Self-monitoring Of Blood Glucose Devices Research Articles

Reliability and utility of blood glucose levels in the periodontal pockets of patients with type 2 diabetes mellitus: a cross-sectional study.

Several studies have measured gingival blood glucose (GBG) levels, but few have confirmed systematic bias using Bland-Altman analysis. This study compared the effectiveness of GBG levels with that of fingertip blood glucose (FTBG) levels using Bland-Altman and receiver operating characteristic (ROC) analyses. A total of 15 healthy volunteers and 15 patients with type 2 diabetes were selected according to inclusion and exclusion criteria. Each group comprised eight male and seven female participants. The GBG and FTBG levels were measured using a self-monitoring blood glucose device after periodontal examination. Pearson's product‒moment correlation and simple linear regression analyses were performed. In addition, Bland‒Altman analysis was also performed to assess the degree of agreement between the two methods. ROC analysis was conducted to determine the sensitivity, specificity, and cutoff values for patients with diabetes. The area under the ROC curve (AUC) was used to identify significant differences. The mean GBG and FTBG levels were 120 ± 44.8 mg/dL and 137 ± 45.1, respectively, for the whole sample. The mean GBG and FTBG levels were 145 ± 47.2 mg/dL and 163 ± 49.1, respectively, in the diabetes group. The mean GBG and FTBG levels in the nondiabetes group were 95.3 ± 25.2 and 111 ± 18.8, respectively. Patients with diabetes were more likely to have a probing pocket depth (PPD) of ≥4 mm at the sampled site. Pearson's product‒moment correlation and simple linear regression analyses revealed a significant correlation between the GBG and FTBG measurements. Bland-Altman analysis revealed that GBG and FTBG measurements differed significantly among all participants; however, no significant differences were observed among the patients with diabetes (mean difference (MD) ± standard deviation (SD) = -18.1 ± 34.2, 95% confidence interval (CI) [-37.0 to 0.88]) or among the participants with a PPD of ≥4 mm (MD ± SD = -15.2 ± 30.4, 95% CI [-30.8 to 0.43]). The sensitivity, specificity, and cutoff values of the GBG measurements for detecting diabetes were 80%, 93%, and 123.5 mg/dL, respectively. The sensitivity, specificity, and cutoff values of the FTBG measurements for detecting diabetes were 73%, 87%, and 134.0 mg/dL, respectively. No significant differences were observed between the AUCs (0.078, 95% CI [-0.006 to 0.161]). The GBG measurements aligned with the FTBG measurements in the patients with diabetes and among the participants with a PPD of ≥4 mm. Patients with diabetes were more likely to have a PPD of ≥4 mm at the sampled site, GBG levels can be used to screen for type 2 diabetes in dental clinics.

Exploring diabetic patients’ intention to switch POCT self-monitoring glucose devices: investigating influence of perceived usefulness and perceived ease of use

Purpose The study aims to examine diabetic patients’ switching intentions toward self-monitoring blood glucose devices, incorporating perceived usefulness and perceived ease of use, with switching cost as a moderator. Design/methodology/approach A self-administered questionnaire was developed using established measuring scales. Data from 321 respondents was collected and analyzed using the partial least squares structural equation modeling approach. Findings Results indicate that perceived usefulness and perceived ease of use influence switching intention. Switching cost does not moderate the perceived usefulness, perceived ease of use and switching intention. This study reveals important information for healthcare practitioners and device manufacturers. Originality/value The significance and originality of this study stem from its pioneering investigation into the switching intentions of diabetic patients regarding self-monitoring glucose devices through the application of the technology acceptance model, thereby addressing a notable gap in the existing literature on diabetes management and technology adoption, which has lacked comprehensive examination of patients’ transition behaviors in this specific context.

Cost-effective analysis focused on hypoglycemia of intermittent-scanning continuous glucose monitoring in type 1 diabetes adults: a ISCHIA randomized clinical trial.

This study aimed to compare the economic value of intermittent-scanning continuous glucose monitoring (isCGM) with self-monitoring of blood glucose (SMBG) in adults with type 1 diabetes (T1D). Participants were placed on either an isCGM or SMBG arm for 84days, in a randomized, crossover setup with a 28-day washout period. Clinically relevant hypoglycemia (<54mg/dL) and severe hypoglycemia (SH) risks were calculated by analyzing the data from isCGM. The effectiveness variable was quality-adjusted life years (QALYs), and costs included medical costs related to the SMBG device. In addition, we performed a sensitivity analysis using a tornado diagram to confirm the robustness of the results. A total of 93 Japanese T1D adults (51.4 ± 15.3years old, male 47.3%, and HbA1c 7.3 ± 0.7%) treated with multiple daily insulin injection (MDI). Compared to the SMBG arm, clinically relevant hypoglycemia and SH risks over daytime (2.7 ± 1.7 vs. 2.4 ± 1.6 times; P = 0.008 and 3.1 ± 3.2 vs. 2.2 ± 2.7; P = 0.001) and night-time periods (2.1 ± 1.6 → 1.7 ± 1.2; P < 0.001 and 5.1 ± 4.0 → 4.2 ± 3.8; P = 0.013) were reduced with isCGM treatment. The isCGM system was associated with an incremental gain in quality-adjusted life expectancy (QALE) of 0.8 QALYs compared with the SMBG arm (74.6 vs. 73.8 QALYs). The resulting incremental cost-effectiveness ratio was JPY4,398,932 (US$41,212) per QALY gained, which is well below the generally accepted cost-effectiveness threshold. SH during the daytime period was the primary driver of the incremental QALE. The findings suggest that isCGM use for Japanese T1D adults treated with MDI is cost saving relative to SMBG.

EFFECTIVENESS OF CONTINUOUS GLUCOSE MONITORING IN UNCONTROLLED TYPE-2 DIABETICS IN TERTIARY HEALTHCARE CENTRE

Long term diabetic complications can be prevented or reduced by achieving good metabolic control, reflected by HbA1c &lt;6.5–7.0%.1-3 Glucose excursions might also contribute to the development of diabetic complications.4,5 Fear of hypoglycemia limits the ability to reach strict glycemic control, because it is usually accompanied by reluctance of the patient to intensify insulin therapy. Indeed, the goal of intensive therapy is to normalize HbA1c and control fasting and postprandial glycemia, while concurrently limiting the number and severity of hypoglycemic events. To reach tight glycemic control, frequent self- monitoring of blood glucose (SMBG) must be performed.6 SMBG devices provide the patient with accurate but discreet blood glucose levels. They do not provide trend information nor do they reflect glycemic fluctuations, which is possible by using continuous glucose monitoring (CGM) systems. Thus, implementation of strict glycemic control may be facilitated by a CGM device. This manuscript critically reviews the proposed benefits and indications of CGM and the current evidence of CGM on health outcomes in diabetic patients.

Noncontact optical device for measuring blood glucose in aqueous humor: a pilot clinical study investigating correlation with blood glucose levels.

Monitoring blood glucose levels is crucial for individuals with diabetes. Noninvasive methods for measuring serum glucose levels have been explored to aid in blood glucose control for diabetes management. We introduced a noncontact optical glucometer (NCGM) for measuring glucose levels in the aqueous humor of the human eye. We also investigated the correlation between glucose levels in the NCGM and the aqueous humor, blood samples, and self-monitoring blood glucose devices. The optical system used in this study measured both the near-infrared absorption and polarized rotatory distribution of glucose molecules in the human aqueous humor. This prospective study's outcomes were eye aqueous glucose level, preoperative blood glucose level, intraoperative blood glucose level, and NCGM reading of patients in a single center in Taiwan. The NCGM's measurements showed a strong correlation with blood glucose levels (intra-class correlation [ICC]: 0.95 to 0.98) and aqueous humor glucose levels (ICC: 0.76), indicating its ability to noninvasively measure blood glucose levels in human subjects. This NCGM may offer a convenient, pain-free, and rapid tool for measuring blood glucose levels in diabetic patients. The device could represent a significant advancement in noncontact hybrid optical glucose measurement systems.

Effects of Digitization of Self-Monitoring of Blood Glucose Records Using a Mobile App and the Cloud System on Outpatient Management of Diabetes: Single-Armed Prospective Study.

In recent years, technologies promoting the digitization of self-monitoring of blood glucose (SMBG) records including app-cloud cooperation systems have emerged. Studies combining these technological interventions with support from remote health care professionals have reported improvements in glycemic control. To assess the use of an app-cloud cooperation system linked with SMBG devices in clinical settings, we evaluated its effects on outpatient management of diabetes without remote health care professional support. In this multicenter, open-label, and single-armed prospective study, 48 patients with diabetes (including type 1 and type 2) at 3 hospitals in Japan treated with insulin or glucagon-like peptide 1 receptor agonists and performing SMBG used the app-cloud cooperation system for 24 weeks. The SMBG data were automatically uploaded to the cloud via the app. The patients could check their data, and their attending physicians reviewed the data through the cloud prior to the patients' regular visits. The primary outcome was changes in glycated hemoglobin (HbA1c) levels. Although HbA1c levels did not significantly change in all patients, the frequency of daily SMBG following applying the system was significantly increased before induction at 12 (0.60 per day, 95% CI 0.19-1.00; P=.002) and 24 weeks (0.43 per day, 95% CI 0.02-0.84; P=.04). In the subset of 21 patients whose antidiabetic medication had not been adjusted during the intervention period, a decrease in HbA1c level was observed at 12weeks (P=.02); however, this significant change disappeared at 24 weeks (P=.49). The Diabetes Treatment Satisfaction Questionnaire total score and "Q4: convenience" and "Q5: flexibility" scores significantly improved after using the system (all P<.05), and 72% (33/46) patients and 76% (35/46) physicians reported that the app-cloud cooperation system helped them adjust insulin doses. The digitization of SMBG records and sharing of the data by patients and attending physicians during face-to-face visits improved self-management in patients with diabetes. Japan Registry of Clinical Trials (jRCT) jRCTs042190057; https://jrct.niph.go.jp/en-latest-detail/jRCTs042190057.

Availability, price and affordability of insulin, delivery devices and self-monitoring blood glucose devices in Indonesia.

Insulin is essential for the survival of people with type 1 diabetes and for better management of people with type 2 diabetes. People with diabetes using insulin also require self-monitoring blood glucose (SMBG) devices (e.g., meters, strips, continuous monitoring systems) for day-to-day management. It is essential to ensure that insulin and these devices are available and affordable. This study aimed to evaluate the availability, price, and affordability of insulin and SMBG devices in Indonesia using an adaptation of the World Health Organization/Health Action International (WHO/HAI) price survey. A total of 34 public health facilities (hospitals, primary healthcare centres/Puskesmas) and 37 private pharmacies were sampled. Information from three major online marketplaces was also collected. Prices were expressed as median patient prices (US$). Affordability was defined as the number of days' wages needed by the lowest paid unskilled government worker (LPGW) to purchase 30 days' supply of insulin, delivery devices and SMBGs. Availability of analogue insulin was slightly higher in public facilities (63.6%) than in the private sector (43.2%), with no human insulin available in both sectors. Conversely, better availability was observed in private facilities for SMBG devices as public sector facilities did not supply devices for self-testing. Median prices for 1000IU analogues varied between the public sector (US$ 5.26) and the private sector (US$11.24). The highest median price of analogues was seen in online marketplaces (US$ 28.65). The least costly median price of SMBG devices were observed in online platforms (meter: US$ 18.37, test strip: US$ 0.27, lancet: US$ 0.02). A low-income person had to work 2-3 days to buy 1000IU of analogues. It required 5-7 days' and 4-5 day's wages to purchase a meter and a month's supply of test strips, respectively. The availability and affordability of insulin and SMBG devices remain important issues in Indonesia requiring holistic approaches for further improvement.

Connection between glycemic variability obtained using the uniGluko system and the quality of life people with type 1 diabetes

Research has shown that glycemic variability increases the risk of the development of acute and chronic complications with diabetes. Accordingly, the assessment of glycemic variability is of great importance to determine the quality of life for people suffering from diabetes. Objective: To examine the connection between glycemic variability and the quality of life for people with type 1 diabetes who use self-monitoring blood glucose devices. Respondents and methods: 42 respondents participated in the research with an average age of 39.6, who are treated with intensified insulin therapy. For the purpose of glycemic variability assessment, an innovative uniGluko system is used, which enables the display of glycemia in a unique graphic interface in the form of numeric values within the last three months from which a glycemic variability index was calculated as well as a general information survey, a survey on the quality of life from the World Health Organization (WHOQOL – BREF) and a short questionnaire regarding illness perception (Brief – IPQ). Results: By usage of standard deviation as a glyemic variability measure, statistically significant results have been obtained and they demonstrate that lower glycemic variability is connected to better quality of life (rs=-0.4571; p=0.0023), higher satisfaction with health (rs=-0.3186; p=0.0398) and reduced impact of disease on emotional life (rs=0.4097; p=0.,0071). Lower glucose variability implies reduced impact of disease on everyday life (rs=0.3091; p=0.0464), reduced incidence of symptoms (rs=0.3441; p=0.0255), and patients’ sense that they have more control over disease (rs=-0.5185; p=0.0004). Conclusion: The glycemic variability has a negative impact on life quality and health of patients with diabetes type 1.

SAT-648 Flash Glucose Monitoring Helps Achieve Better Glycemic Control Than Conventional Self-Monitoring of Blood Glucose in Non-Insulin-Treated Type 2 Diabetes: A Randomized Controlled Trial

Background and aims: Flash glucose monitoring (FGM) is a novel system with which glucose levels are monitored and has been reported to improve glucose variability and glycemic control in type 1 and type 2 diabetes patients treated with insulin. The present study aimed to evaluate the effects of FGM and conventional self-monitoring of blood glucose (SMBG) on glycemic control in patients with non-insulin-treated type 2 diabetes. Reseach design and Methods: In this 24-week, multicenter, open-label, randomized (1:1), parallel group study, non-insulin-treated type 2 diabetic patients at 5 hospitals in Japan were randomly assigned to the FGM (n = 49) or SMBG (n = 51) groups and were provided FGM or SMBG devices for 12 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) level. This trial is registered with UMIN-CTR (UMIN000026452). Results: Forty-eight participants in the FGM group and 45 in the SMBG group completed the study. The mean HbA1c levels were 7·83% (SD 0·25) in the FGM group and 7·84% (SD 0·27) in the SMBG group at baseline, and the values were reduced in both FGM (−0·43%; 95% confidence interval [CI], −0·57 to −0·28; p < 0·0001) and SMBG groups (−0·30%; 95% CI −0·48 to −0·13; p = 0·001) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM: −0·46%, 95% CI −0·59 to −0·32, p < 0·0001; SMBG: −0·17%, 95% CI −0·05 to 0·11, p = 0·124); a significant between-group difference was also observed (difference −0·29%, 95% CI −0·54 to −0·05; p = 0·022). Diabetes Treatment Satisfaction Questionnaire score was significantly improved, and the mean glucose levels, standard deviation of glucose, mean amplitude of glycemic excursions, and duration of hyperglycemia were significantly decreased in the FGM group compared with the SMBG group. Conclusions: Glycemic control was better with FGM than with SMBG after cessation of glucose monitoring in non-insulin-treated type 2 diabetic patients.

Comparing Self Monitoring Blood Glucose Devices and Laboratory Tests: Over 25 Years Experience&#x0D;

Self-monitoring blood glucose (SMBG) devices have been widely used in medical practice for decades. However, there are certain gaps between SMBG device readings and venous blood glucose levels. Here, 3,532 measurement data points were recorded over 25 years to compare SMBG device readings and venous blood glucose levels. The mean absolute difference (MAD) or the GAP was 10.9 mg/dL, and the mean absolute relative difference (MARD) was 8.3%. The absolute relative difference (ARD) (%) and absolute difference (AD or GAP) (mg/dL) coefficients of variation (CV) (%) of 100% indicate high variance between the capillary BG and venous true BG data. There was a slight skewing of MAD and MARD to the lower body mass index (BMI) side, the higher age side, and the female gender side. There were 41 data points that showed unacceptable gaps of over 50 mg/dL. Such large differences may cause incorrect medications or treatments. All healthcare providers should be aware of the gap between SMBG device readings and venous blood glucose levels.

Technical accuracy of ten self-monitoring blood glucose devices commonly used in Dhaka City of Bangladesh

Due to inadequate regulatory mechanisms, the accuracy of the self-monitoring blood glucose (SMBG) devices is not ensured leading to potentially serious clinical consequences in Bangladesh. The present study was undertaken to evaluate the technical accuracy of ten most commonly used SMBG devices marketed in Dhaka City of Bangladesh. Top ten SMBG devices sold in Dhaka City were studied on a group of 100 type 2 diabetes mellitus subjects. Blood glucose values estimated (at fasting and 2 h after breakfast) by SMBG devices, using a blinding technique, were compared with the corresponding laboratory values by enzymatic method using the Dimension RXLMax automated chemistry analyzer. Hematocrit was measured using the Sysmex XT 2000 hematology autoanalyzer. The mean absolute relative error (MARE, %) was used as an indicator of accuracy and precision together. A highly significant correlation was observed between the device and laboratory values. However, none of the devices showed an acceptable accuracy at 5–10% deviation from the corresponding laboratory values either at fasting or postprandial states. On pooling together data from two prandial states, even at 15% deviation limits, 70% of the devices failed to show accurate results. On calculation of MARE, 60% devices were found to be beyond 15% error limit at 95% accuracy level. Corresponding analysis with 90% accuracy level showed 30% beyond the limit. Blood glucose results from around 30% of the top ten SMBG devices sold in Dhaka City do not have even minimum level of technical accuracy, and many others are not optimum in their accuracy levels.

Evaluation of Linearity and Interference Effect on SMBG and POCT Devices, Showing Drastic High Values, Low Values, or Error Messages.

When a patient with diabetes measures blood glucose levels using a simple blood glucose meter, an error message or abnormal value may be displayed because of interfering substances, potentially leading to unnecessary medical treatment. Here, we tested 10 self-monitoring of blood glucose (SMBG) and point-of-care testing (POCT) devices to investigate under what conditions they fail to measure blood glucose levels or display abnormal values instead. We also evaluated the influence and linearity of several well-known interfering substances and hematocrit (Ht). Each adjusted sample was measured by each device twice and the values compared with the reference values. Linearity was favorable in all but one model. The impact of the interfering substances and Ht has been confirmed in many SMBG and POCT devices. In particular, some models showed significant pseudo-high or -low levels for samples that contained ascorbic acid, which is used widely in infusion solutions. Three devices showed error messages to avoid presenting a false value. Since pseudo-high levels may result in the excessive administration of insulin and lead to adverse events, this report serves as a critical reminder of the importance of device choice for specific indications. Three new devices have safety functions that prevent the showing of false values.

Perceptions of Dhaka City Retailers on User Choice of Self-Monitoring Blood Glucose Devices

Self-Monitoring Blood Glucose (SMBG) Devices are now thought to be an integral component in the prevention and management of diabetes mellitus which is increasingly becoming a major health and economic burden particularly in developing countries. The marketing of these Devices, however, are still not well regulated in most of the countries and this, in turn, may lead to more harm than good to the patients who are using these devices. Retailers are the most important contact points who create the interface among the Manufacturers, Professionals and Consumers for popularization of health related devices. In this study, the Users' Choice of SMBG Devices and its determinants, as reflected in the views of the Sales Persons (in a retail shop) in Dhaka City of Bangladesh, have been explored. Twenty Sales Persons from 20 Retail Shops, purposively selected from among major Dhaka City markets where these devices are commonly sold, were individually interviewed using a pretested Interviewer administered Questionnaire. The instrument consisted of six questions covering the Users' preference regarding quality vs cost and also regarding the guidance and motives for purchasing specific items. The results were analyzed by descriptive statistics. It was found that 90% of the consumers are dependent on the suggestions of the Sales Persons regarding the choice of devices. In 80% of the subjects the cost of the System was found to be the determining factor regarding the choice of a meter. Only among 20% subjects, quality played any role in the choice. In conclusion, the choice of specific SMBG devices in Dhaka City is overwhelmingly influenced by Retailers (who, in most cases are not even qualified Pharmacists or Pharmacy Assistants) and, except in few cases; Users are not concerned with quality. Price, particularly the price of the strip, is the dominant factor on Users' choice of SMBG Devices.&#x0D; Bangladesh J Med Biochem 2018; 11(1): 17-21

Changes in Self-Care Behavior (Summary of Diabetes Self-Care Activities Measure) Using Real-Time Blood Glucose Monitoring with the Free Style Libre

No studies have reported changes in self-care behavior, and it remains unclear whether Free Style Libre (Libre) differs from conventional blood glucose self-monitoring devices in this regard. Therefore, we instructed diabetes patients using conventional self-monitoring blood glucose (SMBG) devices to use the Libre and prospectively examined the effect of this new device on self-care behavior and patient treatment satisfaction. The subjects comprised 41 outpatients with diabetes who were using conventional SMBG devices. The subjects were randomly assigned to group A, which comprised patients using Libre for ≥2 weeks (n = 21), or group B, which comprised patients who continued using conventional SMBG devices (n = 20). All patients received 30 minutes of diet and exercise therapy instruction from a registered dietitian and nurse (or clinical laboratory technologists). The Summary of Diabetes Self-Care Activities measure (SDSCA) was administered at baseline, 1, 3, and 6 months. Changes in the SDSCA, glycated hemoglobin (HbA1c), glycated albumin (GA), and body weight from baseline to 1 month were analyzed (UMIN000029016). At baseline, the two groups did not differ significantly in terms of the HbA1c, GA, body weight, or 17 SDSCA items. At 1 month, the numbers of days involving eating five or more servings of fruits and vegetables were 5.0 (3.3, 6.8) in group A and 3.0 (1.0, 6.0) in group B, the numbers of days involving exercise for at least 30 minutes were 5.0 (2.0, 6.0) in group A and 2.0 (0, 3.0) in group B, and the number of days involving specific exercise were 3.0 (2.0, 6.0) in group A and 1.5 (0, 2.3) in group B; both of these values were significantly higher in group A than in group B (p = 0.033, 0.037 and 0.041, respectively). These results suggest that the use of the Libre may improve the self-care behaviors of diabetes patients regarding diet and exercise, compared with the use of conventional SMBG devices. Disclosure A. Kudara: None. T. Tosaki: Other Relationship; Self; Eli Lilly and Company, Takeda Development Center Asia, Pte. Ltd., MSD K.K., Mitsubishi Tanabe Pharma Corporation. S. Sato: None. A. Inagaki: None. M. Kondo: None. S. Tsunekawa: None. Y. Kato: Speaker's Bureau; Self; Merck Sharp &amp; Dohme Corp., Sanofi, Takeda Pharmaceutical Company, Eli Lilly Japan. H. Kamiya: Other Relationship; Self; MSD K.K., Ono Pharmaceutical Co., Ltd., Sanofi K.K., AstraZeneca, Astellas Pharma KK, Eli Lilly and Company, Novartis Pharma K.K., Dainippon Sumitomo Pharma Co., Ltd, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Ltd. J. Nakamura: Other Relationship; Self; Astellas Pharma US, Inc., AstraZeneca, Ono Pharmaceutical Co., Ltd., MSD K.K., Kyowa Hakko Kirin Co., Ltd., Kowa Pharmaceuticals America, Inc., Sanofi K.K., Taisho Pharmaceutical Co., Ltd., Takeda Development Center Asia, Pte. Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly and Company, Novartis Pharma K.K., Pfizer Inc..

Economic Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices for Type 1 and Type 2 Diabetes in England.

The objective was to model clinical and economic outcomes of self-monitoring blood glucose (SMBG) devices with varying error ranges and strip prices for type 1 and insulin-treated type 2 diabetes patients in England. We programmed a simulation model that included separate risk and complication estimates by type of diabetes and evidence from in silico modeling validated by the Food and Drug Administration. Changes in SMBG error were associated with changes in hemoglobin A1c (HbA1c) and separately, changes in hypoglycemia. Markov cohort simulation estimated clinical and economic outcomes. A SMBG device with 8.4% error and strip price of £0.30 (exceeding accuracy requirements by International Organization for Standardization [ISO] 15197:2013/EN ISO 15197:2015) was compared to a device with 15% error (accuracy meeting ISO 15197:2013/EN ISO 15197:2015) and price of £0.20. Outcomes were lifetime costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). With SMBG errors associated with changes in HbA1c only, the ICER was £3064 per QALY in type 1 diabetes and £264 668 per QALY in insulin-treated type 2 diabetes for an SMBG device with 8.4% versus 15% error. With SMBG errors associated with hypoglycemic events only, the device exceeding accuracy requirements was cost-saving and more effective in insulin-treated type 1 and type 2 diabetes. Investment in devices with higher strip prices but improved accuracy (less error) appears to be an efficient strategy for insulin-treated diabetes patients at high risk of severe hypoglycemia.

The UVA/Padova Type 1 Diabetes Simulator Goes From Single Meal to Single Day.

A new version of the UVA/Padova Type 1 Diabetes (T1D) Simulator is presented which provides a more realistic testing scenario. The upgrades to the previous simulator, which was accepted by the Food and Drug Administration in 2013, are described. Intraday variability of insulin sensitivity (SI) has been modeled, based on clinical T1D data, accounting for both intra- and intersubject variability of daily SI. Thus, time-varying distributions of both subject's basal insulin infusion and insulin-to-carbohydrate ratio were calculated and made available to the user. A model of "dawn" phenomenon based on clinical T1D data has been also included. Moreover, the model of subcutaneous insulin delivery has been updated with a recently developed model of commercially available fast-acting insulin analogs. Models of both intradermal and inhaled insulin pharmacokinetics have been included. Finally, new models of error affecting continuous glucose monitoring and self-monitoring of blood glucose devices have been added. One hundred in silico adults, adolescent, and children have been generated according to the above modifications. The new simulator reproduces the intraday glucose variability observed in clinical data, also describing the nocturnal glucose increase, and the simulated insulin profiles reflect real life data. The new modifications introduced in the T1D simulator allow to extend its domain of validity from "single-meal" to "single-day" scenarios, thus enabling a more realistic framework for in silico testing of advanced diabetes technologies including glucose sensors, new insulin molecules and artificial pancreas.

Development of an Automatic Puncturing and Sampling System for a Self-Monitoring Blood Glucose Device.

Performing self-monitoring of blood glucose (SMBG) is a clinical challenge for elderly people with low dexterity. An all-in-one-type SMBG device that can simply and easily puncture and monitor would be useful for them. We developed an automatic skin-puncturing and blood-sampling (APS) system for introducing of an all-in-one-type SMBG device. The aims of this study were to determine if the developed APS system, which has automatic puncturing, squeezing, and application functions, could provide sufficient blood sample volumes for SMBG and to determine the factors associated with failure in the use of the system by adult volunteers. We investigated the success rate of obtaining a 0.8-μL sample volume using the APS system and determined the factors associated with failure in 140 adult volunteers. The participant characteristics, induration of puncturing sites, and states of finger grip conditions were evaluated as factors of a puncturing failure. The participant characteristics, skin hydration, states of finger grip, skin elasticity of the finger pad, and blood flow were evaluated as factors of a squeezing failure. The success rate was 61.9%. Puncturing failure was 21.6%, and squeezing failure was 16.5%. Automatic puncturing factors associated with failure were male sex, larger finger diameter, and thicker finger pad. The only squeezing failure factor was lower peripheral skin temperature. Improvement of the finger station groove shape to prevent ischemia and the squeezing angle would be useful developments of the all-in-one-type SMBG device for elderly people with decreased dexterity.

Type-1 Diabetes Patient Decision Simulator for In Silico Testing Safety and Effectiveness of Insulin Treatments.

Type-1 diabetes (T1D) treatment requires exogenous insulin administrations finely tuned based on glucose monitoring to avoid hyper/hypoglycemia. The safety and effectiveness of insulin treatments is commonly assessed in clinical trials, which are time demanding and expensive. These limitations can be overtaken by in silico clinical trials (ISCT) that require realistic patient and treatment models. The aim is to develop a T1D patient decision simulator usable to perform reliable ISCT. The T1D patient decision simulator was developed by connecting the UVA/Padova T1D model, which describes glucose, insulin, and glucagon kinetics, with modules describing glucose monitoring devices, like self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM), the patient's behavior in making treatment decisions, and insulin administration. The reliability of the simulator was assessed by comparing its predictions with data collected in 44 T1D subjects using the Dexcom G5 Mobile CGM sensor as an adjunct to the Bayer Contour Next USB SMBG device. Metrics like time spent in eu/hypo/hyperglycemia of simulated data well match those observed in subjects. In particular, mean time in euglycemia, mean time in hyperglycemia, and median time in hypoglycemia are 61.75% versus 63.60% (p-value = 0.4825), 33.38% versus 33.40% (p -value = 0.9950), and 3.17% versus 2.14% (p-value = 0.1134), respectively, in real versus simulated data. The proposed simulator can be used to perform credible ISCT in realistic insulin treatment scenarios. The T1D patient decision simulator can be used to reliably assess novel insulin treatments, e.g., based on use of CGM only, in a realistic multiple-day scenario.

Reduction of Blood Glucose Measurements to Calibrate Subcutaneous Glucose Sensors: A Bayesian Multiday Framework.

In most continuous glucose monitoring (CGM) devices used for diabetes management, the electrical signal measured by the sensor is transformed to glucose concentration by a calibration function whose parameters are estimated using self-monitoring of blood glucose (SMBG) samples. The calibration function is usually a linear model approximating the nonlinear relationship between electrical signal and glucose concentration in certain time intervals. Thus, CGM devices require frequent calibrations, usually twice a day. The aim here is to develop a new method able to reduce the frequency of calibrations. The algorithm is based on a multiple-day model of sensor time-variability with second-order statistical priors on its unknown parameters. In an online setting, these parameters are numerically determined by the Bayesian estimation exploiting SMBG sparsely collected by the patient. The method is assessed retrospectively on 108 CGM signals acquired for 7 days by the Dexcom G4 Platinum sensor, testing progressively less-calibration scenarios. Despite the reduction of calibration frequency (on average from 2/day to 0.25/day), the method shows a statistically significant accuracy improvement compared to manufacturer calibration, e.g., mean absolute relative difference when compared to a laboratory reference decreases from 12.83% to 11.62% (p-value of 0.006). The methodology maintains (sometimes improves) CGM sensor accuracy compared to that of the original manufacturer, while reducing the frequency of calibrations. Reducing the need of calibrations facilitates the adoption of CGM technology both in terms of ease of use and cost, an obvious prerequisite for its use as replacement of traditional SMBG devices.

PMD66 - Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices in Germany

PMD66 - Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices in Germany