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2. Estimation of nonlinear differential equation model for glucose-insulin dynamics in type I diabetic patients using generalized smoothing

Author

Chervoneva, Inna, Freydin, Boris, Hipszer, Brian, Apanasovich, Tatiyana V., and Joseph, Jeffrey I.

Subjects
Statistics - Applications
Abstract

In this work we develop an ordinary differential equations (ODE) model of physiological regulation of glycemia in type 1 diabetes mellitus (T1DM) patients in response to meals and intravenous insulin infusion. Unlike for the majority of existing mathematical models of glucose-insulin dynamics, parameters in our model are estimable from a relatively small number of noisy observations of plasma glucose and insulin concentrations. For estimation, we adopt the generalized smoothing estimation of nonlinear dynamic systems of Ramsay et al. [J. R. Stat. Soc. Ser. B Stat. Methodol. 69 (2007) 741-796]. In this framework, the ODE solution is approximated with a penalized spline, where the ODE model is incorporated in the penalty. We propose to optimize the generalized smoothing by using penalty weights that minimize the covariance penalties criterion (Efron [J. Amer. Statist. Assoc. 99 (2004) 619-642]). The covariance penalties criterion provides an estimate of the prediction error for nonlinear estimation rules resulting from nonlinear and/or nonhomogeneous ODE models, such as our model of glucose-insulin dynamics. We also propose to select the optimal number and location of knots for B-spline bases used to represent the ODE solution. The results of the small simulation study demonstrate advantages of optimized generalized smoothing in terms of smaller estimation errors for ODE parameters and smaller prediction errors for solutions of differential equations. Using the proposed approach to analyze the glucose and insulin concentration data in T1DM patients, we obtained good approximation of global glucose-insulin dynamics and physiologically meaningful parameter estimates., Comment: Published in at http://dx.doi.org/10.1214/13-AOAS706 the Annals of Applied Statistics (http://www.imstat.org/aoas/) by the Institute of Mathematical Statistics (http://www.imstat.org)

Published
2014
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3. Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study

Author

Hahnen, Christina, Freeman, Cecilia G, Haldar, Nilanjan, Hamati, Jacquelyn N, Bard, Dylan M, Murali, Vignesh, Merli, Geno J, Joseph, Jeffrey I, and van Helmond, Noud

Subjects
Information technology, T58.5-58.64, Public aspects of medicine, RA1-1270
Abstract

BackgroundNew consumer health devices are being developed to easily monitor multiple physiological parameters on a regular basis. Many of these vital sign measurement devices have yet to be formally studied in a clinical setting but have already spread widely throughout the consumer market. ObjectiveThe aim of this study was to investigate the accuracy and precision of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation (SpO2) measurements of 2 novel all-in-one monitoring devices, the BodiMetrics Performance Monitor and the Everlast smartwatch. MethodsWe enrolled 127 patients (>18 years) from the Thomas Jefferson University Hospital Preadmission Testing Center. SBP and HR were measured by both investigational devices. In addition, the Everlast watch was utilized to measure DBP, and the BodiMetrics Performance Monitor was utilized to measure SpO2. After 5 min of quiet sitting, four hospital-grade standard and three investigational vital sign measurements were taken, with 60 seconds in between each measurement. The reference vital sign measurements were calculated by determining the average of the two standard measurements that bounded each investigational measurement. Using this method, we determined three comparison pairs for each investigational device in each subject. After excluding data from 42 individuals because of excessive variation in sequential standard measurements per prespecified dropping rules, data from 85 subjects were used for final analysis. ResultsOf 85 participants, 36 (42%) were women, and the mean age was 53 (SD 21) years. The accuracy guidelines were only met for the HR measurements in both devices. SBP measurements deviated 16.9 (SD 13.5) mm Hg and 5.3 (SD 4.7) mm Hg from the reference values for the Everlast and BodiMetrics devices, respectively. The mean absolute difference in DBP measurements for the Everlast smartwatch was 8.3 (SD 6.1) mm Hg. The mean absolute difference between BodiMetrics and reference SpO2 measurements was 3.02%. ConclusionsBoth devices we investigated met accuracy guidelines for HR measurements, but they failed to meet the predefined accuracy guidelines for other vital sign measurements. Continued sale of consumer physiological monitors without prior validation and approval procedures is a public health concern.

Published
2020
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7. Progressive Acceleration of Insulin Exposure Over 7 Days of Infusion Set Wear

Author

Kastner, Jasmin R., Bailey, Timothy S., Strange, Poul, Shi, Leon, Oberg, Keith A., Strasma, Paul J., Joseph, Jeffrey I., Muchmore, Douglas B., Kastner, Jasmin R., Bailey, Timothy S., Strange, Poul, Shi, Leon, Oberg, Keith A., Strasma, Paul J., Joseph, Jeffrey I., and Muchmore, Douglas B.

Abstract

Insulin exposure varies over 3 days of insulin infusion set (IIS) wear making day-to-day insulin dosing challenging for people with diabetes (PWD). Here we report insulin pharmacodynamic (PD) and pharmacokinetic (PK) data extending these observations to 7 days of IIS wear. PWD (A1C ≤8.5%, C-peptide tmax (P < 0.001), Cmax (P < 0.05), and mean residence time (P < 0.0001). Area under the insulin concentration curve (AUC0–300) declined by ∼24% from days 0 to 7 (P < 0.05). These results confirm/extend previous observations showing progressive acceleration of insulin exposure over IIS wear time. This may have implications for PWD and designers of closed-loop algorithms, although larger studies are necessary to confirm this. The study was registered in clinicaltrials.gov (NCT04398030).

Published
2022

9. In Vivo Study of the Inflammatory Tissue Response Surrounding a Novel Extended-Wear Kink-Resistant Insulin Infusion Set Prototype Compared With a Commercial Control Over Two Weeks of Wear Time

Author

Kastner, Jasmin R., primary, Eisler, Gabriella, additional, Torjman, Marc C., additional, Khalf, Abdurizzagh, additional, Diaz, David, additional, Dinesen, Alek R., additional, Loeum, Channy, additional, Strasma, Paul J., additional, and Joseph, Jeffrey I, additional

Published
2022
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10. Hypoglycemia

Author

Hipszer, Brian, primary, Heitz, James W., additional, and Joseph, Jeffrey I., additional

Published
2016
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11. Feasibility study of a prototype extended‐wear insulin infusion set in adults with type 1 diabetes

Author

Kastner, Jasmin R., primary, Venkatesh, Nisha, additional, Brown, Katie, additional, Muchmore, Douglas B., additional, Ekinci, Elif, additional, Fourlanos, Spiros, additional, Joseph, Jeffrey I, additional, Shafeeq, Miami, additional, Shi, Leon, additional, Strange, Poul, additional, Strasma, Paul J., additional, and O'Neal, David N., additional

Published
2022
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19. Cuff-Less Methods for Blood Pressure Telemonitoring

Author

Bard, Dylan M., Joseph, Jeffrey I., and van Helmond, Noud

Subjects
tonometry, hypertension, blood pressure telemonitoring, pulse transit time, Mini Review, telemedicine, Cardiovascular Medicine
Abstract

Blood pressure telemonitoring (BPT) is a telemedicine strategy that uses a patient's self-measured blood pressure (BP) and transmits this information to healthcare providers, typically over the internet. BPT has been shown to improve BP control compared to usual care without remote monitoring. Traditionally, a cuff-based monitor with data communication capabilities has been used for BPT; however, cuff-based measurements are inconvenient and cause discomfort, which has prevented the widespread use of cuff-based monitors for BPT. The development of new technologies which allow for remote BP monitoring without the use of a cuff may aid in more extensive adoption of BPT. This would enhance patient autonomy while providing physicians with a more complete picture of their patient's BP profile, potentially leading to improved BP control and better long-term clinical outcomes. This mini-review article aims to: (1) describe the fundamentals of current techniques in cuff-less BP measurement; (2) present examples of commercially available cuff-less technologies for BPT; (3) outline challenges with current methodologies; and (4) describe potential future directions in cuff-less BPT development.

Published
2019

22. In vivo investigation of the tissue response to commercial Teflon insulin infusion sets in large swine for 14 days: the effect of angle of insertion on tissue histology and insulin spread within the subcutaneous tissue.

Author

Eisler, Gabriella, Kastner, Jasmin R., Torjman, Marc C., Khalf, Abdurizzagh, Diaz, David, Dinesen, Alek R., Loeum, Channy, Thakur, Mathew L., Strasma, Paul, Joseph, Jeffrey I., Eisler, Gabriella, Kastner, Jasmin R., Torjman, Marc C., Khalf, Abdurizzagh, Diaz, David, Dinesen, Alek R., Loeum, Channy, Thakur, Mathew L., Strasma, Paul, and Joseph, Jeffrey I.

Abstract

Objective: This study investigated the effects of the inflammatory tissue response (ITR) to an insulin infusion set (IIS) on insulin bolus spread over wear time, as well as the effect of cannula insertion angle on the ITR, bolus shape, and pump tubing pressure. Research design and methods: Angled or straight IISs were inserted every other day for 14 days into the subcutaneous tissue of 11 swine and insulin was delivered continuously. Prior to euthanasia, a 70 µL bolus of insulin/X-ray contrast agent was infused while recording a pressure profile (peak tubing pressure, pmax; area under the pressure curve, AUC), followed by the excision of the tissue-catheter specimen. Bolus surface area (SA) and volume (V) were assessed via micro-CT. Tissue was stained to analyze total area of inflammation (TAI) and inflammatory layer thickness (ILT) surrounding the cannula. Results: A bolus delivered through an angled IIS had a larger mean SA than a bolus delivered through a straight cannula (314.0±84.2 mm2 vs 229.0±99.7 mm2, p<0.001) and a larger volume (198.7±66.9 mm3 vs 145.0±65.9 mm3, p=0.001). Both decreased significantly over wear time, independent of angle. There was a significant difference in TAI (angled, 9.1±4.0 mm2 vs straight, 14.3±8.6 mm2, p<0.001) and ILT (angled, 0.7±0.4 vs straight, 1.2±0.7 mm, p<0.001). pmax (p=0.005) and AUC (p=0.014) were lower using angled IIS. As ILT increased, pmax increased, while SA and V decreased. Conclusions: The progression of the ITR directly affected bolus shape and tubing pressure. Although straight insertion is clinically preferred, our data suggest that an angled IIS elicits lower grades of ITR and delivers a bolus with lower tubing pressure and greater SA and V. The subcutaneous environment plays a crucial role in IIS longevity, and the insertion angle needs to be considered in future IIS designs and clinical trials.

Published
2019

24. In vivo investigation of the tissue response to commercial Teflon insulin infusion sets in large swine for 14 days: the effect of angle of insertion on tissue histology and insulin spread within the subcutaneous tissue

Author

Eisler, Gabriella, primary, Kastner, Jasmin R, additional, Torjman, Marc C, additional, Khalf, Abdurizzagh, additional, Diaz, David, additional, Dinesen, Alek R, additional, Loeum, Channy, additional, Thakur, Mathew L, additional, Strasma, Paul, additional, and Joseph, Jeffrey I, additional

Published
2019
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35. Detailed Analysis of Insulin Absorption Variability and the Tissue Response to Continuous Subcutaneous Insulin Infusion Catheter Implantation in Swine

Author

Hauzenberger, Jasmin R., primary, Hipszer, Brian R., additional, Loeum, Channy, additional, McCue, Peter A., additional, DeStefano, Mark, additional, Torjman, Marc C., additional, Kaner, Mahmut T., additional, Dinesen, Alek R., additional, Chervoneva, Inna, additional, Pieber, Thomas R., additional, and Joseph, Jeffrey I, additional

Published
2017
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38. Glucose Control in the ICU

Author

Preiser, Jean-Charles, primary, Chase, J. Geoffrey, additional, Hovorka, Roman, additional, Joseph, Jeffrey I., additional, Krinsley, James S., additional, De Block, Christophe, additional, Desaive, Thomas, additional, Foubert, Luc, additional, Kalfon, Pierre, additional, Pielmeier, Ulrike, additional, Van Herpe, Tom, additional, and Wernerman, Jan, additional

Published
2016
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39. Assessing the Accuracy of Continuous Glucose Monitoring (CGM) Calibrated With Capillary Values Using Capillary or Venous Glucose Levels as a Reference

Author

Andelin, Mervi, primary, Kropff, Jort, additional, Matuleviciene, Viktorija, additional, Joseph, Jeffrey I., additional, Attvall, Stig, additional, Theodorsson, Elvar, additional, Hirsch, Irl B., additional, Imberg, Henrik, additional, Dahlqvist, Sofia, additional, Klonoff, David, additional, Haraldsson, Börje, additional, DeVries, J. Hans, additional, and Lind, Marcus, additional

Published
2016
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43. Development of an Implantable NIR Spectroscopic Blood Glucose Sensor: In-Vivo Results in Dogs

Author

CROTHALL, KATHERINE D., JOSEPH, JEFFREY I., TORJMAN, MARC C., JAHN, LUIS G., MORITZ, MICHAEL J., SULLIVAN, MICHAEL E., GOLDSTEIN, BARRY J., and BUTOI, BOGDAN

Subjects
Diabetes -- Research, Health
Abstract

Using near-infrared spectroscopy (NIR), we have demonstrated in-vivo measurement of blood glucose in four anethesized dogs on an acute basis. To our knowledge, this is the first such demonstration. Sensor [...]

Published
1999

44. Development of an Implantable NIR Spectroscopic Blood Glucose Sensor: In-Vitro Results with Whole Blood

Author

CROTHALL, KATHERINE D., JAHN, LUIS G., TORJMAN, MARC C., BUTOI, BOGDAN, GOLDSTEIN, BARRY J., JOSEPH, JEFFREY I., and NORRIS, KARL

Subjects
Diabetes -- Research, Health
Abstract

Using near-infrared (NIR) spectroscopy and a universal calibration requiring fewer than 18 wavelengths, we have shown that glucose concentration can be measured accurately in whole blood over the physiological range [...]

Published
1999

47. A Clinical Trial of the Accuracy and Treatment Experience of the Dexcom G4 Sensor (Dexcom G4 System) and Enlite Sensor (Guardian REAL-Time System) Tested Simultaneously in Ambulatory Patients with Type 1 Diabetes

Author

Matuleviciene, Viktorija, primary, Joseph, Jeffrey I., additional, Andelin, Mervi, additional, Hirsch, Irl B., additional, Attvall, Stig, additional, Pivodic, Aldina, additional, Dahlqvist, Sofia, additional, Klonoff, David, additional, Haraldsson, Börje, additional, and Lind, Marcus, additional

Published
2014
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50. Clinical review: Consensus recommendations on measurement of blood glucose and reporting glycemic control in critically ill adults.

Author

Finfer, Simon, Wernerman, Jan, Preiser, Jean-Charles, Cass, Tony, Desaive, Thomas, Hovorka, Roman, Joseph, Jeffrey I, Kosiborod, Mikhail, Krinsley, James, Mackenzie, Iain, Mesotten, Dieter, Schultz, Marcus J, Scott, Mitchell G, Slingerland, Robbert, Van den Berghe, Greet, Van Herpe, Tom, Finfer, Simon, Wernerman, Jan, Preiser, Jean-Charles, Cass, Tony, Desaive, Thomas, Hovorka, Roman, Joseph, Jeffrey I, Kosiborod, Mikhail, Krinsley, James, Mackenzie, Iain, Mesotten, Dieter, Schultz, Marcus J, Scott, Mitchell G, Slingerland, Robbert, Van den Berghe, Greet, and Van Herpe, Tom

Abstract

The management reporting and assessment of glycemic control lacks standardization. The use of different methods to measure the blood glucose concentration and to report the performance of insulin treatment yields major disparities and complicates the interpretation and comparison of clinical trials. We convened a meeting of 16 experts plus invited observers from industry to discuss and where possible reach consensus on the most appropriate methods to measure and monitor blood glucose in critically ill patients and on how glycemic control should be assessed and reported. Where consensus could not be reached, recommendations on further research and data needed to reach consensus in the future were suggested. Recognizing their clear conflict of interest, industry observers played no role in developing the consensus or recommendations from the meeting. Consensus recommendations were agreed for the measurement and reporting of glycemic control in clinical trials and for the measurement of blood glucose in clinical practice. Recommendations covered the following areas: How should we measure and report glucose control when intermittent blood glucose measurements are used? What are the appropriate performance standards for intermittent blood glucose monitors in the ICU? Continuous or automated intermittent glucose monitoring - methods and technology: can we use the same measures for assessment of glucose control with continuous and intermittent monitoring? What is acceptable performance for continuous glucose monitoring systems? If implemented, these recommendations have the potential to minimize the discrepancies in the conduct and reporting of clinical trials and to improve glucose control in clinical practice. Furthermore, to be fit for use, glucose meters and continuous monitoring systems must match their performance to fit the needs of patients and clinicians in the intensive care setting.

Published
2013

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