Long-Term Home Study on Nocturnal Hypoglycemic Alarms Using a New Fully Implantable Continuous Glucose Monitoring System in Type 1 Diabetes

Wang, Xiaolin; Ioacără, Sorin; DeHennis, A.

doi:10.1089/dia.2014.0375

Cited by 15 publications

(9 citation statements)

References 16 publications

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“…The Eversense CGM system has been evaluated in two prior published studies. A feasibility study of 12 participants with T1D found no evidence of nighttime sensor attenuation, 15 which has been reported in transcutaneous sensors. 16 , 17 The system was also evaluated in the multicenter European 180-day PRECISE pivotal study, which demonstrated that use of the CGM device provided improved glycemic control in 71 participants with T1D or T2D.…”

Section: Introductionmentioning

confidence: 82%

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II

Christiansen

Klaff

Brazg

et al. 2018

Diabetes Technology & Therapeutics

122

116

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Background: Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D).Methods: PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system among adult participants with T1D and T2D (NCT02647905). The primary endpoint was the mean absolute relative difference (MARD) between paired Eversense and Yellow Springs Instrument (YSI) reference measurements through 90 days postinsertion for reference glucose values from 40 to 400 mg/dL. Additional endpoints included Clarke Error Grid analysis and sensor longevity. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days postinsertion.Results: Ninety participants received the CGM system. The overall MARD value against reference glucose values was 8.8% (95% confidence interval: 8.1%–9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P < 0.0001). Ninety-three percent of CGM values were within 20/20% of reference values over the total glucose range of 40–400 mg/dL. Clarke Error Grid analysis showed 99.3% of samples in the clinically acceptable error zones A (92.8%) and B (6.5%). Ninety-one percent of sensors were functional through day 90. One related SAE (1.1%) occurred during the study for removal of a sensor.Conclusions: The PRECISE II trial demonstrated that the Eversense CGM system provided accurate glucose readings through the intended 90-day sensor life with a favorable safety profile.

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Section: Introductionmentioning

confidence: 82%

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II

Christiansen

Klaff

Brazg

et al. 2018

Diabetes Technology & Therapeutics

122

116

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“…Advances in continuous glucose monitoring technologies to improve sensor performance and user adherence include long-term (up to six months) implantable glucose sensors that are unaffected by the external sensor-signal attenuation issues faced by conventional sensors [ 66 ]. At present, a factory-calibrated subcutaneous glucose sensor can be worn for up to 2 weeks [ 67 ].…”

Section: Foundations Of Closed-loop Systemsmentioning

confidence: 99%

Coming of age: the artificial pancreas for type 1 diabetes

2016

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The artificial pancreas (closed-loop system) addresses the unmet clinical need for improved glucose control whilst reducing the burden of diabetes self-care in type 1 diabetes. Glucose-responsive insulin delivery above and below a preset insulin amount informed by sensor glucose readings differentiates closed-loop systems from conventional, threshold-suspend and predictive-suspend insulin pump therapy. Insulin requirements in type 1 diabetes can vary between one-third–threefold on a daily basis. Closed-loop systems accommodate these variations and mitigate the risk of hypoglycaemia associated with tight glucose control. In this review we focus on the progress being made in the development and evaluation of closed-loop systems in outpatient settings. Randomised transitional studies have shown feasibility and efficacy of closed-loop systems under supervision or remote monitoring. Closed-loop application during free-living, unsupervised conditions by children, adolescents and adults compared with sensor-augmented pumps have shown improved glucose outcomes, reduced hypoglycaemia and positive user acceptance. Innovative approaches to enhance closed-loop performance are discussed and we also present the outlook and strategies used to ease clinical adoption of closed-loop systems.

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“…Additionally implantable CGM appears to not be susceptible to pressure-induced signal attenuation. 29 …”

Section: Novel Cgm Systemsmentioning

confidence: 99%

Future of Automated Insulin Delivery Systems

Castle

DeVries

Kovatchev

2017

Diabetes Technology & Therapeutics

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Advances in continuous glucose monitoring (CGM) have brought on a paradigm shift in the management of type 1 diabetes. These advances have enabled the automation of insulin delivery, where an algorithm determines the insulin delivery rate in response to the CGM values. There are multiple automated insulin delivery (AID) systems in development. A system that automates basal insulin delivery has already received Food and Drug Administration approval, and more systems are likely to follow. As the field of AID matures, future systems may incorporate additional hormones and/or multiple inputs, such as activity level. All AID systems are impacted by CGM accuracy and future CGM devices must be shown to be sufficiently accurate to be safely incorporated into AID. In this article, we summarize recent achievements in AID development, with a special emphasis on CGM sensor performance, and discuss the future of AID systems from the point of view of their input-output characteristics, form factor, and adaptability.

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Long-Term Home Study on Nocturnal Hypoglycemic Alarms Using a New Fully Implantable Continuous Glucose Monitoring System in Type 1 Diabetes

Cited by 15 publications

References 16 publications

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II

Coming of age: the artificial pancreas for type 1 diabetes

Future of Automated Insulin Delivery Systems

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