Development of a Single-Site Device for Conjoined Glucose Sensing and Insulin Delivery in Type-1 Diabetes Patients

Tschaikner, Mathias; Simic, Amra; Jungklaus, Miro; Fritz, Martin; Ellmerer, Martin; Pieber, Thomas R.; Regittnig, Werner

doi:10.1109/tbme.2019.2919234

Cited by 12 publications

(6 citation statements)

References 32 publications

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“…Several groups have attempted to combine a sensor and infusion set into one device, but it was not practical because of limited infusion set longevity. [11][12][13][14] Recent work by Tschaikner et al reveals that off-the-shelf CGM and infusion sets can be combined by running the sensor wire through the cannula. 13 With the sensor wire extending 6 mm through the infusion set cannula opening, the sensor glucose obtained from the single-site device did not differ significantly from a separately worn CGM.…”

Section: Discussionmentioning

confidence: 99%

“…Thus, any attempt to create a combined sensor and insulin infusion set requires an infusion set with greater longevity. Several groups have attempted to combine a sensor and infusion set into one device, but it was not practical because of limited infusion set longevity 11–14 . Recent work by Tschaikner et al reveals that off‐the‐shelf CGM and infusion sets can be combined by running the sensor wire through the cannula 13 .…”

Section: Discussionmentioning

confidence: 99%

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Longevity of the novel ConvaTec infusion set with Lantern technology

Lal¹,

Hsu

Zhang

et al. 2021

Diabetes Obesity Metabolism

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Current insulin infusion sets are approved for only 2-3 days. The novel ConvaTec infusion set with Lantern technology is designed to extend infusion set wear time.The goal of this pilot study was to evaluate the duration of wear for this set. This was a pilot safety study in adults with type 1 diabetes using tethered insulin pumps. Participants inserted the set and wore it for 10 days or until failure. Among 24 participants, two were excluded. Forty-five per cent of the sets lasted 10 days. Median wear time was 9.1 (7.1, 10.0) days. Among 12 premature failures, six (50%) involved adhesive failures, four (33%) hyperglycaemia unresponsive to correction, one (8%) hyperglycaemia with ketones and one (8%) infection. Average CGM glucose per day of infusion set wear showed a statistically significant increase over time, while total daily insulin over the same period did not change. In this pilot study, the duration of wear for the novel infusion set exceeded previously reported commercial sets (P < .001). This extended wear technology may eventually allow for a combined glucose sensor and infusion set.CSII, insulin pump therapy, insulin therapy, type 1 diabetes | INTRODUCTIONThe weak link in insulin pump and closed-loop therapy is the insulin infusion set that is inserted under the skin. There is limited information on the interaction between the infusion set, subcutaneous tissue and insulin. The infusion set can become occluded or kinked, and local inflammation and infection around the site can result in insufficient insulin delivery, high glucose levels, ketoacidosis and death. 1,2 There are few studies [3][4][5][6][7] published on the extended use of infusion sets beyond 3 days, although investigation is in progress by Capillary Biomedical (NCT04398030) and Medtronic (NCT04113694). Past studies have tested infusion sets for up to 7 days: Patel et al. reported a median wear time of 6.06 (4.35, 6.98) days, 5 Karlin et al. a least squares mean wear time of 4.12-4.31 days, 6 and Waldenmaier et al. a mean wear time of 6.2 ± 1.5 days. 7 The study conducted by Patel et al. established failure criteria for infusion sets and was a randomized, open-label, crossover study of 20 subjects who wore Teflon catheter (Quick-Set) and steel catheter (Sure-T) infusions set for up to 1 week with no difference in the survival curves of the infusion sets.Length of wear of any infusion set was subject specific, and 30% of failures were secondary to uncorrectable hyperglycaemia, indicating partial catheter occlusion or limitations on insulin absorption in the subcutaneous space. 5 The Karlin study was a multicentre, crossover trial that showed no difference in infusion set survival or mean glucose in 20 individuals with type 1 diabetes wearing the sets in lipohypertrophied and non-lipohypertrophied tissue.Our hypothesis was that the ConvaTec infusion set with Lantern technology, a novel infusion set (Figure 1) with additional slitted

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Longevity of the novel ConvaTec infusion set with Lantern technology

Lal¹,

Hsu

Zhang

et al. 2021

Diabetes Obesity Metabolism

View full text Add to dashboard Cite

show abstract

“…The distance between the glucose sensing element and the insulin egress pathway was 6 mm (5). Earlier in the year Tschaikner and colleagues reported the creation of an improvised single-port device from commercially available supplies and 3D-printed adapter (6). The glucose sensor extended 6 mm below the cannula opening utilizing an older generation Dexcom with longer wire length.…”

Section: Commentmentioning

confidence: 99%

“…High-protein meals require 30% additional insulin to prevent delayed postprandial hyperglycaemia Coast, Australia; 6 School of Medicine, Griffith University, Gold Coast, Queensland, Australia; 7 Insulin Pump Angels, Gold Coast, Australia Diabet Med 2020; 37: 1185-1191…”

Section: Commentmentioning

confidence: 99%

Insulin Delivery Hardware: Pumps and Pens

Lal

Leelarathna

2021

Diabetes Technology & Therapeutics

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“…Synthetic biology sensors have been embedded into face masks to detect pathogens such as coronavirus in breath aerosols . The fabrication of thin-film electrochemical glucose sensors onto insulin infusion cannulas required for insulin infusion obviates the need for insertion of two devices . However, examples and capabilities of such dual-functional devices remain limited.…”

mentioning

confidence: 99%

S-Nitrosothiol-Impregnated Silicone Catheter for Colorimetric Sensing of Indole and E. coli: Toward On-Body Detection of Urinary Tract Infections

Brady

Farooque

et al. 2022

ACS Sens.

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Although there are many techniques to detect pathogenic bacteria, most of them are only suited for in vitro diagnostics. We report a urinary catheter-based colorimetric sensor for potential on-body detection of E. coli, the most prevalent bacterial species in urinary tract infections associated with the use of urinary catheters. In urine, indole is secreted by E. coli and reacts with a nitrosating agent incorporated in a silicone catheter. A red dimeric product, indoxyl red, is generated within silicone rubber to allow for color-based indole sensing with high sensitivity, linearity, and specificity. This reaction is initiated by the nitrosation reaction of indole at its C-3 position via reagents like sodium nitrite or Snitroso-N-acetyl-penicillamine under aerobic conditions. The generated 3-nitrosoindole undergoes tautomerization, dimerization, and deoximation to form indoxyl red with high absorbance at 537 nm. In contrast to other indole sensors, the presented method can be applied in real catheters to detect indole and E. coli in biofluids such as urine. The is because (1) S-nitroso-N-acetyl-penicillamine, the nitrosating agent, can be impregnated into silicone elastomers, (2) indole from urine is extracted into silicone due to its hydrophobicity, and (3) the high acidity and oxygen solubility of silicone facilitates the sensing reaction within the silicone matrix. This silicone-based colorimetric sensor clearly differentiates E. coli below and above 10 5 CFU/mL, which is the threshold concentration of bacteriuria. We expect that early diagnosis of urinary tract infections using the naked eye is possible by functionalizing an exposed section of urinary catheters with the proposed molecular probe.

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Development of a Single-Site Device for Conjoined Glucose Sensing and Insulin Delivery in Type-1 Diabetes Patients

Cited by 12 publications

References 32 publications

Longevity of the novel ConvaTec infusion set with Lantern technology

Longevity of the novel ConvaTec infusion set with Lantern technology

Insulin Delivery Hardware: Pumps and Pens

S-Nitrosothiol-Impregnated Silicone Catheter for Colorimetric Sensing of Indole and E. coli: Toward On-Body Detection of Urinary Tract Infections

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