Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes

Russell, Steven; Beck, Roy W.; Damiano, Edward R.; El-Khatib, Firas; Ruedy, Katrina J.; Balliro, Courtney A.; Li, Zoey; Calhoun, Peter; Wadwa, R. Paul; Buckingham, Bruce A.; Zhou, Keren; Daniels, Mark; Raskin, Philip; White, Perrin C.; Lynch, Jane; Pettus, Jeremy; Hirsch, Irl B.; Goland, Robin; Buse, John B.; Kruger, Davida F.; Mauras, Nelly; Muir, Andrew; McGill, Janet B.; Cogen, Fran R.; Weissberg‐Benchell, Jill; Sherwood, Jordan; Castellanos, Luz E.; Hillard, Mallory; Tuffaha, Marwa; Putman, Melissa S.; Sands, Mollie Y.; Forlenza, Gregory P.; Slover, Robert; Messer, Laurel H.; Cobry, Erin; Shah, Viral N.; Polsky, Sarit; Lal, Rayhan; Ekhlaspour, Laya; Hughes, Michael S.; Basina, Marina; Hatipoğlu, Betül; Olansky, Leann; Bhangoo, Amrit; Forghani, Nikta; Kashmiri, Himala; Sutton, Francoise; Choudhary, Abha; Penn, Jimmy; Jafri, Rabab; Rayas, Maria; Escaname, Elia N.; Kerr, Catherine E.; Favela-Prezas, Ruby; Boeder, Schafer; Trikudanathan, Subbulaxmi; Williams, Kristen M.; Leibel, Natasha; Kirkman, M. Sue; Bergamo, Kate; Klein, Klara R.; Dostou, Jean M.; Machineni, Sriram; Young, Laura; Diner, Jamie; Bhan, Arti; Jones, Jennifer K.; Benson, Matthew; Bird, Keisha; Englert, Kimberly; Permuy, Joe; Cossen, Kristina; Felner, Eric I.; Salam, Maamoun; Silverstein, Julie; Adamson, Samantha E.; Cedeno, Andrea E; Meighan, S. Spence; Dauber, Andrew

doi:10.1056/nejmoa2205225

Cited by 85 publications

(21 citation statements)

References 11 publications

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“…At the time of this writing, Beta Bionics have successfully completed several insulin-only configurations of their bionic pancreas (BP) in adults and pediatric patients with type 1 diabetes. The 13-weeks trial, conducted at 16 clinical sites across the United States, enrolled 326 participants ages 6–79 years who had T1D and had been using insulin for at least 1 year 200 . This randomized trial was sponsored by the National Institutes of Health (Bethesda, MD).…”

Section: Glucose Monitoringmentioning

confidence: 99%

“…This system is not approved in the USA (FDA) or in Europe (EMA). Their system does not require carbohydrate counting however patients are asked to enter the size of a meal to deliver the bolus of insulin for the meal 200 . There are five manuscripts that were recently published with BP system in randomized control trials 200 – 204 .…”

Section: Glucose Monitoringmentioning

confidence: 99%

“…Their system does not require carbohydrate counting however patients are asked to enter the size of a meal to deliver the bolus of insulin for the meal 200 . There are five manuscripts that were recently published with BP system in randomized control trials 200 – 204 . The BP with insulin Aspart or insulin Lispro was shown to significantly improve A1c, TIR, and hyperglycemic metrics without increasing CGM measured hypoglycemia when compared with standard of care in adults and youth (ages 6–17 years) with T1D 202 .…”

Section: Glucose Monitoringmentioning

confidence: 99%

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Emerging Diabetes Technologies: Continuous Glucose Monitors/Artificial Pancreases

2023

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Over the past decade there have been many advances in diabetes technologies, such as continuous glucose monitors (CGM CGM : A device that measures glucose values in the subcutaneous space via a sensor and is transmitted to a receiver/smartphone. s), insulin-delivery devices, and hybrid closed loop systems Hybrid Closed Loop (HCL) Systems: An insulin pump able to deliver variable insulin dosages based on CGM values using an algorithm. . Now most CGMs (Medtronic-Guardian, Dexcom-G6, and Abbott-Libre-2) have MARD values of < 10%, in contrast to two decades ago when the MARD used to be > 20%. In addition, the majority of the new CGMs do not require calibrations, and the latest CGMs last for 10–14 days. An implantable 6-months CGM by Eversense-3 is now approved in the USA and Europe. Recently, the FDA approved Libre 3 which provides real-time glucose values every minute. Even though it is approved as an iCGM it is not interoperable with automatic-insulin-delivery (AID) systems. The newer CGMs that are likely to be launched in the next few months in the USA include the 10–11 days Dexcom G7 (60% smaller than the existing G6), and the 7-days Medtronic Guardian 4. Most of the newer CGM have several features like automatic initialization, easy insertion, predictive alarms, and alerts. It has also been noticed that an arm insertion site might have better accuracy than abdomen or other sites, like the buttock for kids. Lag time between YSI and different sensors have been reported differently, sometimes it is down to 2–3 min; however, in many instances, it is still 15–20 min, especially when the rate of change of glucose is > 2 mg/min. We believe that in the next decade there will be a significant increase in the number of people who use CGM for their day-to-day diabetes care.

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Section: Glucose Monitoringmentioning

confidence: 99%

Section: Glucose Monitoringmentioning

confidence: 99%

Section: Glucose Monitoringmentioning

confidence: 99%

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Emerging Diabetes Technologies: Continuous Glucose Monitors/Artificial Pancreases

2023

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“…It has been reported that the frequency of hypoglycemia associated with insulin treatment was reduced by the predictive low glucose suspend (PLGS) function of CGM 22 , and hypoglycemia and TIR were further improved by the hybrid closed‐loop, and it can be worn even in half marathons 23 . Recently, the performance of a fully automatic closed loop has also been reported 24 .…”

Section: Insulin Treatmentmentioning

confidence: 99%

Update information on type 1 diabetes in children/adolescents and adults

Miura

Uchigata

2023

J of Diabetes Invest

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“…In a more recent version of the algorithm (El-Khatib et al 2017), the system incorporated the option to define the type of the meal (breakfast, lunch, or dinner) or grade its size (typical, more than typical, less than typical, or a small bite). The system was assessed in several clinical trials resulting in a satisfactory average %time in 70-180 mg/dL ranging from 65 % to 84.8 % (Russell et al 2012;El-Khatib et al 2014;Russell et al 2014;El-Khatib et al 2017;Russell et al 2020;Castellanos et al 2021;Russell et al 2022). Ahmad Haidar's group, from McGill University, adopted a similar approach to El-Khatib et al ( 2017) for its MPC-based AP system.…”

Section: Partial Announcementmentioning

confidence: 99%

New Contributions Towards Meal and Exercise Announcement-Free Artificial Pancreas Systems

Mira¹

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Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes

Cited by 85 publications

References 11 publications

Emerging Diabetes Technologies: Continuous Glucose Monitors/Artificial Pancreases

Emerging Diabetes Technologies: Continuous Glucose Monitors/Artificial Pancreases

Update information on type 1 diabetes in children/adolescents and adults

New Contributions Towards Meal and Exercise Announcement-Free Artificial Pancreas Systems

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