Pub Date : 2024-12-23DOI: 10.1177/19322968241306127
Mayer B Davidson
Primary care clinicians (PCCs) manage 90% of patients with diabetes, 30% of whom require insulin with a substantial number poorly controlled because of the challenges that PCCs face (time constraints and lack of experience). The author has developed Federal Drug Administration cleared and Conformite Europeenne mark registered comprehensive computerized insulin dose adjustment algorithms (CIDAAs) to enable PCCs to significantly lower HbA1c levels in insulin-requiring patients. Reports sent to PCCs contain scatter plots of glucose readings, their organization into pre- and postprandial and before bedtime values, their analyses, and recommendations for insulin dose adjustments (if indicated) that the PCC can accept or modify. The glucose readings are provided to the CIDAAs for analysis at either in-person visits or remotely. The new doses accepted by PCCs serve as the basis for the subsequent report. Published studies evaluating this comprehensive CIDAA involved 104 poorly controlled patients taking insulin for greater than or equal to six months who were independently managed by PCCs. Over four to six months, initial HbA1c levels of 9.7% fell by 1.7%. Combining these results with 138 other better controlled patients in real-world situations, initial measured and estimated HbA1c levels of 8.3% fell by 0.7% in 6.4 months enabling PCCs to significantly improve glycemic control. Other advantages of PCCs utilizing these comprehensive CIDAAs are saving time for PCCs so that they can address non-diabetes issues and/or see other patients and ongoing PCC education in adjusting insulin doses by matching glucose patterns and dose-change recommendations with subsequent glycemic responses.
{"title":"The Effective Use by Primary Care Clinicians of a Comprehensive Computerized Insulin Dose Adjustment Algorithm.","authors":"Mayer B Davidson","doi":"10.1177/19322968241306127","DOIUrl":"10.1177/19322968241306127","url":null,"abstract":"<p><p>Primary care clinicians (PCCs) manage 90% of patients with diabetes, 30% of whom require insulin with a substantial number poorly controlled because of the challenges that PCCs face (time constraints and lack of experience). The author has developed Federal Drug Administration cleared and Conformite Europeenne mark registered comprehensive computerized insulin dose adjustment algorithms (CIDAAs) to enable PCCs to significantly lower HbA1c levels in insulin-requiring patients. Reports sent to PCCs contain scatter plots of glucose readings, their organization into pre- and postprandial and before bedtime values, their analyses, and recommendations for insulin dose adjustments (if indicated) that the PCC can accept or modify. The glucose readings are provided to the CIDAAs for analysis at either in-person visits or remotely. The new doses accepted by PCCs serve as the basis for the subsequent report. Published studies evaluating this comprehensive CIDAA involved 104 poorly controlled patients taking insulin for greater than or equal to six months who were independently managed by PCCs. Over four to six months, initial HbA1c levels of 9.7% fell by 1.7%. Combining these results with 138 other better controlled patients in real-world situations, initial measured and estimated HbA1c levels of 8.3% fell by 0.7% in 6.4 months enabling PCCs to significantly improve glycemic control. Other advantages of PCCs utilizing these comprehensive CIDAAs are saving time for PCCs so that they can address non-diabetes issues and/or see other patients and ongoing PCC education in adjusting insulin doses by matching glucose patterns and dose-change recommendations with subsequent glycemic responses.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241306127"},"PeriodicalIF":4.1,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-21DOI: 10.1177/19322968241305161
Sebastian F Petry, Marie Bienhaus, Friedrich W Petry, Johannes K Petry, Lutz Heinemann, Stefan Gäth
Background: People with diabetes benefit from continuous glucose monitoring (CGM) systems. A downside of these valuable aids for diabetes management is the generation of a tremendous amount of waste. This study aimed to quantify this CGM-related waste.
Method: Twenty-four used CGM sensors from two different manufacturers (8× FreeStyle Libre 2, 11× FreeStyle Libre 3, and 5× Dexcom G7) were dismantled manually and separated in case, circuit board, and battery. Each component as well as included packaging, applicator, and leaflet were weighed separately.
Results: Packaging, applicators, and leaflets accounted for most of the waste (FL2: 93.4 g; FL3: 58 g; G7: 108.1 g). The plastic case contributed mainly to the total sensor weight (FL2: 1.9 g/63% of 3.3 g; FL3: 0.5 g/49% of 1.1 g; G7: 1.9 g/59% of 3.2 g), whereas the weight of the electronic circuit board and battery varied (FL2: 0.8 g/25%, 0.4 g/12%; FL3: 0.2 g/17%, 0.4 g/34%; G7: 0.7 g/22%, 0.6 g/19%). Extrapolating these data based on annual worldwide usage of around 230 million glucose sensors, approximately 20,000 tons of packaging, applicators, and leaflets and 580 tons of glucose sensors are disposed of, including about 340 tons of casings, 130 tons of circuit boards, and 110 tons of batteries.
Conclusions: Our data highlight the potential for optimized resource utilization by reduction of packaging, sensor size, longer application periods, implementation of multiuse applicators, and the need for recycling options.
{"title":"Quantification of Different Types of Waste and Batteries Associated With the Widespread Usage of Continuous Glucose Monitoring Systems.","authors":"Sebastian F Petry, Marie Bienhaus, Friedrich W Petry, Johannes K Petry, Lutz Heinemann, Stefan Gäth","doi":"10.1177/19322968241305161","DOIUrl":"10.1177/19322968241305161","url":null,"abstract":"<p><strong>Background: </strong>People with diabetes benefit from continuous glucose monitoring (CGM) systems. A downside of these valuable aids for diabetes management is the generation of a tremendous amount of waste. This study aimed to quantify this CGM-related waste.</p><p><strong>Method: </strong>Twenty-four used CGM sensors from two different manufacturers (8× FreeStyle Libre 2, 11× FreeStyle Libre 3, and 5× Dexcom G7) were dismantled manually and separated in case, circuit board, and battery. Each component as well as included packaging, applicator, and leaflet were weighed separately.</p><p><strong>Results: </strong>Packaging, applicators, and leaflets accounted for most of the waste (FL2: 93.4 g; FL3: 58 g; G7: 108.1 g). The plastic case contributed mainly to the total sensor weight (FL2: 1.9 g/63% of 3.3 g; FL3: 0.5 g/49% of 1.1 g; G7: 1.9 g/59% of 3.2 g), whereas the weight of the electronic circuit board and battery varied (FL2: 0.8 g/25%, 0.4 g/12%; FL3: 0.2 g/17%, 0.4 g/34%; G7: 0.7 g/22%, 0.6 g/19%). Extrapolating these data based on annual worldwide usage of around 230 million glucose sensors, approximately 20,000 tons of packaging, applicators, and leaflets and 580 tons of glucose sensors are disposed of, including about 340 tons of casings, 130 tons of circuit boards, and 110 tons of batteries.</p><p><strong>Conclusions: </strong>Our data highlight the potential for optimized resource utilization by reduction of packaging, sensor size, longer application periods, implementation of multiuse applicators, and the need for recycling options.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241305161"},"PeriodicalIF":4.1,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11662339/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-21DOI: 10.1177/19322968241306129
Alessandra T Ayers, Cindy N Ho, Emma Friedman, Juan Espinoza, Shahid N Shah, David C Klonoff
The Diabetes Research Hub (DRH) is a centralized data management system and repository that will revolutionize how diabetes data are gathered, stored, analyzed, and utilized for research. By harnessing advanced analytics for large datasets, the DRH will support a nuanced understanding of physiological patterns and treatment effectiveness, ultimately advancing diabetes management and patient outcomes. This is an opportune time for researchers who are collecting continuous glucose data and related physiological data sources, to leverage the capabilities of the DRH to enhance the value of their data.
{"title":"How the Diabetes Research Hub Will Modernize and Enhance Diabetes Data Utilization.","authors":"Alessandra T Ayers, Cindy N Ho, Emma Friedman, Juan Espinoza, Shahid N Shah, David C Klonoff","doi":"10.1177/19322968241306129","DOIUrl":"10.1177/19322968241306129","url":null,"abstract":"<p><p>The Diabetes Research Hub (DRH) is a centralized data management system and repository that will revolutionize how diabetes data are gathered, stored, analyzed, and utilized for research. By harnessing advanced analytics for large datasets, the DRH will support a nuanced understanding of physiological patterns and treatment effectiveness, ultimately advancing diabetes management and patient outcomes. This is an opportune time for researchers who are collecting continuous glucose data and related physiological data sources, to leverage the capabilities of the DRH to enhance the value of their data.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241306129"},"PeriodicalIF":4.1,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11662337/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-21DOI: 10.1177/19322968241305641
Sujatha Seetharaman, Eda Cengiz
Background: Type 1 diabetes (T1D) is characterized by the autoimmune destruction of pancreatic beta cells, leading to lifelong insulin dependence. Despite advancements in insulin therapies and glucose monitoring, maintaining optimal blood glucose control remains challenging with common issues like weight gain and glucose variability. Glucagon-like peptide 1 receptor agonists (GLP-1 RAs), approved for type 2 diabetes and obesity, are being explored off-label for T1D.
Case report: This case series investigates the effectiveness of GLP-1 RAs, mainly semaglutide and tirzepatide, as an adjunct therapy to insulin in adolescents and young adults (AYA) with T1D, in a single center, providing real-world insights and highlighting practical issues.
Discussion: Most patients had obesity, consistent with typical indication for use in AYA. Common gastrointestinal side effects improved with dose titration, but careful monitoring is needed for persistent symptoms. One patient developed an eating disorder, underscoring the need for vigilance. Insurance and medication shortage issues impacted treatment continuity, highlighting the need for better support. Glycemic parameters improved in most patients, with weight reduction in several patients with obesity, and no reported diabetic ketoacidosis.
Conclusions: GLP-1 RAs can be a beneficial adjunct therapy in T1D, improving glycemic control, reducing insulin needs, and supporting weight management, while potentially preventing long-term cardiovascular and renal complications.
{"title":"Expectations and Outcomes From Glucagon-Like Peptide-1 Receptor Agonists As Adjunct Treatment for Type 1 Diabetes - Case Presentations.","authors":"Sujatha Seetharaman, Eda Cengiz","doi":"10.1177/19322968241305641","DOIUrl":"10.1177/19322968241305641","url":null,"abstract":"<p><strong>Background: </strong>Type 1 diabetes (T1D) is characterized by the autoimmune destruction of pancreatic beta cells, leading to lifelong insulin dependence. Despite advancements in insulin therapies and glucose monitoring, maintaining optimal blood glucose control remains challenging with common issues like weight gain and glucose variability. Glucagon-like peptide 1 receptor agonists (GLP-1 RAs), approved for type 2 diabetes and obesity, are being explored off-label for T1D.</p><p><strong>Case report: </strong>This case series investigates the effectiveness of GLP-1 RAs, mainly semaglutide and tirzepatide, as an adjunct therapy to insulin in adolescents and young adults (AYA) with T1D, in a single center, providing real-world insights and highlighting practical issues.</p><p><strong>Discussion: </strong>Most patients had obesity, consistent with typical indication for use in AYA. Common gastrointestinal side effects improved with dose titration, but careful monitoring is needed for persistent symptoms. One patient developed an eating disorder, underscoring the need for vigilance. Insurance and medication shortage issues impacted treatment continuity, highlighting the need for better support. Glycemic parameters improved in most patients, with weight reduction in several patients with obesity, and no reported diabetic ketoacidosis.</p><p><strong>Conclusions: </strong>GLP-1 RAs can be a beneficial adjunct therapy in T1D, improving glycemic control, reducing insulin needs, and supporting weight management, while potentially preventing long-term cardiovascular and renal complications.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241305641"},"PeriodicalIF":4.1,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11662345/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Type 2 diabetes mellitus (T2DM) and dementia are two of the leading chronic diseases in aging and are known to influence each other's disease progression. There is well-established evidence that T2DM increases the risk for cognitive decline and dementia. At the same time, people with cognitive changes or dementia can find it difficult to manage their diabetes, resulting in hyper- or hypoglycemic events which can exacerbate the dementia disease progression further. Monitoring of glucose variability is, therefore, of critical importance during aging and when people with T2DM develop dementia. The advent of continuous glucose monitoring (CGM) has allowed the monitoring of glucose variability in T2DM more closely. The CGM seems to be highly feasible and acceptable to use in older people with T2DM and has been shown to significantly reduce their hypoglycemic events, often resulting in falls. Less is known as to whether CGM can have a similar beneficial effect on people with T2DM who have cognitive impairment or dementia in community or hospital settings.
Aims: The current perspective will explore how CGM has made an impact on T2DM management in older people and those with comorbid cognitive impairment or dementia. We will further explore opportunities and challenges of using CGM in comorbid T2DM and dementia in community and hospital settings.
{"title":"Continuous Glucose Monitoring in Comorbid Dementia and Diabetes: The Evidence So Far.","authors":"Busra Donat Ergin, Kieran Gadsby-Davis, Katharina Mattishent, Ketan Dhatariya, Nikki Garner, Michael Hornberger","doi":"10.1177/19322968241301058","DOIUrl":"10.1177/19322968241301058","url":null,"abstract":"<p><strong>Background: </strong>Type 2 diabetes mellitus (T2DM) and dementia are two of the leading chronic diseases in aging and are known to influence each other's disease progression. There is well-established evidence that T2DM increases the risk for cognitive decline and dementia. At the same time, people with cognitive changes or dementia can find it difficult to manage their diabetes, resulting in hyper- or hypoglycemic events which can exacerbate the dementia disease progression further. Monitoring of glucose variability is, therefore, of critical importance during aging and when people with T2DM develop dementia. The advent of continuous glucose monitoring (CGM) has allowed the monitoring of glucose variability in T2DM more closely. The CGM seems to be highly feasible and acceptable to use in older people with T2DM and has been shown to significantly reduce their hypoglycemic events, often resulting in falls. Less is known as to whether CGM can have a similar beneficial effect on people with T2DM who have cognitive impairment or dementia in community or hospital settings.</p><p><strong>Aims: </strong>The current perspective will explore how CGM has made an impact on T2DM management in older people and those with comorbid cognitive impairment or dementia. We will further explore opportunities and challenges of using CGM in comorbid T2DM and dementia in community and hospital settings.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241301058"},"PeriodicalIF":4.1,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11653377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-13DOI: 10.1177/19322968241305383
Lutz Heinemann
Millions of people with diabetes have no or only limited access to electricity that limits their ability to store insulin according to the recommendations of the insulin manufacturer in general. At the same time, environmental temperatures are increasing in many countries which have a negative impact on the glucose-lowering effect of insulin not stored adequately. Therefore, the availability of heat-stable insulin formulations that do not require constant cooling would be of help for many patients; however, despite this clinical need, apparently not many are in clinical development. This commentary discusses the different aspects and approaches that are of relevance in this context.
{"title":"Heat-Stable Insulins: Any Progress?","authors":"Lutz Heinemann","doi":"10.1177/19322968241305383","DOIUrl":"10.1177/19322968241305383","url":null,"abstract":"<p><p>Millions of people with diabetes have no or only limited access to electricity that limits their ability to store insulin according to the recommendations of the insulin manufacturer in general. At the same time, environmental temperatures are increasing in many countries which have a negative impact on the glucose-lowering effect of insulin not stored adequately. Therefore, the availability of heat-stable insulin formulations that do not require constant cooling would be of help for many patients; however, despite this clinical need, apparently not many are in clinical development. This commentary discusses the different aspects and approaches that are of relevance in this context.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241305383"},"PeriodicalIF":4.1,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11638932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142818255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-12DOI: 10.1177/19322968241305627
Fiorella Sotomayor, Reynier Hernandez, Chikara Gothong, Monica Y Choe, Garrett I Ash, William Scott, Lillian Pinault, Fernando Gomez-Peralta, Marc R Blackman, Lakshmi G Singh, John D Sorkin, Elias K Spanakis
{"title":"Utilizing a Novel Telemedicine Clinic for Managing Patients With Type 2 Diabetes: A Six-Month Randomized Control Trial Pilot Study.","authors":"Fiorella Sotomayor, Reynier Hernandez, Chikara Gothong, Monica Y Choe, Garrett I Ash, William Scott, Lillian Pinault, Fernando Gomez-Peralta, Marc R Blackman, Lakshmi G Singh, John D Sorkin, Elias K Spanakis","doi":"10.1177/19322968241305627","DOIUrl":"10.1177/19322968241305627","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241305627"},"PeriodicalIF":4.1,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635784/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-10DOI: 10.1177/19322968241304779
Sharon Orrange, Tess Humphrey, Ethan Fayne, Anne Peters
{"title":"Semaglutide for Weight Reduction in Type 1 Diabetes: Promising Results With Uncertain Glycemic Impact.","authors":"Sharon Orrange, Tess Humphrey, Ethan Fayne, Anne Peters","doi":"10.1177/19322968241304779","DOIUrl":"10.1177/19322968241304779","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241304779"},"PeriodicalIF":4.1,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629341/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142801037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-05DOI: 10.1177/19322968241301429
Kagan E Karakus, Janet Snell-Bergeon, Emma Mason, Halis K Akturk
Objective: Extended hypoglycemia (Ehypo) and extended hyperglycemia (Ehyper) are recently defined continuous glucose monitoring (CGM) metrics by the International Consensus for clinical trials as secondary endpoints for continuous outcomes. This study aims to evaluate the changes in Ehypo and Ehyper before and after automated insulin delivery (AID) initiation in adults with type 1 diabetes (T1D).
Research methods: This is a retrospective single-center study that evaluated Ehypo and Ehyper in addition to other CGM metrics in 154 adults that initiated an AID system. Metrics were compared before and after AID initiation by Wilcoxon signed-rank test.
Results: Median (interquartile range) Ehypo (<70 mg/dL) events/week decreased from 0.1 (0-0.4) to 0 (0-0.1) and Ehyper (>250 mg/dL) events/week decreased from 2.2 (0.9-4.5) to 0.8 (0.3-1.7) (both P < .001) after AID initiation compared with before AID initiation. All other CGM metrics improved after AID initiation. There was a strong positive correlation between Ehyper (>250 mg/dL) and mean glucose (before AID: r = 0.947, after AID: r = 0.894), glucose management indicator (before AID: r = 0.947, after AID: r = 0.887), and time above range (TAR; >180 mg/dL) (before AID: r = 0.957, after AID: r = 0.917) and a strong positive correlation between Ehypo (<70 mg/dL) and time below range (TBR; <70 mg/dL) (before AID: r = 0.823, after AID: r = 0.608) before and after AID initiation, respectively.
Conclusion: Automated insulin delivery initiation significantly improved Ehypo and Ehyper metrics. Ehypo and Ehyper had a strong positive correlation with TBR and TAR, respectively. Ehypo and Ehyper events can be used in addition to TBR and TAR metrics in clinical studies as secondary outcomes.
{"title":"Improvement in Newly Defined Continuous Glucose Monitor Metrics, Extended Hypoglycemia, and Extended Hyperglycemia With Automated Insulin Delivery Initiation in Adults With Type 1 Diabetes.","authors":"Kagan E Karakus, Janet Snell-Bergeon, Emma Mason, Halis K Akturk","doi":"10.1177/19322968241301429","DOIUrl":"10.1177/19322968241301429","url":null,"abstract":"<p><strong>Objective: </strong>Extended hypoglycemia (Ehypo) and extended hyperglycemia (Ehyper) are recently defined continuous glucose monitoring (CGM) metrics by the International Consensus for clinical trials as secondary endpoints for continuous outcomes. This study aims to evaluate the changes in Ehypo and Ehyper before and after automated insulin delivery (AID) initiation in adults with type 1 diabetes (T1D).</p><p><strong>Research methods: </strong>This is a retrospective single-center study that evaluated Ehypo and Ehyper in addition to other CGM metrics in 154 adults that initiated an AID system. Metrics were compared before and after AID initiation by Wilcoxon signed-rank test.</p><p><strong>Results: </strong>Median (interquartile range) Ehypo (<70 mg/dL) events/week decreased from 0.1 (0-0.4) to 0 (0-0.1) and Ehyper (>250 mg/dL) events/week decreased from 2.2 (0.9-4.5) to 0.8 (0.3-1.7) (both <i>P</i> < .001) after AID initiation compared with before AID initiation. All other CGM metrics improved after AID initiation. There was a strong positive correlation between Ehyper (>250 mg/dL) and mean glucose (before AID: <i>r</i> = 0.947, after AID: <i>r</i> = 0.894), glucose management indicator (before AID: <i>r</i> = 0.947, after AID: <i>r</i> = 0.887), and time above range (TAR; >180 mg/dL) (before AID: <i>r</i> = 0.957, after AID: <i>r</i> = 0.917) and a strong positive correlation between Ehypo (<70 mg/dL) and time below range (TBR; <70 mg/dL) (before AID: <i>r</i> = 0.823, after AID: <i>r</i> = 0.608) before and after AID initiation, respectively.</p><p><strong>Conclusion: </strong>Automated insulin delivery initiation significantly improved Ehypo and Ehyper metrics. Ehypo and Ehyper had a strong positive correlation with TBR and TAR, respectively. Ehypo and Ehyper events can be used in addition to TBR and TAR metrics in clinical studies as secondary outcomes.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241301429"},"PeriodicalIF":4.1,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11618842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142780241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-05DOI: 10.1177/19322968241298005
Irl B Hirsch, Dorrine Khakpour, Jeffrey Joseph, Michi M Shinohara, Ruikang K Wang, Ulrike Klueh, Donald Kreutzner, Jean-Pierre Riveline, Pauline Jacquemier, Lisa Maier, Michael T Longaker, Christopher G Parkin, Thomas Pieber, Andrea Kalus
Ongoing innovation in diabetes technologies has led to the development of advanced tools such as automated insulin delivery (AID) systems that adjust insulin delivery in response to current and predicted glucose levels, residual insulin action, and other inputs (eg, meal and exercise announcements). However, infusion sets continue to be the "Achilles heel" of accurate and precise insulin delivery and continued device use. A recent study by Kalus et al (DERMIS Study) revealed higher vessel density and signals of inflammation by optical coherence tomography (OCT), in addition to increased inflammation, fat necrosis, fibrosis, and eosinophilic infiltration by histopathology. Although the study provided a comprehensive description of what was happening, the results raise important questions that require additional research. On February 29, 2024, the Leona M. and Harry B. Helmsley Charitable Trust sponsored a conference to begin addressing these issues. This article summarizes the DERMIS study findings and testing methodologies discussed at the conference and proposes the next steps for developing insulin infusion sets that reduce the variability in insulin delivery and extend wear.
{"title":"The DERMIS Study: Methodologies, Results, and Implications for the Future.","authors":"Irl B Hirsch, Dorrine Khakpour, Jeffrey Joseph, Michi M Shinohara, Ruikang K Wang, Ulrike Klueh, Donald Kreutzner, Jean-Pierre Riveline, Pauline Jacquemier, Lisa Maier, Michael T Longaker, Christopher G Parkin, Thomas Pieber, Andrea Kalus","doi":"10.1177/19322968241298005","DOIUrl":"10.1177/19322968241298005","url":null,"abstract":"<p><p>Ongoing innovation in diabetes technologies has led to the development of advanced tools such as automated insulin delivery (AID) systems that adjust insulin delivery in response to current and predicted glucose levels, residual insulin action, and other inputs (eg, meal and exercise announcements). However, infusion sets continue to be the \"Achilles heel\" of accurate and precise insulin delivery and continued device use. A recent study by Kalus et al (DERMIS Study) revealed higher vessel density and signals of inflammation by optical coherence tomography (OCT), in addition to increased inflammation, fat necrosis, fibrosis, and eosinophilic infiltration by histopathology. Although the study provided a comprehensive description of what was happening, the results raise important questions that require additional research. On February 29, 2024, the Leona M. and Harry B. Helmsley Charitable Trust sponsored a conference to begin addressing these issues. This article summarizes the DERMIS study findings and testing methodologies discussed at the conference and proposes the next steps for developing insulin infusion sets that reduce the variability in insulin delivery and extend wear.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241298005"},"PeriodicalIF":4.1,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11618839/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142780247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}