Q-Score Complements the Time in Range in the Evaluation of Short-Term Glycemic Control.

BACKGROUND AND AIMS: The Q-Score is a single-number composite metric that is constructed based on the following components: central glycemic tendency, hyperglycemia, hypoglycemia, and intra- and interday variability. Herein, we refined the Q-Score for the screening and analysis of short-term glycemic control using continuous glucose monitoring (CGM) profiles. METHODS: Continuous glucose monitoring profiles were obtained from noninterventional, retrospective cross-sectional studies. The upper limit of the Q-Score component hyperglycemia' that is, the time above target range (TAR), was adjusted from 8.9 to 10 mmol/L (n = 1562 three-day-sensor profiles). A total of 302 people with diabetes mellitus treated with intermittent CGM for ≥14 days were enrolled. The time to stability was determined via correlation-based analysis. RESULTS: There was a strong correlation between the Q-Scores of the two TARs, that is, 8.9 and 10 mmol/L (Q-ScoreTAR10 = -0.03 + 1.00 Q-ScoreTAR8.9, r = .997, p < .001). The times to stability of the Q-Score and TIR were 10 and 12 days, respectively. The Q-Score was correlated with fructosamine concentrations, the glucose management indicator (GMI), the time in range (TIR), and the glycemic risk index (GRI) (r = .698, .887, -.874, and .941), respectively. The number of Q-Score components above the target increased as the TIR decreased, from two (1.7 ± 0.9) in CGM profiles with a TIR between 70% and 80% to four (3.9 ± 0.5) in the majority of the CGM profiles with a TIR below 50%. A conversion matrix between the Q-Score and glycemic indices was developed. CONCLUSIONS: The Q-Score is a tool for assessing short-term glycemic control. The Q-Score can be translated into clinician opinion using the GRI.

Practical considerations for continuous glucose monitoring in elite athletes with type 1 diabetes mellitus: A narrative review.

Type 1 diabetes mellitus (T1DM) refers to a metabolic condition where a lack of insulin impairs the usual homeostatic mechanisms to control blood glucose levels. Historically, participation in competitive sport has posed a challenge for those with T1DM, where the dynamic changes in blood glucose during exercise can result in dangerously high (hyperglycaemia) or low blood glucoses (hypoglycaemia) levels. Over the last decade, research and technological development has enhanced the methods of monitoring and managing blood glucose levels, thus reducing the chances of experiencing hyper- or hypoglycaemia during exercise. The introduction of continuous glucose monitoring (CGM) systems means that glucose can be monitored conveniently, without the need for frequent fingerpick glucose checks. CGM devices include a fine sensor inserted under the skin, measuring levels of glucose in the interstitial fluid. Readings can be synchronized to a reader or mobile phone app as often as every 1-5 min. Use of CGM devices is associated with lower HbA1c and a reduction in hypoglycaemic events, promoting overall health and athletic performance. However, there are limitations to CGM, which must be considered when being used by an athlete with T1DM. These limitations can be addressed by individualized education plans, using protective equipment to prevent sensor dislodgement, as well as further research aiming to: (i) account for disparities between CGM and true blood glucose levels during vigorous exercise; (ii) investigate the effects of temperature and altitude on CGM accuracy, and (iii) explore of the sociological impact of CGM use amongst sportspeople without diabetes on those with T1DM.

Impact of Flash Glucose Monitoring on the Fear of Hypoglycemia Phenomenon in Adults with Type 1 Diabetes.

Objective: To assess the clinical impact of flash glucose monitoring (FGM) systems on fear of hypoglycemia (FoH) and quality of life in adults with type 1 diabetes mellitus (T1DM). Methods: Prospective quasi-experimental study with a 12-month follow-up. People with T1DM (18-80 years old) and self-monitoring by blood capillary glycemia controls were included. The FH15 questionnaire, a survey validated in Spanish in a comparable study population, was used to diagnose FoH with a cutoff point of 28 points. Results: A total of 181 participants were included, with a FoH prevalence of 69% (n = 123). A mean reduction in FH15 score of -4 points (95% confidence interval [-5.5 to -3]; P < 0.001) was observed, along with an improvement in quality of life (EsDQOL-test (Diabetes Quality of Life, Spanish version), -7 points [-10; -4], P < 0.001) and satisfaction with treatment (Diabetes Treatment Satisfaction questionnaire, self-reported version [DTSQ-s] test, +4.5 points [4; 5.5], P < 0.001). At the end of the follow-up, 64.2% of the participants saw an improved FoH intensity, compared to 35.8% who scored the same or higher. This improvement in FoH status was associated with a higher time-in-range at the end of the follow-up (P = 0.003), as well as a lower time spent in hyperglycemia (P = 0.005). In addition, it was linked to participants with a high baseline FoH levels (P < 0.001) and those who were university degree holders (P = 0.07). Conclusions: FGM is associated with an overall reduction of FoH in adults with T1DM and with an increase in their quality of life. Nevertheless, a significant percentage of patients may experience an increase of this phenomenon leading to clinical repercussions and a profound impact on quality of life.

Effect of Christmas Holidays on Type 1 Diabetes Mellitus in Users of Glucose Flash Systems.

OBJECTIVE: Christmas holidays can impact weight and glycemic control in type 2 diabetes, but their effect on type 1 diabetes (T1D) remains understudied. This study assessed how Christmas holidays affect individuals with T1D who use flash continuous glucose monitoring systems. METHODS: This retrospective study involved 812 adults diagnosed with T1D recruited from 3 hospitals. Clinical, anthropometric, and socioeconomic data were collected. Glucose metrics from 14 days before January 1st, and before December 1st and February 1st as control periods, were recorded. Analyses adjusted for multiple variables were conducted to assess the holiday season's impact on glycemic control. RESULTS: The average time in range during the holidays (60.0 ± 17.2%) was lower compared to December (61.9 ± 17.2%, P < .001) and February (61.7 ± 17.7%, P < .001). Time above range (TAR > 180 mg/dL) was higher during Christmas (35.8 ± 18.2%) compared to December (34.1 ± 18.3%, P < .001) and February (34.2 ± 18.4%, P < .001). Differences were also observed in TAR >250 mg/dL, coefficient of variation, and average glucose (P < .05). No differences were found in time below range or other metrics. Linear regression models showed that the holidays reduced time in range by 1.9% (ß = -1.92, P = .005) and increased TAR >180 mg/dL by 1.8% (ß = 1.75, P = .016). CONCLUSION: Christmas holidays are associated with a mild and reversible deterioration in glucose metrics among individuals with T1D using flash continuous glucose monitoring, irrespective of additional influencing factors. These discoveries can be useful to advise individuals with diabetes during the festive season and to recognize potential biases within studies conducted during this timeframe.

Effectiveness and Safety of the Intermittently Scanned Continuous Glucose Monitoring System FreeStyle Libre 2 in Patients with Type 2 Diabetes Treated with Basal Insulin or Oral Antidiabetic Drugs: An Observational, Retrospective Real-World Study.

Intermittently Scanned Continuous Glucose Monitoring (isCGM) devices are increasingly being used in patients with type 2 diabetes mellitus (T2DM) on insulin therapy for their benefits regarding disease management. Evidence of isCGM use in patients with T2DM on basal or non-insulin therapy is lacking. This study aimed at assessing the efficacy and safety of isCGM in this population. This was an observational, retrospective, real-world study enrolling patients with T2DM who were starting the use of isCGM. Data from medical records (i.e., demographics, clinical characteristics, laboratory assessments, and isCGM metrics) were collected over three time periods (baseline, 3 and 6 months). The endpoints were glycated haemoglobin (HbA1c) changes and changes in isCGM metrics as defined by the International Consensus from baseline to 3 months and 6 months. Overall, 132 patients were included (69.5% male; mean age 68.2 ± 11.0 years; mean disease duration 19.0 ± 9.4 years; 79.7% on basal insulin ±non-insulin therapy; mean baseline HbA1c 8.1% ± 1.3%). The estimated mean change in HbA1c was statistically significant at three (-0.4 ± 1.0%; p = 0.003) and six months (-0.6 ± 1.3%; p < 0.0001). In conclusion, isCGM proved to be effective and safe in improving glycaemic control in patients with T2DM on basal insulin or non-insulin therapy.

A concept for human use of real-time and remote monitoring of diabetic subjects using intermittent scanned continuous glucose measurement.

BACKGROUND: Flash glucose monitoring systems like the FreeStyle Libre (FSL) sensor have gained popularity for monitoring glucose levels in people with diabetes mellitus. This sensor can be paired with an off-label converted real-time continuous glucose monitor (c-rtCGM) plus an ad hoc computer/smartphone interface for remote real-time monitoring of diabetic subjects, allowing for trend analysis and alarm generation. OBJECTIVES: This work evaluates the accuracy and agreement between the FSL sensor and the developed c-rtCGM system. As real-time monitoring is the main feature, the system's connectivity was assessed at 5-min intervals during the trials. METHODS: One week of glucose data were collected from 16 type 1 diabetic rats using the FSL sensor and the c-rtCGM. Baseline blood samples were taken the first day before inducing type 1 diabetes with streptozotocin. Once confirmed diabetic rats, FSL and c-rtCGM, were implanted, and to improve data matching between the two monitoring devices, the c-rtCGM was calibrated to the FSL glucometer readings. A factorial design 2 × 3^3 and a second-order regression was used to find the base values of the linear model transformation of the raw data obtained from the sensor. Accuracy, agreement, and connectivity were assessed by median absolute relative difference (Median ARD), range averaging times, Parkes consensus error grid analysis (EGA), and Bland-Altman analysis with a non-parametric approach. RESULTS: Compared to the FSL sensor, the c-rtCGM had an overall Median ARD of 6.58%, with 93.06% of results in zone A when calibration was not carried out. When calibration frequency changed from every 50 h to 1 h, the overall Median ARD improved from 6.68% to 2.41%, respectively. The connectivity evaluation showed that 95% of data was successfully received every 5 min by the computer interface. CONCLUSIONS AND CLINICAL IMPORTANCE: The results demonstrate the feasibility and reliability of real-time and remote subjects with diabetes monitoring using the developed c-rtCGM system. Performing calibrations relative to the FSL readings increases the accuracy of the data displayed at the interface.

Short-term glycemic variability in non-diabetic, non-obese dogs assessed by common glycemic variability indices.

Glycemic variability (GV) refers to swings in blood glucose levels and is an emerging measure of glycemic control in clinical practice. It is associated with micro- and macrovascular complications and poor clinical outcomes in diabetic humans. Although an integral part of patient assessment in human patients, it is to a large extent neglected in insulin-treated diabetic dogs. This prospective pilot study was performed to describe canine within-day GV in non-diabetic dogs with the aim to provide a basis for the interpretation of daily glucose profiles, and to promote GV as an accessible tool for future studies in veterinary medicine. Interstitial glucose concentrations of ten non-diabetic, non-obese beagles were continuously measured over a 48-h period using a flash glucose monitoring system. GV was assessed using the common indices MAGE (mean amplitude of glycemic excursion), GVP (Glycemic variability percentage) and CV (coefficient of variation). A total of 2260 sensor measurements were obtained, ranging from 3.7 mmol/L (67 mg/dL) to 8.5 mmol/L (153 mg/dL). Glucose profiles suggested a meal-dependent circadian rhythmicity with small but significant surges during the feeding periods. No differences in GV indices were observed between day and night periods (p > 0.05). The MAGE (mmol/L), GVP (%) and CV (%) were 0.86 (± 0.19), 7.37 (± 1.65), 6.72 (± 0.89) on day one, and 0.83 (± 0.18), 6.95 (± 1.52), 6.72 (± 1.53) on day two, respectively. The results of this study suggest that GV is low in non-diabetic dogs and that glucose concentrations are kept within narrow ranges.

Comparative Effectiveness of Oral Hypoglycemic Agents for Glycemic Control and Glycemic Variability in Patients with Type 2 Diabetes Mellitus: Using Flash Glucose Monitoring.

AIM: The study aimed to compare the effectiveness of oral hypoglycemic agents (OHAs) as monotherapy, dual and quadruple therapy for glycemic control (GC) and glycemic variability (GV) in patients with type-2 diabetes (T2DM) using flash glucose monitoring system (FGM). BACKGROUND: Diabetes management largely relies on HbA1c monitoring. Glycemic variability (GV) has been an evolving glycemic target for preventing complications related to type 2 diabetes mellitus (T2DM). OBJECTIVE: The purpose of the study was to compare glycemic control (GC) measures and glycemic variability (GV) measures among study groups and to study the relationships between GC and GV indices. METHODS: Retrospectively, FGM data were collected from 50 T2DM patients. The patients were classified based on prescribed number of OHAs as monotherapy [group 1: dipeptidyl peptidase- 4 (DPP-4) inhibitors (n=10), group 2: sodium-glucose co-transporter-2 (SGLT2) inhibitors (n=10), group 3: sulphonylureas (n=10), group 4: dual therapy (n=10), and group 5: quadruple therapy (n=10)]. Measures of GC and GV were evaluated. RESULTS: Significant differences between study groups were observed in GC and GV measurements. The SGLT2 inhibitors monotherapy group demonstrated optimal GC [eA1c (%): 6.5 ± 2.2; MBG: 140.80 ± 63.94; TIR: 60.60 ± 19.96] and GV (SD: 42.38 ± 34.57; CV: 27.85 ± 6.68; MAGE: 96.76 ± 52.47; MODD: 33.96 ± 22.91) in comparison to other study groups. On using Pearson correlation analysis, mean blood glucose (MBG) and mean amplitude of glycemic excursion (MAGE) showed moderate correlation (r = 0.742)(r2 = 0.551), depicting distinct glucose variabilities at the same mean blood glucose levels. CONCLUSION: The monotherapy group of SGLT2 inhibitors demonstrated glucose-lowering effects with reduced glycemic variability. Hence, optimum glycemic control is associated with decreased glycemic variability.

Association of scan frequency with CGM-derived metrics and influential factors in adults with type 1 diabetes mellitus.

Introduction: This study aimed to investigate the association between scan frequency and intermittently scanned continuous glucose monitoring (isCGM) metrics and to clarify the factors affecting scan frequency in adults with type 1 diabetes mellitus (T1D). Methods: We enrolled adults with T1D who used FreeStyle® Libre. Scan and self-monitoring of blood glucose (SMBG) frequency and CGM metrics from the past 90-day glucose data were collected. The receiver operating characteristic curve was plotted to obtain the optimal cutoff values of scan frequency for the target values of time in range (TIR), time above range (TAR), and time below range (TBR). Results: The study was conducted on 211 adults with T1D (mean age, 50.9 ± 15.2 years; male, 40.8%; diabetes duration, 16.4 ± 11.9 years; duration of CGM use, 2.1 ± 1.0 years; and mean HbA1c, 7.6 ± 0.9%). The average scan frequency was 10.5 ± 3.3 scan/day. Scan frequency was positively correlated with TIR and negatively correlated with TAR, although it was not significantly correlated with TBR. Scan frequency was positively correlated with the hypoglycemia fear survey-behavior score, while it was negatively correlated with some glycemic variability metrics. Adult patients with T1D and good exercise habits had a higher scan frequency than those without exercise habits. The AUC for > 70% of the TIR was 0.653, with an optimal cutoff of 11 scan/day. Conclusions: In real-world conditions, frequent scans were linked to improved CGM metrics, including increased TIR, reduced TAR, and some glycemic variability metrics. Exercise habits and hypoglycemia fear-related behavior might affect scan frequency. Our findings could help healthcare professionals use isCGM to support adults with T1D.Clinical Trial Registry No. UMIN000039376.

Blood Glucose Levels during Decathlon Competition: An Observational Study in Timing of Intake and Competing Time.

During a men's decathlon, a combined event conducted over two consecutive days, fluctuations in blood glucose were measured using flash glucose monitoring. Because decathletes repeatedly intake and exercise, high and low blood glucose levels are observed, but the actual conditions have not yet been clarified. Low blood glucose levels (<80 mg/dL) were observed in nine athletes, while high blood glucose levels (>139 mg/dL) were observed in all athletes at least once during the competition days. Furthermore, low blood glucose levels were observed in nine athletes at least once during and after intake ("intake" refers to consuming energy-containing food and beverages). Additionally, high blood glucose levels were observed in nine athletes at least once during and after intake. Five athletes had low blood glucose during competing time. It was suggested that even if they had eaten a meal just prior to the competition, their intake was likely insufficient for their energy expenditure. A significant positive correlation was found between the mean blood glucose level and the number of intakes on competition days. It is believed that meals may have had a strong influence on blood glucose, even on competition days with a high frequency of eating and exercise for the decathlon.

Effectiveness of Continuous Glucose Monitoring on Metrics of Glycemic Control in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

PURPOSE: To provide a systematic review and meta-analysis synthesizing the findings of randomized controlled trials (RCTs) of continuous glucose monitors (CGMs) in the management of adults with type 2 diabetes mellitus (T2DM) on glucose control and clinical outcomes. METHODS: MEDLINE, Embase, and Cochrane were searched for RCTs that assessed the effectiveness of real-time CGM (rt-CGM) or flash CGM (FGM) in adults (≥18 years) with T2DM that reported on at least 1 of the following outcomes: hemoglobin A1c (HbA1c), time in range, time in hyperglycemia, or time in hypoglycemia. The GRADE approach was used to assess certainty of evidence for primary outcomes. RESULTS: Fourteen RCTs assessing CGM were included, with 825 patients in 9 RCTs using rt-CGM and 822 in 5 RCTs using FGM. Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%. Our analyses of each device type separately showed similar reductions in HbA1c (0.34% and 0.33%, respectively, for rt-CGM and FGM), with trends for improvement in other glucose metrics favoring rt-CGM over self-monitored blood glucose. CONCLUSION: Both rt-CGM and flash CGM led to modest but statistically significant declines in HbA1c among individuals with T2DM, with little heterogeneity in the results. However, the duration of the included RCTs was relatively short and few studies reported on important clinical outcomes, such as adverse events, emergency department use, or hospitalization. Longer term studies are needed to determine if the short-term improvements in glucose control leads to improvements in clinically important outcomes.

Mediterranean diet adherence and glycemic control in children and adolescents with type 1 diabetes.

To effectively manage type 1 diabetes (T1D) insulin is essential, with dosages based on lifestyle. The Mediterranean diet has demonstrated its advantages in preventing and enhancing the management of chronic diseases. Our objective was to investigate the potential mediation of sensor activity on the relationship between adherence to the Mediterranean diet and glycemic control in children and adolescents. A total of 150 children and adolescents (mean age = 13.09, SD = 3.54; 44% female) with T1D were recruited. Adherence to the Mediterranean diet was assessed using the KIDMED questionnaire which evaluates 16 items and gives higher scores when adherence is higher. Glycemic control and the duration of sensor activity were evaluated with data from flash glucose monitoring. The data confirmed our hypothesis by revealing that adherence to the Mediterranean diet positively influenced glycemic control (direct effect = 1.505; P < 0.01) and that this relationship was mediated by the duration of sensor activity (indirect effect = 0.531; P < 0.01).  Conclusions: Our results support the increased utilization of glycemic control devices, as they contribute to improve glycemic control and mediate on the positive relationship between adherence to the Mediterranean diet and adequate glycemic control. Furthermore, our findings highlight the importance of incorporating Mediterranean diet recommendations to achieve better glycemic control in children and adolescents with T1D. What is Known: • The Mediterranean diet and glycemic control have proven benefits in improving cardiovascular health in the general population. Scarce evidence exists of these benefits among children and adolescents with T1D. What is New: • Adherence to the Mediterranean diet and greater use of glucose monitoring devices in children and adolescents with T1D are related to better glycemic control. These variables can be enhanced by psychoeducational interventions such as structured diabetes education programs or peer group-based sessions, which highlights the importance of focusing on these aspects.

Scans per day as predictors of optimal glycemic control in people with type 1 diabetes mellitus using flash glucose monitoring: what number of scans per day should raise a red flag?

AIMS: This study aimed to determine the minimum frequency of flash glucose monitoring (FGM) scans necessary for optimal glycemic control in patients with type 1 diabetes (T1D). METHODS: Data were collected from 692 patients (47.5% female, with a median age of 47.4 years) who used FGM systems daily and recorded their clinical variables and device data. RESULTS: Logistic regression models showed that performing more than 12 scans per day was associated with improved T1D control (OR = 4.22, p < 0.001) and a reduction in HbA1c (7.6 vs 7.0%, 60-53 mmol/mol p < 0.001). However, those performing less than 6 scans showed no improvement in HbA1c (7.9 vs 7.8%, 63-61 mmol/mol p = 0.514). Thirteen daily scans were determined as the optimal cutoff point for predicting optimal glycemic control using a maximally selected rank algorithm. Significant reductions were observed in mean glucose (< 0.001), coefficient of variation (< 0.001), HbA1c (< 0.001), and an increase in TIR (< 0.001) in patients who performed more than 12 daily scans. CONCLUSIONS: The results suggest that a higher frequency of daily scans by T1D patients using FGM systems leads to improved chronic glycemic control. The minimum recommended frequency for optimal control is 13 scans per day, and more than 6 daily scans are needed to improve HbA1c.

Feasibility and acceptability of the use of flash glucose monitoring encountered by Indigenous Australians with type 2 diabetes mellitus: initial experiences from a pilot study.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is highly prevalent within the Indigenous Australian community. Novel glucose monitoring technology offers an accurate approach to glycaemic management, providing real-time information on glucose levels and trends. The acceptability and feasibilility of this technology in Indigenous Australians with T2DM has not been investigated. OBJECTIVE: This feasibility phenomenological study aims to understand the experiences of Indigenous Australians with T2DM using flash glucose monitoring (FGM). METHODS: Indigenous Australians with T2DM receiving injectable therapy (n = 8) who used FGM (Abbott Freestyle Libre) for 6-months, as part of a clinical trial, participated in semi-structured interviews. Thematic analysis of the interviews was performed using NVivo12 Plus qualitative data analysis software (QSR International). RESULTS: Six major themes emerged: 1) FGM was highly acceptable to the individual; 2) FGM's convenience was its biggest benefit; 3) data from FGM was a tool to modify lifestyle choices; 4) FGM needed to be complemented with health professional support; 5) FGM can be a tool to engage communities in diabetes management; and 6) cost of the device is a barrier to future use. CONCLUSIONS: Indigenous Australians with T2DM had positive experiences with FGM. This study highlights future steps to ensure likelihood of FGM is acceptable and effective within the wider Indigenous Australian community.

Continuous glucose monitoring in people with diabetes and end-stage kidney disease-review of association studies and Evidence-Based discussion.

Diabetic nephropathy is currently the leading cause of end-stage kidney disease. The present methods of assessing diabetes control, such as glycated hemoglobin or self-monitoring of blood glucose, have limitations. Over the past decade, the field of continuous glucose monitoring has been greatly improved and expanded. This review examines the use of continuous glucose monitoring in people with end-stage kidney disease treated with hemodialysis (HD), peritoneal dialysis (PD), or kidney transplantation. We assessed the use of both real-time continuous glucose monitoring and flash glucose monitoring technology in terms of hypoglycemia detection, glycemic variability, and efficacy, defined as an improvement in clinical outcomes and diabetes control. Overall, the use of continuous glucose monitoring in individuals with end-stage kidney disease may improve glycemic control and detection of hypoglycemia. However, most of the published studies were observational with no control group. Moreover, not all studies used the same assessment parameters. There are very few studies involving subjects on peritoneal dialysis. The small number of studies with limited numbers of participants, short follow-up period, and small number of manufacturers of continuous glucose monitoring systems are limitations of the review. More studies need to be performed to obtain more reliable results.

Continuous Glucose Monitoring Metrics in High-Risk Pregnant Women with Type 2 Diabetes.

Objective: To describe glucose metrics in a high-risk population of women with type 2 diabetes (T2DM) in pregnancy and to explore the associations with neonatal outcomes. Research Design and Methods: Prospective observational study of 57 women. Continuous glucose monitoring (CGM) trajectories were determined from metrics collected in early and late gestation using the first and last two (mean 16 and 35) weeks of Freestyle Libre data. Logistic regression was used to examine associations of CGM metrics with neonatal hypoglycemia (glucose <2.6 mmol/L requiring intravenous dextrose) and large for gestational age (LGA) (>90th percentile for gestational age and sex). Pregnancy-specific target glucose range was 3.5-7.8 mmol/L (63-140 mg/dL). Results: Forty-one women used CGM for 15 weeks (mean age 33 years, 73% Aboriginal or Torres Strait Islander, 32% living remotely). There was limited change in average metrics from early to late pregnancy. For the subgroup with sensor use >50% (n = 29), mean time in range (TIR) increased by 9%, time above range reduced by 12%, average glucose reduced by 1 mmol/L, and time below range increased by 3%. Neonatal hypoglycemia was associated with most CGM metrics, HbA1c and CGM targets, particularly those from late pregnancy. LGA was associated with hyperglycemic metrics from early pregnancy. Each 1% increase TIR was associated with a 4%-5% reduction in risk of neonatal complications. Conclusion: In this high-risk group of women with T2DM, CGM metrics only improved during pregnancy in those with greater sensor use and were associated with LGA in early pregnancy and neonatal hypoglycemia throughout. Culturally appropriate health care strategies are critical for successful use of CGM technology.

Flash glucose monitoring system in gestational diabetes: a study of accuracy and usability.

PURPOSE: Studies of flash glucose monitoring systems (FGMSs) in pregnancy are insufficient, especially in gestational diabetes (GD). Our aim was to evaluate Freestyle Libre's usability and accuracy (compared to self-monitoring of blood glucose [SMBG]) for GD patients in real-life conditions. METHODS: This is a prospective study with pregnant women diagnosed with GD (n = 24 for the usability analysis; n = 19 for the accuracy analysis). The study duration was up to 28 days (lifetime of two sensors). Participants executed a minimum of four daily FGMS readings obtained immediately after capillary SMBG. Analytical accuracy was assessed with mean absolute relative difference (MARD) and mean absolute difference (MAD); clinical accuracy was assessed with Surveillance Error Grid (SEG). Usability was evaluated with a user acceptability questionnaire. RESULTS: The mean pregestational BMI was 25.21 ± 5.15 kg/m2 (mean ± SD), the mean gestational age was 30.31 ± 2.02 weeks, and the mean glucose values were 76.63 ± 7.49 mg/dL. A total of 1339 SMBG-FGMS pairs of values were obtained. Analytical accuracy was good with an overall MARD of 14.07% and an in-target MARD of 13.79%. The number of SMBG-FMGS pairs for above-target values was low (122 of 1339) with an associated MARD of 17.95%. Clinical accuracy of the FGMS was demonstrated, with 94.4% of values in the no-risk or slight, lower risk zones of the SEG. FGMS accuracy was unaffected by pregestational BMI or gestational age. The user acceptability questionnaire showed high levels of satisfaction, with 95.8-100% preferring FGMS to SMBG. No unexpected or severe adverse effects occurred. CONCLUSION: FGMS showed good performance in GD regarding accuracy and usability. Larger studies are needed to corroborate our results, verify the analytical accuracy of above-target values as this glucose range might lead to initiation or adjustment of pharmacological therapy, and ultimately establish definitive recommendations regarding prescription of FGMS for GD patients.

Correlation Between Blood Glucose Indexes Generated by the Flash Glucose Monitoring System and Diabetic Vascular Complications.

Objective: To discuss the relationship between time in range (TIR) which is deprived of the FGMS and the risk of diabetic vascular complications and to provide a theoretical foundation for the clinical application of TIR and other FGMS-deprived indexes. Methods: Patients with T2DM who wore the FGMS sensor continuously were enrolled. Relevant indexes such as TIR, time below range (TBR), time above range (TAR), a standard deviation of blood glucose (SDBG), coefficient of variation of blood glucose (CV), and mean amplitude of glycemic excursion (MAGE) generated by the FGMS were recorded, and the risk of diabetic vascular complications were followed up for one year. The TIR was measured by continuous glucose monitoring at baseline, and patients were grouped according to TIR every 20%. Finally, the Cox proportional hazards regression model was used to estimate the association of different levels of TIR with different rates of diabetic vascular complications. Results: TIR was negatively correlated with HbA1C, CV, SDBG, and amplitude of glycemic excursion (MV), wherein, the lower the TIR, the higher the HbA1C, CV, SDBG, and MV. TIR in the diabetic microvascular complication was significantly lower than that in the non-microvascular complication group, and the difference was statistically significant. TIR <40% was identified as a risk factor for DN, DPN, and DR according to the risk assessment. The mean TAR in the DN group was significantly higher than that in the non-DN group. TAR, CV, SD, MAGE, and HbA1C in the DR group were significantly higher than those in the non-DR group. TAR, ABG, CV, SD, MAGE, and HbA1C in the DPN group were significantly higher than those in the non-DPN group. Conclusion: The relationships between the TIR and the prevalence and risk of diabetic vascular complications and the HbA1C may be negative. Other CGM-deprived indexes such as CV and MV should be integrated into glycemic control and diabetes complication prediction.

Glucose metabolism profile recorded by flash glucose monitoring system in patients with hypopituitarism during prednisone replacement.

BACKGROUND: Commonly used glucocorticoids replacement regimens in patients with hypopituitarism have difficulty mimicking physiological cortisol rhythms and are usually accompanied by risks of over-treatment, with adverse effects on glucose metabolism. Disorders associated with glucose metabolism are established risk factors of cardiovascular events, one of the life-threatening ramifications. AIM: To investigate the glycometabolism profile in patients with hypopituitarism receiving prednisone (Pred) replacement, and to clarify the impacts of different Pred doses on glycometabolism and consequent adverse cardiovascular outcomes. METHODS: Twenty patients with hypopituitarism receiving Pred replacement [patient group (PG)] and 20 normal controls (NCs) were recruited. A flash glucose monitoring system was used to record continuous glucose levels during the day, which provided information on glucose-target-rate, glucose variability (GV), period glucose level, and hypoglycemia occurrence at certain periods. Islet ß-cell function was also assessed. Based on the administered Pred dose per day, the PG was then regrouped into Pred > 5 mg/d and Pred ≤ 5 mg/d subgroups. Comparative analysis was carried out between the PG and NCs. RESULTS: Significantly altered glucose metabolism profiles were identified in the PG. This includes significant reductions in glucose-target-rate and nocturnal glucose level, along with elevations in GV, hypoglycemia occurrence and postprandial glucose level, when compared with those in NCs. Subgroup analysis indicated more significant glucose metabolism impairment in the Pred > 5 mg/d group, including significantly decreased glucose-target-rate and nocturnal glucose level, along with increased GV, hypoglycemia occurrence, and postprandial glucose level. With regard to islet ß-cell function, PG showed significant difference in homeostasis model assessment (HOMA)-ß compared with that of NCs; a notable difference in HOMA-ß was identified in Pred > 5 mg/d group when compared with those of NCs; as for Pred ≤ 5 mg/d group, significant differences were found in HOMA-ß, and fasting glucose/insulin ratio when compared with NCs. CONCLUSION: Our results demonstrated that Pred replacement disrupted glycometabolic homeostasis in patients with hypopituitarism. A Pred dose of > 5 mg/d seemed to cause more adverse effects on glycometabolism than a dose of ≤ 5 mg/d. Comprehensive and accurate evaluation is necessary to consider a suitable Pred replacement regimen, wherein, flash glucose monitoring system is a kind of promising and reliable assessment device. The present data allows us to thoroughly examine our modern treatment standards, especially in difficult cases such as hormonal replacement mimicking delicate natural cycles, in conditions such as diabetes mellitus that are rapidly growing in worldwide prevalence.

Case Report: Post-gastrectomy reactive hyperinsulinemic hypoglicaemia: glucose trends before and after canagliflozin treatment.

The pathogenesis of post-gastrectomy reactive hyperinsulinaemic hypoglycaemia is not yet fully clarified. Recent studies suggest an up-regulation of the intestinal glucose transporter SGLT-1 aimed to prevent carbohydrate malabsorption. The overexpression of SGLT-1 could therefore represents one of the mechanisms underlying the wide glycemic excursions found in patients after gastrectomy, but studies investigating the use of SGLT-1/SGLT-2 inhibitors in patients with post-gastrectomy reactive hyperinsulinemic hypoglycaemia are very scant in the literature. We report the case of a 37-year-old non diabetic man who frequently presented symptoms of hypoglycaemia in the postprandial period. In 2012, he underwent Roux en-Y gastric bypass (RYGB) and after two years, he started to experience typical symptoms of reactive hyperinsulinaemic hypoglycaemia. We suggested healthy modifications of dietary habits and periodic follow-up visits with a dietitian. After three months, the patient still presented symptoms of reactive hypoglycaemia; we provided him with Flash Glucose Monitoring (FGM) to assess trend of glucose levels in interstitial fluid during the day and we decided to introduce canagliflozin 300 mg/day before the main meal. Hypoglycaemic events previously referred by the patient and clearly recorded by FGM completely disappeared taking canagliflozin. We found a reduction of time spent in hypoglycaemia, an improvement of glycemic variability and an increase of time in target range. It was also noted a reduction of time spent in hyperglicemia with consequent improvement of average glucose values and of glucose main indicator. This is the first report with FGM supporting a role of canagliflozin in the management of post-gastrectomy reactive hyperinsulinaemic hypoglycaemia. Our preliminary results are very limited but in line with those of the literature and showed for the first time a reduction of hypoglycaemic events and an improvement of glycemic variability through a flash glucose monitoring system. Further studies are mandatory to confirm this therapeutic opportunity.