An Overview of Minimally Invasive Technologies

Abstract Self-measurement of blood glucose is an integral part of diabetes mellitus therapy. As many as 65% of diabetic people (4-5 million people) perform some degree of self-monitoring and approximately 20-30% do so frequently. Most patients consider this the most onerous part of their diabetes therapy. It requires obtaining blood, frequently in public, and is usually the most painful part of therapy, being significantly more painful than insulin self-administration. Patients therefore are anxious for a less-invasive method for glucose measurement. Methods exist or are being developed for minimally invasive glucose monitoring, which use body fluids other than blood (e.g., sweat and saliva), subcutaneous tissue, or blood measured less invasively. Sweat and saliva are relatively easily obtained but their glucose concentration lags significantly behind blood glucose. Methods to increase sweating have been developed and seem to increase the timeliness of the sweat glucose measurement. Subcutaneous glucose measurement seems to lag only a few minutes behind blood glucose and may actually be a better measurement of the critical values of glucose concentrations in brain, muscle, and other tissue. Glucose can be measured by noninvasive or minimally invasive methods, such as those making skin or mucous membranes permeable to glucose or those placing a reporter molecule in the subcutaneous tissue. Needle-type sensors have been improved in accuracy, size, and stability and can be placed into the subcutaneous tissue or peripheral veins to monitor blood glucose with miniature instruments.

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Basics and use of continuous glucose monitoring (CGM) in diabetes therapy

Journal of Laboratory Medicine ◽

10.1515/labmed-2019-0189 ◽

2020 ◽

Vol 44 (2) ◽

pp. 71-79 ◽

Cited By ~ 4

Author(s):

Guido Freckmann

Keyword(s):

Continuous Glucose Monitoring ◽

Glucose Monitoring ◽

Measurement Procedure ◽

Glucose Measurement ◽

Diabetes Therapy ◽

Self Monitoring ◽

Glucose Levels ◽

Frequent Use ◽

Long Time ◽

Implantable Sensor

AbstractBackgroundFor a long time, self-monitoring of blood glucose (SMBG) was widely viewed as the essential glucose measurement procedure in the therapy of insulin-treated people with diabetes. With increasing accuracy and simplified handling of continuous glucose monitoring (CGM) systems, this evolving technology challenges and at least partly replaces SMBG systems.ContentSensors of all currently available CGM systems measure glucose levels in the subcutaneous interstitial fluid for 6–14 days. The only available implantable sensor facilitates a measurement span of up to 6 months. Depending on the used system, glucose levels are either shown in real time (rtCGM systems) or after scanning (iscCGM systems). Functions such as alerts, alarms and trend arrows and data presentation encourage independent self-management of diabetes therapy. The high frequency of glucose data and the multitude of existing functions require an extensive training of people with diabetes and their caregivers.SummaryCGM systems provide a much more detailed picture of glycemia in people with diabetes. Educated patients can use these data to react adequately to their glucose levels and therefore avoid hypoglycemic and hyperglycemic events. Studies showed that glycated hemoglobin (HbA1c) levels and hypoglycemic events can be significantly reduced by frequent use of CGM systems.

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Hemoglobin A1C as an indicator of the accuracy of blood glucose measurement: comparative study of three technologies used for blood glucose measurements

JOURNAL OF ADVANCES IN BIOTECHNOLOGY ◽

10.24297/jbt.v6i3.6262 ◽

2017 ◽

Vol 6 (3) ◽

pp. 919-923

Author(s):

Hassan Almarshad

Keyword(s):

Blood Glucose ◽

Comparative Study ◽

Hemoglobin A1c ◽

Glucose Monitoring ◽

Blood Glucose Measurement ◽

Blood Glucose Monitoring ◽

Glucose Measurement ◽

Self Monitoring ◽

Blood Glucose Self Monitoring ◽

Monitoring Devices

In previous studies, the accuracy of glucose measurements were found with significant variations in different self-monitoring devices. This study suggests Hemoglobin a1c (Hba1c) to be used as as an indicator for the accuracy of blood-glucose monitoring devices. In this study, the association between the readings of glycohematoglobin HbA1C and the hyperglycemic readings of thirty hyperglycemic patients is used as an indicator of the accuracy of three types of glucometer devices. The association between hyperglycemic readings and the percentage of HbA1C for the same patients was investigated. The results showed significant association between levels of blood glucose and the percentage of HbA1C in three devices with statistically significant ( p < 0.05). Such relationship is suggested to be used as a relative accuracy of various types of blood glucose self-monitoring devices.

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SELF-MONITORING OF BLOOD GLUCOSE WITH A NON-INVASIVE METHOD USING NEAR INFRARED SENSOR

SANITAS : Jurnal Teknologi dan Seni Kesehatan ◽

10.36525/sanitas.2020.10 ◽

2020 ◽

Vol 11 (2) ◽

pp. 111-121

Author(s):

Rinda Nur Hidayati ◽

Nur Hasanah Ahniar ◽

Gita Rindang Lestari ◽

Atika Hendryani ◽

Faris Al Hakim

Keyword(s):

Blood Glucose ◽

Glucose Level ◽

Glucose Monitoring ◽

Blood Glucose Monitoring ◽

Self Monitoring ◽

Glucose Levels ◽

Non Invasive ◽

Chronic Hyperglycemia ◽

Invasive Method ◽

Minimum System

Diabetes mellitus or commonly called diabetes is a worldwide epidemic caused by chronic hyperglycemia. Simplify the blood glucose monitoring and easy to use is an essential part of diabetes management. Currently, the use of blood glucose meters conventional in clinical practice needs sufficient reliability. Therefore, self-monitoring of blood glucose with a non-invasive method was presented. A non-invasive blood glucose monitoring device was initially for information on glucose level measurements. A non-invasive method to determine the level of glucose by applying the physical properties of the absorption of the laser sensor that can produce a voltage change at various glucose levels. In this paper, a glucose monitoring module was fabricated with dimensions of 25x27x15 cm which has a minimum system, sensor, and LCD as a display of glucose levels. A minimum system to control the output of data digital value using microcontroller Android nano v.3. Experimentally, testing this module is by comparing the glucose monitoring modules that have been made with a gold standard. The result showed that non-invasive glucose monitoring is the potential for glucose level measurement a sensitivity, resolution, and accuracy of 0.86 mg/dL, 0.01 mg/dL, and 98.96%, respectively. The purposed module of glucose level monitoring offered simple testing for the rapid measurement of glucose levels.

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Glucose measurement in interstitial fluid by microdialysis for the calibration of minimally invasive blood glucose monitoring

10.1117/12.2003853 ◽

2013 ◽

Author(s):

Dachao Li ◽

Ridong Wang ◽

Hao Chong ◽

Yu Liu ◽

Kexin Xu

Keyword(s):

Blood Glucose ◽

Minimally Invasive ◽

Interstitial Fluid ◽

Glucose Monitoring ◽

Blood Glucose Monitoring ◽

Glucose Measurement

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Blood Glucose Monitoring Data Should Be Reported in Detail When Studies About Efficacy of Continuous Glucose Monitoring Systems Are Published

Journal of Diabetes Science and Technology ◽

10.1177/1932296817753629 ◽

2018 ◽

Vol 12 (5) ◽

pp. 1061-1063 ◽

Cited By ~ 8

Author(s):

Stefan Pleus ◽

Lutz Heinemann ◽

Guido Freckmann

Keyword(s):

Blood Glucose ◽

Continuous Glucose Monitoring ◽

Glucose Monitoring ◽

Monitoring Data ◽

Blood Glucose Monitoring ◽

Glucose Measurement ◽

Diabetes Therapy ◽

Low Glucose ◽

Flash Glucose Monitoring System

Recently, two clinical trials about a “sensor-based flash glucose monitoring system” and its efficacy in reducing time in hypoglycemia were published. Interestingly, patients spent more time at low glucose concentrations in these studies than in other studies related to the efficacy of real-time continuous glucose monitoring (rtCGM). Although it is possible that the study populations differed from those in other studies, another potential explanation is that the CGM system used in these two studies had a negative glucose measurement bias. Such a negative bias was reported in recent literature, suggesting that the CGM system may inaccurately indicate hypoglycemia. Reporting blood glucose monitoring data would help to interpret the CGM data at least in the context of time spent in various glucose ranges as a parameter with which quality of diabetes therapy is measured.

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Evaluation of a continuous glucose monitoring system in cats with diabetes mellitus

Journal of Feline Medicine and Surgery ◽

10.1016/j.jfms.2004.07.006 ◽

2005 ◽

Vol 7 (3) ◽

pp. 153-162 ◽

Cited By ~ 25

Author(s):

Jelena ME Ristic ◽

Michael E Herrtage ◽

Sabine MM Walti-Lauger ◽

Linda A. Slater ◽

David B. Church ◽

...

Keyword(s):

Diabetes Mellitus ◽

Blood Glucose ◽

Monitoring System ◽

Continuous Glucose Monitoring ◽

Blood Glucose Concentration ◽

Subcutaneous Tissue ◽

Glucose Monitoring ◽

Continuous Glucose Monitoring System ◽

Glucose Measurement ◽

Glucose Curve

A continuous glucose monitoring system (CGMS) was evaluated in 14 cats with naturally occurring diabetes mellitus. The device measures interstitial fluid glucose continuously, by means of a sensor placed in the subcutaneous tissue. All cats tolerated the device well and a trace was obtained on 15/16 occasions. There was good correlation between the CGMS values and blood glucose concentration measured using a glucometer ( r=0.932, P<0.01). Limitations to the use of the CGMS are its working glucose range of 2.2–22.2 mmol/l (40–400 mg/dl) and the need for calibration with a blood glucose measurement at least every 12 h. When compared to a traditional blood glucose curve, the CGMS is minimally invasive, reduces the number of venepunctures necessary to assess the kinetics of insulin therapy in a patient and provides a truly continuous glucose curve.

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Real-time continuous glucose monitoring versus self-monitoring of blood glucose in adults with insulin-treated type 2 diabetes: a protocol for a randomised controlled single-centre trial

BMJ Open ◽

10.1136/bmjopen-2020-040648 ◽

2021 ◽

Vol 11 (1) ◽

pp. e040648

Author(s):

Nanna Lind ◽

Dorte Lindqvist Hansen ◽

Signe Sætre Rasmussen ◽

Kirsten Nørgaard

Keyword(s):

Type 2 Diabetes ◽

Blood Glucose ◽

Peer Support ◽

Continuous Glucose Monitoring ◽

Data Protection ◽

Treatment Options ◽

Glucose Monitoring ◽

Single Centre ◽

Self Monitoring

IntroductionMedical treatment options for type 2 diabetes (T2D) have increased over the last decade and enhance the possibility of individualised treatment strategies where insulin is still one of them. In spite of the advancements in treatment options, less than one-third of the population with T2D obtain their optimal glycaemic goal. In persons with type 1 diabetes, continuous glucose monitoring (CGM) has shown to be the most important driver for improvement in glycaemic control, even more than insulin-pump therapy. The use of technology in T2D has only been investigated in few studies.The overall objective of the research study is to examine the effectiveness of the use of CGM versus self-monitoring of blood glucose (SMBG) in persons with insulin-treated T2D on glycaemic variables and patient-reported outcomes on treatment satisfaction, health behaviour and well-being. The independent effect of peer support will also be studied.Methods and analysisThe study is a single centre, prospective, randomised, open-labelled, three-armed study with the randomisation 2:1:2 in group A with CGM, group B with CGM and peer support, and group C as a control group with SMBG. The participants receive a training course unique for the allocation group. The study runs for 12 months and includes 100 adult participants with insulin-treated T2D, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Primary outcome is difference in change in time in range. Recruitment begins in August 2020 and ends in July 2021. Final 12-month follow-up is anticipated to be in August 2022.Ethics and disseminationThe study will be carried out in accordance with the Helsinki Declaration and is approved by the Scientific Ethics Committee of the Capital Region (H-20000843). Data collection and handling will be performed in accordance with the General Data Protection Regulation and is approved by the Danish Data Protection Agency (J-2020-100). Dissemination will be in international peer-reviewed journals, conferences and a plain-language summary for participants.Trial registration numberClinicalTrials.gov Registry (NCT04331444).Protocol versionV.3, 11 December 2020.

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