scholarly journals Open source automated insulin delivery: addressing the challenge

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Nick Oliver ◽  
Monika Reddy ◽  
Claire Marriott ◽  
Tomas Walker ◽  
Lutz Heinemann
Keyword(s):  
Type 1 Diabetes ◽  
Education Policy ◽  
Open Source ◽  
Open Source Software ◽  
Healthcare Professionals ◽  
Insulin Delivery ◽  
Glucose Sensors ◽  
Self Management ◽  
Do It Yourself

AbstractDo-it-yourself automated insulin delivery systems for people living with type 1 diabetes use commercially available continuous glucose sensors and insulin pumps linked by unregulated open source software. Uptake of these systems is increasing, with growing evidence suggesting that positive glucose outcomes may be feasible. Increasing interest from people living with, or affected by, type 1 diabetes presents challenges to healthcare professionals, device manufacturers and regulators as the legal, governance and risk frameworks for such devices are not defined. We discuss the data, education, policy, technology and medicolegal obstacles to wider implementation of DIY systems and outline the next steps required for a co-ordinated approach to reducing variation in access to a technology that has potential to enable glucose self-management closer to target.

Open-source automated insulin delivery systems for the management of type 1 diabetes during pregnancy

2021 ◽  
Vol 14 (9) ◽  
pp. e243522
Author(s):  
Khulood Bukhari ◽  
Rana Malek
Keyword(s):  
Type 1 Diabetes ◽  
Open Source ◽  
Closed Loop ◽  
Glycated Hemoglobin ◽  
Insulin Delivery ◽  
Third Trimester ◽  
Time In Range ◽  
Insulin Delivery System ◽  
Iphone Application

A 40-year-old woman used an open-source automated insulin delivery system to manage her type 1 diabetes (T1D) prior to conception. The code for building the iPhone application called ‘Loop’ that carried the software for the hybrid closed-loop controller was available online. Her glycated hemoglobin before conception was 6.4%. Between 6 and 12 weeks gestation, she spent 66% time-in-range (TIR), 28% time-above-range (TAR) and 6% time-below-range (TBR). Between 18 and 24 weeks gestation, she spent 68% TIR, 27% TAR and 5% TBR. During her third trimester, she spent 72% TIR, 21% TAR and 7% TBR. She delivered a healthy infant with no neonatal complications. Clinicians should be aware of this technology as it gains traction in the T1D community and seeks Food and Drug Administration approval.

scholarly journals Evolution of Do-It-Yourself Remote Monitoring Technology for Type 1 Diabetes

2020 ◽  
Vol 14 (5) ◽  
pp. 854-859
Author(s):  
Michelle Ng ◽  
Emily Borst ◽  
Ashley Garrity ◽  
Emily Hirschfeld ◽  
Joyce Lee
Keyword(s):  
Type 1 Diabetes ◽  
Open Source ◽  
Remote Monitoring ◽  
Diabetes Management ◽  
Rapid Development ◽  
Artificial Pancreas ◽  
Commercial Space ◽  
Technology Innovations ◽  
Do It Yourself

Background: The Nightscout Project is a leading example of patient-designed, do-it-yourself (DIY), open-source technology innovations to support type 1 diabetes management. We are unaware of studies that have described the evolution of patient-driven innovations from the Nightscout Project to date. Methods: We identified patient-driven, DIY innovations from posts and comments in the “CGM in the Cloud” private Facebook group as well as data from Twitter, GitHub, and the Nightscout website. For each innovation, we described its intent or its unaddressed need as well as the associated features and improvements. We conducted a thematic analysis to identify overarching patterns among the innovations, features, and improvements, and compared the timeline of innovations in the DIY space with the timing of similar innovations in the commercial space. Results: We identified and categorized innovations in Nightscout with the most commonly appearing themes of: visualization improvements, equipment improvements, and user experience improvements. Other emerging themes included: Care Portal support, safety, remote monitoring, decision support, international support, artificial pancreas, pushover notifications, and open-source collaboration. Conclusions: This rapid development of patient-designed DIY innovations driven by unmet needs in the type 1 diabetes community reflects a revolutionary, bottom–up approach to medical innovation. Nightscout users accessed features earlier than if they had waited for commercial products, and they also personalized their tools and devices, empowering them to become the experts of their own care.

scholarly journals Do-It-Yourself (DIY) Artificial Pancreas Systems for Type 1 Diabetes: Perspectives of Two Adult Users, Parent of a User and Healthcare Professionals

2020 ◽  
Vol 37 (9) ◽  
pp. 3929-3941 ◽  
Author(s):  
Syed Haris Ahmed ◽  
David L. Ewins ◽  
Jane Bridges ◽  
Alison Timmis ◽  
Nicola Payne ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Healthcare Professionals ◽  
Artificial Pancreas ◽  
Do It Yourself

scholarly journals Hybrid Closed-Loop Insulin Delivery Systems for People With Type 1 Diabetes

2021 ◽  
Vol 1 (3) ◽  
Author(s):  
CADTH Health Technology Assessment Service
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Closed Loop ◽  
Insulin Pump ◽  
Insulin Delivery ◽  
Blood Glucose Monitoring ◽  
Self Management ◽  
Publicly Funded ◽  
Delivery Methods

Blood glucose monitoring and insulin delivery are essential parts of the management of type 1 diabetes. Hybrid closed-loop insulin delivery (HCL) systems are a treatment option for people with type 1 diabetes and consist of an insulin pump, a continuous glucose monitor (CGM), and a computer program (algorithm) that allows the devices to communicate with each other and calculates insulin needs. CADTH conducted a Health Technology Assessment (HTA) of the use of HCL systems compared to other insulin delivery methods in people with type 1 diabetes to inform decisions regarding whether HCL systems have a place in the management of type 1 diabetes. HCL therapy generally improved the amount of time a person spent in target blood glucose ranges. Additionally, people who used HCL systems had improved average blood glucose levels (glycated hemoglobin [A1C]) over the preceding 2 or 3 months. However, the effectiveness or safety of HCL systems based on age, sex, race, glucose management, or other clinical features (e.g., those who are pregnant or planning pregnancy, or who have hypoglycemia unawareness or a history of severe hypoglycemia) is unknown. HCL systems were generally as safe as other insulin delivery methods. Additional studies with longer follow-up periods and more participants are needed to confirm the clinical effectiveness and safety of HCL systems. From a pan-Canadian, publicly funded health care system perspective, the cost of covering HCL systems for individuals with type 1 diabetes who are eligible for insulin pumps in their jurisdictions was estimated to be an additional $822,635,045 over 3 years compared with diabetes supplies that are currently covered. If HCL systems are covered for all individuals with type 1 diabetes, regardless of their current insulin-pump eligibility, the budget impact will be higher. HCL systems can help provide distance from demanding self-management and monitoring tasks for people living with type 1 diabetes; however, in order to do this, people using these systems must navigate complex relationships built on trust and collaboration. Given that type 1 diabetes self-management to date has required considerable attention to blood glucose numbers and technical tasks, developing these relationships of trust and collaboration will require a shift in understanding what it means to care for someone who has — or to self-manage — type 1 diabetes. It is not possible to conclude whether HCL systems will improve overall population health over the longer-term because the data for this are not available. It is also unclear which people with type 1 diabetes would benefit most from HCL systems. Eligibility criteria for the existing public insulin-pump program may be useful in making coverage decisions; trial periods may be considered to ensure HCL systems are working well for new users. Education and support are needed for people living with type 1 diabetes when they start to use HCL systems. Clinicians noted the need for interactions between diabetes educators and HCL system pump users. User-friendly devices and understandable reports are key to effective use. Eligibility for access through any publicly funded program for HCL systems should be based on evidence. The criteria for coverage should be consistent with broader public health goals and should not contribute to existing inequities in diabetes management.

scholarly journals Adolescents’ Experiences of Using a Smartphone Application Hosting a Closed-loop Algorithm to Manage Type 1 Diabetes in Everyday Life: Qualitative Study

2021 ◽  
pp. 193229682199420
Author(s):  
David Rankin ◽  
Barbara Kimbell ◽  
Janet M. Allen ◽  
Rachel E. J. Besser ◽  
Charlotte K. Boughton ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Management Practices ◽  
Closed Loop ◽  
Age Groups ◽  
Insulin Delivery ◽  
Smartphone Application ◽  
Self Management ◽  
Smartphone App ◽  
Medical App

Background: Closed-loop technology may help address health disparities experienced by adolescents, who are more likely to have suboptimal glycemic control than other age groups and, because of their age, find diabetes self-management particularly challenging. The CamAPS FX closed-loop has sought to address accessibility and usability issues reported by users of previous prototype systems. It comprises small components and a smartphone app used to: announce meal-time boluses, adjust (“boost” or “ease-off”) closed-loop insulin delivery, customize alarms, and review/share data. We explored how using the CamAPS FX platform influences adolescents’ self-management practices and everyday lives. Methods: Eighteen adolescents were interviewed after having ≥6 months experience using the closed-loop platform. Data were analyzed thematically. Results: Participants reported feeling less burdened and shackled by diabetes because closed-loop components were easier to carry/wear, finger-pricks were not required, the smartphone app provided a discreet and less stigmatizing way of managing diabetes in public, and they were able to customize alarms. Participants also reported checking and reviewing data more regularly, because they did so when using the smartphone for other reasons. Some reported challenges in school settings where use of personal phones was restricted. Participants highlighted how self-management practices were improved because they could easily review glucose data and adjust closed-loop insulin delivery using the “boost” and “ease-off” functions. Some described how using the system resulted in them forgetting about diabetes and neglecting certain tasks. Conclusions: A closed-loop system with small components and control algorithm on a smartphone app can enhance usability and acceptability for adolescents and may help address the health-related disparities experienced by this age group. However, challenges can arise from using a medical app on a device which doubles as a smartphone. Trial registration: Closed Loop From Onset in Type 1 Diabetes (CLOuD); NCT02871089; https://clinicaltrials.gov/ct2/show/NCT02871089

„Do it yourself“ (DIY) Automated Insulin Delivery (AID) Systems: Stand der Dinge

2019 ◽  
Vol 14 (01) ◽  
pp. 31-43 ◽  
Author(s):  
Lutz Heinemann ◽  
Karin Lange
Keyword(s):  
Type 1 Diabetes ◽  
Medical Devices ◽  
Insulin Delivery ◽  
Point Of View ◽  
Current Status ◽  
Experimental Systems ◽  
Legal Questions ◽  
Medical Devices Act ◽  
Do It Yourself

AbstractOver the past few years, a group of dedicated people with an affinity for technology and type 1 diabetes has developed systems that enable automated insulin delivery (AID). Patients build these AID systems themselves (do it yourself; DIY). The quality of glucose control achieved with DIY AID systems is impressively good, but the effort for users in everyday life is considerable. So far, no results of clinical studies have been obtained that prove these individual experiences.Main obstacles for the use (also by more patients) are legal questions, because DIY AID systems do not represent approved medical devices. They must be regarded as “experimental” systems. As long as patients build and use these systems for themselves and do not endanger other people, they act at their own risk. Legal questions are more complex and more difficult to answer if, for example, a traffic accident occurs. A legal assessment (in particular of the medical situation) of such systems, initiated by the German Diabetes Society (DDG) (see DDG homepage), comes to the following key statements:– From the patient’s point of view, the assembly of a DIY AID system does not constitute a criminal offence. However, since the intended purpose of the devices is violated, there is no liability on the part of the manufacturers of the medical devices used for this purpose.– Patients who assemble DIY AID systems and “sell” them to other patients are liable to prosecution under the Medical Devices Act (MPG).– Doctors do not have to refer patients with type 1 diabetes to DIY AID systems.If a patient expresses interest in such a system or is already using it, the attending physician must inform the patient about the improper use of the medical devices used and about the associated risks. He should document this information accordingly.This overview presents the current status of this development from various points of view.

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