The Clinical Case for the Integration of a Ketone Sensor as Part of a Closed Loop Insulin Pump System

Lee, Melissa H; Paldus, Barbora; Krishnamurthy, Balasubramanium; McAuley, Sybil A; Shah, Rajiv; Jenkins, Alicia J.; O’Neal, David N

doi:10.1177/1932296818822986

Cited by 15 publications

(18 citation statements)

References 22 publications

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“…Measuring urine or blood ketone levels using a strip-based technology has its limitations. 16 It provides episodic information that confirms an already ongoing ketosis or DKA event. Early identification of production of ketones may warn of impending ketoacidosis that could reduce the complications of DKA and perhaps even prevent it.…”

Section: Discussionmentioning

confidence: 99%

“…Lee et al suggest that a multianalyte system incorporating a ketone sensor could provide an additional input to a closed loop system’s safety algorithm, warning of impending DKA to allow appropriate action to be taken. 16 Attempts have been made to measure ketones continuously using a spectroscopy-based approach and have demonstrated that this concept works in an animal model. 17 A microneedle-based continuous ketone sensor based on β-HBDH was demonstrated in a skin mimicking model.…”

Section: Introductionmentioning

confidence: 99%

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Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue using a Ketone Sensor

Alva

Castorino

Cho

et al. 2021

J Diabetes Sci Technol

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Background: The feasibility of measuring β-hydroxybutyrate in ISF using a continuous ketone monitoring (CKM) sensor using a single calibration without further adjustments over 14 days is described. Methods: A CKM sensor was developed using wired enzyme technology with β-hydroxybutyrate dehydrogenase chemistry. In vitro characterization of the sensor was performed in phosphate buffered saline at 37°C. In vivo performance was evaluated in 12 healthy participants on low carbohydrate diets, who wore 3 ketone sensors on the back of their upper arms to continuously measure ketone levels over 14 days. Reference capillary ketone measurements were performed using Precision Xtra® test strips at least 8 times a day. Results: The sensor is stable over 14 days and has a linear response over the 0-8 mM range. The operational stability of the sensor is very good with a 2.1% signal change over 14 days. The first human study of the CKM sensor demonstrated that the sensor can continuously track ketones well through the entire 14 days of wear. The performance with a single retrospective calibration of the sensor showed 82.4% of data pairs within 0.225 mM/20% and 91.4% within 0.3 mM/30% of the capillary ketone reference (presented as mM at <1.5 mM and as percentage at or above 1.5 mM). This suggests that the sensor can be used with a single calibration for the 14 days of use. Conclusions: Measuring ketones in ISF using a continuous ketone sensor is feasible. Additional studies are required to evaluate the performance in intended patient populations, including conditions of ketosis and diabetic ketoacidosis.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue using a Ketone Sensor

Alva

Castorino

Cho

et al. 2021

J Diabetes Sci Technol

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“…Scenarios where addition of CKM data might enhance the value of using an AID system are presented in Table 4. 121 A PwD using open loop insulin pump control with a CGM and a CKM would be able to manually increase their basal or bolus insulin doses beyond their requirements for controlling glucose concentrations if they received an alert that they had an elevated ketone concentration. The extra insulin could be sufficient to prevent the development of DKA.…”

Section: Discussionmentioning

confidence: 99%

Continuous Ketone Monitoring Consensus Report 2021

Nguyen

Zhang

et al. 2021

J Diabetes Sci Technol

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This article is the work product of the Continuous Ketone Monitoring Consensus Panel, which was organized by Diabetes Technology Society and met virtually on April 20, 2021. The panel consisted of 20 US-based experts in the use of diabetes technology, representing adult endocrinology, pediatric endocrinology, advanced practice nursing, diabetes care and education, clinical chemistry, and bioengineering. The panelists were from universities, hospitals, freestanding research institutes, government, and private practice. Panelists reviewed the medical literature pertaining to ten topics: (1) physiology of ketone production, (2) measurement of ketones, (3) performance of the first continuous ketone monitor (CKM) reported to be used in human trials, (4) demographics and epidemiology of diabetic ketoacidosis (DKA), (5) atypical hyperketonemia, (6) prevention of DKA, (7) non-DKA states of fasting ketonemia and ketonuria, (8) potential integration of CKMs with pumps and automated insulin delivery systems to prevent DKA, (9) clinical trials of CKMs, and (10) the future of CKMs. The panelists summarized the medical literature for each of the ten topics in this report. They also developed 30 conclusions (amounting to three conclusions for each topic) about CKMs and voted unanimously to adopt the 30 conclusions. This report is intended to support the development of safe and effective continuous ketone monitoring and to apply this technology in ways that will benefit people with diabetes.

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“…However, there exists the possibility of integrating additional sensors in currently used devices such as CGM and CSII to avoid additional user burden. Previous studies have identified relationships between invasive inputs and T1D (eg, ketone sensors to identify diabetic ketoacidosis [62]). Although rich relationships exist, progress is stunted because of the lack of sensors for carrying out continuous measurements.…”

Section: Invasive Inputsmentioning

confidence: 99%

Integrating Multiple Inputs Into an Artificial Pancreas System: Narrative Literature Review

Hettiarachchi¹,

Daskalaki²,

Desborough³

et al. 2022

JMIR Diabetes

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Background Type 1 diabetes (T1D) is a chronic autoimmune disease in which a deficiency in insulin production impairs the glucose homeostasis of the body. Continuous subcutaneous infusion of insulin is a commonly used treatment method. Artificial pancreas systems (APS) use continuous glucose level monitoring and continuous subcutaneous infusion of insulin in a closed-loop mode incorporating a controller (or control algorithm). However, the operation of APS is challenging because of complexities arising during meals, exercise, stress, sleep, illnesses, glucose sensing and insulin action delays, and the cognitive burden. To overcome these challenges, options to augment APS through integration of additional inputs, creating multi-input APS (MAPS), are being investigated. Objective The aim of this survey is to identify and analyze input data, control architectures, and validation methods of MAPS to better understand the complexities and current state of such systems. This is expected to be valuable in developing improved systems to enhance the quality of life of people with T1D. Methods A literature survey was conducted using the Scopus, PubMed, and IEEE Xplore databases for the period January 1, 2005, to February 10, 2020. On the basis of the search criteria, 1092 articles were initially shortlisted, of which 11 (1.01%) were selected for an in-depth narrative analysis. In addition, 6 clinical studies associated with the selected studies were also analyzed. Results Signals such as heart rate, accelerometer readings, energy expenditure, and galvanic skin response captured by wearable devices were the most frequently used additional inputs. The use of invasive (blood or other body fluid analytes) inputs such as lactate and adrenaline were also simulated. These inputs were incorporated to switch the mode of the controller through activity detection, directly incorporated for decision-making and for the development of intermediate modules for the controller. The validation of the MAPS was carried out through the use of simulators based on different physiological models and clinical trials. Conclusions The integration of additional physiological signals with continuous glucose level monitoring has the potential to optimize glucose control in people with T1D through addressing the identified limitations of APS. Most of the identified additional inputs are related to wearable devices. The rapid growth in wearable technologies can be seen as a key motivator regarding MAPS. However, it is important to further evaluate the practical complexities and psychosocial aspects associated with such systems in real life.

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The Clinical Case for the Integration of a Ketone Sensor as Part of a Closed Loop Insulin Pump System

Cited by 15 publications

References 22 publications

Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue using a Ketone Sensor

Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue using a Ketone Sensor

Continuous Ketone Monitoring Consensus Report 2021

Integrating Multiple Inputs Into an Artificial Pancreas System: Narrative Literature Review

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