Efficacy, safety, and user experience of DIY or open-source artificial pancreas systems: a systematic review

Asarani, Nurul Aliah Mohd; Reynolds, Andrew; Elbalshy, Mona; Burnside, Mercedes; Bock, Martin de; Lewis, Dana; Wheeler, Benjamin J

doi:10.1007/s00592-020-01623-4

Cited by 31 publications

(32 citation statements)

References 54 publications

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“…As open‐source AID systems use as a treatment option is unregulated, their safe and effective use in fasting adds to the growing literature on them and provides further reassurance for their use in keeping with recent reports 14,27,28 . This experience provides newer insights about how AID systems can support people with type 1 diabetes undergo considerable physiological challenges, such as fasting, and can aid healthcare professionals when counseling individuals planning on fasting with open‐source AID systems.…”

Section: Discussionmentioning

confidence: 84%

Use of automated insulin delivery systems in people with type 1 diabetes fasting during Ramadan: An observational study

Aldibbiat

Alqashami²,

Hussain

2021

J of Diabetes Invest

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Fasting among people with type 1 diabetes imposes the risk of metabolic decompensation. Automated insulin dosing systems can allow better glycemic control without safety concerns. The utility in prolonged and repetitive fasting has not been studied. In this observational study, validated glycemic data were reviewed and analyzed from people with type 1 diabetes who observed fasting during Ramadan in 2019 and 2020 using automated insulin dosing systems. Six profiles met the inclusion criteria. The average age was 33.7 ± 4.8 years, diabetes duration was 23.5 ± 7.9 years, body mass index 23.6 ± 1.9 kg/m2 and glycated hemoglobin was 6.3 ± 0.2% (45 ± 5 mmol/mol). The average glucose during Ramadan was 7.0 ± 0.5 mmol/L (126 ± 9 mg/dL), coefficient of variation 28.5%, percentage of time in range 3.9–10 mmol/L (70–180 mg/dL) 88.8 ± 7.3% and percentage time <3.9 mmol/L (<70.0 mg/dL) 2.5 ± 1.3%. The number of fasting days was 27.3 ± 3.3, and the number of days where fasting was broken due diabetes was 1 ± 1.5/participant. No significant differences in glycemic outcomes were noted between Ramadan and non‐Ramadan periods. In this first clinically validated study, automated insulin dosing systems showed a safe and effective management strategy to support prolonged and consecutive fasting in people with type 1 diabetes.

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Section: Discussionmentioning

confidence: 84%

Use of automated insulin delivery systems in people with type 1 diabetes fasting during Ramadan: An observational study

Aldibbiat

Alqashami²,

Hussain

2021

J of Diabetes Invest

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“…94,95 However, no randomized controlled trials have been completed to date. 96,97 In addition, the success stories found in individual case reports, selfreported results or in social media are not a general concern against using this approach when families are aware of the potential risks involved. Furthermore, open-source systems are highly effective in real-life evaluation.…”

Section: Implications For the Use Of Open-source Technologymentioning

confidence: 99%

The automated pancreas: A review of technologies and clinical practice

Biester

Tauschmann

Chobot

et al. 2021

Diabetes Obesity Metabolism

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Insulin pumps and glucose sensors are effective in improving diabetes therapy and reducing acute complications. The combination of both devices using an algorithm‐driven interoperable controller makes automated insulin delivery (AID) systems possible. Many AID systems have been tested in clinical trials and have proven safety and effectiveness. However, currently, none of these systems are available for routine use in children younger than 6 years in Europe. For continued use, both users and prescribers must have sound knowledge of the features of the individual AID systems. Presently, all systems require various user interactions (e.g. meal announcements) because fully automated systems are not yet developed. Open‐source systems are non‐regulated variants to circumvent existing regulatory conditions. There are risks here for both users and prescribers. To evaluate AID therapy, the metric data of the glucose sensors, ‘time in target range’ and ‘glucose management index’, are novel recognized and suitable parameters allowing a consultation based on real glucose and insulin pump download data from the daily life of people with diabetes. Read out via cloud‐based software or automatic download of such individual treatment data provides the ideal technical basis for shared decision‐making through telemedicine, which must be further evaluated for general use.

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“…This is true for the earliest studies of open source systems, where the first self-reported study showed TIR increase from 58 to 81% 4 and later analyses of larger populations also showed similar increased TIR. 5-8 These open source closed loop systems reduce hyperglycemia without increasing hypoglycemia 9 and improve quality of life. 10 They have been studied not only in retrospective and observational studies 11,12 but also in silico 13 as well as ongoing, randomized control trials.…”

Section: “How It Started” For Artificial Pancreas Systemsmentioning

confidence: 99%

How It Started, How It Is Going: The Future of Artificial Pancreas Systems (Automated Insulin Delivery Systems)

Lewis¹

2021

J Diabetes Sci Technol

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Originally, the future of automated insulin delivery (AID) systems, or artificial pancreas systems (APS), was having them at all, in any form. We’ve learned in the last half dozen years that the future of all artificial pancreas systems holds higher time in range, less work required to manage automated insulin delivery systems to improve quality of life, and the ability to input critical information back into the system itself. The data and user experience stories make it clear: APS works. APS are an improvement over other diabetes therapy methods when they are made available, accessible, and affordable. Understanding the unmet expectations of current users of first generation APS technology may also aid in the development of improved technology and user experiences for the future of APS.

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Efficacy, safety, and user experience of DIY or open-source artificial pancreas systems: a systematic review

Cited by 31 publications

References 54 publications

Use of automated insulin delivery systems in people with type 1 diabetes fasting during Ramadan: An observational study

Use of automated insulin delivery systems in people with type 1 diabetes fasting during Ramadan: An observational study

The automated pancreas: A review of technologies and clinical practice

How It Started, How It Is Going: The Future of Artificial Pancreas Systems (Automated Insulin Delivery Systems)

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