An Amperometric Glucose Sensor Integrated into an Insulin Delivery Cannula: In Vitro and In Vivo Evaluation

Ward, W. Kenneth; Heinrich, Gabriel; Breen, Matthew; Benware, Sheila; Vollum, Nicole; Morris, Kristin; Knutsen, Chad; Kowalski, Joseph D.; Campbell, Scott E.; Biehler, J.; Vreeke, Mark; Vanderwerf, Scott M.; Castle, Jessica R.; Cargill, Robert S.

doi:10.1089/dia.2016.0407

Cited by 10 publications

(7 citation statements)

References 23 publications

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“…Hence, with such a design, high friction forces generated during the insertion process may increase the probability of sensor failure. 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].…”

Section: Discussionmentioning

confidence: 99%

“…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]. The MARD values reported in these studies ranged from 13.5% to 22.5% [15], [28], [29].…”

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%

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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

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“…Additional barriers to AP use in young children include the limited amount of body surface area and adequate sites to wear two devices, 31 as well as frequent skin reactions and site failures in these patients. [32][33][34] Improved technologies, including a combined insulin infusion set and CGM sensor, 35 show promise and will be of great importance in this population. Finally, the use of AP algorithms that have been designed and tested in adults may not be appropriate for the management of very young children with T1D.…”

Section: Diabetes Technology and Therapeuticsmentioning

confidence: 99%

Artificial Pancreas in Young Children

Ohman-Hanson

Forlenza

2017

Diabetes Technology & Therapeutics

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T here have been many recent advancements in available technology for management of type 1 diabetes (T1D) in the past few years. Notably, the recent commercial approval of the Medtronic 670G system has made the first artificial pancreas (AP) available for use in patients older than 14 years. 1 Additional clinical studies are underway to develop, refine, and test various devices from almost a dozen industry and academic research groups. [2][3][4] Relatively few studies, however, have looked at AP use and feasibility in toddlers and young children; a population with unique management challenges such as unpredictable dietary habits, increased insulin sensitivity, and rapid glucose fluctuations with meals and activity, 5-7 as well as cognitive and verbal immaturity, which make it challenging to identify and report hypoglycemia. 8,9 These challenges cause significant parental stress and decreased quality of life for both the patients and their families. 9,10 Specifically, the fear of hypoglycemia (and its potential detrimental effects on neurocognitive development) leads to worse glycemic control and suboptimal HbA1c levels in this age group. [11][12][13][14] Recent technological advancements with continuous subcutaneous insulin infusion (CSII) pumps and continuous glucose monitors (CGMs) have led to decreased parental anxiety and improved quality of life in the T1D population. [15][16][17][18] Several small studies using AP in young children have shown reduced rates of hypoglycemia, although without significant improvements in glycemic control [19][20][21] as has been seen in older children and adults. [22][23][24][25] While these results are encouraging, widespread use of AP in young children may continue to be limited by parental fear of hypoglycemia. Specifically, fear regarding ability of the child to interact with increasingly complex devices and the risk of inadvertent delivery of inappropriate amounts of insulin, leading to either hypoglycemia or hyperglycemia. As the incidence of T1D in young children is on the rise, 13,26 optimal management options, including the use of AP technology, are of great importance.In this issue of Diabetes Technology and Therapeutics, DeBoer et al. present results of a small, randomized, crossover trial assessing the safety, feasibility, and efficacy of an AP system in young children with T1D (age 5-8 years) compared to their usual home regimen of sensor-augmented pump (SAP) therapy. 27 Unique to this study was the use of altered Diabetes Assistant control-platform software, which included child-resistant (password-protected) lock-out screens for pump settings and carbohydrate ingestion; an addition meant specifically to address the potential safety issue of accidental or intentional tampering with the control settings of an AP system. The authors report significantly improved glycemic control with increased time of blood glucose inrange (70-180 mg/dL) within the AP period versus the SAP period (73% vs. 47%; P < 0.001) and increased percent time of blood glucose in tight control ...

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“…In this issue of Diabetes Technology and Therapeutics, Ward, et al present preclinical results on a comprehensive series of CGM studies focused on the development of a single site combined IIS and CGM sensor device. 14 The need to wear two separate devices when conducting sensor augmented pump or AP therapy has been frequently raised as a barrier by patients in clinical care and during research studies. Previously held assumptions about combined devices have reasoned that measuring glucose at the insulin delivery site will result in inaccurate CGM values due to the local effects of insulin.…”

mentioning

confidence: 99%

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

Forlenza

2017

Diabetes Technology & Therapeutics

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An Amperometric Glucose Sensor Integrated into an Insulin Delivery Cannula: In Vitro and In Vivo Evaluation

Cited by 10 publications

References 23 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

Artificial Pancreas in Young Children

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

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