Insulin Micropump with Embedded Pressure Sensors for Failure Detection and Delivery of Accurate Monitoring
Open accessAbstract
Improved glycemic control with insulin pump therapy in patients with type 1 diabetes mellitus has shown gradual reductions in nephropathy and retinopathy. More recently, the emerging concept of the artificial pancreas, comprising an insulin pump coupled to a continuous glucose meter and a control algorithm, would become the next major breakthrough in diabetes care. The patient safety and the efficiency of the therapy are directly derived from the delivery accuracy of rapid-acting insulin. For this purpose, a specific precision-oriented design of micropump has been built. The device, made of a stack of three silicon wafers, comprises two check valves and a pumping membrane that is actuated against stop limiters by a piezo actuator. Two membranes comprising piezoresistive strain gauges have been implemented to measure the pressure in the pumping chamber and at the outlet of the pump. Their high sensitivity makes possible the monitoring of the pumping accuracy with a tolerance of ±5% for each individual stroke of 200 nL. The capability of these sensors to monitor priming, reservoir overpressure, reservoir emptying, outlet occlusion and valve leakage has also been studied.
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Written from the paper’s full text.
TL;DR
A MEMS reciprocating displacement insulin micropump with two integrated piezoresistive pressure sensors was characterized for delivery accuracy and failure detection. The sensors detected priming, occlusion, reservoir over/underpressure, leakage, and air bubbles, with delivery accuracy better than ±5% for observation windows larger than four minutes and a mean flow error of +0.28%.
Key findings
- The pump chip is a stack of three silicon wafers with two check valves and a pumping membrane actuated by a piezo actuator against stop limiters; nominal stroke volume is 200 nL, compression ratio is about 1.9:1, and two pressure sensors are placed in the pumping chamber and downstream of the outlet valve. The sensors have a sensitivity of 18 mV·V⁻¹·bar⁻¹, maximum offset of ±2 mV·V⁻¹·bar⁻¹, and minimum resolution of 1 mbar.
- Total occlusion was detected during the first actuation after the event, preferably using the outer sensor; stroke volume remained constant from −0.3 bar to +0.2 bar inlet pressure and did not vary with basal rate from 0.1 U/h to 70 U/h.
- Leakage detection is based on pressure decay after outlet valve closure and can detect an accuracy loss larger than 5%; a back-flow equivalent to a 5% decrease of nominal stroke volume changed the pressure decay. A 200 nL air bubble introduced into the pumping chamber enlarged and reduced inner-sensor pressure peaks and was progressively expelled over following strokes.
- At 1 U/h and 38 °C, delivery accuracy was better than ±5% for observation windows larger than four minutes, with mean flow error +0.28%. Maximum flow rate for water was 4.3 mL/h at 18 Hz; for water/glycerol mixes, maximum flow rate fell to 0.85 mL/h at 10 cP and 0.46 mL/h at 25 cP.
Methods
- The micropump was characterized in a clean room using a Sartorius MC5 precision scale with microgram resolution; a glass capillary was immersed in insulin Novorapid, with paraffin oil to prevent evaporation and temperature regulated at 20 ± 1 °C. Pressure sensor signals were recorded with NI 6143 data acquisition cards, and a Druck DPI520 pressure controller simulated occlusion, reservoir overpressure, or an empty reservoir; an oven at 38 °C simulated patch-pump in-use temperature.
- Tests covered priming at 3.125 Hz, occlusion in basal mode at 7.2 U/h, stroke volume versus inlet pressure, flow rate, actuation voltage, and viscosity using water and water/glycerol mixes, leakage using 6 × 10⁵ particles/mL of 0.5 micron silica particles, air bubble introduction of 200 nL, and delivery accuracy via trumpet curves according to IEC60601-2-24 processed with Infuscale 7.0.
Limitations
- Stated: air bubble results are only qualitative because fractioning of the air bubble makes estimation of the quantity of air in the pumping chamber during the test difficult.
- Stated: delivery accuracy test setup had limitations, in particular instabilities due to the temperature gradient in the flexible tube between the scale and the pumping unit, and the norm’s stabilization period was intentionally reduced from 24 h to 1 h.
- Evident from the text: characterization is bench/in vitro only, with no human or clinical outcomes reported; leakage testing removed the particle filter and used silica particles, and occlusion was simulated by clamping the cannula with tweezers.
Model-written summary. Check it against the paper before relying on it.
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Cites
Statistics
Claims the paper makes
0 of 2 cited sources checked · 0 supported · 0 flagged
- Findingreasoning
The device exhibits self-priming capabilities due to its high compression ratio of about 1.9:1 for a nominal stroke volume of 200 nL.
“Due to its high compression ratio, about 1.9:1 for a nominal stroke volume of 200 nL, the device exhibits self-priming capabilities.”
Quote in the paperNot a substantial claim - Findingreasoning
The pressure sensors' high sensitivity enables monitoring of pumping accuracy with a tolerance of ±5% for each individual 200 nL stroke.
“Their high sensitivity makes possible the monitoring of the pumping accuracy with a tolerance of ±5% for each individual stroke of 200 nL.”
Quote in the paperSubstantial claim - Findingown data
Infrared inspection revealed silica particles forming clusters on both valve seats.
“Infrared (IR) inspection has revealed an important amount of silica particles forming clusters on both valve seats.”
Quote in the paperNot a substantial claim - Findingown data
The pressure decay after outlet valve closure during the push phase is significantly changed for a back-flow equivalent to a 5% decrease of nominal stroke volume.
“It is worth noting that the pressure decay following the outlet valve closure, during the push phase, is significantly changed in the case of a back-flow equivalent to a decrease of 5% of the nominal stroke volume.”
Quote in the paperSubstantial claim - Findingown data
Delivery accuracy better than ±5% is obtained for observation windows larger than four minutes, despite test setup limitations.
“Despite the limitations induced by the test setup itself (in particular, the instabilities due to the temperature gradient in the flexible tube between the scale and the pumping unit), delivery accuracy better than ±5% is obtained for observation windows larger than four minutes.”
Quote in the paperSubstantial claim
- Findingown data
Stroke volume does not vary with insulin basal rate from 0.1 U/h to 70 U/h.
“Figure 8 shows that the stroke volume does not vary with the insulin basal rate, from a slow basal rate of 0.1 U/h to a very high basal rate of 70 U/h.”
Quote in the paperNot a substantial claim - Findingown data
The mean flow error with respect to the set rate is +0.28%.
“The mean flow error with respect to the set rate is equal to +0.28% here.”
Quote in the paperSubstantial claim - Findingown data
In both standard and reverse mode, the stroke volume remains constant for inlet pressures from -0.3 bar to +0.2 bar.
“Figure 6 shows that in both standard and reverse mode, the stroke volume remains constant in the range -0.3 bar to +0.2 bar.”
Quote in the paperSubstantial claim - Findingown data
The air bubble in the pumping chamber is expelled progressively during the following strokes.
“The air bubble in the pumping chamber is then expelled progressively during the following strokes.”
Quote in the paperNot a substantial claim - Findingnone given
Under normal pressure conditions, the mechanical stops are reached at 100 V.
“Under normal pressure conditions, the mechanical stops are reached at 100 V.”
Quote in the paperNot a substantial claim - Findingown data
Introducing air during Stroke 1 in the pumping chamber induces an enlargement and height reduction of the pressure peaks.
“The air is introduced during Stroke 1 in the pumping chamber, inducing an enlargement and a height reduction of the pressure peaks.”
Quote in the paperSubstantial claim - Findingown data
Both inner and outer sensor signals can be used to monitor pump priming because the change of signal shape after liquid introduction is significant.
“Both signals could be used to monitor the pump priming, since the change of the signal shape after the introduction of liquid in the pumping chamber is significant.”
Quote in the paperSubstantial claim - Findingown data
The inner sensor records typical pressure curves during introduction of a 200 nL air bubble in the pumping chamber.
“Figure 11 shows typical pressure curves recorded by the inner sensor during the introduction of this bubble in the pumping chamber.”
Quote in the paperSubstantial claim - Findingnone given
Reservoir over- and under-pressures are monitored in the filling phase of the pumping cycle using the inner sensor.
“Reservoir over-and under-pressures are monitored in the filling phase of the pumping cycle (i.e., when the inlet valve opens during a pull), using the inner sensor.”
Quote in the paperSubstantial claim - Interpretationown data
The leakage detection algorithm analyzes pressure decay just after pressure peaks and compares it to a threshold fraction of outlet valve pretension.
“The leakage detection algorithm is based on the analysis of the pressure decay just after the pressure peaks, which is compared to a threshold value being a fraction of the outlet valve pretension.”
Quote in the paperSubstantial claim - Interpretationreasoning
Any accuracy loss larger than 5% would be detected.
“Any accuracy loss larger than 5% would therefore be detected.”
Quote in the paperSubstantial claim - Interpretationown data
The constant stroke volume range is in good agreement with check valve pretension values of about 0.1 bar.
“This is in good agreement with the check valve pretension values in the range of 0.1 bar.”
Quote in the paperNot a substantial claim - Interpretationreasoning
Occlusion detection is a key factor for patient safety.
“Occlusion detection is therefore a key factor for patient safety.”
Quote in the paperNot a substantial claim- Rests on an assumption: Occlusion is a common failure of insulin pumps.
- Study design and conductreasoning
Removal of the particle filter does not change pump dynamics because its fluidic resistance is more than 100 times smaller than that of the pump chip.
“Since the fluidic resistance of this filter is more than 100-times smaller than the fluidic resistance of the pump chip itself, this removal does not change the pump dynamics.”
Quote in the paperSubstantial claim - Interpretationnone given
Integration of a pressure sensor within the pumping chamber is a powerful tool to understand the fluid dynamics inside the device.
“We show here that the integration of a pressure sensor within the pumping chamber is a powerful tool to understand the fluid dynamics inside the device.”
Quote in the paperSubstantial claim - Interpretationreasoning
The micropump can detect any malfunction (bubble, leakage) that leads to an accuracy loss larger than 5%.
“Thanks to its high compression ratio and small elasticity, this micropump is able to detect any malfunction (bubble, leakage) that leads to an accuracy loss larger than 5%.”
Quote in the paperSubstantial claim - Interpretationreasoning
The integrated pressure sensor is an essential element of the insulin micropump to prevent severe hyperglycemic episodes.
“This integrated pressure sensor is therefore an essential element of the insulin micropump to prevent any severe hyperglycemic episodes.”
Quote in the paperSubstantial claim - Interpretationnone given
The absence of positive pressure in the reservoir prevents insulin flow in case of valve leakage.
“In addition, the absence of positive pressure in the reservoir prevents any insulin flow in the case of valve leakage.”
Quote in the paperSubstantial claim - Interpretationown data
The air bubble detection algorithm is based on analysis of the shape of inner sensor pressure peaks.
“The air bubble detection algorithm is therefore based on the analysis of the shape of the inner sensor pressure peaks.”
Quote in the paperSubstantial claim
- May combine two claims. 9
- Classified as probably not a substantial claim. 5
May combine two claims.
Findingown dataFor water, flow rate varies linearly with actuation frequency up to 2.5 mL/h at 3.5 Hz, and maximum flow rate is 4.3 mL/h at 18 Hz.
“For water, the flow rate varies linearly with the actuation frequency up to 2.5 mL/h (actuation frequency of 3.5 Hz), and a maximum flow rate of 4.3 mL/h is measured at 18 Hz.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingreasoningTotal occlusion can be detected during the first actuation after the event, allowing an alarm and pump stop to prevent large pressure.
“Total occlusion could be detected during the first actuation that follows the event, thus triggering an alarm and stopping the pump to prevent the generation of large pressure, which may damage the fluidic line.”
Quote in the paperSubstantial claimMay combine two claims.
FindingreasoningAny occlusion induces a large increase of outlet pressure that can be detected by both sensors.
“Because the fluidic pathway downstream the micropump exhibits a very low compressibility, any occlusion will induce a large increase of the outlet pressure, which could be detected by both sensors.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Study design and conductnone givenStabilization of the scale is the key parameter to obtain reproducible results.
“The stabilization of the scale is the key parameter to obtain reproducible results.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationSwitching from multiple daily infusion (MDI) to continuous subcutaneous insulin infusion (CSII) reduces swings in blood glucose levels and limits severe hypoglycemia.
“Switching from multiple daily infusion (MDI) to continuous subcutaneous insulin infusion (CSII) induces well-known advantages, including the reduction of swings in blood glucose levels and the limitation of severe hypoglycemia [5][6][7].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [5][6][7]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Classified as probably not a substantial claim.
InterpretationreasoningThe outer sensor is preferably used to monitor occlusion.
“The outer sensor, which is in direct communication with the infusion site (i.e., without any valve in-between), is preferably used to monitor occlusion.”
Quote in the paperSubstantial claimMay combine two claims.
Interpretationnone givenThe height increase of the pressure peak in the pumping chamber during priming is mainly related to a change of compressibility, while the height of the pressure peak at the outer sensor location is more related to the viscosity change between gas and liquid.
“The height increase of the pressure peak in the pumping chamber during priming is mainly related to a change of compressibility, while the height of the pressure peak at the outer sensor location is more related to the viscosity change (between gas and liquid).”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationThe MEMS-based micropump provides outstanding delivery accuracy and failure detection capabilities.
“In addition, this MEMS-based micropump provides outstanding delivery accuracy and failure detection capabilities, as reported in recent in vitro and in vivo studies comparing the pumping capability of several pump systems [8].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [8] Borot, 2014, Accuracy of a new patch pump based on a microelectromechanical system (MEMS) compared to other commercially available insulin pumps: Results of the first in vitro and in vivo studies, J. Diabetes Sci. Technol. source
May combine two claims.
InterpretationreasoningStroke volume is independent of viscosity for incompressible media, but maximum flow rate is reduced for viscous liquid.
“The stroke volume is independent of viscosity for incompressible media, since the device is a volumetric pump, but the maximum flow rate is reduced for viscous liquid.”
Quote in the paperSubstantial claimMay combine two claims.
Interpretationnone givenThe device can pump with very high accuracy up to 2.5 mL/h and its integrated piezoresistive pressure sensors can detect malfunctions (occlusion, reservoir over/under pressure, air bubbles, leakage) that could lead to accuracy loss larger than 5%.
“In addition to its capability to pump with very high accuracy up to a rate of 2.5 mL/h, the device comprises powerful integrated piezoresistive pressures sensors able to detect malfunctions, like occlusion, reservoir over/under pressure, air bubbles or leakage, which could lead to an accuracy loss larger than 5%.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationreasoningA sensor in the pumping chamber able to monitor delivery accuracy is a key element to prevent severe hypoglycemic episodes and improve safety of future closed-loop systems.
“The presence of a sensor in the pumping chamber able to monitor delivery accuracy is a key element to prevent severe hypoglycemic episodes and to improve the safety of future closed-loop systems.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe air bubble results are only qualitative because fractioning makes estimation of air quantity difficult.
“These results are only qualitative, because of the fractioning of the air bubble, making the estimation of the quantity of air in the pumping chamber during the test difficult.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Occlusion is a common failure of insulin pumps.
“Occlusion is a common failure of insulin pumps.”
The paper relies on this without support.
Patient safety and efficiency of insulin therapy are directly derived from delivery accuracy of rapid-acting insulin.
“The patient safety and the efficiency of the therapy are directly derived from the delivery accuracy of rapid-acting insulin.”
The paper relies on this without support.
Microfluidic devices are usually not able to guarantee correct infusion, in particular in the case of failure.
“In contrast to syringe pumps, which control the residual volume of the insulin reservoir via the monitoring of the plunger position, microfluidic devices are usually not able to guarantee correct infusion, in particular in the case of failure.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Hypoglycemia can occur if an occlusion is due to kinking or compression and the insulin infusion rate is increased to overcome the occlusion and maintain normoglycemia, because after the occlusion is relieved a relatively large volume of noninfused insulin is suddenly delivered.
“hypoglycemia if an occlusion is due to kinking or compression and if the insulin infusion rate is increased to overcome the occlusion and maintain normoglycemia, then after the occlusion is relieved, a relatively large volume of noninfused insulin that was not infused during the occlusion will suddenly be delivered.4”
From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [4]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured
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Digital technologies for personal health management and preventative healthcare
Wortley, D. J. (2018) · Digital Medicine · doi:10.4103/digm.digm_21_18
“Examples of this approach include the use of embedded sensor devices that detect glucose levels and control an insulin pump for people living with diabetes.[5] With the growing pressure on global health resources, solutions such as this and digital applications that allow patients to monitor their health and engage in…”
BackgroundFast Electrochemical Micropump for Portable Drug Delivery Module
Uvarov, I. V., Shlepakov, P. S., Abramychev, A. M., et al. (2023) · Микроэлектроника · doi:10.31857/s0544126923700345
Chappel, E. (2024) · Encyclopedia · doi:10.3390/encyclopedia4020052
“Indeed, residual air bubbles lower the stroke volume as the compliance (or fluid capacitance) of the pumping chamber increases: a part of the volume displaced by the pumping chamber serves to compress air instead of pushing insulin through the infusion line [40,98].”
BackgroundMethodInfluentialSelf-citationSwashplate type micropumps for use in microneedle array patches: Concept development
Schwegler, A., & Kazi, A. (2026) · Sensors and Actuators A Physical · doi:10.1016/j.sna.2026.118391
- Authors
- Dumont-Fillon, D., Tahriou, H., Conan, C., & Chappel, E.
- Affiliations
- Debiotech (Switzerland) (CH)
- Corresponding author
- Chappel, Eric
- ORCID
- Chappel, Eric
- Venue
- Micromachines
- Publisher
- MDPI AG
- Published
- 2014-11-18
- Volume
- 5
- Issue
- 4
- Pages
- 1161-1172
- ISSN
- 2072-666X (ISSN-L)
- OpenAlex
- W2089992465
- Semantic Scholar
- 40febafaf4e1cd297311891ebbabfa4dfab0ecaa
- Cited by
- 38
- References
- 14
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 5 · 2022: 7 · 2021: 5 · 2020: 6 · 2019: 2 · 2018: 2 · 2017: 4 · 2016: 3 · 2015: 1
- FWCI
- 1.41
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Micromachines (publishedVersion, cc-by)
- HAL (Le Centre pour la Communication Scientifique Directe) (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Physical Sciences › Engineering › Electrical and Electronic Engineering › Advanced MEMS and NEMS Technologies
- Physical Sciences › Engineering › Biomedical Engineering › Microfluidic and Capillary Electrophoresis Applications
- Physical Sciences › Engineering › Biomedical Engineering › Intravenous Infusion Technology and Safety
- Keywords
- pressure sensors, piezoresistive strain gauges, piezoelectric actuators, fault detection, type 1 diabetes, artificial pancreas, continuous glucose monitoring, rapid-acting insulin, check valves, valve leakage
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