First application of a transcutaneous optical single-port glucose monitoring device in patients with type 1 diabetes mellitus

Rumpler, Markus; Mader, Julia K.; Fischer, J.P.; Thar, R.; Granger, Jaimie; Deliane, Florent; Klimant, Ingo; Aberer, Felix; Sinner, Frank; Pieber, Thomas R.; Hajnsek, Martin

doi:10.1016/j.bios.2016.08.039

Cited by 21 publications

(17 citation statements)

References 28 publications

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“…For example, following insertion into adipose tissue of swine, Ward et al observed fractures or short circuits in approximately one third of their electrochemical glucose sensors integrated onto the outer cannula walls [28]. To reduce the probability of experiencing such structural integrity issues Rumpler et al pre-punctured the human skin with a large gauge needle prior to inserting the device [29]. However, a more permanent solution would require time-and costintensive single-port design refinements like creating an additional lumen for the sensor-probe, increasing the glucose sensor's mechanical robustness or developing completely new insertion techniques.…”

Section: Discussionmentioning

confidence: 99%

“…To our knowledge, so far only two other research groups reported the in vivo assessment of the accuracy of the glucose sensing with their single-port devices. In a study conducted under hospital settings, the glucose sensing accuracy of the single-port device was evaluated in type 1 diabetes subjects without however administering any insulin via the device [29]. In other in vivo studies, the glucose sensing accuracy of the single-port devices was assessed in anesthetized swine during either constant basal insulin delivery [15], [34], [35] or following the administration of bolus insulin [28], [34].…”

Section: Discussionmentioning

confidence: 99%

“…In other in vivo studies, the glucose sensing accuracy of the single-port devices was assessed in anesthetized swine during either constant basal insulin delivery [15], [34], [35] or following the administration of bolus insulin [28], [34]. The MARD values reported in these studies ranged from 13.5% to 22.5% [15], [28], [29]. Unfortunately, since a retrospective calibration method was used to convert the sensor currents into blood glucose concentrations, it is difficult to directly compare the reported MARD values with those of commercial CGM devices which typically employ a prospective calibration scheme [36].…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Novel Single-Site Device for Conjoined Glucose Sensing and Insulin Infusion: Performance Evaluation in Diabetes Patients During Home-Use

Tschaikner

Powell

Jungklaus

et al. 2020

IEEE Trans. Biomed. Eng.

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Diabetes patients are increasingly using a continuous glucose sensor to monitor blood glucose and an insulin pump connected to an infusion cannula to administer insulin. Applying these devices requires two separate insertion sites, one for the sensor and one for the cannula. Integrating sensor with cannula to perform glucose sensing and insulin infusion through a single insertion site would significantly simplify and improve diabetes treatment by reducing the overall system size and the number of necessary needle pricks. Presently, several research groups are pursuing the development of combined glucose sensing and insulin infusion devices, termed single-port devices, by integrating sensing and infusion technologies created from scratch. Methods: Instead of creating the device from scratch, we utilized already existing technologies and introduced three design concepts of integrating commercial glucose sensors and infusion cannulas. We prototyped and evaluated each concept according to design simplicity, ease of insertion, and sensing accuracy. Results: We found that the best single-port device is the one in which a Dexcom sensor is housed inside a Medtronic cannula so that its glucose sensitive part protrudes from the cannula tip. The low degree of component modification required to arrive at this configuration allowed us to test the efficiency and safety of the device in humans. Conclusion: Results from these studies indicate the feasibility of combining commercial glucose sensing and insulin delivery technologies to realize a functional single-port device. Significance: Our development approach may be generally useful to provide patients with innovative medical devices faster and at reduced costs.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Novel Single-Site Device for Conjoined Glucose Sensing and Insulin Infusion: Performance Evaluation in Diabetes Patients During Home-Use

Tschaikner

Powell

Jungklaus

et al. 2020

IEEE Trans. Biomed. Eng.

View full text Add to dashboard Cite

show abstract

“…Rumpler, et al recently reported results of such a device during in vitro and human in vivo studies. 17 Rumpler's in vitro studies showed a very strong linear correlation (R 2 = 0.998) between the CGM and reference glucose value in the range of 0-300 mg/dL. The human-use studies showed a mean absolute relative difference (MARD) of 22.5% with a consensus error grid (CEG) analysis 18,19 showing 87% of values in zone A+B.…”

mentioning

confidence: 98%

Insulin Infusion Sets and Continuous Glucose Monitoring Sensors: Where the Artificial Pancreas Meets the Patient

Forlenza

2017

Diabetes Technology & Therapeutics

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“…In recent years, various glucose-sensing mechanisms for non-invasive, or at least minimally invasive, CGM have been tested [18][19][20][21][22][23][24][25][26], in an attempt to match all fundamental requirements for an extended in vivo use, e.g., sensitivity, specificity, linearity within biological relevant range, biocompatibility, and lifetime [13]. Among all the proposed techniques, i.e., electrochemical, optical, and piezoelectric, the one that is today exploited by most of the commercialized CGM systems is the glucose-oxidase electrochemical principle [8].…”

Section: Cgm Sensor Technologiesmentioning

confidence: 99%

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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First application of a transcutaneous optical single-port glucose monitoring device in patients with type 1 diabetes mellitus

Cited by 21 publications

References 28 publications

Novel Single-Site Device for Conjoined Glucose Sensing and Insulin Infusion: Performance Evaluation in Diabetes Patients During Home-Use

Novel Single-Site Device for Conjoined Glucose Sensing and Insulin Infusion: Performance Evaluation in Diabetes Patients During Home-Use

Insulin Infusion Sets and Continuous Glucose Monitoring Sensors: Where the Artificial Pancreas Meets the Patient

Wearable Continuous Glucose Monitoring Sensors: A Revolution in Diabetes Treatment

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