Article
Medicine, General & Internal
Mercedes J. Burnside, Dana M. Lewis, Hamish R. Crocket, Renee A. Meier, Jonathan A. Williman, Olivia J. Sanders, Craig A. Jefferies, Ann M. Faherty, Ryan G. Paul, Claire S. Lever, Sarah K. J. Price, Carla M. Frewen, Shirley D. Jones, Tim C. Gunn, Christina Lampey, Benjamin J. Wheeler, Martin de Bock
Summary: In patients with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range compared to a sensor-augmented insulin pump.
NEW ENGLAND JOURNAL OF MEDICINE
(2022)
Review
Endocrinology & Metabolism
Munachiso Nwokolo, Roman Hovorka
Summary: Diabetes technologies, such as CSII pumps and CGM, have significantly improved diabetes care by enhancing glycemic control and reducing diabetes distress. Closed-loop systems, including hybrid and fully closed-loop systems, have demonstrated safety and efficacy in research settings. However, the clinical adoption of closed-loop therapy is still in its early stages, with challenges in equitable access and regulatory navigation.
JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
(2023)
Article
Medicine, General & Internal
Richard M. Bergenstal, Revital Nimri, Roy W. Beck, Amy Criego, Lori Laffel, Desmond Schatz, Tadej Battelino, Thomas Danne, Stuart A. Weinzimer, Judy Sibayan, Mary L. Johnson, Ryan J. Bailey, Peter Calhoun, Anders Carlson, Elvira Isganaitis, Rachel Bello, Anastasia Albanese-O'Neill, Klemen Dovc, Torben Biester, Kate Weyman, Korey Hood, Moshe Phillip
Summary: In adolescents and young adults with type 1 diabetes, the use of an investigational advanced hybrid closed-loop system was found to reduce hyperglycemia without increasing the occurrence of hypoglycemia compared to a commercially available MiniMed 670G system. Further testing of this technology in underserved populations and in individuals with impaired awareness of hypoglycemia could advance its effective use.
Article
Endocrinology & Metabolism
Olivia M. McCarthy, Merete B. Christensen, Kasper Birch Kristensen, Signe Schmidt, Ajenthen G. Ranjan, Stephen C. Bain, Richard M. Bracken, Kirsten Norgaard
Summary: This study aimed to assess the effectiveness of the automated insulin delivery system in adults with type 1 diabetes during exercise. The results showed that reducing insulin dose and providing exercise announcement 90 minutes before exercise was the most effective strategy in minimizing blood glucose abnormalities during postprandial exercise.
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Article
Biochemistry & Molecular Biology
Michele Schiavon, Claudio Cobelli, Chiara Dalla Man
Summary: Standard insulin therapy for type 1 diabetes involves subcutaneous administration of exogenous insulin, but intraperitoneal insulin administration has been shown to be a valid alternative with potential benefits. This study aimed to develop a mathematical model describing the absorption and distribution of insulin after intraperitoneal administration, using data from T1D patients treated with implanted pumps. The selected model involved a linear, two-compartment model for insulin absorption in the IP space, coupled with a two-compartment model for whole-body insulin kinetics.
Article
Endocrinology & Metabolism
Gregory P. Forlenza, Bruce A. Buckingham, Sue A. Brown, Bruce W. Bode, Carol J. Levy, Amy B. Criego, R. Paul Wadwa, Erin C. Cobry, Robert J. Slover, Laurel H. Messer, Cari Berget, Susan McCoy, Laya Ekhlaspour, Ryan S. Kingman, Mary K. Voelmle, Jennifer Boyd, Grenye O'Malley, Aimee Grieme, Kaisa Kivilaid, Krista Kleve, Bonnie Dumais, Todd Vienneau, Lauren M. Huyett, Joon Bok Lee, Jason O'Connor, Eric Benjamin, Trang T. Ly
Summary: The study showed that the Omnipod 5 automated insulin delivery system is effective and safe for children and adults with T1D, as it increased time in range and avoided serious device-related adverse events.
DIABETES TECHNOLOGY & THERAPEUTICS
(2021)
Article
Endocrinology & Metabolism
Olivia M. M. McCarthy, Merete Bechmann Christensen, Kasper Birch Kristensen, Signe Schmidt, Ajenthen G. G. Ranjan, Stephen C. C. Bain, Richard M. M. Bracken, Kirsten Norgaard
Summary: In a switch study involving in-patients, 10 adults with type 1 diabetes (T1D) performed 45 minutes of moderate-intensity exercise using their usual insulin pump and after transitioning to automated insulin delivery (MiniMed (TM) 780G). The study found that switching to automated insulin delivery did not significantly alter glycemic patterns during sustained moderate-intensity exercise in adults with T1D.
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Review
Endocrinology & Metabolism
Rama Lakshman, Charlotte Boughton, Roman Hovorka
Summary: Automated insulin delivery systems, also known as closed-loop or 'artificial pancreas' systems, are revolutionizing the management of type 1 diabetes. These systems use an algorithm to automatically adjust insulin delivery based on real-time glucose sensor levels. This review explores the evolution of these systems over the years, discusses their clinical and psychosocial benefits, and addresses future directions and challenges in ensuring access to closed-loop technology.
ENDOCRINE CONNECTIONS
(2023)
Review
Multidisciplinary Sciences
Bruce A. Perkins, Jennifer L. Sherr, Chantal Mathieu
Summary: Despite innovations in insulin therapy, most type 1 diabetes patients still struggle to achieve sufficient glycemic control. The future may lie in combining pharmacological solutions with automated insulin delivery methods, utilizing machine learning and other technologies to enhance effectiveness.
Review
Endocrinology & Metabolism
Panagiota Michou, Nikolaos Gkiourtzis, Athanasios Christoforidis, Eleni P. Kotanidou, Asimina Galli-Tsinopoulou
Summary: Automated insulin delivery (AID) systems have been proven to be effective in the management of type 1 diabetes in children and adolescents. They show significant improvements in blood glucose levels and enhance the quality of life compared to traditional diabetes treatment.
DIABETES RESEARCH AND CLINICAL PRACTICE
(2023)
Article
Obstetrics & Gynecology
Kaat Beunen, Nancy Van Wilder, Dominique Ballaux, Gerd Vanhaverbeke, Youri Taes, Xavier-Philippe Aers, Frank Nobels, Joke Marlier, Dahae Lee, Joke Cuypers, Vanessa Preumont, Sarah E. Siegelaar, Rebecca C. Painter, Annouschka Laenen, Pieter Gillard, Chantal Mathieu, Katrien Benhalima
Summary: This study aims to evaluate the efficacy, safety and cost-effectiveness of the MiniMed (TM) 780G HCL system in pregnant women with T1D. It is an international, open-label, randomized controlled trial that will compare the MiniMed (TM) 780G HCL system to standard of care. The primary outcome is the time spent within the pregnancy glucose target range.
BMC PREGNANCY AND CHILDBIRTH
(2023)
Article
Endocrinology & Metabolism
Laurel H. Messer, Bruce A. Buckingham, Fran Cogen, Mark Daniels, Greg Forlenza, Rabab Z. Jafri, Nelly Mauras, Andrew Muir, R. Paul Wadwa, Perrin C. White, Steven J. Russell, Edward R. Damiano, Firas H. El-Khatib, Katrina J. Ruedy, Courtney A. Balliro, Zoey Li, Martin Chase Marak, Peter Calhoun, Roy W. Beck
Summary: In youth with type 1 diabetes aged 6-17, the insulin-only configuration of the iLet bionic pancreas improved HbA1c levels, time in range, and hyperglycemic metrics without increasing the risk of hypoglycemia compared to standard care. The improvements were most pronounced in participants with higher baseline HbA1c levels.
DIABETES TECHNOLOGY & THERAPEUTICS
(2022)
Review
Endocrinology & Metabolism
Torben Biester, Martin Tauschmann, Agata Chobot, Olga Kordonouri, Thomas Danne, Thomas Kapellen, Klemen Dovc
Summary: Insulin pumps and glucose sensors combined with an algorithm can create automated insulin delivery systems, which are not yet available for children under 6 in Europe. These systems require user interactions and fully automated systems are still under development. Open-source systems present risks as unregulated variants.
DIABETES OBESITY & METABOLISM
(2022)
Article
Endocrinology & Metabolism
Shane O'Donnell, Drew Cooper, Yanbing Chen, Hanne Ballhausen, Dana M. Lewis, Timothee Froment, Katarzyna Anna Gajewska, Adrian Tappe, Timothy Skinner, Bryan Cleal, Katarina Braune
Summary: This study aims to investigate the perceived barriers towards adoption and maintaining of open-source automated insulin delivery (AID) systems. The findings show that sourcing necessary components, lack of confidence in technology knowledge and skills, perceived time and energy required to build a system, and fear of losing healthcare provider support are major barriers to the uptake of open-source AID.
DIABETES RESEARCH AND CLINICAL PRACTICE
(2023)
Article
Chemistry, Analytical
Jesus Berian, Ignacio Bravo, Alfredo Gardel-Vicente, Jose-Luis Lazaro-Galilea, Mercedes Rigla
Summary: This paper presents a novel approach to dynamically determine the basal insulin needs of patients and incorporate this information into a closed-loop algorithm, improving the safety and performance of the system. Simulation results demonstrate that the proposed algorithm can adapt to various situations and achieve similar blood glucose control outcomes as in normal conditions.
Article
Endocrinology & Metabolism
Stuart A. Weinzimer, Ryan J. Bailey, Richard M. Bergenstal, Revital Nimri, Roy W. Beck, Desmond Schatz, Louise Ambler-Osborn, Darja Smigoc Schweiger, Thekla von dem Berge, Judy Sibayan, Mary L. Johnson, Peter Calhoun, Moshe Phillip, Amy Criego, Anders Carlson, Thomas Martens, Shannon Beasley, Diane Whipple, Jamie Hyatt, Alina Punel, Aimee Grieme, Lee Ann Thomas, Amy LaFrance, Caitlin Hasledalen, Lori Laffel, Elvira Isganaitis, Emily Freiner, Hannah Desrochers, Christine Turcotte, Nisha Naik, Lindsay Roethke, Margaret Fisher, Michal Nevo, Rachel Bello, Alona Hamou, Orna Hermon, Orit Horesh, Galit Shiovitch Mantzuri, Irit Drotz, Nava Yehiel, Rachel Naveh, Michael Haller, Anastasia Albanese-O'Neill, Eleni Sheehan, Eleni Sheehan, Madison Smith, Laura Jacobsen, Janey Adams, Jennifer Hosford, Loren Whyte, Tadej Battelino, Klemen Dovc, Natasa Bratina, Darja Smigoc Schweiger, Urska Sever, Ana Gianini, Barbara Murn Berkopec, Brigita Mali, Kate Weyman, Lori Carria, Melinda Zgorski, Thomas Danne, Torben Biester, Jantje Weiskorn, Olga Kordonouri, Sarah Biester, Baerbel Aschemeier, Kerstin Remus, Nicole Pisarek, Judy Sibayan, Thomas Mouse, Julie Davis, Ryan J. Bailey, Amanda Hellmann, Nicole Reese, Peter Calhoun, Heidi Strayer, Nathan Cohen, Robert Henderson, Craig Kollman, Jennifer Kennedy, William Woodall, Israel Mahr, Korey Hood, Guillermo Arreaza-Rubin, Thomas Eggerman, Neal Green, Robert Janicek, Deanna Gabrielson, Steven H. Belle, Jessica Castle, Jennifer Green, Laurent Legault, Steven M. Willi, Carol Wysham, Thomas Eggerman
Summary: Analysis of postprandial glycemic control in a study comparing two closed-loop systems showed that the advanced system performed better in reducing high blood sugar levels, potentially due to improvements in later postprandial or overnight effects, rather than early postprandial glycemic excursions. Refinements to mealtime bolus algorithms and strategies may enhance control of postprandial glycemic excursions.
DIABETES TECHNOLOGY & THERAPEUTICS
(2022)
Article
Endocrinology & Metabolism
Michelle A. Van Name, Lauren G. Kanapka, Linda A. DiMeglio, Kellee M. Miller, Anastasia Albanese-O'Neill, Persis Commissariat, Sarah D. Corathers, Kara R. Harrington, Marisa E. Hilliard, Barbara J. Anderson, Jennifer C. Kelley, Lori M. Laffel, Sarah A. MacLeish, Brandon M. Nathan, William V. Tamborlane, R. Paul Wadwa, Steven M. Willi, Kristen M. Williams, Kupper A. Wintergerst, Stephanie Woerner, Jenise C. Wong, Daniel J. DeSalvo
Summary: This study examined the durability of continuous glucose monitoring (CGM) coupled with a family behavioral intervention (FBI) to improve glycemia in young children with type 1 diabetes (T1D). The results showed that CGM technology could reduce the incidence of hypoglycemia, but had limited effect on hyperglycemia.
JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY
(2023)
Article
Endocrinology & Metabolism
Ryan Bailey, Peter Calhoun, Richard M. Bergenstal, Roy W. Beck
Summary: By comparing the glucose management indicator (GMI) calculated using different durations of data, it was found that there was minimal difference between GMI computed with 7 days and 14 days of data. For most patients, satisfactory estimation of HbA1c can be obtained with 7 days of data.
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Article
Endocrinology & Metabolism
Roy W. Beck, Dan Raghinaru, Peter Calhoun, Richard M. Bergenstal
Summary: This study investigated the relationship between the time spent with glucose levels below 70 mg/dL and below 54 mg/dL in patients with diabetes. The results showed that as the time below 70 mg/dL increased, the time below 54 mg/dL also increased. Furthermore, it was found that patients who monitored their glucose levels blindly had more time below 54 mg/dL compared to those who did not, and their data was similar to that of patients using an automated insulin delivery system.
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Article
Endocrinology & Metabolism
Maamoun Salam, Ryan Bailey, Peter Calhoun, Janet B. McGill, Richard M. Bergenstal, David Price, Roy W. Beck
Summary: The relationship between mean glucose and HbA1c varies according to race and type of diabetes. Although HbA1c is higher in T2D compared to T1D for the same mean glucose, there is no meaningful difference in the mean glucose-HbA1c relationship between T1D and T2D after accounting for race. The relationship may differ between different racial groups, but seems to be similar between White non-Hispanic and Hispanic individuals. The published glucose management indicator formula appears to be suitable for both T1D and T2D.
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Editorial Material
Endocrinology & Metabolism
Roy W. Beck
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Article
Endocrinology & Metabolism
Nelly R. Mauras, Edward H. Damiano, Firas El-Khatib, Martin Chase Marak, Peter J. Calhoun, Katrina Ruedy, Courtney Balliro, Zoey W. Li, Roy J. Beck, Steven Russell
Summary: This article describes how the bionic pancreas (BP) autonomously doses insulin without carbohydrate counting, using qualitative meal announcements. In case of device malfunction, the BP generates backup insulin doses for injection or pump users, including long-acting insulin dose, a four-period basal insulin profile, short-acting meal doses, and a glucose correction factor. In a 13-week trial, participants using the BP had similar glycemic outcomes compared to those using their prestudy insulin regimen, with both groups having higher mean glucose and lower time-in-range than while using the BP. In conclusion, a backup insulin regimen automatically generated by the BP can be safely implemented if needed.
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Article
Endocrinology & Metabolism
Zoey Li, Peter Calhoun, Katrina J. J. Ruedy, Roy W. W. Beck
Summary: The importance of capillary hemoglobin A1c (HbA1c) collection has increased due to its convenience during situations such as the COVID-19 pandemic and virtual visits. This study analyzed 773 paired capillary and venous samples taken from 258 participants and found high congruence between capillary and venous HbA1c values, further confirming the accuracy of capillary measurements as an alternative to venous measurements.
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Article
Endocrinology & Metabolism
Persis A. Commissariat, Linda G. DiMeglio, Lauren M. Kanapka, Lori M. Laffel, Kellee J. Miller, Barbara E. Anderson, Marisa Hilliard
Summary: The study found that providing continuous glucose monitoring and family behavioral intervention can reduce stress for parents of young children with type 1 diabetes. In a 52-week trial, the group using continuous glucose monitoring with family behavioral intervention and the group using continuous glucose monitoring alone reported improvements in diabetes burden, fear of hypoglycemia, and technology satisfaction. The group that transitioned from blood glucose monitoring to continuous glucose monitoring with family behavioral intervention also showed similar results between 26 and 52 weeks.
Article
Medicine, General & Internal
R. Paul Wadwa, Zachariah W. Reed, Bruce A. Buckingham, Mark D. DeBoer, Laya Ekhlaspour, Gregory P. Forlenza, Melissa Schoelwer, John Lum, Craig Kollman, Roy W. Beck, Marc D. Breton, PEDAP Trial Study Grp
Summary: This study evaluated the efficacy and safety of a closed-loop insulin delivery system in young children with type 1 diabetes. The results showed that the closed-loop system was more effective in maintaining glucose levels within the target range compared to standard care. There were no significant differences in safety outcomes between the two groups.
NEW ENGLAND JOURNAL OF MEDICINE
(2023)
Article
Mathematical & Computational Biology
Lauren Kanapka, Anastasia Ivanova
Summary: This article discusses a multi-arm trial design with multiple active treatments and a control group. By assuming a certain order for the treatment effects, the objective is to compare each active treatment to the control group while maintaining control of the type 1 error rate. The results show that using the order of treatment effects to calculate the test statistic and set the testing order can reduce the sample size by at least 20% compared to testing each active treatment against the control independently.
STATISTICS IN MEDICINE
(2023)
Article
Mathematical & Computational Biology
Lauren Kanapka, Anastasia Ivanova
Summary: A basket trial is designed to speed up the drug development process by evaluating a new therapy in multiple populations within the same clinical trial. This paper proposes a frequentist approach to dynamic borrowing for basket trials using adaptive lasso. Simulation studies show that adaptive lasso can achieve similar power and type 1 error as existing Bayesian methods, while being easier to implement and faster. The proposed approach is flexible and can be extended to basket trials with any number of treatment arms and any type of endpoint.
STATISTICS IN MEDICINE
(2023)