Praveen Samuel MBBS , Nabeel Khan BSc , Gerri Klein RN , Sergey Skobkarev MS , Benjamin Mammon BSc, MD , Marc Fournier Dipl , Kate Hawke MBBS, FRACP , Arthur Weissinger PhD , Tom Elliott MBBS
{"title":"开源人工胰腺系统在临床上得到支持时是安全有效的:248名连续1型患者的结果。","authors":"Praveen Samuel MBBS , Nabeel Khan BSc , Gerri Klein RN , Sergey Skobkarev MS , Benjamin Mammon BSc, MD , Marc Fournier Dipl , Kate Hawke MBBS, FRACP , Arthur Weissinger PhD , Tom Elliott MBBS","doi":"10.1016/j.jcjd.2023.09.003","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>Our aim in this study was to determine the safety, glycemia, and quality of life<span><span> (QoL) associated with in-clinic installation and management of supported open-source artificial pancreas systems (SOSAPS) in </span>type 1 diabetes (T1D).</span></p></div><div><h3>Methods</h3><p><span><span>This investigation is a retrospective cohort study of consecutive SOSAPS users at a Canadian diabetes centre. SOSAPS were offered to all moderately tech-savvy T1D clients on sensor-augmented multiple daily injection or pump, able to pay for hardware, and willing to sign a consent and waiver document. SOSAPS were installed and maintained by clinic staff at no cost to clients. iPhone users were assigned to either Loop (n=108) or iPhone artificial pancreas systems (iAPS; n=114) and Android users to Android-type APS (n=24). Outcomes included severe hypoglycemia and </span>diabetic ketoacidosis (DKA), time in range (TIR) 4.0 to 10.0 mmol/L, time below range (TBR) <4 mmol/L, glucose management indicator (GMI), mean sensor glucose (MSG), change in </span>glycated hemoglobin (A1C), and QoL.</p></div><div><h3>Results</h3><p>Two hundred forty-eight subjects (131 males, 117 females), with a mean age of 36 years and diabetes duration of 21 years, experienced 3 episodes of severe hypoglycemia and no DKA over a follow-up of 17 months. TIR rose by 16%, from 64% to 80% (p<0.0001); TBR fell by 1.0%, from 3.5% to 2.5% (p=0.001); MSG fell from 9.0 to 8.1 mmol/L (p<0.001); GMI fell from 7.3% to 6.7% (p<0.001); and A1C fell from 7.2% to 6.7% (p<0.0001). QoL scores were healthy before and improved after SOSAPS.</p></div><div><h3>Conclusions</h3><p>Clients with T1D using SOSAPS and supported with no-cost care to the client (software, technology, and physician/physician assistant) safely achieved improved TIR, GMI, A1C, and QoL.</p></div>","PeriodicalId":9565,"journal":{"name":"Canadian Journal of Diabetes","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Open-source Artificial Pancreas Systems Are Safe and Effective When Supported In-clinic: Outcomes in 248 Consecutive Type 1 Diabetes Clients\",\"authors\":\"Praveen Samuel MBBS , Nabeel Khan BSc , Gerri Klein RN , Sergey Skobkarev MS , Benjamin Mammon BSc, MD , Marc Fournier Dipl , Kate Hawke MBBS, FRACP , Arthur Weissinger PhD , Tom Elliott MBBS\",\"doi\":\"10.1016/j.jcjd.2023.09.003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>Our aim in this study was to determine the safety, glycemia, and quality of life<span><span> (QoL) associated with in-clinic installation and management of supported open-source artificial pancreas systems (SOSAPS) in </span>type 1 diabetes (T1D).</span></p></div><div><h3>Methods</h3><p><span><span>This investigation is a retrospective cohort study of consecutive SOSAPS users at a Canadian diabetes centre. SOSAPS were offered to all moderately tech-savvy T1D clients on sensor-augmented multiple daily injection or pump, able to pay for hardware, and willing to sign a consent and waiver document. SOSAPS were installed and maintained by clinic staff at no cost to clients. iPhone users were assigned to either Loop (n=108) or iPhone artificial pancreas systems (iAPS; n=114) and Android users to Android-type APS (n=24). Outcomes included severe hypoglycemia and </span>diabetic ketoacidosis (DKA), time in range (TIR) 4.0 to 10.0 mmol/L, time below range (TBR) <4 mmol/L, glucose management indicator (GMI), mean sensor glucose (MSG), change in </span>glycated hemoglobin (A1C), and QoL.</p></div><div><h3>Results</h3><p>Two hundred forty-eight subjects (131 males, 117 females), with a mean age of 36 years and diabetes duration of 21 years, experienced 3 episodes of severe hypoglycemia and no DKA over a follow-up of 17 months. TIR rose by 16%, from 64% to 80% (p<0.0001); TBR fell by 1.0%, from 3.5% to 2.5% (p=0.001); MSG fell from 9.0 to 8.1 mmol/L (p<0.001); GMI fell from 7.3% to 6.7% (p<0.001); and A1C fell from 7.2% to 6.7% (p<0.0001). QoL scores were healthy before and improved after SOSAPS.</p></div><div><h3>Conclusions</h3><p>Clients with T1D using SOSAPS and supported with no-cost care to the client (software, technology, and physician/physician assistant) safely achieved improved TIR, GMI, A1C, and QoL.</p></div>\",\"PeriodicalId\":9565,\"journal\":{\"name\":\"Canadian Journal of Diabetes\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Canadian Journal of Diabetes\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1499267123002216\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Canadian Journal of Diabetes","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1499267123002216","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Open-source Artificial Pancreas Systems Are Safe and Effective When Supported In-clinic: Outcomes in 248 Consecutive Type 1 Diabetes Clients
Objective
Our aim in this study was to determine the safety, glycemia, and quality of life (QoL) associated with in-clinic installation and management of supported open-source artificial pancreas systems (SOSAPS) in type 1 diabetes (T1D).
Methods
This investigation is a retrospective cohort study of consecutive SOSAPS users at a Canadian diabetes centre. SOSAPS were offered to all moderately tech-savvy T1D clients on sensor-augmented multiple daily injection or pump, able to pay for hardware, and willing to sign a consent and waiver document. SOSAPS were installed and maintained by clinic staff at no cost to clients. iPhone users were assigned to either Loop (n=108) or iPhone artificial pancreas systems (iAPS; n=114) and Android users to Android-type APS (n=24). Outcomes included severe hypoglycemia and diabetic ketoacidosis (DKA), time in range (TIR) 4.0 to 10.0 mmol/L, time below range (TBR) <4 mmol/L, glucose management indicator (GMI), mean sensor glucose (MSG), change in glycated hemoglobin (A1C), and QoL.
Results
Two hundred forty-eight subjects (131 males, 117 females), with a mean age of 36 years and diabetes duration of 21 years, experienced 3 episodes of severe hypoglycemia and no DKA over a follow-up of 17 months. TIR rose by 16%, from 64% to 80% (p<0.0001); TBR fell by 1.0%, from 3.5% to 2.5% (p=0.001); MSG fell from 9.0 to 8.1 mmol/L (p<0.001); GMI fell from 7.3% to 6.7% (p<0.001); and A1C fell from 7.2% to 6.7% (p<0.0001). QoL scores were healthy before and improved after SOSAPS.
Conclusions
Clients with T1D using SOSAPS and supported with no-cost care to the client (software, technology, and physician/physician assistant) safely achieved improved TIR, GMI, A1C, and QoL.
期刊介绍:
The Canadian Journal of Diabetes is Canada''s only diabetes-oriented, peer-reviewed, interdisciplinary journal for diabetes health-care professionals.
Published bimonthly, the Canadian Journal of Diabetes contains original articles; reviews; case reports; shorter articles such as Perspectives in Practice, Practical Diabetes and Innovations in Diabetes Care; Diabetes Dilemmas and Letters to the Editor.