NIH Fifth Artificial Pancreas Workshop 2023: Meeting Report: The Fifth Artificial Pancreas Workshop: Enabling Fully Automation, Access, and Adoption.

The Fifth Artificial Pancreas Workshop: Enabling Fully Automation, Access, and Adoption was held at the National Institutes of Health (NIH) Campus in Bethesda, Maryland on May 1 to 2, 2023. The organizing Committee included representatives of NIH, the US Food and Drug Administration (FDA), Diabetes Technology Society, Juvenile Diabetes Research Foundation (JDRF), and the Leona M. and Harry B. Helmsley Charitable Trust. In previous years, the NIH Division of Diabetes, Endocrinology, and Metabolic Diseases along with other diabetes organizations had organized periodic workshops, and it had been seven years since the NIH hosted the Fourth Artificial Pancreas in July 2016. Since then, significant improvements in insulin delivery have occurred. Several automated insulin delivery (AID) systems are now commercially available. The workshop featured sessions on: (1) Lessons Learned from Recent Advanced Clinical Trials and Real-World Data Analysis, (2) Interoperability, Data Management, Integration of Systems, and Cybersecurity, Challenges and Regulatory Considerations, (3) Adaptation of Systems Through the Lifespan and Special Populations: Are Specific Algorithms Needed, (4) Development of Adaptive Algorithms for Insulin Only and for Multihormonal Systems or Combination with Adjuvant Therapies and Drugs: Clinical Expected Outcomes and Public Health Impact, (5) Novel Artificial Intelligence Strategies to Develop Smarter, More Automated, Personalized Diabetes Management Systems, (6) Novel Sensing Strategies, Hormone Formulations and Delivery to Optimize Close-loop Systems, (7) Special Topic: Clinical and Real-world Viability of IP-IP Systems. "Fully automated closed-loop insulin delivery using the IP route," (8) Round-table Panel: Closed-loop performance: What to Expect and What are the Best Metrics to Assess it, and (9) Round-table Discussion: What is Needed for More Adaptable, Accessible, and Usable Future Generation of Systems? How to Promote Equitable Innovation? This article summarizes the discussions of the Workshop.

Diabetes Technology Meeting 2022.

Diabetes Technology Society hosted its annual Diabetes Technology Meeting from November 3 to November 5, 2022. Meeting topics included (1) the measurement of glucose, insulin, and ketones; (2) virtual diabetes care; (3) metrics for managing diabetes and predicting outcomes; (4) integration of continuous glucose monitor data into the electronic health record; (5) regulation of diabetes technology; (6) digital health to nudge behavior; (7) estimating carbohydrates; (8) fully automated insulin delivery systems; (9) hypoglycemia; (10) novel insulins; (11) insulin delivery; (12) on-body sensors; (13) continuous glucose monitoring; (14) diabetic foot ulcers; (15) the environmental impact of diabetes technology; and (16) spinal cord stimulation for painful diabetic neuropathy. A live demonstration of a device that can allow for the recycling of used insulin pens was also presented.

Diabetes Technology Meeting 2021.

Diabetes Technology Society hosted its annual Diabetes Technology Meeting on November 4 to November 6, 2021. This meeting brought together speakers to discuss various developments within the field of diabetes technology. Meeting topics included blood glucose monitoring, continuous glucose monitoring, novel sensors, direct-to-consumer telehealth, metrics for glycemia, software for diabetes, regulation of diabetes technology, diabetes data science, artificial pancreas, novel insulins, insulin delivery, skin trauma, metabesity, precision diabetes, diversity in diabetes technology, use of diabetes technology in pregnancy, and green diabetes. A live demonstration on a mobile app to monitor diabetic foot wounds was presented.

Diabetes Technology Meeting 2020.

Diabetes Technology Society hosted its annual Diabetes Technology Meeting on November 12 to November 14, 2020. This meeting brought together speakers to cover various perspectives about the field of diabetes technology. The meeting topics included artificial intelligence, digital health, telemedicine, glucose monitoring, regulatory trends, metrics for expressing glycemia, pharmaceuticals, automated insulin delivery systems, novel insulins, metrics for diabetes monitoring, and discriminatory aspects of diabetes technology. A live demonstration was presented.

The YSI 2300 Analyzer Replacement Meeting Report.

This is a summary report of the most important aspects discussed during the YSI 2300 Analyzer Replacement Meeting. The aim is to provide the interested reader with an overview of the complex topic and propose solutions for the current issue. This solution should not only be adequate for the United States or Europe markets but also for all other countries. The meeting addendum presents three outcomes of the meeting.

Patch Pumps for Insulin.

Newly developed patch pumps are starting to occupy a noticeable fraction of the insulin delivery market. New entrants, using novel technologies, promise accurate, flexible insulin delivery at lower costs. In the section, we review the currently available devices, discuss some of the devices on the horizon, and speculate about some fascinating new approaches. In this first article, we provide an overview of the simplified devices-V-Go, PAQ, and One Touch Via-and of the more complex devices-Omnipod, Cellnovo, JewelPump, Solo, SFC Fluidics pump, Libertas, Medtronic pump, and EOPatch. We also discuss controllers, smartphones, and cybersecurity.

Self-Monitoring of Blood Glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research.

Current clinical guidelines for diabetes care encourage self-monitoring of blood glucose (SMBG) to improve glycemic control. Specific protocols remain variable, however, particularly among non-insulin-using patients. This is due in part to efficacy studies that neglect to consider (1) the performance of monitoring equipment under real-world conditions, (2) whether or how patients have been taught to take action on test results, and (3) the physiological, behavioral, and social circumstances in which SMBG is carried out. As such, a multidisciplinary group of specialists, including several endocrinologists, a health psychologist, a diabetes nurse practitioner, and a patient advocate (the Panel), discuss within this review article how the potential of SMBG might be fully realized in today's healthcare environment. The resulting recommendations cover technological, clinical, behavioral, and research considerations with the aim of achieving short- and long-term benefits, ranging from fewer hypoglycemic episodes to lower complication-related costs. The panel also made suggestions for designing future studies that increase the ability to discern optimal models of SMBG utilization for individuals with diabetes who may, or may not, use insulin.

Meeting Report: The Fourth Artificial Pancreas Workshop: Testing and Adoption of Current and Emerging Technologies.

On July 6 and 7, 2016 the Fourth Artificial Pancreas Workshop: Testing and Adoption of Current and Emerging Technologies was held on the National Institutes of Health (NIH) Campus at the Lister Hill Auditorium. The meeting was sponsored by a group of governmental organizations and NGOs, listed in Appendix A. This was a very timely meeting as the artificial pancreas appears to be growing from academic studies to commercial projects. The first artificial pancreas may be marketed within 12 months and a few may be approved within 24 months. The NIH, the FDA, the JDRF, Helmsley Trust, Diabetes Technology Society, and other agencies, funders, and organizations have been strongly supportive of advancing artificial pancreas technology and usability, and thus the proceedings from this conference should be of exceptional interest to the diabetes technology community.

Clinical Use and Evaluation of Insulin Pens.

Insulin pens are more accurate and easier to teach than other methods of insulin delivery. They also do not suffer from the risk of mismatch of insulin concentration and type of insulin syringe. The ISO standard used to test insulin pens, however, needs to be updated to reflect their clinical use.

Mixing Pens and the Future of Diabetes Drugs.

With the availability of a smaller mixing pen, mass marketing of less stable medications is possible. Bidureon is one such medication, and the properties of its pen are discussed along with the prospects for future mixing pens.

Practical use of self-monitoring of blood glucose data.

Self-monitoring of blood glucose provides information about blood glucose control. The data become useful information and knowledge through careful analysis for patterns that are appropriate or can be corrected. Some analyses can be performed on newer blood glucose meters, but most often, this needs to be done on a computer, tablet, or smartphone. There are a few established methods of presenting the data that make analysis easier. In this article, we discuss four types of data presentations and the methods for utilizing them.

Evaluating the OneTouch® Delica™: a low-pain lancing system for self-monitoring of blood glucose.

The pain associated with lancing can be a significant barrier to self-monitoring of blood glucose (SMBG). The OneTouch® Delica™ lancing device contains features to reduce lancing pain, including improved lancet control and stability, reduced vibration, and a thinner, 33-gauge lancet. This 2-visit, randomized controlled trial assessed perceived pain of lancing with the OneTouch® Delica™ compared with 4 other common lancing devices: OneTouch® Comfort™, ACCU-CHEK® Softclix, ACCU-CHEK® Multiclix, and Ascensia® Microlet™2. Two hundred patients with type 1 or type 2 diabetes mellitus were assigned to the OneTouch® Delica™ and also randomized to 1 of the 4 comparator devices (n=50 per device pair). At visit 1, we determined the minimum depth settings required to produce≥1 µL of fingertip blood for each patient with each device. At visit 2, patients lanced their fingertips with the devices at the predetermined depths and used a 150-mm visual analog scale (VAS) to rate lancing pain relative to their "usual pain" associated with SMBG. The VAS ranged from "much less painful" (0 mm) to "much more painful" (150 mm), with the midpoint (75 mm) labeled as "usual pain." Fingertip pain scores from patients using OneTouch® Delica™ were significantly lower than those obtained using OneTouch® Comfort™, ACCU-CHEK® Multiclix, and Ascensia® Microlet™2. Pain scores for OneTouch® Delica™ and ACCU-CHEK® Softclix were not significantly different. In conclusion, OneTouch® Delica™ was either less painful or no different than the comparator devices when used for fingertip lancing. Innovative lancing devices that cause less pain may improve compliance and persistence with prescribed SMBG.

We need tighter regulatory standards for blood glucose monitoring, but they should be for accuracy disclosure.

Regulatory interest has focused on the accuracy of blood glucose monitoring systems. Currently, almost all systems meet the International Organization for Standardization (ISO) 15197 clinical standard (≥95% of the values within 20% of the reference for values above 75 mg/dl and within 15 mg/dl below that level). Should the systems have to meet one of the extended ISO standards of 15%, 10%, or even 5%? There is a wide variety of people with diabetes doing glucose monitoring, and the majority do not need better accuracy. Indeed, when selecting an insulin dose, the inaccuracy of the glucose reading has little effect compared with the inaccuracy in counting carbohydrates and the variability in insulin absorption. It might be far better to evaluate the accuracy in a standard method and provide the accuracy values on a standard label. Patients and health care providers could then select the monitoring system that best meets their needs.

Factors affecting blood glucose monitoring: sources of errors in measurement.

Glucose monitoring has become an integral part of diabetes care but has some limitations in accuracy. Accuracy may be limited due to strip manufacturing variances, strip storage, and aging. They may also be due to limitations on the environment such as temperature or altitude or to patient factors such as improper coding, incorrect hand washing, altered hematocrit, or naturally occurring interfering substances. Finally, exogenous interfering substances may contribute errors to the system evaluation of blood glucose. In this review, I discuss the measurement of error in blood glucose, the sources of error, and their mechanism and potential solutions to improve accuracy in the hands of the patient. I also discuss the clinical measurement of system accuracy and methods of judging the suitability of clinical trials and finally some methods of overcoming the inaccuracies. I have included comments about additional information or education that could be done today by manufacturers in the appropriate sections. Areas that require additional work are discussed in the final section.

An analysis: to code or not to code-that is the question.

Most blood glucose monitoring systems need coding to correct for variation in lots of enzyme, which leads to differences in lots of strips. About 16% of patients miscode the meters, although the magnitude of the miscoding is unstudied. This miscoding has the potential to cause errors as high as 30% and to cause errors in adjusting insulin therapy that could lead to hypoglycemia at least 10% of the time. Studies of these systems suggest that they have accuracy similar to other current meters and have similar physical characteristics. Because they do not require coding, they are often easier to use. No-coding systems have the potential to avoid some errors in blood glucose.

Use of the GlucoWatch biographer in children and adolescents with diabetes.

OBJECTIVE: This study was done to evaluate the accuracy and safety of measuring glucose with the GlucoWatch biographer in children and adolescents with diabetes. METHODS: Accuracy was assessed by comparing biographer glucose measurements with hourly blood glucose measurements using the HemoCue (Aktiebolaget Leo, Helsingborg, Sweden) Photometer for up to 12 h of monitoring. Safety was evaluated by examining the biographer application sites immediately upon removal of the devices, and then at regular intervals. RESULTS: Sixty-six subjects each wore three biographers at sites including the forearm, upper arm, leg, and torso. For forearm biographers, the mean absolute relative difference between biographer readings and blood glucose was 21%. Ninety-five per cent of biographer readings fell into the A or B regions of the Clarke error grid, and 97.3% into the A or B regions of the consensus error grid. Data from biographers worn at the alternative sites were similar to data from the forearm biographers. Two strong reactions to the adhesive pad of the biographer AutoSensor were observed. Most skin reactions were mild. CONCLUSIONS: The GlucoWatch biographer is well tolerated by children and adolescents with diabetes. Performance is similar when the device is worn at different anatomical sites, and is similar to the performance on the forearm, previously reported in adults.