Protocol for a prospective, multicenter, parallel-group, open-label randomized controlled trial comparing standard care with Closed lOoP In chiLdren and yOuth with Type 1 diabetes and high-risk glycemic control: the CO-PILOT trial.

Purpose: Advanced hybrid closed loop (AHCL) systems have the potential to improve glycemia and reduce burden for people with type 1 diabetes (T1D). Children and youth, who are at particular risk for out-of-target glycemia, may have the most to gain from AHCL. However, no randomized controlled trial (RCT) specifically targeting this age group with very high HbA has previously been attempted.

Following in Banting's footsteps or straying from the path? Observations from contemporary diabetes innovation.

While advancements in the treatment of diabetes continue to rapidly evolve, many of the newer technologies have financial barriers to care, opposing the egalitarian ethos of Banting who sold his patent on insulin for a nominal cost to allow it to be made widely available. Inequity in access to new therapies drives disparity in diabetes burden with potential for these gaps to widen in the future. The 2023 International Conference on Advanced Technologies and Treatments of Diabetes (ATTD) presented ground-breaking and current research in diabetes technology.

The Effect of Do-It-Yourself Real-Time Continuous Glucose Monitoring on Glycemic Variables and Participant-Reported Outcomes in Adults With Type 1 Diabetes: A Randomized Crossover Trial.

Aim: Real-time continuous glucose monitoring (rtCGM) has several advantages over intermittently scanned continuous glucose monitoring (isCGM) but generally comes at a higher cost. Do-it-yourself rtCGM (DIY-rtCGM) potentially has benefits similar to those of rtCGM. This study compared outcomes in adults with type 1 diabetes using DIY-rtCGM versus isCGM.

Do-it-yourself continuous glucose monitoring in people aged 16 to 69 years with type 1 diabetes: A qualitative study.

Aims: In many countries, real-time continuous glucose monitoring (rt-CGM) is not funded, and cost presents a barrier to access. A do-it-yourself conversion of intermittently scanned CGM (DIY-CGM) is a cheaper alternative. This qualitative study aimed to explore user experiences with DIY-CGM in people aged 16 to 69 years with type 1 diabetes (T1D).

Interviews with Indigenous Māori with type 1 diabetes using open-source automated insulin delivery in the CREATE randomised trial.

Purpose: Open-source automated insulin delivery (AID) is used by thousands of people with type 1 diabetes (T1D), but has unknown generalisability to marginalised ethnic groups. This study explored experiences of Indigenous Māori participants in the CREATE trial with use of an open-source AID system to identify enablers/barriers to health equity.

Methods: The CREATE randomised trial compared open-source AID (OpenAPS algorithm on an Android phone with a Bluetooth-connected pump) to sensor-augmented pump therapy.

Extended Use of an Open-Source Automated Insulin Delivery System in Children and Adults with Type 1 Diabetes: The 24-Week Continuation Phase Following the CREATE Randomized Controlled Trial.

To assess long-term efficacy and safety of open-source automated insulin delivery (AID) in children and adults (7-70 years) with type 1 diabetes. Both arms of a 24-week randomized controlled trial comparing open-source AID (OpenAPS algorithm within a modified version of AndroidAPS, preproduction DANA-i™ insulin pump, Dexcom G6 continuous glucose monitor) with sensor-augmented pump therapy (SAPT), entered a 24-week continuation phase where the SAPT arm (termed SAPT-AID) crossed over to join the open-source AID arm (termed AID-AID). Most participants (69/94) used a preproduction YpsoPump insulin pump during the continuation phase.

Open-Source Automated Insulin Delivery in Type 1 Diabetes.

Background: Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system.

Methods: In this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control).

The effect of do-it-yourself real-time continuous glucose monitoring on psychological and glycemic variables in children with type 1 diabetes: A randomized crossover trial.

Background: Continuous glucose monitoring (CGM) decreases fear of hypoglycemia (FOH) and improves glycemic control among those affected by type 1 diabetes (T1D). No studies to date have examined the impact of using do-it-yourself real-time continuous glucose monitoring (DIY RT-CGM) on psychological and glycemic outcomes.

Methods: Child-parent dyads were recruited for a multicentre randomized crossover trial.

A comparison of FreeStyle Libre 2 to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control: a 12-week randomised controlled trial protocol.

Purpose: Frequent glucose monitoring is necessary for optimal glycaemic control. Second-generation intermittently scanned glucose monitoring (isCGM) systems inform users of out-of-target glucose levels and may reduce monitoring burden. We aim to compare FreeStyle Libre 2 (Abbott Diabetes Care, Witney, U.

Learning challenges of healthcare professionals supporting open-source automated insulin delivery.

Background: Open-source automated insulin delivery (AID) is a user-driven treatment modality used by thousands globally. Healthcare professionals' (HCPs) ability to support users of this technology is limited by a lack of knowledge of these systems.

Aims: To describe the challenges experienced by HCPs supporting participants' use of open-source automated insulin delivery in the Community deRivEd AuTomatEd insulin delivery (CREATE) study.

Parental experiences of short term supported use of a do-it-yourself continuous glucose monitor (DIYrtCGM): A qualitative study.

Aims: To investigate the experiences of parents caring for young children with type 1 diabetes type 1 diabetes using a do-it-yourself continuous glucose monitor (DIYrtCGM) in a supported setting.

Methods: Exit interviews were conducted with parents from 11 families at the end of the MiaoMiao study: a randomised cross-over trial focusing on parental fear of hypoglycaemia. Technical support was provided to participants while using DIYrtCGM during the trial.

The MiaoMiao study: can do-it-yourself continuous glucose monitoring technology improve fear of hypoglycaemia in parents of children affected by type 1 diabetes?

Purpose: Type 1 diabetes (T1D) is one of the most common chronic diseases of childhood and comes with considerable management and psychological burden for children and their families. Fear of hypoglycaemia (FOH), particularly nocturnal hypoglycaemia, is a common worry. Continuous glucose monitoring (CGM) is a tool that may help reduce FOH, as well as reduce overall diabetes burden.

Initial experiences of adolescents and young adults with type 1 diabetes and high-risk glycemic control after starting flash glucose monitoring - a qualitative study.

Purpose: This study explored early experiences with a flash glucose monitoring system among adolescents and young adults with type 1 diabetes and high-risk glycemic control.

Methods: Adolescents and young adults with high-risk glycemic control (HbA1c ≥ 75 mmol/mol (9.0%) in the previous 6 months) who had recently commenced on flash glucose monitoring as part of a trial took part in a semi-structured interview exploring their experiences with the technology.

Do-It-Yourself Automated Insulin Delivery: A Leading Example of the Democratization of Medicine.

Digital innovations have led to an explosion of data in healthcare, driving processes of democratization and foreshadowing the end of the paternalistic era of medicine and the inception of a new epoch characterized by patient-centered care. We illustrate that the "do it yourself" (DIY) automated insulin delivery (AID) innovation of diabetes is a leading example of democratization of medicine as evidenced by its application to the three pillars of democratization in healthcare (intelligent computing; sharing of information; and privacy, security, and safety) outlined by Stanford but also within a broader context of democratization. The heuristic algorithms integral to DIY AID have been developed and refined by human intelligence and demonstrate intelligent computing.

Exploring Parental Experiences of Using a Do-It-Yourself Solution for Continuous Glucose Monitoring Among Children and Adolescents With Type 1 Diabetes: A Qualitative Study.

Background: MiaoMiao (MM) is a Bluetooth transmitter, which when paired with a smart phone/device, converts the Abbott FreeStyle Libre flash glucose monitoring system into a Do-It-Yourself (DIY) continuous glucose monitor (CGM). Families are increasingly adopting DIY CGM solutions, but little is known about parent and child experiences with these add-on technologies. We aimed to explore experiences of families using MM-CGM including challenges faced and their advice to others who may choose to use the technology.

Peer Mentoring in the Do-it-Yourself Artificial Pancreas System Community.

Background: The do-it-yourself (DIY) artificial pancreas system (APS) community is led by people with diabetes (PWD) and their families. In contrast to standard models of care, in which health care professionals are responsible for the education and training of PWD and their families, within the DIY APS, community users are reliant on their peers for education and training. The provision of this support has not previously been studied.