ArticleDiabetes technology & therapeutics2018
A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II.
Article in Diabetes technology & therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02647905 (A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II), which is not on this map. Cited by 56 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II
Who cites it
56 citing papers in PubMed, 2 syntheses or guidelines pooled it, 140 citations in OpenAlex.
- Non-invasive and minimally invasive glucose monitoring devices: a systematic review and meta-analysis on diagnostic accuracy of hypoglycaemia detection.Systematic reviews · 2021Pooled it
- Cutaneous Complications With Continuous or Flash Glucose Monitoring Use: Systematic Review of Trials and Observational Studies.Journal of diabetes science and technology · 2020Pooled it
- Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance.Journal of endocrinological investigation · 2022Trial
- First assessment of the performance of an implantable continuous glucose monitoring system through 180 days in a primarily adolescent population with type 1 diabetes.Diabetes, obesity & metabolism · 2019Trial
- β‑Anomeric Mannopentaose-Based Nonenzymatic NIR Glucose Sensor Enabling Cost-Effective Continuous Monitoring.ACS measurement science au · 2026Article
- Advancing Diabetic Care Through Non-Invasive Glucose Monitoring Using Optical Sensors and IoT Technologies.F1000Research · 2026Article
- Beyond glucose: wearable and implantable biosensors for continuous monitoring of metabolic, hormonal, and inflammatory biomarkers in personalized cardiometabolic care.Frontiers in bioengineering and biotechnology · 2026Review
- AI-enhanced non-invasive monitoring of critical biochemical analytes in perioperative care: a review of signal processing and clinical applications.Frontiers in physiology · 2026Review
- The open-source multi-wavelength non-invasive blood glucose sensing system.Scientific reports · 2025Article
- Fluorescent Chemosensors in the Creation of a Commercially Available Continuous Glucose Monitor.ACS sensors · 2024Article
- Computational Model-Assisted Development of a Nonenzymatic Fluorescent Glucose-Sensing Assay.ACS sensors · 2024Article
- Expanding the horizon of continuous glucose monitoring into the future of pediatric medicine.Pediatric research · 2024Review
- A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance.Journal of diabetes science and technology · 2024Review
- Development of sensor system and data analytic framework for non-invasive blood glucose prediction.Scientific reports · 2024Article
- Evaluating the precision and reliability of real-time continuous glucose monitoring systems in ambulatory settings: a systematic review.Therapeutic advances in endocrinology and metabolism · 2024Review
- Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting.Journal of diabetes science and technology · 2023Article
- Prevalence, characteristics, and health-related quality of life of continuous glucose monitoring use according to the Behavioral Risk Factor Surveillance System 2014-2020.Journal of managed care & specialty pharmacy · 2023Article
- [Research progress on minimally invasive and non-invasive blood glucose detection methods].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2023Article
- Insight into continuous glucose monitoring: from medical basics to commercialized devices.Mikrochimica acta · 2023Review
- Continuous Glucose Monitoring Enabled by Fluorescent Nanodiamond Boronic Hydrogel.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023Article
Corrections and comments
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Authors and funding
12 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPersistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D).
methodsPRECISE 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.
resultsNinety 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.
conclusionsThe 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.