Multisite Study of an Implanted Continuous Glucose Sensor Over 90 Days in Patients With Diabetes Mellitus

DeHennis, A.; Mortellaro, Mark; Ioacără, Sorin

doi:10.1177/1932296815596760

Cited by 31 publications

(21 citation statements)

References 25 publications

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“…This last category of optical sensing technique has been recently successfully applied by Senseonics (Senseonics, Inc., Germantown, MD, USA) to develop a fully implanted CGM system [22,53], the Eversense sensor, which provides real-time glucose measurements through the external coupled transmitter for an expected lifetime of six months [54]. Currently, the Eversense CGM is approved to be used in European countries only (CE mark received in 2016) with a lifetime of 90 days and an accuracy of 11.4% MARD [55]. While biocompatibility and patient acceptance of the new fully implanted technology remain key issues, lifetime and ease of use are the fundamental strengths of this approach.…”

Section: Technological Trends and Challenges For The Next Generation mentioning

confidence: 99%

“…Currently available CGM systems already incorporate smart features, such as alerts and alarms generation in case of hypoglycemic or hyperglycemic events, incorporation of glucose trend information, detection of sensor faults and artifacts [55,56]. Next generation systems certainly need to incorporate these features and to deal with data management and integration into external devices, e.g., smartphone apps or dedicated cloud platforms.…”

Section: Technological Trends and Challenges For The Next Generation mentioning

confidence: 99%

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Wearable Continuous Glucose Monitoring Sensors: A Revolution in Diabetes Treatment

et al. 2017

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Worldwide, the number of people affected by diabetes is rapidly increasing due to aging populations and sedentary lifestyles, with the prospect of exceeding 500 million cases in 2030, resulting in one of the most challenging socio-health emergencies of the third millennium. Daily management of diabetes by patients relies on the capability of correctly measuring glucose concentration levels in the blood by using suitable sensors. In recent years, glucose monitoring has been revolutionized by the development of Continuous Glucose Monitoring (CGM) sensors, wearable non/minimally-invasive devices that measure glucose concentration by exploiting different physical principles, e.g., glucose-oxidase, fluorescence, or skin dielectric properties, and provide real-time measurements every 1-5 min. CGM opened new challenges in different disciplines, e.g., medicine, physics, electronics, chemistry, ergonomics, data/signal processing, and software development to mention but a few. This paper first makes an overview of wearable CGM sensor technologies, covering both commercial devices and research prototypes. Then, the role of CGM in the actual evolution of decision support systems for diabetes therapy is discussed. Finally, the paper presents new possible horizons for wearable CGM sensor applications and perspectives in terms of big data analytics for personalized and proactive medicine.

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Section: Technological Trends and Challenges For The Next Generation mentioning

confidence: 99%

Section: Technological Trends and Challenges For The Next Generation mentioning

confidence: 99%

Wearable Continuous Glucose Monitoring Sensors: A Revolution in Diabetes Treatment

et al. 2017

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“…1,2 While recent studies of implanted SQ sensors have shown promising results, there is still much room for improvement, including the reduction of encapsulation-induced sensor lag. 3,4 We present a proof-of-concept study of a novel flushing assembly to routinely clean the sensor surface, thereby prolonging its lifetime. Placing the sensor in the intraperitoneal (IP) space allows flushing with saline that would not be possible in the restricted SQ space.…”

Section: Letter To the Editormentioning

confidence: 99%

“…3,4 We present a proof-of-concept study of a novel flushing assembly to routinely clean the sensor surface, thereby prolonging its lifetime. Placing the sensor in the intraperitoneal (IP) space allows flushing with saline that would not be possible in the restricted SQ space.…”

mentioning

confidence: 99%

Preliminary Evaluation of a Long-Term Intraperitoneal Glucose Sensor With Flushing Mechanism

Huyett

Mittal

Zisser

et al. 2016

J Diabetes Sci Technol

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Encapsulation is known to deteriorate the performance of subcutaneous (SQ) continuous glucose monitors (CGMs), preventing these devices from meeting the long-term functionality requirements for widespread use and creating a bottleneck in artificial pancreas (AP) development.1,2 While recent studies of implanted SQ sensors have shown promising results, there is still much room for improvement, including the reduction of encapsulation-induced sensor lag. 3,4 We present a proof-of-concept study of a novel flushing assembly to routinely clean the sensor surface, thereby prolonging its lifetime. Placing the sensor in the intraperitoneal (IP) space allows flushing with saline that would not be possible in the restricted SQ space.Fluorescent glucose sensors were implanted in the SQ or IP space of sheep. Sensors were provided by the manufacturer in a lengthened, tethered format. The IP sensors were modified with silicone tubing, flush port, Dacron cuff, and adaptors to allow flushing with saline solution. Experiments were conducted under an IACUC-approved protocol by BioSurg, Inc (Davis, CA). After preliminary testing to optimize the flushing procedure, long-term responsiveness was evaluated with an IP sensor placed in 1 sheep and an SQ sensor placed in a second sheep. The IP sensor was flushed weekly with saline. Glucose response challenges were performed periodically over 3 months by infusing 0.5 g/kg dextrose through an ear vein over 60 s (13 challenges over 114 days for IP, 9 challenges over 91 days for SQ). The results are summarized in Figure 1.The IP sensor demonstrated anomalously slow response during the first challenge (day 8) due to tissue trauma following implantation, which is known to cause inflammatory response.3 Excluding day 8, the IP sensor maintained consistent responsiveness throughout the 114-day period, with time to half-maximum (t 1/2) between 2.7 and 4.7 min and time to maximum (t max ) between 11.6 and 17.2 min. Conversely, the nonflushed sensor in the SQ space gradually lost responsiveness, with t 1/2 between 2.6 and 13.5 min and t max between 9.7 and 72 min. By 91 days following implantation, the SQ sensor signal did not peak within the 60-min testing period (see Figure 1B).The development of long-term implantable CGMs is a key step toward making this technology more practical; however, CGM performance is hindered by diffusion lag and loss of sensitivity caused by encapsulation driven by the foreign body response.2,3 The IP space has already been shown to be valuable to AP applications, with experimental evidence showing both faster insulin action and faster glucose sensing in this space. 5,6 The performance of the flushed IP sensor presented here far exceeded that of the conventional SQ sensor after long implantation periods, showing promise for further investigation of the flushing method.This proof-of-concept study introduces the use of a flushing mechanism to allow CGM in the IP space with consistent responsiveness during 3 months in vivo. Future iterations of this system will utilize auto...

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“…9,10 Implantable CGM systems can provide the patient additional ease of use because no sensor is inserted through the skin, and consequently the transmitter can be removed easily and more frequently without the need for sensor replacement. Furthermore, the hassle of weekly sensor replacement with warm-up time and the risk of damage to the inserted sensor is reduced.…”

Section: Cgm Technology and Directions For Future Developmentmentioning

confidence: 99%

Continuous Glucose Monitoring, Future Products, and Update on Worldwide Artificial Pancreas Projects

Kropff

DeVries

2016

Diabetes Technology & Therapeutics

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The development of accurate and easy-to-use continuous glucose monitoring (CGM) improved diabetes treatment by providing additional temporal information on glycemia and glucose trends to patient and physician. Although CGM enables users to lower their average glucose level without an increased incidence of hypoglycemia, this comes at the price of additional patient effort. Automation of insulin administration, also known as closed-loop (CL) or artificial pancreas treatment, has the promise to reduce patient effort and improve glycemic control. CGM data serve as the conditional input for insulin automation devices. The first commercial product for partial automation of insulin administration used insulin delivery shutoff at a predefined glucose level. These systems showed a reduction in hypoglycemia. Insulin-only CL devices show increased time spent in euglycemia and a reduction of hypo-and hyperglycemia. Improved glycemic control, coinciding with a minor decrease in hemoglobin A1c level, was confirmed in recent long-term home studies investigating these devices, paving the way for pivotal studies for commercialization of the artificial pancreas. Although the first results from dual-hormone CL systems are promising, because of increased cost of consumables of these systems, long-term head-to-head studies will have to prove superiority over insulin-only approaches. Now CL glucose control for daily use might finally become reality. Improved continuous glucose sensing technology, miniaturization of electrical devices, and development of algorithms were key in making this possible. Clinical adoption challenges, including device usability and reimbursement, need to be addressed. Time will tell for which patient groups CL systems will be reimbursed and whether these devices can deliver the promise that they hold.

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Multisite Study of an Implanted Continuous Glucose Sensor Over 90 Days in Patients With Diabetes Mellitus

Cited by 31 publications

References 25 publications

Wearable Continuous Glucose Monitoring Sensors: A Revolution in Diabetes Treatment

Wearable Continuous Glucose Monitoring Sensors: A Revolution in Diabetes Treatment

Preliminary Evaluation of a Long-Term Intraperitoneal Glucose Sensor With Flushing Mechanism

Continuous Glucose Monitoring, Future Products, and Update on Worldwide Artificial Pancreas Projects

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