loss, ranging from 5 to 20 min. We observed no skin reaction related to sensor insertion or sensor adhesives. <b><i>Conclusions:</i></b> In our ICU cohort of patients receiving vasopressor infusion, subcutaneous CGM demonstrated acceptable overall numerical and clinical accuracy. However, suboptimal accuracy may occur outside glucose ranges of 6-10 mmol/L (108-180 mg/dL), during higher dose vasopressor infusion, and during the first 36 h after CGM start.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"763-772"},"PeriodicalIF":5.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140956738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01Epub Date: 2024-03-12DOI: 10.1089/dia.2023.0529
Anirban Roy, Benyamin Grosman, Andrea Benedetti, Bahman Engheta, Diana Miller, Maya Laron-Hirsh, Yael Cohen, Roseline Ré, Shannon N Edd, Robert Vigersky, Ohad Cohen, Amir Tirosh
Background: Carbohydrate counting (CC) and meal announcements, before eating, introduce a significant burden for individuals managing type 1 diabetes (T1D). An automated insulin delivery system with automatic bolusing that eliminates the need for CC and premeal bolusing (i.e., a hands-free closed-loop [HFCL] system) was assessed in a feasibility trial of adults with T1D. Methods: The system included the MiniMed™ 780G pump and a smartphone-paired smartwatch with the Klue application (Klue, Inc.) that detects eating and drinking gestures. A smartphone algorithm converted gestures into carb amounts that were transmitted to the pump for automatic bolusing. For 5 days, participants (N = 17, 18-75 years of age) used the system at home with meal announcements based on traditional CC, with the Klue application disabled (Home-stay phase). Thereafter, participants moved to a supervised hotel setting, where the Klue application was enabled for 5 days and meals were not announced (Hotel-stay phase). Participants consumed the same eight test meals (six solid and two liquid) of varying caloric and carb size at the same time and day of the week for both phases, and glycemic metrics were compared. Otherwise, there were no other meal restrictions. Results: The overall time in range (70-180 mg/dL) was 83.4% ± 7.0% and 80.6% ± 6.7% for the Home-stay and Hotel-stay, respectively (P = 0.08). The average time at <70 mg/dL was 3.1% and 3.0% (P = 0.9144), respectively, and the average time at >180 mg/dL was 13.5% and 16.3% (P = 0.1046), respectively. Postprandial glycemia following low-carb test meals was similar between the two phases. The system's ability to accommodate high-carb meals was somewhat limited. There were no episodes of severe hypoglycemia or diabetic ketoacidosis. Conclusion: Preliminary findings show that a HFCL system was safe and maintained overall glycemic control, similar to that observed with traditional CC and manual meal bolusing. By eliminating these daily T1D burdens, a HFCL system may improve quality of life for individuals with T1D. ClinicalTrials.gov number: NCT04964128.
{"title":"An Automated Insulin Delivery System with Automatic Meal Bolus Based on a Hand-Gesturing Algorithm.","authors":"Anirban Roy, Benyamin Grosman, Andrea Benedetti, Bahman Engheta, Diana Miller, Maya Laron-Hirsh, Yael Cohen, Roseline Ré, Shannon N Edd, Robert Vigersky, Ohad Cohen, Amir Tirosh","doi":"10.1089/dia.2023.0529","DOIUrl":"10.1089/dia.2023.0529","url":null,"abstract":"<p><p><b><i>Background:</i></b> Carbohydrate counting (CC) and meal announcements, before eating, introduce a significant burden for individuals managing type 1 diabetes (T1D). An automated insulin delivery system with automatic bolusing that eliminates the need for CC and premeal bolusing (i.e., a hands-free closed-loop [HFCL] system) was assessed in a feasibility trial of adults with T1D. <b><i>Methods:</i></b> The system included the MiniMed™ 780G pump and a smartphone-paired smartwatch with the Klue application (Klue, Inc.) that detects eating and drinking gestures. A smartphone algorithm converted gestures into carb amounts that were transmitted to the pump for automatic bolusing. For 5 days, participants (<i>N</i> = 17, 18-75 years of age) used the system at home with meal announcements based on traditional CC, with the Klue application disabled (Home-stay phase). Thereafter, participants moved to a supervised hotel setting, where the Klue application was enabled for 5 days and meals were not announced (Hotel-stay phase). Participants consumed the same eight test meals (six solid and two liquid) of varying caloric and carb size at the same time and day of the week for both phases, and glycemic metrics were compared. Otherwise, there were no other meal restrictions. <b><i>Results:</i></b> The overall time in range (70-180 mg/dL) was 83.4% ± 7.0% and 80.6% ± 6.7% for the Home-stay and Hotel-stay, respectively (<i>P</i> = 0.08). The average time at <70 mg/dL was 3.1% and 3.0% (<i>P</i> = 0.9144), respectively, and the average time at >180 mg/dL was 13.5% and 16.3% (<i>P</i> = 0.1046), respectively. Postprandial glycemia following low-carb test meals was similar between the two phases. The system's ability to accommodate high-carb meals was somewhat limited. There were no episodes of severe hypoglycemia or diabetic ketoacidosis. <b><i>Conclusion:</i></b> Preliminary findings show that a HFCL system was safe and maintained overall glycemic control, similar to that observed with traditional CC and manual meal bolusing. By eliminating these daily T1D burdens, a HFCL system may improve quality of life for individuals with T1D. ClinicalTrials.gov number: NCT04964128.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"633-643"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01Epub Date: 2024-05-16DOI: 10.1089/dia.2024.0122
Abhayjit Singh, Steven E Nissen
The global prevalence of obesity has risen sharply during the past half-century, reaching pandemic proportions and creating a public health crisis. Obesity is a recognized risk factor for the development of diabetes, atherosclerosis, hypertension, hepatic steatosis, and many other cardiometabolic disorders with significant resultant morbidity and mortality. Though treatment of obesity can prevent or slow the progression of the aforementioned illnesses, efforts to help patients achieve reliable and sustainable weight loss have had limited success. Improving nutrition and increasing physical activity results in a host of health benefits; however, the weight loss achieved with lifestyle interventions alone is modest and difficult to sustain. Early attempts at medical and surgical treatment of obesity were plagued with adverse effects and complications. Moreover, these approaches failed to demonstrate long-term health benefits, even when weight loss was achieved. Recently, novel incretin-based therapies targeting glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors have gained popularity because of their effectiveness in achieving substantial weight loss in patients both with and without diabetes. Following many successful clinical trials, there are now multiple GLP-1 receptor agonists and one dual GLP-1-GIP receptor agonist approved by the Food and Drug Administration for chronic weight management. Advancements in laparoscopic surgical technique and refinements in procedure selection have similarly improved the safety and efficacy of bariatric metabolic surgery for patients with obesity. In this review, we discuss the advantages and disadvantages of contemporary pharmacologic and surgical weight management strategies. We review the data regarding expected weight loss, glycemic control, cardiometabolic benefits, and potential adverse effects of various treatment approaches. As obesity rates continue to rise worldwide, it is imperative that clinicians keep these considerations in mind in order to better care for patients.
在过去的半个世纪里,全球肥胖症发病率急剧上升,达到了流行病的程度,造成了公共卫生危机。肥胖是导致糖尿病、动脉粥样硬化、高血压、肝脂肪变性和许多其他心血管代谢疾病的公认风险因素,会导致严重的发病率和死亡率。虽然治疗肥胖症可以预防或减缓上述疾病的发展,但帮助患者实现可靠、可持续的减肥效果的努力却收效甚微。虽然改善营养和增加体育锻炼对健康大有裨益,但仅靠生活方式干预所实现的减肥效果并不明显,而且难以持久。早期尝试的肥胖症药物和手术治疗方法存在很多不良反应和并发症。此外,即使实现了体重减轻,这些方法也未能显示出长期的健康益处。最近,以胰高血糖素样肽-1(GLP-1)和葡萄糖依赖性促胰岛素多肽(GIP)受体为靶点的新型增量素疗法在糖尿病患者和非糖尿病患者中获得了显著的减肥效果,因而受到了广泛欢迎。经过多次成功的临床试验,目前已有多种 GLP-1 和一种 GLP-1-GIP 双受体激动剂获得 FDA 批准用于慢性体重管理。腹腔镜手术技术的进步和手术方法选择的改进同样提高了减肥代谢手术的安全性和有效性,使超重和肥胖患者的体重得以减轻。在本综述中,我们将讨论当代药物和手术体重管理策略的优缺点。我们回顾了有关各种治疗方法的预期减重、血糖控制、心脏代谢益处和潜在不良反应的数据。随着全球肥胖率的持续上升,临床医生必须牢记这些注意事项,以便更好地照顾患者。
{"title":"Contemporary Management of Obesity: A Comparison of Bariatric Metabolic Surgery and Novel Incretin Mimetic Drugs.","authors":"Abhayjit Singh, Steven E Nissen","doi":"10.1089/dia.2024.0122","DOIUrl":"10.1089/dia.2024.0122","url":null,"abstract":"<p><p>The global prevalence of obesity has risen sharply during the past half-century, reaching pandemic proportions and creating a public health crisis. Obesity is a recognized risk factor for the development of diabetes, atherosclerosis, hypertension, hepatic steatosis, and many other cardiometabolic disorders with significant resultant morbidity and mortality. Though treatment of obesity can prevent or slow the progression of the aforementioned illnesses, efforts to help patients achieve reliable and sustainable weight loss have had limited success. Improving nutrition and increasing physical activity results in a host of health benefits; however, the weight loss achieved with lifestyle interventions alone is modest and difficult to sustain. Early attempts at medical and surgical treatment of obesity were plagued with adverse effects and complications. Moreover, these approaches failed to demonstrate long-term health benefits, even when weight loss was achieved. Recently, novel incretin-based therapies targeting glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors have gained popularity because of their effectiveness in achieving substantial weight loss in patients both with and without diabetes. Following many successful clinical trials, there are now multiple GLP-1 receptor agonists and one dual GLP-1-GIP receptor agonist approved by the Food and Drug Administration for chronic weight management. Advancements in laparoscopic surgical technique and refinements in procedure selection have similarly improved the safety and efficacy of bariatric metabolic surgery for patients with obesity. In this review, we discuss the advantages and disadvantages of contemporary pharmacologic and surgical weight management strategies. We review the data regarding expected weight loss, glycemic control, cardiometabolic benefits, and potential adverse effects of various treatment approaches. As obesity rates continue to rise worldwide, it is imperative that clinicians keep these considerations in mind in order to better care for patients.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"673-685"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140849911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01Epub Date: 2024-05-13DOI: 10.1089/dia.2023.0605
Schafer Boeder, Michael J Davies, Janet B McGill, Richard Pratley, Manon Girard, Phillip Banks, Jeremy Pettus, Satish Garg
Introduction: Sodium glucose cotransporter inhibitors may increase beta-hydroxybutyrate (BHB) in insulin-requiring patients. We determined factors associated with BHB changes from baseline (ΔBHB) and diabetic ketoacidosis (DKA) in patients with type 1 diabetes (T1D) receiving sotagliflozin as an insulin adjunct. Research Design and Methods: This post hoc analysis compared ΔBHB levels in adults with T1D receiving sotagliflozin 400 mg or placebo for 6 months. We evaluated clinical and metabolic factors associated with ΔBHB and used logistic regression models to determine predictors associated with BHB values >0.6 and >1.5 mmol/L (inTandem3 population; N = 1402) or with DKA events in a pooled analysis (inTandem1-3; N = 2453). Results: From baseline (median, 0.13 mmol/L), median fasting BHB increased by 0.04 mmol/L (95% confidence interval, 0.03-0.05; P < 0.001) at 24 weeks with sotagliflozin versus placebo; 67% of patients had no or minimal changes in BHB over time. Factors associated with on-treatment BHB >0.6 or >1.5 mmol/L included baseline BHB and sotagliflozin use. Age, insulin pump use, sotagliflozin use, baseline BHB, and ΔBHB were significantly associated with DKA episodes. Independent of treatment, DKA risk increased by 18% with each 0.1-mmol/L increase in baseline BHB and by 8% with each 0.1-mmol/L increase from baseline. Conclusion: Incremental increases in baseline BHB and ΔBHB were associated with a higher DKA risk independent of treatment. Adding sotagliflozin to insulin increased median BHB over 24 weeks in patients with T1D and was associated with increased DKA events. These results highlight the importance of BHB testing and monitoring and individualizing patient education on DKA risk, mitigation, identification, and treatment.
{"title":"Beta-Hydroxybutyrate Levels and Risk of Diabetic Ketoacidosis in Adults with Type 1 Diabetes Treated with Sotagliflozin.","authors":"Schafer Boeder, Michael J Davies, Janet B McGill, Richard Pratley, Manon Girard, Phillip Banks, Jeremy Pettus, Satish Garg","doi":"10.1089/dia.2023.0605","DOIUrl":"10.1089/dia.2023.0605","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Sodium glucose cotransporter inhibitors may increase beta-hydroxybutyrate (BHB) in insulin-requiring patients. We determined factors associated with BHB changes from baseline (ΔBHB) and diabetic ketoacidosis (DKA) in patients with type 1 diabetes (T1D) receiving sotagliflozin as an insulin adjunct. <b><i>Research Design and Methods:</i></b> This post hoc analysis compared ΔBHB levels in adults with T1D receiving sotagliflozin 400 mg or placebo for 6 months. We evaluated clinical and metabolic factors associated with ΔBHB and used logistic regression models to determine predictors associated with BHB values >0.6 and >1.5 mmol/L (inTandem3 population; <i>N</i> = 1402) or with DKA events in a pooled analysis (inTandem1-3; <i>N</i> = 2453). <b><i>Results:</i></b> From baseline (median, 0.13 mmol/L), median fasting BHB increased by 0.04 mmol/L (95% confidence interval, 0.03-0.05; <i>P</i> < 0.001) at 24 weeks with sotagliflozin versus placebo; 67% of patients had no or minimal changes in BHB over time. Factors associated with on-treatment BHB >0.6 or >1.5 mmol/L included baseline BHB and sotagliflozin use. Age, insulin pump use, sotagliflozin use, baseline BHB, and ΔBHB were significantly associated with DKA episodes. Independent of treatment, DKA risk increased by 18% with each 0.1-mmol/L increase in baseline BHB and by 8% with each 0.1-mmol/L increase from baseline. <b><i>Conclusion:</i></b> Incremental increases in baseline BHB and ΔBHB were associated with a higher DKA risk independent of treatment. Adding sotagliflozin to insulin increased median BHB over 24 weeks in patients with T1D and was associated with increased DKA events. These results highlight the importance of BHB testing and monitoring and individualizing patient education on DKA risk, mitigation, identification, and treatment.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"618-625"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140027633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01Epub Date: 2024-04-08DOI: 10.1089/dia.2024.0017
Alanna Weisman, Gillian L Booth, Karl Everett, George A Tomlinson
Aims: We evaluated attainment of the hemoglobin A1c (HbA1c) target of ≤7.0%, its temporal trends, and associated factors among adults with type 1 diabetes in Ontario, Canada, using administrative data. Methods: We conducted a retrospective cohort study, including Ontarians with type 1 diabetes ≥18 years old with ≥1 HbA1c test between April 1, 2012 (fiscal year 2013), and March 31, 2023. Generalized estimating equations were used to determine probabilities of meeting the HbA1c target, as well as associations between fiscal year and individual-, physician-, and system-level factors on odds of meeting the target. Results: Among 28,827 adults with type 1 diabetes [14,385 (49.9%) female, 17,998 (62.4%) pump users], with median age at index of 25 years [interquartile range (IQR) 18-37] and median diabetes duration of 12 years [6-18], there were 474,714 HbA1c tests [median 2/individual/year (IQR: 1-3)]. The model-estimated probability of meeting the HbA1c target of ≤7.0% was 22.1% (95% confidence interval, CI: 21.6 to 22.5) in 2013, remained stable until 2020, and increased to 34.7% (95% CI: 34.3 to 35.2) in 2023. The age- and sex-adjusted odds ratio for meeting the target in 2023 versus 2013 was 1.87 (95% CI: 1.79 to 1.96). Young adults (18-25 years), diabetic ketoacidosis, greater comorbidity, and receiving diabetes care from a nonspecialist physician were associated with reduced odds of meeting the HbA1c target. Conclusions: One-third of adults with type 1 diabetes in Ontario met the recommended HbA1c target of ≤7.0% in 2023, with improvement noted since 2021, which may be due to advanced technologies or effects of the COVID-19 pandemic.
{"title":"Recent Improvements in Attainment of the Hemoglobin A1c Target of ≤7.0% Among Adults with Type 1 Diabetes in Ontario: A Retrospective Cohort Study.","authors":"Alanna Weisman, Gillian L Booth, Karl Everett, George A Tomlinson","doi":"10.1089/dia.2024.0017","DOIUrl":"10.1089/dia.2024.0017","url":null,"abstract":"<p><p><b><i>Aims:</i></b> We evaluated attainment of the hemoglobin A1c (HbA1c) target of ≤7.0%, its temporal trends, and associated factors among adults with type 1 diabetes in Ontario, Canada, using administrative data. <b><i>Methods:</i></b> We conducted a retrospective cohort study, including Ontarians with type 1 diabetes ≥18 years old with ≥1 HbA1c test between April 1, 2012 (fiscal year 2013), and March 31, 2023. Generalized estimating equations were used to determine probabilities of meeting the HbA1c target, as well as associations between fiscal year and individual-, physician-, and system-level factors on odds of meeting the target. <b><i>Results:</i></b> Among 28,827 adults with type 1 diabetes [14,385 (49.9%) female, 17,998 (62.4%) pump users], with median age at index of 25 years [interquartile range (IQR) 18-37] and median diabetes duration of 12 years [6-18], there were 474,714 HbA1c tests [median 2/individual/year (IQR: 1-3)]. The model-estimated probability of meeting the HbA1c target of ≤7.0% was 22.1% (95% confidence interval, CI: 21.6 to 22.5) in 2013, remained stable until 2020, and increased to 34.7% (95% CI: 34.3 to 35.2) in 2023. The age- and sex-adjusted odds ratio for meeting the target in 2023 versus 2013 was 1.87 (95% CI: 1.79 to 1.96). Young adults (18-25 years), diabetic ketoacidosis, greater comorbidity, and receiving diabetes care from a nonspecialist physician were associated with reduced odds of meeting the HbA1c target. <b><i>Conclusions:</i></b> One-third of adults with type 1 diabetes in Ontario met the recommended HbA1c target of ≤7.0% in 2023, with improvement noted since 2021, which may be due to advanced technologies or effects of the COVID-19 pandemic.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"607-617"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140206475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01Epub Date: 2024-05-10DOI: 10.1089/dia.2023.0571
Alex Mesa, Clara Solà, Irene Vinagre, Daria Roca, Montse Granados, Irene Pueyo, Carla Cabré, Ignacio Conget, Marga Giménez
This study aimed to evaluate the impact of advanced hybrid closed loop (AHCL) on glycemic control throughout the menstrual cycle (MC) in women with type 1 diabetes. We included 39 pairs of spontaneous MCs from 13 participants, before and after switching from sensor-augmented pump to AHCL. Baseline time below range <70 mg/dL (TBR <70) was significantly higher during the midfollicular phase than during late luteal phase (5.7% ± 5.0% vs. 4.1% ± 3.0%), but similar time in range 70-180 mg/dL (TIR) was observed throughout the MC. After switching to AHCL, a reduction in TBR <70 and an increase in TIR were observed in all phases. Phase-dependent changes in insulin infusion were detected and pre-existing differences in TBR <70 were eradicated (3.5% ± 3.2% vs. 3.0% ± 3.0%). However, TIR became significantly higher during the early follicular phase than during the late luteal phase (79.1% ± 9.3% vs. 74.5% ± 10.0%). In conclusion, AHCL improved glycemic control throughout the MC, but performance differed according to phase.
{"title":"Impact of an Advanced Hybrid Closed-Loop System on Glycemic Control Throughout the Menstrual Cycle in Women with Type 1 Diabetes Prone to Hypoglycemia.","authors":"Alex Mesa, Clara Solà, Irene Vinagre, Daria Roca, Montse Granados, Irene Pueyo, Carla Cabré, Ignacio Conget, Marga Giménez","doi":"10.1089/dia.2023.0571","DOIUrl":"10.1089/dia.2023.0571","url":null,"abstract":"<p><p>This study aimed to evaluate the impact of advanced hybrid closed loop (AHCL) on glycemic control throughout the menstrual cycle (MC) in women with type 1 diabetes. We included 39 pairs of spontaneous MCs from 13 participants, before and after switching from sensor-augmented pump to AHCL. Baseline time below range <70 mg/dL (TBR <70) was significantly higher during the midfollicular phase than during late luteal phase (5.7% ± 5.0% vs. 4.1% ± 3.0%), but similar time in range 70-180 mg/dL (TIR) was observed throughout the MC. After switching to AHCL, a reduction in TBR <70 and an increase in TIR were observed in all phases. Phase-dependent changes in insulin infusion were detected and pre-existing differences in TBR <70 were eradicated (3.5% ± 3.2% vs. 3.0% ± 3.0%). However, TIR became significantly higher during the early follicular phase than during the late luteal phase (79.1% ± 9.3% vs. 74.5% ± 10.0%). In conclusion, AHCL improved glycemic control throughout the MC, but performance differed according to phase.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"667-672"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140027634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}