Self-monitoring Of Blood Glucose Testing Research Articles

7296 Gestational Diabetes RT-Continuous Glucose Monitoring Users Utilized Fingerstick less in Pregnancy than Recommended Compared to Fingerstick Monitoring Alone with No Difference in A1c Outcomes

Abstract Disclosure: N.M. Ehrhardt: Advisory Board Member; Self; Bayer, Inc., Novo Nordisk, Dexcom. Grant Recipient; Self; Novo Nordisk. Research Investigator; Self; Novo Nordisk, Dexcom. P. Mandava: None. E. Fay: None. G. Abdalla: None. S. Fonda: None. Background: The Federal Drug Agency recently approved continuous glucose monitoring (CGM) use in gestational diabetes (GDM). However, self-monitoring of blood glucose (SMBG) with fingersticks is still recommended as an adjunct to CGM use. Here we report on SMBG with and without CGM and A1c, as part of a randomized controlled trial (RCT) of CGM for women with GDM. Methods: This is an RCT of 104 participants with GDM who were randomized to real-time CGM (RT-CGM) (N=48) or SMBG alone (control group; N=56). Sixty-one percent in the control group (N=34) withdrew after randomization because they desired a CGM device. Data collection was completed remotely given COVID-19 pandemic. A1c data was collected at baseline and 36 weeks gestation. Fingerstick data was collected at each of 4 study visits (2 weeks apart) until 38 weeks or delivery. All participants were advised to perform SMBG by fingerstick as instructed by their obstetric provider. This analysis is of participants who completed the study (control N=22; RT-CGM N=47). Results: The average age was 33.77 (+/- 5.26) years, 68.11% had a college degree or greater, 69.57% had an income of >$50,000, 95.65% had health insurance, 30.43% reported being Asian and 42.03% reported being white. Baseline mean A1c (+/- SD) was 5.39 (+/- 0.39) in the RT-CGM group and 5.41 (+/- 0.37) in in the control group. Mean A1c at ∼36 weeks of pregnancy was 5.44 (+/-0.43) in the RT-CGM group and 5.37 (+/- 0.44) in the control group. In the RT-CGM group, 20/47 (42.55%) provided SMBG data for ≥3 study visits, 18/47 (38.30%) had data for 1-2 visits, and 9/47 (19.15%) provided no SMBG data at all 4 visits. The mean (+/- SD) tests/day for the RT-CGM group who provided any meter data was 1.31 (+/- 1.89). In the control group, 16/22 (72.73%) provided SMBG data for ≥3 visits, 2/22 (9.09%) had data for 1-2 visits, and 4/22 (18.18%) never provided SMBG data. The mean (+/- SD) tests/day for the control group was 3.4 (+/- 0.73). For the RT-CGM group, simple correlation analyses found no association between number of visits in which fingerstick data were provided and A1c at visit 3 (r=-0.14; p=0.40) or average fingerstick tests/day and A1c at visit 3 (r=0.10; p=0.40). For the control group, there was no association between number of study visits in which fingerstick data were provided and A1c at visit 3 (r=0.38; p=0.11). However, for the control group, more fingerstick tests/day was associated with lower A1c at visit 3 (r=-0.45; p=0.07). Conclusions. Data is limited by missing data as participants did not always supply fingerstick data. Overall A1c in both groups remained stable, despite less SMBG testing in the CGM group. This suggests that SMBG data may add little in GDM management in conjunction with CGM use. More data is necessary to remove the recommended requirement for fingerstick with CGM in pregnancy. Presentation: 6/2/2024

An Analysis of the Distribution of Direct Cost of Diabetes Care in Selected Districts in Italy.

This study aims to define the distribution of direct healthcare costs for people with diabetes treated in two healthcare regions in Italy, based on number of comorbidities and treatment regimen. This was a retrospective analysis using data from two local health authority administrative databases (Campania and Umbria) in Italy for the years2014-2018. Data on hospital care, pharmaceutical and specialist outpatient and laboratory assistance were collected. All people with diabetes in 2014-2018 were identified on the basis of at least one prescription of hypoglycemic drugs (ATC A10), hospitalization with primary or secondary diagnosis of diabetes mellitus (ICD9CM 250.xx) or diabetes exemption code (code 013). Subjects were stratified into three groups according to their pharmaceutical prescriptions during the year: Type1/type2 diabetes (T1D/T2D) treated with multiple daily injections with insulin (MDI), type2 diabetes on basal insulin only (T2D-Basal) and type2 diabetes not on insulin therapy (T2D-Oral). We identified 304,779 people with diabetes during the period for which data was obtained. Analysis was undertaken on 288,097 subjects treated with glucose-lowering drugs (13% T1D/T2D-MDI, 13% T2D-Basal, 74% T2D-Oral). Average annual cost per patient for the year2018 across the total cohort was similar for people with T1D/T2D-MDI and people with T2D-Basal (respectively €2580 and €2254) and significantly lower for T2D-Oral (€1145). Cost of hospitalization was the main driver (47% for T1D/T2D-MDI, 45% for T2D-Basal, 45% for T2D-Oral) followed by drugs/devices (35%, 39%, 43%) and outpatient services (18%, 16%, 12%). Average costs increased considerably with increasing comorbidities: from €459 with diabetes only to €7464 for a patient with four comorbidities. Similar trends were found across all subgroups analysis. Annual cost of treatment for people with diabetes is similar for those treated with MDI or with basal insulin only, with hospitalization being the main cost driver. This indicates that both patient groups should benefit from having access to scanning continuous glucose monitoring (CGM) technology which is known to be associated with significantly reduced hospitalization for acute diabetes events, compared to self-monitored blood glucose (SMBG) testing.

Effect of emerging digital technologies and methodologies combined with incentives on HbA1c in patients with type 2 diabetes mellitus: study protocol for a parallel, open randomized controlled trial

BackgroundType 2 diabetes mellitus (T2DM) is a common metabolic disease that requires long-term management and treatment. Digital intervention, as an emerging medical model, has been widely used in the treatment of T2DM patients. Behavioral economics theory provides a favorable perspective for studying the effect of digital intervention because it can reveal the decision-making mechanisms behind human behavior and provide more effective interventions for digital intervention. The purpose of this trial is to evaluate the impact of behaviorally based digital intervention on T2DM patients’ HbA1c, self-monitoring of blood glucose (SMBG) testing rate, diabetes self-efficacy, and other indicators compared to conventional treatment.MethodsThis trial is a prospective randomized controlled trial conducted at the First People’s Hospital of Kunshan City from April 1, 2023, to December 31, 2024, with a follow-up period of 3 months. The specific randomization method was established and implemented through the EDC clinical trial center’s randomization system. We will measure and collect baseline data from three groups, including Group A: digital intervention + virtual incentives + conventional treatment, Group B: digital intervention + physical incentives + conventional treatment, and Group C: conventional treatment. HbA1c, weight, SMBG testing rate, diabetes self-efficacy, and diabetes-related medical expenses will be recorded at baseline, 1 month, 2 months, and 3 months for all three groups. The Shapiro-Wilk test will be used to test for normality, and Pearson correlation analysis will be used for correlation analysis. Dropouts will be analyzed separately. Analysis of variance or exact probability calculation will be used to compare demographic data and other baseline indicators.DiscussionThis study is a novel clinical trial that integrates multiple disciplines (economics and medicine) and uses digital technology to deliver the intervention. Most published studies were offline interventions based on behavioral economics theory, but very few were on online interventions for T2DM patients. This study has both novelty and social value.Trial registrationChinese Clinical Trial Registry ChiCTR2300070753. Registered on 2023/04/22.

To Use or Not to Use a Self-monitoring of Blood Glucose System? Real-world Flash Glucose Monitoring Patterns Using a Cluster Analysis of the FGM-Japan Study.

Objective This study investigated self-monitoring of blood glucose (SMBG) adherence and flash glucose monitoring patterns using a cluster analysis in Japanese type 1 diabetes (T1D) patients with intermittently scanned continuous glucose monitoring (isCGM). Methods We measured SMBG adherence and performed a data-driven cluster analysis using a hierarchical clustering in T1D patients from Japan using the FreeStyle Libre system. Clusters were based on three variables (testing glucose frequency and referred Libre data for hyperglycemia or hypoglycemia). Patients We enrolled 209 participants. Inclusion criteria were patients with T1D, duration of isCGM use ≥3 months, age ≥20 years old, and regular attendance at the collaborating center. Results The rate of good adherence to SMBG recommended by a doctor was 85.0%. We identified three clusters: cluster 1 (low SMBG test frequency but high reference to Libre data, 17.7%), cluster 2 (high SMBG test frequency but low reference to Libre data, 34.0%), and cluster 3 (high SMBG test frequency and high reference to Libra data, 48.3%). Compared with other clusters, individuals in cluster 1 were younger, those in cluster 2 had a shorter Libre duration, and individuals in cluster 3 had lower time-in-range, higher severe diabetic distress, and high intake of snacks and sweetened beverages. There were no marked differences in the incidence of diabetic complications and rate of wearing the Libre sensor among the clusters. Conclusions We stratified the patients into three subgroups with varied clinical characteristics and CGM metrics. This new substratification might help tailor diabetes management of patients with T1D using isCGM.

632-P: Glycemic Control in Diabetes Camp Attendees Remotely Monitored and Nonadjunctively Managed with CGM

Remote monitoring of CGM data of children and youth attending diabetes camp has been shown to reduce overall and nocturnal hypoglycemia, compared to treatment decisions based on self-monitored blood glucose (SMBG) values. However, some diabetes camps still require regular SMBG testing. We compared at-home versus at-camp glucose control where CGM data were used as the basis for diabetes treatment decisions. Thirty-four campers with T1D (mean±SD age 12±3 years, A1C 7.5±1.2%) were eligible for inclusion if they were using Control-IQ technology (Tandem Diabetes Care) prior to and during their attendance at Camp Buck, a diabetes-focused facility near Lake Tahoe. At camp, their CGM data (Dexcom G6) were integrated with the CampViews EMR system (Nevada-California Diabetes Association). CGM data from at-home and at-camp intervals were compared. As shown in the Table, mean glucose and overall time in range (TIR, 70-180 mg/dL) improved at camp, with statistical significance in the overnight (10PM-6AM) interval. Although time in Level 1 hypoglycemia increased at camp, there were no significant changes between at-home and at-camp levels of Level 2 hypoglycemia. CGM data can be used nonadjunctively in the camp setting to maintain or improve glycemic control. Centralized remote monitoring of glucose data allows camp attendees and staff to safely reduce or eliminate SMBG testing. Disclosure S.E.Gleich: Research Support; Dexcom, Inc. H.R.Tecca: Employee; Dexcom, Inc. N.D.Gibson-north: None. S.B.Andrade: Employee; Dexcom, Inc. J.Welsh: Employee; Dexcom, Inc. E.Schuster: Employee; Dexcom, Inc. T.C.Walker: Employee; Dexcom, Inc., Stock/Shareholder; Dexcom, Inc.

Feasibility and effectiveness of self-monitoring of blood glucose among insulin-dependent patients with type 2 diabetes: open randomized control trial in three rural districts in Rwanda

BackgroundThe prevalence of type 2 diabetes in sub Saharan Africa (SSA) has been on the rise. Effective control of blood glucose is key towards reducing the risk of diabetes complications. Findings mainly from high-income countries have demonstrated the effectiveness of self-monitoring of blood-glucose (SMBG) in controlling blood glucose levels. However, there are limited studies describing the implementation of SMBG in rural SSA. This study explores the feasibility and effectiveness of implementing SMBG among patients diagnosed with insulin-dependent type 2 diabetes in rural Rwanda.MethodsParticipants were randomized into intervention (n = 42) and control (n = 38) groups. The intervention group received a glucose-meter, blood test-strips, log-book, waste management box and training on SMBG in addition to usual care. The control group continued with their usual care consisting of, routine monthly medical consultation and health education. The primary outcomes were adherence to the implementation of SMBG (testing schedule and recording data in the log-book) and change in hemoglobin A1c. Descriptive statistics and a paired t-test were used to analyze the primary outcomes.ResultsIn both the intervention and control arms, majority of the participants were female (59.5% vs 52.6%) and married (71.4% vs 73.7%). Most had at most a primary level education (83.3% vs. 89.4%) and were farmers (54.8% vs. 50.0%). Among those in the intervention group, 63.4% showed good adherence to implementing SMBG based on the number of tests recorded in the glucose meter. Only 20.3% demonstrated accurate recording of the glucose level tests in log-books. The mean difference of the HbA1C from baseline to six months post-intervention was significantly better among the intervention group -0.94% (95% CI -1.46, -0.41) compared to the control group 0.73% (95% CI -0.09, 1.54) p < 0.001.ConclusionOur study showed that among patients with insulin-dependent type 2 diabetes residing in rural Rwanda, SMBG was feasible and demonstrated positive outcomes in improving blood glucose control. However, there is need for strategies to enhance accuracy in recording blood glucose test results in the log-book.Trial registrationThe trial was registered retrospectively on the Pan African Clinical Trial Registry, on 17th May 2019. The registration number is PACTR201905538846394.

Adherence to antidiabetic treatment in primary health care in individuals with type 2 diabetes. A survey including socio-demographic, patient related and clinical factors

BackgroundAdherence to medications is a critical element in diabetes management. ObjectiveTo investigate patient-related factors associated with adherence to antidiabetic treatment in patients with type 2 diabetes in primary health-care units. MethodsA cross-sectional study among patients receiving diabetes care in 18 primary care units in Mexico City was conducted. Data were collected from medical records and medical interviews. Adherence to antidiabetic therapy and patient-related factors associated with adherence were evaluated through a self-administered questionnaire. Socio-demographic, clinical, behavioral (self-care activities including a healthy diet, exercise or physical activity, self-monitoring of blood glucose testing, and foot care), and patients-adherence-related factors (health-care provider-patient communication; daily and social activities, and support network; alternative treatment beliefs; comorbidity, diabetes symptoms, and treatment; side effects and treatment access) were compared between the adherent and non-adherent group. ResultsOf 319 outpatients, 48.3% were adherent to their antidiabetic therapy. In the adjusted analysis, patient-related factors associated to adherence were exercise and physical activity self-care behavior (OR=1.26; 95%CI 1.09–1.46), treatment interference with daily activities (OR=0.27; 95%CI 0.14–0.52), not satisfied with resolution of questions by the physician (OR=0.42; 95%CI 0.19–0.94), independently to increased cardiovascular risk and insulin treatment. ConclusionA low proportion of outpatients with T2D with regular primary care were adherent to diabetes treatment and this was associated with patient-related factors like answering patients’ treatment-related questions by the physician. This information may be useful to identify patients at risk for low adherence, and to guide the design of quality-of-care strategies, like diabetes education programs to address suboptimal adherence in patients, and health-care professional communication skills training, particularly in primary care health systems.

Development and Usability of a Text Messaging Program for Women With Gestational Diabetes: Mixed Methods Study.

BackgroundGestational diabetes mellitus (GDM) affects 5%-10% of pregnancies and can lead to serious fetal and maternal complications. SMS text messaging is an effective way to improve diabetes management outside of pregnancy, but has not been well studied in GDM.ObjectiveThis study aimed to perform user experience testing and assess usability and acceptability of an SMS text messaging program (Text 4 Success) for women with GDM.MethodsAn automated 2-way texting program was developed. It included (1) reminders to check blood glucose levels, (2) positive feedback to user-reported glucose levels, (3) weekly educational messages, and (4) weekly motivational messages. For the user experience testing, women received simulated messages. For the usability study, women were enrolled in the program and received messages for 2 weeks. All women participated in semistructured interviews. For women in the usability study, data from glucose measuring devices were downloaded to assess adherence to self-monitoring of blood glucose (SMBG), measured as the percentage of recommended SMBG checks performed (a secondary outcome).ResultsTen women participated in user experience testing. Suggestions for optimization included further customization of message timing and minimization of jargon, which were incorporated. Ten women participated in the usability study. All 10 would recommend the program to other women with GDM. Participants liked the immediate feedback to glucose values. Suggestions included further flexibility of messages related to mealtimes and the ability to aggregate blood glucose data into a table or graph. Overall, adherence to SMBG testing was high at baseline (222/238 recommended checks, 93%). In comparing the week prior to the trial with the 2 weeks during the trial, there was a small but statistically insignificant difference (P=.48) in the percentage of recommended SMBG performed (median 93% [25th-75th IQR 89%-100%] vs median 97% [25th-75th IQR 92%-100%]).ConclusionsOverall, women with GDM would recommend the Text 4 Success in GDM program and think it is helpful for GDM self-management. The program was usable and acceptable. The program may be better suited to those who have low levels of adherence to SMBG at baseline or to women at time of their diagnosis of GDM. Adaptations to the program will be made based on user suggestions. Further study of SMS text messaging to improve SMBG in GDM is needed.

Efficacy of a New Protocol of Premixed 70/30 Human Insulin in Haitian Youth with Diabetes.

IntroductionControlling insulin-treated diabetes is challenging in low-resource settings where only Neutral Protamine Hagedorn (NPH), regular (R) and premixed insulin formulations are available, self-monitoring of blood glucose (SMBG) supplies are scarce and food insecurity is common. We examined the impact of a treatment protocol that includes sliding scale-based 70/30 insulin adjustments in Haiti.MethodsThirty young patients aged 11–28 years with diabetes treated with premixed 70/30 insulin twice daily were included in the study. The participants performed one or two daily self-monitoring of blood glucose (SMBG) tests and attended our diabetes clinic monthly. They were randomized to two treatment groups, with one group remaining on the 70/30 insulin formulation (group 70 [G70]) and the other group switching to self-mixed NPH + R (group NR [GNR]). Sliding scales for insulin correction doses and meal insulin doses were designed based on the total daily insulin dose (TDD), carbohydrate ratio and insulin sensitivity factor. SMBG tests and insulin were administered before the morning and evening meals. The frequency of visits to the diabetes clinic was increased to biweekly during a 14-week follow-up.ResultsFifteen patients of each group were included in the analysis. Baseline characteristics, increase in total daily dose and number of missed SMBG tests and skipped meals at 14 weeks did not differ between the two groups. Hemoglobin A1c (HbA1c) decreased from 9.5% (interquartile range [IQR] 8.8, 10.5) (80.3 mmol/mol) to 8.0% (IQR 7.1%, 9.0%) (63.9 mmol/mol) in G70 (p = 0.01), and from 10.6% (IQR 8.1,% 13.1)% (92.4 mmol/mol) to 9.0% (IQR 7.6%, 9.6%) (74.9 mmol/mol) in GNR (p = 0.10), with no significant between-group difference in reductions (p = 0.12). No serious acute complications were reported. Stopping the use of sliding scales and resuming monthly visits increased HbA1c to values not significantly different from baseline in both groups after 15 weeks.ConclusionThe use of sliding scales adjusted for missed SMBG tests and skipped meals, and frequent clinic visits that focus on patient self-management education significantly improved glycemic control in the patients with youth-onset diabetes in our study treated with premixed 70/30 human insulin in a low-resource setting.

Self-Monitoring of Blood Glucose Requirements with the Use of Intermittently Scanned Continuous Glucose Monitoring: A Follow-Up Analysis Using Real-Life Data.

Hypoglycemia-prone individuals with type 1 diabetes (T1D) who use intermittently scanned continuous glucose monitoring (isCGM) systems spend about 5 h/day in states where self-monitoring of blood glucose (SMBG) is indicated. Here we present estimates of the need for SMBG testing by retrospectively analyzing isCGM data from a cohort of real-world isCGM users. Data from 67 individuals were included in the analysis. Mean (SD) 3.18 (1.63) h/day was spent in an SMBG-indicated state and the number of transitions to an SMBG-indicated state was 3.86 (1.46)/day. Frequency of clinically important hypoglycemia [<3.0 mmol/L (<54 mmol/dL)] was median (IQR) 1.5 (0.6-3.4) episodes/week, of which only 50% were associated with a scan during the episode, and the average duration was 75.2 (63.9-91.8) min/episode. The need for continued SMBG testing remains important for all isCGM users and may affect the overall cost-effectiveness of isCGM. Impaired awareness of hypoglycemia and incidence of asymptomatic hypoglycemia may be underreported among real-life isCGM users in clinical practice.

An Exploratory Research of 18 Years on the Economic Burden of Diabetes for the Romanian National Health Insurance System.

The prevalence of diabetes mellitus (DM) rises constantly each year worldwide. Because of that, the funds allocated for the DM treatment have increased over time. Regarding the number of DM cases, Romania is among the top ten countries in Europe. Based on the National Diabetes Programme (NDP), antidiabetic drugs and other expenditures (Self-monitoring blood glucose (SMBG) test, HbA1c, insulin pumps/insulin pumps supplies) are free of charge. This programme has undergone many changes in drugs supply, in the last two decades: re-organizing the NDP, authorization of new molecules with high prices (e.g., SGLT-2 inhibitors, etc.) or new devices (e.g., insulin pumps, etc.) The main purpose of this study is to identify and analyse the impact of the DM costs on the Romanian health budget and to highlight the evolution of these costs. A retrospective longitudinal research on the official data regarding the DM costs from 2000 to 2017 was performed. The DM funds (DMF) were adjusted with the inflation rate. In this period, the average share of DMF in the total funds allocated for health programmes was 21.3 ± 3.4%, and DMF average growth rate was 25.4% (r = 0.488, p = 0.047). On the other hand, the DMF increased more than 14 times, in spite of the patients’ number having increased only about 2.5 times. Referring to the structure of DMF, the mean value of the antidiabetic drugs cost was of 96,045 ± 67,889 thousand EUR while for other expenditures it was of 11,530 ± 7922 thousand EUR (r = 0.945, p < 0.001). Between 2008 and 2017, the total DMF was 181,252 ± 74,278 thousand EUR/year. Moreover, the average patients’ number was 667,384 ± 94,938 (r = 0.73, p = 0.016), and the cost of treatment was 215 ± 36 EUR/patient/year. Even if the cost is rising, the correct and optimal treatment is a main condition for the diabetic patient’s health and for the prevention of its complications, which have multiple socio-economic repercussions.

The impact of limited and strategic blood glucose monitoring on metabolic control in a type 1 diabetes clinic in Central India

Self-monitoring of blood glucose (SMBG) is an essential component of type 1 diabetes (T1D) management and typically involves several daily tests. However, due to high cost, SMBG supplies are often unavailable in low-resource settings. This study assessed whether the use of two SMBG tests per day improves glycemic control, measured by a change in HbA1c, in youth with T1D followed at the DREAM Trust (DT) in Nagpur, India. Single-site prospective cohort study of youth ??????23 years of age with T1D ??????1 year followed by DT, who were provided with SMBG meters and two test strips per day. Patients received education regarding SMBG and how to respond to blood glucose values and trends. They were followed every 3 months with HbA1c and questionnaires for a total of 21 months. HbA1c declined significantly from 10.2????????2.5% (88????????4 mmol/mol) at baseline to 9.5????????2.4% (80????????3 mmol/mol) at 21 months (p???<???0.001). In univariable analysis, change in HbA1c was associated with adherence to insulin dosing, number of patient education sessions, household income, and holding a below the poverty line certificate. In multivariable analysis, only adherence to insulin dosing was a significant predictor for a decrease in HbA1c. There was no increase in diabetes-related acute complications. The use of two SMBG test strips per day for the management of T1D in a low-resource setting was safe, and over the 21 months following its introduction, there was a clinically and statistically significant decrease in HbA1c.

Difference Analysis of System Accuracy Criteria between Self-Monitoring Blood Glucose Test System and Point-of-Care Blood Glucose Monitoring Systems

According to users and places, blood glucose monitoring systems(BGMSs) can be divided into self-monitoring blood glucose test systems(SMBGs) and Point-of-Care Blood Glucose monitoring systems(POC-BGMSs). The Food and Drug Administration(FDA) believes that standards for SMBGs and POC-BGMSs should be different because of different operators, different use environments, different intendance uses and different applicable populations. Now the international standards for evaluating BGMSs include ISO 15197:2013 issued by International Organization for Standardization(ISO), two guidelines on blood glucose monitoring systems issued by FDA, and POCT12-A3 guidelines issued by the American Association for Clinical and Laboratory Standardization(CLSI), ISO standard and FDA guideline-OTC are applicable in SMBGs, CLSI guideline and FDA guideline-POCTI2-A3 are suitable for POC-BGMSs. By analyzing the accuracy evaluation processes of BGMSs based on four standard documents, it is found that the accuracy evaluation of medical BGMSs is more stringent. It is proposed that SMBGs and POC-BGMSs should be supervised separately.

An anti-HCT-interference glucose sensor based on a fiber paper-based screen-printed carbon electrode

As the number of diabetic patients increases year by year, the demand for a self-monitoring blood glucose test also increases. Additionally, more in-depth studies of blood glucose biosensors have led to increasing accuracy requirements. However, at present, most enzyme glucose sensors have difficulty solving issues related to hematocrit (HCT) interference. Most studies on anti-HCT interference in blood glucose sensing have mainly focused on correction factors, such as glucose correction, and electrical impedance or resistivity characteristics to correct the impact of HCT. In this work, we developed an anti-HCT-interference blood glucose sensor based on a fiber paper-based screen-printed carbon electrode with a mediator (potassium ferricyanide) and glucose oxidase (GOD), which were fixed through inkjet printing. When testing whole blood samples with HCT levels of 20%–70% and a fluid dropping method, the results of a consensus error grid analysis showed that 91% of the data points lied within zones A and B. The glucose sensor was exclusively designed with a 16 μL chamber in the working area of the sensor. When the testing fluid was taken in by capillary sucking, the effect of HCT was further reduced, and 95% of the data points lied within zones A and B in the consensus error grid.

91-LB: Ongoing Requirements for SMBG Testing among isCGM Users

Some factory-calibrated continuous glucose monitoring (CGM) systems are approved for non-adjunctive use, although these systems require adjunctive self-monitored blood glucose (SMBG) tests in specific instances. We estimated how often users of an intermittently-scanned CGM (isCGM) system might be required to perform SMBG testing. Criteria under which an adjunctive SMBG test is required were obtained from the U.S.-specific 14-day isCGM user guide (Figure). Real-world glucose values were obtained from a random sample of 10,000 adults (ages 18+) who used Dexcom G6 real-time CGM at least 90% of the time for at least 14 days between 7/1/2018-9/30/2018. The percentage of values meeting one or more of the criteria for mandatory SMBG testing was calculated as hours per day. Glucose readings were changing &amp;gt; 2 mg/dL/min a mean (SD) of 1.34 (0.77) hours/day, predicted to be &amp;lt; 70 mg/dL within 15 minutes for 1.03 (0.95) hours/day, and &amp;lt; 70 mg/dL for 0.67 (0.79) hours/day; one or more of these criteria were present for 2.35 (1.30) hours/day. Added to the 0.86 hour/day warmup period, SMBG testing would be indicated for an isCGM user for an average of 3.20 (1.30) hours/day. This may be a conservative estimate as the isCGM label demonstrates that the system overestimates hypoglycemia. Users of the isCGM system are likely to confront multiple intervals during which SMBG is required and reliance on their isCGM glucose values for diabetes management decisions is contraindicated. Disclosure D.A. Price: Employee; Self; Dexcom, Inc. Stock/Shareholder; Self; Johnson &amp; Johnson.

Flash Glucose Monitoring Accepted in Daily Life of Children and Adolescents with Type 1 Diabetes and Reduction of Severe Hypoglycemia in Real-Life Use.

Background: Flash glucose monitoring (FGM) is covered by the Belgian public health insurance for type 1 diabetes since 2016. The objective of this study was to describe the use of FGM and diabetes outcomes in type 1 diabetic children and adolescents 1 year after reimbursement. Methods: All patients had the choice to convert to FGM or to continue with self-monitoring of blood glucose (SMBG). Clinical data were collected at baseline, at the next visit, and after 12 months; glucose profiles at next visit and after 12 months. Regression analyses were performed to identify predictors of FGM acceptance and changes in metabolic control. Results: A total of 334 subjects were included, of whom 278 (83.2%) switched to FGM. They were younger (13.6 vs. 15.2 years; P = 0.012) and performed more SMBG testing at baseline than patients who did not switch (4.3 vs. 4.1 tests daily; P = 0.008). At the end of follow-up, the rate of severe hypoglycemia decreased by 53% in the group of FGM users (P = 0.012) while it remained stable in SMBG users. Median glycated hemoglobin did not change significantly in both groups. Among subjects who switched to FGM, 15.8% reverted to SMBG after a median use of 5.3 months. Adverse events, diabetes duration, and FGM utilization were independent predictors of the risk for reverting. FGM-related adverse events were associated with a fivefold increased risk to revert to SMBG (hazard ratio = 5.12; P < 0.0001). Conclusions: FGM is relatively well accepted and decreases the risk of severe hypoglycemic events in our pediatric population. FGM is more often discontinued in patients experiencing adverse events and with longer diabetes duration.

Ideglira is Associated With Improved Short-Term Clinical Outcomes and Cost Savings Compared With Insulin Glargine U100 Plus Insulin Aspart in the U.S.

In the DUAL (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) VII trial, IDegLira (a combination of insulin degludec and liraglutide) was compared with insulin glargine U100 plus insulin aspart. Both treatment approaches achieved similar glycemic control, but there were differences in hypoglycemia, changes in body weight, and injection frequency. The aim of the present analysis was to assess the short-term cost effectiveness of IDegLira versus insulin glargine U100 plus insulin aspart for treatment of patients with type 2 diabetes mellitus not meeting glycemic targets on basal insulin in the U.S. A cost-utility model was developed to evaluate the clinical and economic outcomes associated with the 2 treatments over a 1-year time horizon, capturing the impact on quality of life of hypoglycemic events, body mass index, and injection frequency. Costs were captured from a healthcare payer perspective in 2017 U.S. dollars ($). IDegLira was associated with improved quality of life by 0.12 quality-adjusted life years compared with insulin glargine U100 plus insulin aspart. The key drivers of this difference were reduced injection frequency and hypoglycemic events avoided. IDegLira was associated with increased annual drug costs, but this was entirely offset by reduced needle costs and reduced costs of self-monitoring of blood glucose testing. IDegLira was associated with total annual cost savings of $743 per patient. IDegLira was found to improve quality-adjusted life expectancy and reduce costs when compared with insulin glargine U100 plus insulin aspart for treatment of patients with type 2 diabetes not achieving glycemic control on basal insulin in the U.S. ADA = American Diabetes Association; BMI = body mass index; CI = confidence interval; DUAL = Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes; GLP-1 = glucagon-like peptide-1; HbA1c = glycated hemoglobin; ICER = incremental cost-effectiveness ratio; IU = international units; QALY = quality-adjusted life year; SMBG = self-monitoring of blood glucose.

The Effect of Reduced Self-Monitored Blood Glucose Testing After Adoption of Continuous Glucose Monitoring on Hemoglobin A1c and Time in Range.

The effectiveness of real-time continuous glucose monitoring (rtCGM) in adults with diabetes treated with insulin injections was evaluated in the 24-week DIAMOND clinical trial comparing rtCGM users to a control group using self-monitored blood glucose (SMBG) testing ( Clinicaltrials.gov : NCT02282397). All participants were instructed to use SMBG results for diabetes management decisions; however, SMBG testing frequency varied within the rtCGM group. This brief report evaluated how SMBG frequency changes in the rtCGM group were correlated with glycemic outcomes in the same trial. Baseline and end-of-study hemoglobin A1c (HbA1c) levels, percentages of CGM values in the 70-180 mg/dL target range (time in range [TIR]), mean of daily differences (MODD), and glycemic coefficients of variation (CVs) were compared. The rtCGM group analyzed included 175 participants-99 with type 1 diabetes (T1D) and 76 with type 2 diabetes (T2D). When comparing participants whose SMBG testing frequency decreased by >1/day versus ≤1/day, mean change in HbA1c was similar (-0.9 ± 0.7 percentage points in both groups, P = 0.59), as was change in TIR (+3.9 ± 14.3 vs. +5.7 ± 13.7 percentage points, respectively, P = 0.39). Likewise, when comparing participants in the highest and lowest quartiles of SMBG frequency reduction (≥2.2 vs. ≤0.4 fewer tests/day, respectively), changes in HbA1c (-0.8 ± 0.6 vs. -0.9 ± 0.6 percentage points, respectively, P = 0.52) and TIR (+4.8 ± 13.2 vs. +5.6 ± 12.7 percentage points, respectively, P = 0.98) were similar. The mean (standard deviation [SD]) change in MODD was -8.3 mg/dL (14.8) and -5.5 mg/dL (14.7) for participants who reduced their SMBG frequency by >1 test/day and ≤1 test/day, respectively; the mean (SD) change in CV was -3.6% (5.0) and -1.6% (5.1) for participants who reduced their SMBG frequency by >1 test/day and ≤1 test/day, respectively. These findings suggest that individuals who decrease the frequency of SMBG testing can effectively base some of their diabetes-related treatment decisions on glucose concentrations, trend information, and alarms provided by their rtCGM systems.

Performance of the GLUCOCARD® Shine XL Blood Glucose Monitoring System Compared with FDA 2016 Guidance Accuracy Criteria

Background: Blood Glucose Monitoring Systems (BGMS) are important tools used in the management of diabetes mellitus. Accurate BGMS readings are needed to prevent potential micro and macrovascular complications due to uncontrolled blood glucose levels. The FDA’s 2016 Guidance, “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter (OTC) Use”, is FDA’s recommendation for measuring the accuracy of OTC BGMS. The accuracy boundaries of the guidance require that 95% of all results fall within ±15% of reference and 99% within ±20% of reference. Purpose: This study evaluated the GLUCOCARD® Shine XL BGMS performance against the accuracy boundaries set by the FDA’s 2016 Guidance. Methods: Three lots of test strips were evaluated in a side-by-side comparison at the ARKRAY Factory in Minneapolis, Minnesota. Blood samples were drawn from the fingertip of people with diabetes (n=180) by trained laboratory professionals between November and December 2017. Reference values were obtained using the YSI Model 2300 Analyzer. Data was evaluated against the accuracy boundaries of the FDA’s 2016 Guidance for Self-Monitoring Blood Glucose Test Systems for OTC Use. Results: 98.3% (177/180) of the combined results for the three lots of GLUCOCARD® Shine XL BGMS fell within the ±15% of reference and 99.4% (179/180) were within ±20% of reference. Overall bias was 2.2% and the correlation coefficient was 0.99 (r). Conclusion: The GLUCOCARD® Shine XL BGMS performed within the accuracy boundaries of the FDA’s 2016 Guidance, Self-Monitoring Blood Glucose Test Systems for OTC Use. Disclosure J. Walker: Employee; Self; Arkray, Inc. P. Gill: Employee; Self; Arkray, Inc. D. Maher: Employee; Self; Arkray, Inc. J.M. Gleisner: Employee; Self; Arkray, Inc..

Health Literacy, Glycemic Control, and Physician-Advised Glucose Self-Monitoring Use in Type 2 Diabetes

Objective.To measure the association between health literacy and both patient-reported and clinical outcomes in patients with non–insulin-treated type 2 diabetes.Research Design and Methods.We surveyed patients with non–insulin-treated type 2 diabetes (n = 448) from 15 primary care practices. The association between health literacy and patient-reported and clinical outcomes, including numeracy of self-monitoring of blood glucose (SMBG) use, how often physicians advised patients to conduct SMBG testing, and glycemic control (as measured by A1C), was investigated.Results.Study participants included 448 patients with non–insulin-treated type 2 diabetes located within central North Carolina. Participants with limited health literacy had poorer glycemic control (A1C 7.7 ± 1.1% vs. 7.5 ± 1.0%, P = 0.016) despite using SMBG testing more frequently (daily SMBG testing 49.3 vs. 30.7%, P = 0.001) compared to individuals with adequate health literacy. The difference in how often physicians advised patients to conduct SMBG testing between limited and adequate health literacy groups was not significant (P = 0.68).Conclusion.Limited health literacy was associated with poorer glycemic control and an increased frequency of SMBG testing in patients with non–insulin-treated type 2 diabetes. There was no significant difference in how often physicians advised patients to conduct SMBG testing between patients with limited and adequate health literacy.