scholarly journals Derivation and Validation of Gray-Box Models to Estimate Non-Invasive In-vivo Percentage Glycated Hemoglobin Using Digital Volume Pulse Waveform

Author(s):  
Shifat Hossain ◽  
Shantanu Sen Gupta ◽  
Tae-Ho Kwon ◽  
Ki-Doo Kim

Abstract Glycated hemoglobin and blood oxygenation are the two most important factors for monitoring a patient’s oxygen levels in the blood and the amount of average blood glucose levels. Digital Volume Pulse acquisition is a convenient method, even for a person with no previous training or experience, can be utilized to estimate the two abovementioned physiological parameters. The physiological basis assumptions are utilized to develop two-finger models for estimating the percent glycated hemoglobin and blood oxygenation levels. The first model consists of a blood vessel only hypothesis, while the second model is based on a whole-finger model system. We validated our two gray-box systems on diabetic and non-diabetic patients and obtained the mean absolute errors for the percent glycated hemoglobin (%HbA1c) and percent oxygen saturation (%SpO2) of 0.375 and 1.676, respectively, for the blood vessel model and 0.271 and 1.395, respectively, for the whole-finger model. The precision analysis indicated that these models resulted in 2.08% and 1.74% mean %CV for %HbA1c and 0.54% and 0.49% mean %CV for %SpO2 in the respective models. Herein, both models exhibit close performances to each other (HbA1c estimation Pearson R values are 0.92 and 0.96, respectively), even though the model assumptions greatly differed between them. Both of the models have a very high potential to be used in real-world scenarios. The whole-finger model performs better in terms of higher precision and accuracy compared to the blood vessel model.

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Shifat Hossain ◽  
Shantanu Sen Gupta ◽  
Tae-Ho Kwon ◽  
Ki-Doo Kim

AbstractGlycated hemoglobin and blood oxygenation are the two most important factors for monitoring a patient’s average blood glucose and blood oxygen levels. Digital volume pulse acquisition is a convenient method, even for a person with no previous training or experience, can be utilized to estimate the two abovementioned physiological parameters. The physiological basis assumptions are utilized to develop two-finger models for estimating the percent glycated hemoglobin and blood oxygenation levels. The first model consists of a blood-vessel-only hypothesis, whereas the second model is based on a whole-finger model system. The two gray-box systems were validated on diabetic and nondiabetic patients. The mean absolute errors for the percent glycated hemoglobin (%HbA1c) and percent oxygen saturation (%SpO2) were 0.375 and 1.676 for the blood-vessel model and 0.271 and 1.395 for the whole-finger model, respectively. The repeatability analysis indicated that these models resulted in a mean percent coefficient of variation (%CV) of 2.08% and 1.74% for %HbA1c and 0.54% and 0.49% for %SpO2 in the respective models. Herein, both models exhibited similar performances (HbA1c estimation Pearson’s R values were 0.92 and 0.96, respectively), despite the model assumptions differing greatly. The bias values in the Bland–Altman analysis for both models were – 0.03 ± 0.458 and – 0.063 ± 0.326 for HbA1c estimation, and 0.178 ± 2.002 and – 0.246 ± 1.69 for SpO2 estimation, respectively. Both models have a very high potential for use in real-world scenarios. The whole-finger model with a lower standard deviation in bias and higher Pearson’s R value performs better in terms of higher precision and accuracy than the blood-vessel model.


2021 ◽  
Vol 11 (15) ◽  
pp. 6867
Author(s):  
Shifat Hossain ◽  
Chowdhury Azimul Haque ◽  
Ki-Doo Kim

Diabetes is a serious disease affecting the insulin cycle in the human body. Thus, monitoring blood glucose levels and the diagnosis of diabetes in the early stages is very important. Noninvasive in vivo diabetes-diagnosis procedures are very new and require thorough studies to be error-resistant and user-friendly. In this study, we compare two noninvasive procedures (two-wavelength- and three-wavelength-based methods) to estimate glycated hemoglobin (HbA1c) levels in different scenarios and evaluate them with error level calculations. The three-wavelength method, which has more model parameters, results in a more accurate estimation of HbA1c even when the blood oxygenation (SpO2) values change. The HbA1c-estimation error range of the two-wavelength model, due to change in SpO2, is found to be from −1.306% to 0.047%. On the other hand, the HbA1c estimation error for the three-wavelength model is found to be in the magnitude of 10−14% and independent of SpO2. The approximation of SpO2 from the two-wavelength model produces a lower error for the molar concentration based technique (−4% to −1.9% at 70% to 100% of reference SpO2) as compared to the molar absorption coefficient based technique. Additionally, the two-wavelength model is less susceptible to sensor noise levels (max SD of %error, 0.142%), as compared to the three-wavelength model (max SD of %error, 0.317%). Despite having a higher susceptibility to sensor noise, the three-wavelength model can estimate HbA1c values more accurately; this is because it takes the major components of blood into account and thus becomes a more realistic model.


Entropy ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. 754
Author(s):  
Hai-Cheng Wei ◽  
Wen-Rui Hu ◽  
Na Ta ◽  
Ming-Xia Xiao ◽  
Xiao-Jing Tang ◽  
...  

Diabetic peripheral neuropathy (DPN) is a very common neurological disorder in diabetic patients. This study presents a new percussion-based index for predicting DPN by decomposing digital volume pulse (DVP) signals from the fingertip. In this study, 130 subjects (50 individuals 44 to 89 years of age without diabetes and 80 patients 37 to 86 years of age with type 2 diabetes) were enrolled. After baseline measurement and blood tests, 25 diabetic patients developed DPN within the following five years. After removing high-frequency noise in the original DVP signals, the decomposed DVP signals were used for percussion entropy index (PEIDVP) computation. Effects of risk factors on the incidence of DPN in diabetic patients within five years of follow-up were tested using binary logistic regression analysis, controlling for age, waist circumference, low-density lipoprotein cholesterol, and the new index. Multivariate analysis showed that patients who did not develop DPN in the five-year period had higher PEIDVP values than those with DPN, as determined by logistic regression model (PEIDVP: odds ratio 0.913, 95% CI 0.850 to 0.980). This study shows that PEIDVP can be a major protective factor in relation to the studied binary outcome (i.e., DPN or not in diabetic patients five years after baseline measurement).


2015 ◽  
Vol 41 (1-3) ◽  
pp. 18-24 ◽  
Author(s):  
Ahad Qayyum ◽  
Tahseen A. Chowdhury ◽  
Elizabeth Ley Oei ◽  
Stanley L. Fan

Introduction: Glycated hemoglobin is used to assess diabetic control although its accuracy in dialysis has been questioned. How does it compare to the Continuous Glucose Monitoring System (CGMS) in peritoneal dialysis (PD) patients? Methods: We conducted a retrospective analysis of 60 insulin-treated diabetic patients on PD. We determined the mean interstitial glucose concentration and the proportion of patients with hypoglycemia (<4 mmol/l) or hyperglycemia (>11 mmol/l). Results: The correlation between HbA1c and glucose was 0.48, p < 0.0001. Three of 15 patients with HbA1c >75 mmol/mol experienced significant hypoglycemia (14-144 min per day). The patients with frequent episodes of hypoglycemia could not be differentiated from those with frequent hyperglycemia by demographics or PD prescription. Conclusion: HbA1c and average glucose levels measured by the CGMS are only weakly correlated. On its own, HbA1c as an indicator of glycemic control in patients with diabetes on PD appears inadequate. We suggest that the CGMS technology should be more widely adopted.


2020 ◽  
Vol 17 (6) ◽  
pp. 787-798
Author(s):  
Sara Melisa Arciniegas ◽  
Sergio Andres Saavedra ◽  
Danaé Balderas ◽  
Sara del Carmen Caballero ◽  
María Josefa Bernad ◽  
...  

Background: Insulin has been included in a variety of dosage forms; nevertheless, liposomes have shown protection to degradation and better absorption. The addition of surfactant to liposomes could give the ability to deform and pass through intact membranes, and could increase the stability and the release of the drug. Introduction: Due to the limitations of the current treatment of insulin in diabetic patients, investigation in alternatives routes has increased. The oral route is the most convenient because of the similarity with the natural secretion of this hormone. The aim was to evaluate the in-vivo effect of fourteen formulations of Insulin-loaded flexible liposomes with different surfactants by oral and subcutaneous routes. Methods: Fourteen formulations of insulin were obtained with the addition of different surfactants. Size distribution, polydispersion index and Z potential were obtained for all formulations. In-vivo tests were performed in rats induced with experimental diabetes with streptozotocin, and glucose curves were obtained during 480 minutes. Results: All formulations by the subcutaneous route caused an optimal reduction in glucose levels. However, the addition of Brij L23 produced a better reduction, lasting for 420 minutes. By the oral route, the reduction of glucose did not reach the normal levels, but the addition of Poloxamer 407 and Brij S10 showed the best reduction in the glucose levels by this route. Conclusion: The addition of surfactants to the lipid structure can modify the release of the insulin by different routes of administration, but this behavior depends on the characteristics of the surfactant, such as the melting phase transition temperature of the lipid bilayer.


Author(s):  
Adel M Aly ◽  
Bassam I Amro ◽  
Feras D El Hajji

The objective of this work was to prepare Glimepiride (1 mg) rapidly disintegrating tablets (RDT) by direct compression, and also, to evaluate Pharmaburst™ as a newly introduced diluent for this type of tablets, either alone or in combination with other well known tablet excipients. Another goal was to study the stability, as well as, the in vivo effects of selected formulations. Orange flavor was the most preferred flavor for the prepared rapidly disintegrating tablets containing Pharmaburst™ as a single diluent. Pharmaburst™ alone is sufficient to produce rapidly (orally) disintegrating tablets of Glimepiride with good physical characteristics, better compactability and shorter in-vivo and in-vitro disintegration time. The prepared Glimepiride RDT were found to have faster onset of action than the conventional Glimepiride tablets. Also, they were effective in lowering fasting blood glucose levels (FBG) in rabbits. Glimepiride RDT containing Pharmaburst™ alone were found to be stable when subjected to accelerated stability conditions (40 °C / 75 % relative humidity) for at least 3 months. Packaging the prepared Glimepiride  RDT in 40 CC high density polyethylene (HDPE) bottles with 2 grams silica gel desiccant canisters and rayon had provided sufficient protection for the tablets. The used packaging system is believed to be very practical and convenient for elderly diabetic patients. It is also assumed to be preferred by the manufacturers.


Entropy ◽  
2019 ◽  
Vol 21 (12) ◽  
pp. 1229 ◽  
Author(s):  
Hai-Cheng Wei ◽  
Na Ta ◽  
Wen-Rui Hu ◽  
Ming-Xia Xiao ◽  
Xiao-Jing Tang ◽  
...  

This study investigated the application of a modified percussion entropy index (PEIPPI) in assessing the complexity of baroreflex sensitivity (BRS) for diabetic peripheral neuropathy prognosis. The index was acquired by comparing the obedience of the fluctuation tendency in the change between the amplitudes of continuous digital volume pulse (DVP) and variations in the peak-to-peak interval (PPI) from a decomposed intrinsic mode function (i.e., IMF6) through ensemble empirical mode decomposition (EEMD). In total, 100 middle-aged subjects were split into 3 groups: healthy subjects (group 1, 48–89 years, n = 34), subjects with type 2 diabetes without peripheral neuropathy within 5 years (group 2, 42–86 years, n = 42, HbA1c ≥ 6.5%), and type 2 diabetic patients with peripheral neuropathy within 5 years (group 3, 37–75 years, n = 24). The results were also found to be very successful at discriminating between PEIPPI values among the three groups (p < 0.017), and indicated significant associations with the anthropometric (i.e., body weight and waist circumference) and serum biochemical (i.e., triglycerides, glycated hemoglobin, and fasting blood glucose) parameters in all subjects (p < 0.05). The present study, which utilized the DVP signals of aged, overweight subjects and diabetic patients, successfully determined the PPI intervals from IMF6 through EEMD. The PEIPPI can provide a prognosis of peripheral neuropathy from diabetic patients within 5 years after photoplethysmography (PPG) measurement.


Author(s):  
Alvina Alvina ◽  
Pusparini Pusparini ◽  
Meiyanti Meiyanti ◽  
Lie T Merijanti

<p><strong>Background</strong></p><p>Diabetes mellitus (DM) is a metabolic disease with a large incidence in the world and constitutes a global health problem. By 2030 it is estimated that there will be around 439 million people suffering from DM. Diabetes mellitus is a metabolic disease caused by a lack or absence of the hormone insulin. In type 2 DM pharmacotherapy can be given one of which is insulin. To monitor therapy, random blood glucose, glycated hemoglobin (HbA1c) and glycated albumin (GA) levels can be examined. The objective of this study was to determine the relationship of glycated albumin and glycated hemoglobin (HbA1c) with random blood glucose in insulin-treated diabetics.</p><p><strong> </strong></p><p><strong>Methods</strong></p><p>A cross-sectional study was conducted involving 92 type 2 diabetic patients treated with insulin. The study used a questionnaire and blood samples. We measured the GA , HbA1C and random blood glucose levels. A multiple linear regression was used to analyze the data.</p><p><strong> </strong></p><p><strong>Results</strong></p><p>Mean HbA1c was 9.21 ± 2.15%, mean glycated albumin was 24.4 ± 8.65%, and mean blood glucose was 229.47 ± 98.7 mg / dL. Multiple linear regression tests showed that HbA1c (B= 5,544;β=0.121;p=0.420) and GA (B=5.899;β=0.517;p=0.001) was signigicantly corelated with random blood gucose, respectively, indicating that glycated albumin is significantly related to and has the greatest influence on glucose level.</p><p><strong> </strong></p><p><strong>Conclusion</strong></p><p>Glycated albumin is correlated with and has greater influence on glucose level than does HbA1c. Glycated albumin could be a better marker for glycemic control than glycated hemoglobin in diabetic patients treated with insulin.</p>


1987 ◽  
Vol 57 (02) ◽  
pp. 201-204 ◽  
Author(s):  
P Y Scarabin ◽  
L Strain ◽  
C A Ludlam ◽  
J Jones ◽  
E M Kohner

SummaryDuring the collection of samples for plasma β-thromboglobulin (β-TG) determination, it is well established that artificially high values can be observed due to in-vitro release. To estimate the reliability of a single β-TG measurement, blood samples were collected simultaneously from both arms on two separate occasions in 56 diabetic patients selected for a clinical trial. From each arm, blood was taken into two tubes containing an anticoagulant mixture with (tube A) and without (tube B) PGE!. The overall mean value of B-TG in tube B was 1.14 times higher than in tube A (p <0.01). The markedly large between-arms variation accounted for the most part of within-subject variation in both tubes and was significantly greater in tube B than in tube A. Based on the difference between B-TG values from both arms, the number of subjects with artifically high B-TG values was significantly higher in tube B than in tube A on each occasion (overall rate: 28% and 14% respectively). Estimate of between-occasions variation showed that B-TG levels were relatively stable for each subject between two occasions in each tube. It is concluded that the use of PGEi decreases falsely high B-TG levels, but a single measurement of B-TG does not provide a reliable estimate of the true B-TG value in vivo.


1972 ◽  
Vol 27 (01) ◽  
pp. 114-120 ◽  
Author(s):  
A. A Hassanein ◽  
Th. A El-Garf ◽  
Z El-Baz

SummaryADP-induced platelet aggregation and calcium-induced platelet aggregation tests were studied in 14 diabetic patients in the fasting state and half an hour after an intravenous injection of 0.1 unit insulin/kg body weight. Platelet disaggregation was significantly diminished as compared to a normal control group, and their results were negatively correlated with the corresponding serum cholesterol levels. Insulin caused significant diminution in the ADP-induced platelet aggregation as a result of rapid onset of aggregation and disaggregation. There was also a significant increase in platelet disaggregation. In the calcium-induced platelet aggregation test, there was a significant shortening of the aggregation time, its duration, and the clotting time. The optical density fall due to platelet aggregation showed a significant increase. Insulin may have a role in correcting platelet disaggregation possibly through improvement in the intracellular enzymatic activity.


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