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Article ; Online: Open-source Artificial Pancreas Systems Are Safe and Effective When Supported In-clinic: Outcomes in 248 Consecutive Type 1 Diabetes Clients.

Samuel, Praveen / Khan, Nabeel / Klein, Gerri / Skobkarev, Sergey / Mammon, Benjamin / Fournier, Marc / Hawke, Kate / Weissinger, Arthur / Elliott, Tom

Canadian journal of diabetes

2023  Volume 48, Issue 1, Page(s) 59–65.e1

Abstract: 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: ... ...

Abstract 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.
MeSH term(s) Male ; Female ; Humans ; Adult ; Diabetes Mellitus, Type 1/drug therapy ; Hypoglycemic Agents/therapeutic use ; Glycated Hemoglobin ; Quality of Life ; Insulin/therapeutic use ; Retrospective Studies ; Pancreas, Artificial ; Insulin Infusion Systems ; Canada/epidemiology ; Hypoglycemia/prevention & control ; Hypoglycemia/complications ; Diabetic Ketoacidosis/epidemiology ; Diabetic Ketoacidosis/prevention & control ; Diabetic Ketoacidosis/complications ; Blood Glucose Self-Monitoring ; Glucose ; Blood Glucose
Chemical Substances Hypoglycemic Agents ; Glycated Hemoglobin ; Insulin ; Glucose (IY9XDZ35W2) ; Blood Glucose
Language English
Publishing date 2023-10-05
Publishing country Canada
Document type Journal Article
ISSN 2352-3840
ISSN (online) 2352-3840
DOI 10.1016/j.jcjd.2023.09.003
Database MEDical Literature Analysis and Retrieval System OnLINE

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