Impact of Self-Monitoring Blood Glucose on Glycaemic Control Among Insulin-Treated Patients With Diabetes Mellitus in Northeastern Tanzania: A Randomised Controlled Trial.

Introduction: Tracking of blood glucose levels by patients and care providers remains an integral component in the management of diabetes mellitus (DM). Evidence, primarily from high-income countries, has illustrated the effectiveness of self-monitoring of blood glucose (SMBG) in controlling DM. However, there is limited data on the feasibility and impact of SMBG among patients in the rural regions of sub-Saharan Africa. This study is aimed at assessing SMBG, its adherence, and associated factors on the effect of glycaemic control among insulin-treated patients with DM in northeastern Tanzania. Materials and Methods: This was a single-blinded, randomised clinical trial conducted from December 2022 to May 2023. The study included patients with DM who had already been on insulin treatment for at least 3 months. A total of 85 participants were recruited into the study and categorised into the intervention and control groups by a simple randomization method using numbered envelopes. The intervention group received glucose metres, test strips, logbooks, and extensive SMBG training. The control group received the usual care at the outpatient clinic. Each participant was followed for a period of 12 weeks, with glycated haemoglobin (HbA1c) and fasting blood glucose (FBG) being checked both at the beginning and at the end of the study follow-up. The primary and secondary outcomes were adherence to the SMBG schedule, barriers associated with the use of SMBG, and the ability to self-manage DM, logbook data recording, and change in HbA1c. The analysis included descriptive statistics, paired t-tests, and logistic regression. Results: Eighty participants were analysed: 39 in the intervention group and 41 in the control group. In the intervention group, 24 (61.5%) of patients displayed favourable adherence to SMBG, as evidenced by tests documented in the logbooks and glucometer readings. Education on SMBG was significantly associated with adherence. Structured SMBG improved glycaemic control with a HbA1c reduction of -1.01 (95% confidence interval (CI) -1.39, -0.63) in the intervention group within 3 months from baseline compared to controls of 0.18 (95% CI -0.07, 0.44) (p < 0.001). Conclusion: Structured SMBG positively impacted glycaemic control among insulin-treated patients with DM in the outpatient clinic. The results suggest that implementing a structured testing programme can lead to significant reductions in HbA1c and FBG levels. Trial Registration: Pan African Clinical Trials Registry identifier: PACTR202402642155729.

Frequent Self-Monitoring Blood Glucose Correlated to Better Medication Adherence and Glycemic Control in Children with Type 1 Diabetes Mellitus.

Background: Type 1 diabetes mellitus (T1DM) is the most common chronic disease in children, with several severe short and long-term complications. Glycemic control is an important aspect of diabetes management with the most influential factor being compliance with self-monitoring blood glucose (SMBG). Mostly, in Indonesia, the finger stick devices as a glucose monitoring tool were frequently used. About 20% of children follow the recommendation to measure blood glucose four to six times daily. Methods: This is a single center, cross-sectional study that was conducted between July-November 2022. The Population is children with T1DM at the Pediatric Outpatient Clinic of Dr. Soetomo Hospital, Surabaya, Indonesia. Children with T1DM aged 4-18 years were enrolled using consecutive sampling. A compliance questionnaire was used to assess SMBG. Psychosocial conditions were assessed using the Pediatric Symptom Checklist 17, and medication adherence was evaluated using the Adherence to Refills and Medications Scale for Diabetes (ARMS-D). Pearson correlation and linear regression were employed for statistical analyses using Statistical Package for Social Sciences version 21.0, with p < 0.05 indicating statistical significance. Results: A total of 36 children were included in this study. SMBG frequency over 4x per day was significantly associated with increased medication adherence as measured by the ARMS-D score (p = 0.012). Higher SMBG frequency was also correlated with decreased HbA1c (p = 0.014, r = 0.406) and nutritional status (p = 0.031, r = 0.360). Less than 50% of the patients in Indonesia adhered to the recommended guidelines for SMBG (ie, ≥4 times per day). Conclusion: Higher SMBG frequency was correlated with better glycemic control. This finding suggests the need for further support in conducting SMBG based on the national guideline. However, due to it being conducted in a single center, we suggest increasing the sample size or conducting multi-centre collaborations in future studies. Originality/Value: By specifically investigating the relationship between adherence to self-monitoring of blood glucose (SMBG) and glycemic control in children with type 1 diabetes mellitus (T1DM), our study represents a novel contribution to the field of pediatric diabetes management in Indonesia. While previous research has explored similar relationships in other populations, our study focuses exclusively on the unique context of Indonesia, where rates of adherence to SMBG in pediatric patients have not been well studied and are relatively low compared to global standards.

Concordance of Blood Glucose and CGM During a Pilot Trial of Automated Insulin Delivery in Type 1 Diabetes Pregnancies.

Background: Customized and standard automated insulin delivery (AID) systems for use in pregnancies of women with preexisting type 1 diabetes (T1D) are being developed and tested to achieve pregnancy appropriate continuous glucose monitoring (CGM) targets. Guidance on the use of CGM for treatment decisions during pregnancy in the United States is limited. Methods: Ten pregnant women with preexisting T1D participated in a trial evaluating at-home use of a pregnancy-specific AID system. Seven-point self-monitoring of blood glucose (SMBG) was compared to the closest sensor glucose (Dexcom G6 CGM) value biweekly to assess safety and reliability based on the 20%/20 mg/dL criteria. Results: All participants completed the study with 7 participants satisfying the safety and reliability criteria with a mean absolute relative difference of 10.3%. Three participants did not fulfill the criteria, mainly because the frequency of SMBG did not meet the requirements. Conclusion: Dexcom G6 CGM is safe and accurate in the real-world setting for use in pregnant women with preexisting T1D with reduced SMBG testing as part of a pregnancy-specific AID system.

Measuring capillary blood glucose concentration: Is the first blood drop really the right blood drop?

BACKGROUND: Capillary blood glucose (CBG) is fundamental for diabetes mellitus management. However, it is still unclear whether the first or the subsequent blood drops most accurately reflect patients' blood glucose levels. METHODS: 128 healthy volunteers were included in this prospective cohort study from November 2021 to December 2021. Capillary blood glucose concentrations of the first four blood drops, measured using glucose meters were compared with venous blood concentrations of the respective donors, measured using an in-lab hexokinase method. ANOVA, the Spearman correlation coefficient and Bland-Altman plots were used to analyze the data. RESULTS: The mean plasma glucose concentration was 90.46 mg/dl with an SD of ± 14.416 (5.02 ± 0.8 mmol/l). There were statistically strong correlations among the glucose concentrations of all capillary blood drops (correlation coefficients of r > 0.8). The first capillary blood drops showed the lowest mean difference to plasma blood glucose concentrations (+4.92 mg/dl; +0.27 mmol/l), followed by the third drop (+7.28 mg/dl; +0.4 mmol/l), second drop (+7.30 mg/dl; +0.4 mmol/l) and fourth drop (+8.87 mg/dl; +0.49 mmol/l). CONCLUSION: There is a strong correlation and good agreement between the different capillary blood drops, making all blood drops equally suitable for blood glucose monitoring. In practice, the given setting (clinical or patient self-monitoring) should be considered upon choosing a specific blood drop.

The Effectiveness of Continuous Glucose Monitoring Devices in Managing Uncontrolled Diabetes Mellitus: A Retrospective Study.

This retrospective study aimed to assess the effectiveness of continuous glucose monitoring (CGM) devices in managing uncontrolled diabetes mellitus (DM). The study cohort comprised 25 patients with uncontrolled diabetes who received treatment at an internal medicine resident clinic. The objective was to evaluate the impact of transitioning from self-monitoring of blood glucose (SMBG) to CGM devices on glycemic control, as measured by changes in hemoglobin A1c (HbA1c) levels, average blood glucose levels, hypoglycemic events, time spent within the target blood sugar range, and glucose variability. The findings indicated significant improvements in glycemic control with the adoption of CGM devices, highlighting their potential benefits for optimizing diabetes management. The study is particularly interesting because it was done in an internal medicine continuity clinic with the main participation of the internal medicine residents under the supervision of an endocrinologist. It was not done as the majority of the other studies used CGM in specialized endocrinology clinics.

Self-monitoring of blood glucose two-weekly versus weekly in gestational diabetes on nutrition therapy: A randomized trial.

OBJECTIVE: To evaluate 4-point per day self-monitoring of blood glucose (SMBG) every 2 weeks compared with every week. METHODS: A total of 104 patients with lifestyle-controlled gestational diabetes (GDMA1) were randomized to 2-weekly or weekly 4-point per day (fasting on awakening and 2-h post-meals) SMBG. Primary outcome was the change in glycated hemoglobin (HbA1c) level from enrollment to 36 weeks of pregnancy across trial arms. The non-inferiority margin was an HbA1c increase of 0.2%. RESULTS: The mean difference for change in HbA1c from enrollment to 36 weeks was 0.003% (95% confidence interval [CI] -0.098% to +0.093%), within the 0.2% non-inferiority margin. The change in HbA1c level increased significantly within both trial arms-0.275% ± 0.241% (P < 0.001) in 2-weekly arm versus 0.277% ± 0.236% (P < 0.001) in the weekly arm. Participants randomized to 2-weekly SMBG were significantly less likely to receive anti-glycemic treatment-5/52 (9.6%) versus 14/50 (28.0%) (relative risk 0.34, 95% CI 0.13-0.88; P = 0.017). All secondary outcomes-maternal weight gain, preterm delivery, cesarean delivery, birthweight, and neonatal admission-were not significantly different. CONCLUSIONS: In GDMA1, 2-weekly is non-inferior to weekly SMBG on the change in HbA1c level. Two-weekly SMBG appeared to be adequate for monitoring women with GDMA1. CLINICAL TRIAL REGISTRATION: This study was registered in ISRCTN registry on March 25, 2022 with trial identification number: ISRCTN13404790 (https://doi.org/10.1186/ISRCTN13404790). The first participant was recruited on April 12, 2022.

Accuracy of the Third Generation of a 14-Day Continuous Glucose Monitoring System.

INTRODUCTION: We have evaluated the performance of the FreeStyle Libre® 3 continuous glucose monitoring system (FSL3) compared to (1) the venous plasma reference for participants aged ≥ 6 years and (2) the fingerstick capillary blood glucose (BG) reference for pediatric participants aged 4 and 5 years. The analytical performance of the third-generation factory-calibrated FSL3 CGM system was compared to the plasma venous blood glucose reference using the YSI 2300 STAT PLUS Glucose and Lactate Analyzer (the YSI reference) and the self-monitoring blood glucose (SMBG) reference for participants aged ≥ 6 years and participants aged 4 and 5 years, respectively. METHODS: A total of 108 participants aged ≥ 4 years with type 1 or type 2 diabetes from four sites in the USA were enrolled in the study. The data of 100 participants were ultimately evaluated. Adult participants (aged ≥ 18 years) participated in three in-clinic sessions, and pediatric participants (aged 4-17 years) participated in up to two in-clinic sessions, all stratified to provide data for days 1, 2, 3, 7, 8, 9, 12, 13 or 14 of sensor wear. Performance evaluation included accuracy measures, such as proportion of CGM values that fell within ± 20% or ± 20 mg/dL (1.1 mmol/L) of the reference glucose values, and difference measures, such as the mean absolute relative difference (MARD) between the CGM and reference values. RESULTS: Data from the 100 study participants were analyzed. The overall MARD was 7.8%, and 93.4% of the CGM values were within ± 20% or ± 20 mg/dL of the YSI reference for participants aged ≥ 6 years, with 6845 CGM-YSI matched pairs. The performance was stable over the 14-day wear period. For participants aged 4-5 years, MARD was 10.0%, and 88.9% of the CGM values were within 20%/20 mg/dL compared to a SMBG reference. No serious adverse events were reported. CONCLUSIONS: The FSL3 CGM system demonstrated accurate performance across the dynamic glycemic range during the 14-day sensor wear period.

A systematic review: Cost-effectiveness of continuous glucose monitoring compared to self-monitoring of blood glucose in type 1 diabetes.

Continuous glucose monitoring (CGM) is rapidly becoming a vital tool in the management of type 1 diabetes. Its use has been shown to improve glycaemic management and reduce the risk of hypoglycaemic events. The cost of CGM remains a barrier to its widespread application. We aimed to identify and synthesize evidence about the cost-effectiveness of utilizing CGM in patients with type 1 diabetes. Studies were identified from MEDLINE, Embase and Cochrane Library from January 2010 to February 2022. Those that assessed the cost-effectiveness of CGM compared to self-monitored blood glucose (SMBG) in patients with type 1 diabetes and reported lifetime incremental cost-effectiveness ratio (ICER) were included. Studies on critically ill or pregnant patients were excluded. Nineteen studies were identified. Most studies compared continuous subcutaneous insulin infusion and SMBG to a sensor-augmented pump (SAP). The estimated ICER range was [$18,734-$99,941] and the quality-adjusted life year (QALY) gain range was [0.76-2.99]. Use in patients with suboptimal management or greater hypoglycaemic risk revealed more homogenous results and lower ICERs. Limited studies assessed CGM in the context of multiple daily injections (MDI) (n = 4), MDI and SMBG versus SAP (n = 2) and three studies included hybrid closed-loop systems. Most studies (n = 17) concluded that CGM is a cost-effective tool. This systematic review suggests that CGM appears to be a cost-effective tool for individuals with type 1 diabetes. Cost-effectiveness is driven by reducing short- and long-term complications. Use in patients with suboptimal management or at risk of severe hypoglycaemia is most cost-effective.

Three Days Compared to One Day Per Week of Self-Monitoring of Blood Glucose in Mild Gestational Diabetes: A Randomized Trial.

Background: The International Diabetes Federation estimates that 16.2% of livebirths in 2017 were affected by hyperglycemia in pregnancy, with 85.1% due to gestational diabetes mellitus (GDM). Daily blood glucose monitoring compared with alternate day testing in mild GDM is associated with similar pregnancy outcomes. Data are sparse on the ideal frequency for self-monitoring of blood glucose (SMBG) in mild GDM for glycemic control. A higher HbA1c at late pregnancy is associated with adverse pregnancy outcomes. We sought to evaluate three days compared to one day per week of four-point self-monitoring of blood glucose (SMBG) in gestational diabetes mellitus (GDM) controlled by lifestyle changes for glycemic control. Methods: This randomized trial was conducted from February−December 2018. A total of 106 women with lifestyle-controlled GDM were randomized to three days (SMBG3) or one day (SMBG1) per week of four-point (fasting and two-hours post-meal) SMBG. The primary outcome was the change in the HbA1c level at recruitment and 36-weeks gestation within and across trial arms. The student t-test was used for between-arm analyses and a paired t-test for within-arm analyses. Results: The HbA1c level through pregnancy increased significantly in both trial arms: mean increase of 0.21% ± 0.26%, p < 0.001 (SMBG3), and 0.19% ± 0.24%, p < 0.001 (SMBG1), but the 0.02% difference across trial arms was not significant (p = 0.79). Maternal weight gain (3.1 ± 2.1 kg vs. 3.3 ± 3.0 kg, p = 0.72), cesarean delivery (24/52 (48%) vs. 23/53 (43%), RR 1.06, 95% CI: 0.69−1.62, p = 0.77), neonatal birthweight (3.1 ± 0.4 kg vs. 3.0 ± 0.4 kg, p = 0.53) and neonatal intensive care unit admission (4/52 (8%) vs. 3/53 (6%), RR 1.36, 95% CI: 0.32−5.78, p = 0.68) were not significantly different for SMBG3 vs. SMBG1, respectively. Other maternal and neonatal secondary outcomes were not significantly different. Conclusion: In mild GDM, three days compared to one day per week showed a similar HbA1c levels change at 36-weeks gestation. Maternal and neonatal outcomes were also not significantly different. Less frequent monitoring of SMBG as a standard of care in mild GDM deserves further study and consideration.

Efficacy of Personalized Diabetes Self-care Using an Electronic Medical Record-Integrated Mobile App in Patients With Type 2 Diabetes: 6-Month Randomized Controlled Trial.

BACKGROUND: A system that combines technology and web-based coaching can help treat chronic conditions such as diabetes. However, the effectiveness of apps in mobile health (mHealth) interventions is inconclusive and unclear due to heterogeneous interventions and varying follow-up durations. In addition, randomized controlled trial data are limited, and long-term follow-up is lacking, especially for apps integrated into electronic medical records. OBJECTIVE: We aimed to assess the effect of an electronic medical record-integrated mobile app for personalized diabetes self-care, focusing on the self-monitoring of blood glucose and lifestyle modifications, on glycemic control in patients with type 2 diabetes mellitus. METHODS: In a 26-week, 3-arm, randomized, controlled, open-label, parallel group trial, patients with type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) level of ≥7.5% were recruited. The mHealth intervention consisted of self-monitoring of blood glucose with the automatic transfer of glucose, diet, and physical activity counseling data (iCareD system). Participants were randomly assigned to the following three groups: usual care (UC), mobile diabetes self-care (MC), and MC with personalized, bidirectional feedback from physicians (MPC). The primary outcome was the change in HbA1c levels at 26 weeks. In addition, diabetes-related self-efficacy, self-care activities, and satisfaction with the iCareD system were assessed after the intervention. RESULTS: A total of 269 participants were enrolled, and 234 patients (86.9%) remained in the study at 26 weeks. At 12 weeks after the intervention, the mean decline in HbA1c levels was significantly different among the 3 groups (UC vs MC vs MPC: -0.49% vs -0.86% vs -1.04%; P=.02). The HbA1c level decreased in all groups; however, it did not differ among groups after 26 weeks. In a subgroup analysis, HbA1c levels showed a statistically significant decrease after the intervention in the MPC group compared with the change in the UC or MC group, especially in patients aged <65 years (P=.02), patients with a diabetes duration of ≥10 years (P=.02), patients with a BMI of ≥25.0 kg/m2 (P=.004), patients with a C-peptide level of ≥0.6 ng/mL (P=.008), and patients who did not undergo treatment with insulin (P=.004) at 12 weeks. A total of 87.2% (137/157) of the participants were satisfied with the iCareD system. CONCLUSIONS: The mHealth intervention for diabetes self-care showed short-term efficacy in glycemic control, and the effect decreased over time. The participants were comfortable with using the iCareD system and exhibited high adherence. TRIAL REGISTRATION: Clinical Research Information Service, Republic of Korea KCT0004128; https://tinyurl.com/bdd6pa9m.

Perceived value of self-monitoring blood glucose by primary care physicians and endocrinologists.

The value of self-monitoring blood glucose (SMBG) in patients with non-insulin-treated type 2 diabetes (NITT2DM) has been debated; however, the practice remains common. Patient perception of SMBG has been documented in several qualitative studies. However, the literature is lacking on the perceived value of SMBG by providers. This study used a structured questionnaire to evaluate and compare the perceived value, recommended frequency, and utility of SMBG in patients with NITT2DM by primary care providers (PCPs) and endocrinologists. A total of 70 PCPs and 14 endocrinologists completed the questionnaire. The results suggest that PCPs and endocrinologists find the practice of SMBG valuable in NITT2DM and believe it promotes behavioral changes in their patients. However, endocrinologists tend to recommend more frequent SMBG and find SMBG values more useful in making medication decisions. Conversely, PCPs tend to find the hemoglobin A1c more valuable than SMBG in making medication adjustments.

Largest Amplitude of Glycemic Excursion Calculating from Self-Monitoring Blood Glucose Predicted the Episodes of Nocturnal Asymptomatic Hypoglycemia Detecting by Continuous Glucose Monitoring in Outpatients with Type 2 Diabetes.

Aims: Nocturnal asymptomatic hypoglycemia (NAH) is a serious complication of diabetes, but it is difficult to be detected clinically. This study was conducted to determine the largest amplitude of glycemic excursion (LAGE) to predict the episodes of NAH in outpatients with type 2 diabetes. Methods: Data were obtained from 313 outpatients with type 2 diabetes. All subjects received continuous glucose monitoring (CGM) for consecutive 72 hours. The episodes of NAH and glycemic variability indices (glucose standard deviation [SD], mean amplitude of plasma glucose excursion [MAGE], mean blood glucose [MBG]) were accessed via CGM. LAGE was calculated from self-monitoring blood glucose (SMBG). Results: A total of 76 people (24.3%) had NAH. Compared to patients without NAH, patients with NAH showed higher levels of glucose SD (2.4 ± 0.9 mmol/L vs 1.7 ± 0.9 mmol/L, p <0.001), MAGE (5.2 ± 2.1 mmol/L vs 3.7 ± 2.0, p<0.001) and LAGE (4.6 ± 2.3 mmol/L vs 3.8 ± 1.9 mmol/L, p=0.007), and lower level of MBG (7.5 ± 1.5 mmol/L vs 8.4 ± 2.2 mmol/L, p=0.002). LAGE was significantly associated with the incidence of NAH and time below rang (TBR) in model 1 [NAH: 1.189 (1.027-1.378), p=0.021; TBR: 0.008 (0.002-0.014), p=0.013] with adjustment for age, BMI, sex, work, hyperlipidemia, complication and medication, and in model 2 [NAH: 1.177 (1.013-1.367), p=0.033; TBR: 0.008 (0.002-0.014), p=0.012] after adjusting for diabetes duration based on model 1, as well as in model 3 [NAH: 1.244 (1.057-1.464), p=0.009; TBR: 0.009 (0.002-0.016), p=0.007] with further adjustment for HbA1c based on model 2. In addition, no significant interactions were found between LAGE and sex, age, HbA1c, duration of diabetes, BMI and insulin therapy on the risk of NAH. The receiver operator characteristic (ROC) curve shows the ideal cutoff value of LAGE for the prediction of NAH was 3.48 mmol/L with 66.7% sensitivity, 50% specificity and 0.587 (95% CI: 0.509-0.665) of area under the ROC curve. Conclusions: High glycemic variability is strongly associated with the risk of NAH. The LAGE based on SMBG could be an independent predictor of NAH for outpatients with type 2 diabetes, and LAGE greater than 3.48 mmol/L could act as a warning alarm for high risk of NAH in daily life.

Reductions in HbA1c with Flash Glucose Monitoring Are Sustained for up to 24 Months: A Meta-Analysis of 75 Real-World Observational Studies.

INTRODUCTION: Real-world evidence (RWE) confirms that reductions in HbA1c for children and adults with type 1 diabetes (T1DM) and adults with type 2 diabetes (T2DM) are associated with use of the FreeStyle Libre system. This current meta-analysis aims to investigate whether HbA1c benefits are sustained over 24 months and to identify patterns of change in HbA1c for users of the FreeStyle Libre system for people living with T1DM or T2DM. METHODS: A bibliographic search up to December 2020 identified 75 studies reporting data on change in lab HbA1c in 30,478 participants with type 1 (n = 28,063; 62 trials) or type 2 diabetes (n = 2415; 13 trials) using the FreeStyle Libre system, including observations on children, adolescents and adults. Meta-analysis was performed using a random effects model. RESULTS: Reductions in HbA1c at 3-4 months were similar for adults with T1DM (- 0.53%, 95% CI - 0.69 to - 0.38) or with T2DM (- 0.45%, 95% CI - 0.57 to - 0.33), continuing through 4.5-7.5 months in T1DM (- 0.42%, 95% CI - 0.58 to - 0.27) and in T2DM (- 0.59%, 95% CI - 0.80 to - 0.39). Meta-regression analysis shows that higher starting HbA1c is correlated with greater reductions in HbA1c in T1DM and in T2DM. These patterns of change in HbA1c were sustained for 24 months in T1DM and for at least 12 months in T2DM. CONCLUSIONS: Meta-analysis of RWE confirms that using the FreeStyle Libre system is associated with significant reductions in HbA1c for adults with T1DM or with T2DM. Reductions are greater for people with higher baseline HbA1c and are sustained for 24 and 12 months in T1DM and TD2M respectively.

New PK/PD model directly links diabetes drug dose to blood glucose level for personalized care.

The management of diabetes mellitus focuses on close monitoring of a patient's blood glucose level while the clinician experiments with a dosing strategy using clinical guidelines and his/her own experience. We propose a pharmacokinetic and pharmacodynamics model that characterizes the dose-response of patients receiving anti-diabetic drug therapy. We derive and establish a direct relationship between drug dosage and blood glucose level. This new drug-dose drug-effect model, combined with a linear disease progression model, is used to fit the patient's daily self-monitored blood glucose (SMBG) data to obtain the personalized treatment effect for each patient. The model predicts the long-term drug effect using the prescribed dose, thus allowing for dose optimization. The model is evaluated on patients with gestational diabetes mellitus. SMBG data collected during the first month of treatment is used to train the model. The model is able to characterize the personalized dose-response and disease progression. Moreover, when compared to a descriptive autoregression model, our model gives a better long-term prediction of the drug effect on the trend of the blood glucose level. This mechanism-based treatment effect model utilizes daily recorded blood glucose data to estimate and predict a patient's personalized dose-response and disease progression. Such evidence can be used by clinicians to individualize and optimize dose regimens to achieve better treatment outcomes.

Efficacy of Flash Glucose Monitoring in Type 1 and Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

Objective: Flash glucose monitoring (FlashGM) is a sensor-based technology that displays glucose readings and trends to people with diabetes. In this meta-analysis, we assessed the effect of FlashGM on glycaemic outcomes including HbA1c, time in range, frequency of hypoglycaemic episodes and time in hypo/hyperglycaemia compared to self-monitoring of blood glucose, using data from randomised controlled trials. Methods: A systematic search was conducted on MEDLINE, EMBASE and CENTRAL for articles published between 2014 and 2021. We selected randomised controlled trials comparing flash glucose monitoring to self-monitoring of blood glucose that reported change in HbA1c and at least one other glycaemic outcome in adults with type 1 or type 2 diabetes. Two independent reviewers extracted data from each study using a piloted form. Meta-analyses using a random-effects model was conducted to obtain a pooled estimate of the treatment effect. Heterogeneity was assessed using forest plots and the I2 statistic. Results: We identified 5 randomised controlled trials lasting 10 - 24 weeks and involving 719 participants. Flash glucose monitoring did not lead to a significant reduction in HbA1c. However, it resulted in increased time in range (mean difference 1.16 hr, 95% CI 0.13 to 2.19, I2 = 71.7%) and decreased frequency of hypoglycaemic episodes (mean difference -0.28 episodes per 24 hours, 95% CI -0.53 to -0.04, I2 = 71.4%). Conclusions: Flash glucose monitoring did not lead to a significant reduction in HbA1c compared to self-monitoring of blood glucose, however, it improved glycaemic management through increased time in range and decreased frequency of hypoglycaemic episodes. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier PROSPERO (CRD42020165688).

Awareness of Preconception Care and Its Related Factors Among Women of Childbearing Age with Type 1 Diabetes in the South of Saudi Arabia: A Cross-Sectional Survey Study.

BACKGROUND: Pregnancies in women with type 1 diabetes mellitus (T1DM) are associated with an increased risk of poor outcomes for mothers and their infants. OBJECTIVE: To assess the awareness of preconception care among women with T1DM and their self-management status in the southern region of Saudi Arabia. METHODS: This study is a cross-sectional study that was done on 187 women participated of childbearing age with T1DM who were seen in diabetic centers between June 2019 and September 2020. Pre-pregnancy care and disease management were assessed via a questionnaire. RESULTS: The prevalence of preconception awareness of diabetes management was 66.9%. Several factors significantly influenced the level of awareness, including education level (P= 0.001) and HbA1c (P= 0.014). In multivariate analysis, the lower educational level turns out to be a significant risk factor for low awareness (OR = 3.71, 95% CI [1.65, 8.31], P= 0.001). Additionally, compared to controlled DM, uncontrolled diabetes had a twofold increased risk of low awareness (OR = 2.03, 95% CI [1.08, 3.81], P= 0.027). CONCLUSION: The awareness level was significantly correlated with a high educational level and better glycemic control. Meanwhile, it was not significantly correlated with diabetes duration.

Disposable electrochemical glucose sensor based on water-soluble quinone-based mediators with flavin adenine dinucleotide-dependent glucose dehydrogenase.

Glucose level measurement is essential for the point-of-care diagnosis, primarily for persons with diabetes. A disposable electrochemical glucose sensor is constructed using flavin adenine dinucleotide-dependent glucose dehydrogenase (FAD-GDH) and redox mediator for electron transfer from the enzyme to the electrode surface. Ideally, a suitable mediator should have high water solubility, high kinetic constant, high stability, and redox potential between -0.2 and 0.1 V vs. Ag|AgCl|sat. KCl. We designed and synthesized two new quinone-based water-soluble mediators: quinoline-5,8-dione (QD) and isoquinoline-5,8-dione (IQD). The formal potentials for both QD and IQD at pH 7.0 were -0.07 V vs. Ag|AgCl|sat. KCl. The logarithms of the electron exchange rate constants (k2/(M-1 s-1)) between QD/IQD and FAD-GDH were 7.7 ± 0.1 and 7.4 ± 0.1 for QD and IQD, respectively, which are the highest value among the water-soluble mediators for FAD-GDH reported to date. Disposable amperometric glucose sensors were fabricated by dropping FAD-GDH and QD or IQD onto a test strip. The sensor achieved a linear response up to glucose concentrations of 55.5 mM. The linear response was obtained even when the mediator loading was low (0.5 nmol/strip); loading was only 0.2 mol% of glucose. The results proved that the response current was primarily controlled by glucose diffusion. In addition, the sensor using QD exhibited high stability over 3 months at room temperature.

Standardization process of continuous glucose monitoring: Traceability and performance.

People with diabetes are required to regularly check their glucose to make therapy decisions. So far, systems for self-monitoring of blood glucose were used, but nowadays minimally invasive continuous glucose monitoring (CGM) systems are increasingly more often employed, sometimes to partially replace self-monitoring of blood glucose. Most CGM systems on the market measure glucose concentrations continuously in the interstitial fluid of the subcutaneous fatty tissue. However, CGM has a principle limitation. Collecting interstitial fluid frequently in sufficiently large volumes over short time periods is not easy. As a consequence, no internationally accepted reference measurement procedure is currently available for glucose in interstitial fluid which is a prerequisite to achieve an optimal metrological traceability. Recent studies indicate that the analytical performance of minimally invasive CGM systems differs not only between manufacturers but also between individual sensors of the same system, sometimes even in the same subject. Because manufacturers don't provide detailed information about the traceability chain and the measurement uncertainty of their systems glucose values obtained with CGM can currently not be adequately traced to higher-order standards or methods. Therefore, the Working Group on Continuous Glucose Monitoring aims at establishing a traceability chain for minimally invasive CGM systems, as well as procedures and metrics for the assessment of their analytical performance.

Type 2 Diabetes Patients' Perspectives, Experiences, and Barriers Toward Diabetes-Related Self-Care: A Qualitative Study From Pakistan.

Objective: This study aimed to qualitatively explore perspectives, practices, and barriers to self-care practices (eating habits, physical activity, self-monitoring of blood glucose, and medicine intake behavior) in urban Pakistani adults with type 2 diabetes mellitus (T2DM). Methods: Pakistani adults with T2DM were recruited from the outpatient departments of two hospitals in Lahore. Semistructured interviews were conducted and audiorecorded until thematic saturation was reached. Two researchers thematically analyzed the data independently using NVivo® software with differences resolved by a third researcher. Results: Thirty-two Pakistani adults (aged 35-75 years, 62% female) participated in the study. Six themes were identified from qualitative analysis: role of family and friends, role of doctors and healthcare, patients' understanding about diabetes, complication of diabetes and other comorbidities, burden of self care, and life circumstances. A variable experience was observed with education and healthcare. Counseling by healthcare providers, family support, and fear of diabetes-associated complications are the key enablers that encourage study participants to adhere to diabetes-related self-care practices. Major barriers to self care are financial constraints, physical limitations, extreme weather conditions, social gatherings, loving food, forgetfulness, needle phobia, and a hectic job. Conclusion: Respondents identified many barriers to diabetes self care, particularly related to life situations and diabetes knowledge. Family support and education by healthcare providers were key influencers to self-care practices among Pakistani people with diabetes.

Glycemic qualification rate and frequency of self-monitoring blood glucose glycemic qualification rate and frequency of self-monitoring blood glucose (SMBG) in women with gestational diabetes mellitus (GDM).

AIMS: To explore the relationship between blood glucose (BG) control rate and self-monitoring blood glucose (SMBG) compliance of women with gestational diabetes mellitus (GDM). METHODS: Women with GDM (n = 309) were randomized to receive routine clinical prenatal care or additional online management. Follow-up visits were conducted every two weeks (noted here as T) from enrollment to delivery. SMBG records were used for the analysis. RESULTS: Both the intervention group and the control group had an increasing BG control rate and decreasing SMBG compliance during the whole follow-up period. Detailed data analysis on separate follow-up periods showed that the SMBG frequency was negatively correlated with the BG control rate in most Ts and that the BG control rate of Tn-1 was negatively correlated with the SMBG frequency of Tn in the adjacent T. Only in the intervention group was T2 SMBG compliance not under the influence of the T1 BG control rate. CONCLUSIONS: Our data suggested that regardless of management approach, the BG control rate increased, and the SMBG frequency decreased as gestational weeks increased in women with GDM. Even in separate follow-up periods, the SMBG frequency was negatively correlated with the BG control rate both within one follow-up period and between two adjacent follow-up periods.