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Objective: This study investigated the association of Time In Range (TIR) obtained from Blood Glucose Monitoring (BGM) with Cognitive Impairment (CI) inpatients with middle-aged Type 2 Diabetes Mellitus (T2DM) and further explored whether a TIR goal for T2DM in adults with > 70% possess a protective effect on cognitive function. Research design and methods: A total of 274 inpatients with T2DM aged 40–64 years, who underwent seven-point BGM (pre meals and 120 min post meals and at bedtime) were recruited in this cross-sectional study. TIR was defined as the percentage of blood glucose within the target range of 3.9-10.0mmol/L. Subjects were divided into Normal Cognitive Function (NCF) (n = 160) and CI (n = 114) groups according to the results of the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE). The association of TIR and other glycemic metrics, calculated from seven-point BGM data, with cognitive dysfunction was analyzed. Results: The prevalence of CI was 41.6% in patients with middle-aged T2DM (median age 58 years). TIR was lower in CI group than in NCF group (28.6% vs. 42.9%, P = 0.004). The prevalence of CI decreased with ascending tertiles of TIR (p for trend < 0.05). Binary logistic regression analysis showed a significant association between TIR and CI (odds ratio [OR] = 0.84, p < 0.001) after adjusting for confounders (age, education, marital status, age at Diabetes Mellitus (DM) onset, cerebrovascular disease). Further adjustment of Standard Deviation (SD)(OR = 0.84, p = 0.001) or Coefficient of Variation (CV)(OR = 0.83, p < 0.001), TIR was still associated with CI. While a TIR goal of > 70% probably possessed independent protective effect on cognitive function (OR = 0.25, p = 0.001) after controlling for confounders above. Conclusions: TIR obtained from BGM was related to CI in middle-aged T2DM individuals and a TIR goal of > 70% probably possessed a protective effect on cognitive function for middle-aged T2DM. [ABSTRACT FROM AUTHOR]

The case report shows the safety and efficacy of insulin treatment with Advanced Hybrid Closed Loop (AHCL) system in a young patient affected by permanent neonatal diabetes mellitus (PNDM) due to chromosome 8 deletion syndrome involving the GATA4 gene. In the first days of life, he presented hyperglycaemia and started an intravenous insulin infusion therapy, replaced by a continuous subcutaneous insulin infusion (CSII) with Medtronic Minimed 780G® insulin pump (Medtronic, Northridge, CA, USA). At the age of 2 years, the off-label activation of SmartGuard® automated insulin delivery mode led to a great improvement in glycaemic control, reaching all recommended targets. At the 1-month follow-up visit, Time in Range (TIR) increased from 66% to 79%, with a Time in Tight Range (TTIR) of 55% and a reduction of 11% in time in hyperglycaemia and of 2% in time in hypoglycaemia. During the entire follow-up, no episodes of ketoacidosis or severe hypoglycaemia were observed and the patient maintained the glycaemic recommended targets reached at 1 month. Maintaining optimal glycaemic control and reducing hyperglycaemia are essential for brain growth and neurocognitive development in young patients. AHCL use should be considered to ensure good glycaemic control in patients affected by neonatal diabetes. [ABSTRACT FROM AUTHOR]

Abstract Objective This study investigated the association of Time In Range (TIR) obtained from Blood Glucose Monitoring (BGM) with Cognitive Impairment (CI) inpatients with middle-aged Type 2 Diabetes Mellitus (T2DM) and further explored whether a TIR goal for T2DM in adults with > 70% possess a protective effect on cognitive function. Research design and methods A total of 274 inpatients with T2DM aged 40–64 years, who underwent seven-point BGM ( pre meals and 120 min post meals and at bedtime) were recruited in this cross-sectional study. TIR was defined as the percentage of blood glucose within the target range of 3.9-10.0mmol/L. Subjects were divided into Normal Cognitive Function (NCF) (n = 160) and CI (n = 114) groups according to the results of the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE). The association of TIR and other glycemic metrics, calculated from seven-point BGM data, with cognitive dysfunction was analyzed. Results The prevalence of CI was 41.6% in patients with middle-aged T2DM (median age 58 years). TIR was lower in CI group than in NCF group (28.6% vs. 42.9%, P = 0.004). The prevalence of CI decreased with ascending tertiles of TIR (p for trend 70% probably possessed independent protective effect on cognitive function (OR = 0.25, p = 0.001) after controlling for confounders above. Conclusions TIR obtained from BGM was related to CI in middle-aged T2DM individuals and a TIR goal of > 70% probably possessed a protective effect on cognitive function for middle-aged T2DM .

Background and aims: Cystic fibrosis related diabetes (CFRD) is correlated with worsening of nutritional status and greater deterioration of lung function. The role of new technologies for the treatment of CFRD is little explored. The aim of the study was to evaluate the efficacy of Advanced Hybrid Closed Loop (AHCL) systems on glycemic control in CF patients. Methods: A single-center retrospective study on CFRD patients using AHCL systems was performed. Glycated hemoglobin (HbA1c) values and Continuous Glucose Monitoring (CGM) metrics were collected at T0 (AHCL placement), T1 (1-month), T2 (6-months) and T3 (1-year) to evaluate glycemic control. Results: 10 patients were included in the study. Data showed a reduction of HbA1c value (7.31 ± 0.34 to 6.35 ± 1.00; p=0.03), glycemic variability (p=0.05) and insulin requirement (p=0.03). The study population reached American Diabetes Association (ADA) recommended glycemic targets at 1-year. An increase in the Time in Range (TIR) and a reduction in time in hyperglycemia were also observed, although not statistically significant. Conclusions: In patients with CFRD, the use of AHCL leads to an improvement in glycemic control in terms of HbA1c and glycemic variability. The increase in TIR and the reduction of time in hyperglycemia, although not statistically significant, are extremely encouraging from a clinical point of view. Further studies with a larger population and a longer follow-up are needed. The results of this study demonstrate the importance of proposing the use of AHCL even in CF patients, who could benefit from glycemic improvement also in terms of nutritional status and respiratory function. [ABSTRACT FROM AUTHOR]

Currently, glycated hemoglobin A1c (HbA1c) has been widely used to assess the glycemic control of patients with diabetes. However, HbA1c has certain limitations in describing both short-term and long-term glycemic control. To more accurately evaluate the glycemic control of diabetes patients, the continuous glucose monitoring (CGM) technology has emerged. CGM technology can provide robust data on short-term glycemic control and introduce new monitoring parameters such as time in range, time above range, and time below range as indicators of glycemic fluctuation. These indicators are used to describe the changes in glycemic control after interventions in clinical research or treatment modifications in diabetes patient care. Recent studies both domestically and internationally have shown that these indicators are not only associated with microvascular complications of diabetes mellitus but also closely related to cardiovascular disease complications and prognosis. Therefore, this article aims to comprehensively review the association between CGM-based glycemic parameters and cardiovascular disease complications by analyzing a large number of domestic and international literature. The purpose is to provide scientific evidence and guidance for the standardized application of these indicators in clinical practice, in order to better evaluate the glycemic control of diabetes patients and prevent the occurrence of cardiovascular disease complications. This research will contribute to improving the quality of life for diabetes patients and provide important references for clinical decision-making. [ABSTRACT FROM AUTHOR]

Aim: Many adolescents with T1D experience a decline in metabolic control due to erratic eating habits and subpar adherence to treatment regimens. The objective of our retrospective observational study was to assess the effect of the Tandem Control IQ (CIQ) advanced hybrid closed-loop (AHCL) system on a cohort of adolescents with suboptimal glucose control. Methods: We retrospectively evaluated 20 non-adherent patients with T1D, who were inconsistently using Multiple Daily Injections (MDIs) and flash glucose monitoring and were subsequently started and on CIQ. Glucometrics and the Glucose Risk Index were assessed at baseline and after 2 weeks, 1 month, and 6 months of CIQ use. Results: The study included 20 adolescents with T1D (HbA1c: 10.0% ± 1.7). Time in range (TIR) increased from 27.1% ± 13.7 at baseline to 68.6% ± 14.2 at 2 weeks, 66.6% ± 10.7 at 1 month, and 60.4% ± 13.3 at 6 months of CIQ use. Time above range (TAR) >250 mg/dL decreased from 46.1% ± 23.8 to 9.9% ± 9.5 at 2 weeks, 10.8% ± 6.1 at 1 month, and 15.5% ± 10.5 at 6 months of AHCL use. Mean glucose levels improved from 251 mg/dL ± 68.9 to 175mg/dL ± 25.5 after 6 months of CIQ use. The Glucose Risk Index (GRI) also significantly reduced from 102 to 48 at 6 months of CIQ. HbA1c also improved from 10.0% ± 1.7 at baseline to 7.0% ± 0.7 after 6 months. Two patients experienced a single episode of mild diabetic ketoacidosis (DKA). Conclusions: AHCL systems provide a significant, rapid, and safe improvement in glucose control. This marks a pivotal advancement in technology that primarily benefited those who were already compliant. [ABSTRACT FROM AUTHOR]

The case report shows the safety and efficacy of insulin treatment with Advanced Hybrid Closed Loop (AHCL) system in a young patient affected by permanent neonatal diabetes mellitus (PNDM) due to chromosome 8 deletion syndrome involving the GATA4 gene. In the first days of life, he presented hyperglycaemia and started an intravenous insulin infusion therapy, replaced by a continuous subcutaneous insulin infusion (CSII) with Medtronic Minimed 780G® insulin pump (Medtronic, Northridge, CA, USA). At the age of 2 years, the off-label activation of SmartGuard® automated insulin delivery mode led to a great improvement in glycaemic control, reaching all recommended targets. At the 1-month follow-up visit, Time in Range (TIR) increased from 66% to 79%, with a Time in Tight Range (TTIR) of 55% and a reduction of 11% in time in hyperglycaemia and of 2% in time in hypoglycaemia. During the entire follow-up, no episodes of ketoacidosis or severe hypoglycaemia were observed and the patient maintained the glycaemic recommended targets reached at 1 month. Maintaining optimal glycaemic control and reducing hyperglycaemia are essential for brain growth and neurocognitive development in young patients. AHCL use should be considered to ensure good glycaemic control in patients affected by neonatal diabetes.

Intensive therapy with exogenous insulin is the treatment of choice for individuals living with type 1 diabetes (T1D) and some with type 2 diabetes, alongside regular glucose monitoring. The development of systems allowing (semi-)automated insulin delivery (AID), by connecting glucose sensors with insulin pumps and algorithms, has revolutionized insulin therapy. Indeed, AID systems have demonstrated a proven impact on overall glucose control, as indicated by effects on glycated hemoglobin (HbA1c), risk of severe hypoglycemia, and quality of life measures. An alternative endpoint for glucose control that has arisen from the use of sensor-based continuous glucose monitoring is the time in range (TIR) measure, which offers an indication of overall glucose control, while adding information on the quality of control with regard to blood glucose level stability. A review of literature on the health-economic value of AID systems was conducted, with a focus placed on the growing place of TIR as an endpoint in studies involving AID systems. Results showed that the majority of economic evaluations of AID systems focused on individuals with T1D and found AID systems to be cost-effective. Most studies incorporated HbA1c, rather than TIR, as a clinical endpoint to determine treatment effects on glucose control and subsequent quality-adjusted life year (QALY) gains. Likely reasons for the choice of HbA1c as the chosen endpoint is the use of this metric in most validated and established economic models, as well as the limited publicly available evidence on appropriate methodologies for TIR data incorporation within conventional economic evaluations. Future studies could include the novel TIR metric in health-economic evaluations as an additional measure of treatment effects and subsequent QALY gains, to facilitate a holistic representation of the impact of AID systems on glycemic control. This would provide decision makers with robust evidence to inform future recommendations for health care interventions. [ABSTRACT FROM AUTHOR]

Aims: Assess the effectiveness of virtual reality (VR) technology, in reducing pain and anxiety, and improving adherence and glycemic control among children with type 1 diabetes (T1D). Methods: Children with T1D, managed with continuous glucose monitoring and insulin pumps, were recruited for a randomized cross-over trial. Children were randomized to one of two interventions for diabetes management: group 1 used VR glasses first and group 2 listened to vocal-guided affective imagery first (audio). After 1 month, the interventions were crossed over. The outcome measures included pain and anxiety assessment, adherence, glycemic control, and patient-reported outcome measures (PROMs) of VR satisfaction and effectiveness. Results: Forty children, mean age 11.4 ± 1.8 years, were participated. During the VR part, the monthly mean pain score compared to the baseline improved in both groups by 30% (p = 0.03). A 14% reduction in the state anxiety score was observed from baseline to 1 month in both groups (p = 0.009). Glycemic control measures including time in range, time above range, and glucose management indicator improved in both groups during VR part (p < 0.004 for all), compared to audio part. After one month, the patient-reported outcome measure (PROM) of satisfaction and effectiveness was sixfold higher after 1 month in group 1 compared to group 2 (p = 0.002). Adherence improved for both groups. Conclusions: VR was shown to be effective in reducing pain and anxiety, improving adherence, PROM, and glycemic control among children with T1D. We suggest incorporating VR technology in pediatric diabetes clinics to facilitate and improve coping and management of diabetes. Trial registration: Trial registration number and date of registration for prospectively registered trials:ClinicalTrials.gov Identifier: NCT05883267, May 10th, 2023. [ABSTRACT FROM AUTHOR]

Background and aimsCystic fibrosis related diabetes (CFRD) is correlated with worsening of nutritional status and greater deterioration of lung function. The role of new technologies for the treatment of CFRD is little explored. The aim of the study was to evaluate the efficacy of Advanced Hybrid Closed Loop (AHCL) systems on glycemic control in CF patients.MethodsA single-center retrospective study on CFRD patients using AHCL systems was performed. Glycated hemoglobin (HbA1c) values and Continuous Glucose Monitoring (CGM) metrics were collected at T0 (AHCL placement), T1 (1-month), T2 (6-months) and T3 (1-year) to evaluate glycemic control.Results10 patients were included in the study. Data showed a reduction of HbA1c value (7.31 ± 0.34 to 6.35 ± 1.00; p=0.03), glycemic variability (p=0.05) and insulin requirement (p=0.03). The study population reached American Diabetes Association (ADA) recommended glycemic targets at 1-year. An increase in the Time in Range (TIR) and a reduction in time in hyperglycemia were also observed, although not statistically significant.ConclusionsIn patients with CFRD, the use of AHCL leads to an improvement in glycemic control in terms of HbA1c and glycemic variability. The increase in TIR and the reduction of time in hyperglycemia, although not statistically significant, are extremely encouraging from a clinical point of view. Further studies with a larger population and a longer follow-up are needed. The results of this study demonstrate the importance of proposing the use of AHCL even in CF patients, who could benefit from glycemic improvement also in terms of nutritional status and respiratory function.

AimMany adolescents with T1D experience a decline in metabolic control due to erratic eating habits and subpar adherence to treatment regimens. The objective of our retrospective observational study was to assess the effect of the Tandem Control IQ (CIQ) advanced hybrid closed-loop (AHCL) system on a cohort of adolescents with suboptimal glucose control.MethodsWe retrospectively evaluated 20 non-adherent patients with T1D, who were inconsistently using Multiple Daily Injections (MDIs) and flash glucose monitoring and were subsequently started and on CIQ. Glucometrics and the Glucose Risk Index were assessed at baseline and after 2 weeks, 1 month, and 6 months of CIQ use.ResultsThe study included 20 adolescents with T1D (HbA1c: 10.0% ± 1.7). Time in range (TIR) increased from 27.1% ± 13.7 at baseline to 68.6% ± 14.2 at 2 weeks, 66.6% ± 10.7 at 1 month, and 60.4% ± 13.3 at 6 months of CIQ use. Time above range (TAR) >250 mg/dL decreased from 46.1% ± 23.8 to 9.9% ± 9.5 at 2 weeks, 10.8% ± 6.1 at 1 month, and 15.5% ± 10.5 at 6 months of AHCL use. Mean glucose levels improved from 251 mg/dL ± 68.9 to 175mg/dL ± 25.5 after 6 months of CIQ use. The Glucose Risk Index (GRI) also significantly reduced from 102 to 48 at 6 months of CIQ. HbA1c also improved from 10.0% ± 1.7 at baseline to 7.0% ± 0.7 after 6 months. Two patients experienced a single episode of mild diabetic ketoacidosis (DKA).ConclusionsAHCL systems provide a significant, rapid, and safe improvement in glucose control. This marks a pivotal advancement in technology that primarily benefited those who were already compliant.

Abstract Background Advanced hybrid closed loop (AHCL) system provides both automated basal rate and correction boluses to keep glycemic values in a target range. Objectives To evaluate the real-world performance of the MiniMed™ 780G system among different age groups of Egyptian patients with type 1diabetes. Methods One-hundred seven AHCL system users aged from 3 to 71 years were enrolled. Data uploaded by patients were aggregated and analyzed. The mean glucose management indicator (GMI), percentage of time spent within glycemic ranges (TIR), time below range (TBR) and time above range (TAR) were determined. Results Six months after initiating Auto Mode, patients spent a mean of 85.31 ± 22.04% of the time in Auto Mode (SmartGuard) and achieved a mean GMI of 6.95 ± 0.58% compared with 7.9 ± 2.1% before AHCL initiation (p 250 mg/dL, TBR

Aims: We sought to assess whether conversion from Freestyle Libre to Freestyle Libre 2 (with low and high glucose alert functions) was associated with improved glucose metrics. Research Design and Methods: A prospective observational study to assess changes in CGM metrics in 672 adults with type 1 diabetes when converting to Freestyle Libre 2. Secondary outcomes included predictors of reduction in time below range (TBR) and increase in time in range (TIR). Results: TBR fell by a median of 1.0% (IQR −2.7 to 0.3, p < 0.001) after 12 months and TIR decreased by 1.0% (−8.7 to 6.0, p = 0.004). TIR did not fall in people using high glucose alerts (p = 0.353). Average duration of low glucose events (<3.9 mmoL/L) fell by 10 min (−46 to 18, p < 0.001). Significant improvements in TIR (p = 0.029) and time above 13.9 mM (p = 0.002) were observed in those using high glucose alerts. Alert threshold settings were not associated with glycaemic response; however, low alert use was independently associated with a fall in TBR of ≥0.5% (HR 1.9 [95% CI 1.2–3.1], p = 0.009) and high alert use was independently associated with a rise in TIR of ≥5% (HR 1.6 [95% CI 1.0–2.5], p = 0.043) at 12 months. Conclusions: Conversion to Freestyle Libre 2 was associated with significant improvements in low glucose metrics. Alert function users were more likely to see improvements across all CGM metrics. Challenges remain in encouraging alert use, helping users set optimal alert thresholds and optimizing response to alerts. [ABSTRACT FROM AUTHOR]

Background: Advanced hybrid closed loop (AHCL) system provides both automated basal rate and correction boluses to keep glycemic values in a target range. Objectives: To evaluate the real-world performance of the MiniMed™ 780G system among different age groups of Egyptian patients with type 1diabetes. Methods: One-hundred seven AHCL system users aged from 3 to 71 years were enrolled. Data uploaded by patients were aggregated and analyzed. The mean glucose management indicator (GMI), percentage of time spent within glycemic ranges (TIR), time below range (TBR) and time above range (TAR) were determined. Results: Six months after initiating Auto Mode, patients spent a mean of 85.31 ± 22.04% of the time in Auto Mode (SmartGuard) and achieved a mean GMI of 6.95 ± 0.58% compared with 7.9 ± 2.1% before AHCL initiation (p < 0.001). TIR 70–180 mg/dL was increased post-AHCL initiation from 63.48 ± 10.14% to 81.54 ± 8.43% (p < 0.001) while TAR 180–250 mg/dL, TAR > 250 mg/dL, TBR < 70 mg/dL and TBR < 54 mg/dL were significantly decreased (p < 0.001). After initiating AHCL, TIR was greater in children and adults compared with adolescents (82.29 ± 7.22% and 83.86 ± 9.24% versus 78.4 ± 7.34%, respectively; p < 0.05). The total daily dose of insulin was increased in all age groups primarily due to increased system-initiated insulin delivery including auto correction boluses and basal insulin. Conclusions: MiniMed™ 780G system users across different age groups achieved international consensus-recommended glycemic control with no serious adverse effects even in challenging age group as children and adolescents. [ABSTRACT FROM AUTHOR]

Abstract Background Continuous glucose monitoring (CGM)-derived time in range (TIR) is closely associated with micro- and macrovascular complications in type 2 diabetes mellitus (T2DM). This study was performed to investigate the relationship between key CGM-derived metrics and specific cognitive domains in patients with T2DM. Methods Outpatients with T2DM who were otherwise healthy were recruited for this study. A battery of neuropsychological tests was performed to evaluate cognitive function, including memory, executive functioning, visuospatial ability, attention, and language. Participants wore a blinded flash continuous glucose monitoring (FGM) system for 72 h. The key FGM-derived metrics were calculated, including TIR, time below range (TBR), time above range (TAR), glucose coefficient of variation (CV), and mean amplitude of glycemic excursions (MAGE). Furthermore, the glycemia risk index (GRI) was also calculated by the GRI formula. Binary logistic regression was used to assess risk factors for TBR, and we further analysed the associations between neuropsychological test results and key FGM-derived metrics with multiple linear regressions. Results A total of 96 outpatients with T2DM were recruited for this study, with 45.8% experiencing hypoglycemia (TBR 13.9 mmol/L (β = -0.216, P = 0.030) and TAR10.1–13.9 mmol/L (β = 0.206, P = 0.042) were significantly correlated with cued recall scores after adjusting for confounding factors. However, TIR, GRI, CV and MAGE showed no significant correlation with the results of neuropsychological tests (P > 0.05). Conclusions A higher TBR 13.9 mmol/L were associated with worse cognitive functions (memory, visuospatial ability, and executive functioning). Conversely, a higher TAR of 10.1–13.9 mmol/L was associated with better memory performance in memory tasks.

Background: The adoption of continuous glucose monitoring (CGM) results in vast amounts of data, but their interpretation is still more art than exact science. The International Consensus on Time in Range (TIR) proposed the widely accepted TIR system of metrics, which we now take forward by introducing a finite and fixed set of clinically similar clusters (CSCs), such that the TIR metrics of daily CGM profiles within a cluster are homogeneous. Methods: CSC definition and validation used 204,710 daily CGM profiles in health, and types 1 and 2 diabetes (T1D and T2D) on different treatments. The CSCs were defined using 23,916 daily CGM profiles (Training set), and the final fixed set of CSCs was obtained using another 37,758 profiles (Validation set). The Testing set (143,036 profiles) was used to establish the robustness and generalizability of CSCs. Results: The final set of CSCs contains 32 clusters. Any daily CGM profile was classifiable to a single CSC, which approximated common glycemic metrics of the daily CGM profile, as evidenced by regression analyses with 0 intercept (R-squares ≥0.83, e.g., correlation ≥0.91), for all TIR and several other metrics. The CSCs distinguished CGM profiles in health, T2D, and T1D on different treatments, and allowed tracking of daily changes in a person's glycemic control over time. Conclusion: Daily CGM profiles can be classified into one of 32 prefixed CSCs, which enables a host of applications, for example, tabulated data interpretation and algorithmic approaches to treatment, database indexing, pattern recognition, and tracking disease progression. Clinical Trial Registration: N/A—not a clinical trial. [ABSTRACT FROM AUTHOR]

Background: Continuous glucose monitoring (CGM)-derived time in range (TIR) is closely associated with micro- and macrovascular complications in type 2 diabetes mellitus (T2DM). This study was performed to investigate the relationship between key CGM-derived metrics and specific cognitive domains in patients with T2DM. Methods: Outpatients with T2DM who were otherwise healthy were recruited for this study. A battery of neuropsychological tests was performed to evaluate cognitive function, including memory, executive functioning, visuospatial ability, attention, and language. Participants wore a blinded flash continuous glucose monitoring (FGM) system for 72 h. The key FGM-derived metrics were calculated, including TIR, time below range (TBR), time above range (TAR), glucose coefficient of variation (CV), and mean amplitude of glycemic excursions (MAGE). Furthermore, the glycemia risk index (GRI) was also calculated by the GRI formula. Binary logistic regression was used to assess risk factors for TBR, and we further analysed the associations between neuropsychological test results and key FGM-derived metrics with multiple linear regressions. Results: A total of 96 outpatients with T2DM were recruited for this study, with 45.8% experiencing hypoglycemia (TBR< 3.9 mmol/L). Spearman analysis results revealed that a higher TBR< 3.9 mmol/L was correlated with worse performance on the Trail Making Test A (TMTA), Clock Drawing Test (CDT), and cued recall scores (P < 0.05). Logistic regression analysis results indicated that the TMTA (OR = 1.010, P = 0.036) and CDT (OR = 0.429, P = 0.016) scores were significant factors influencing the occurrence of TBR< 3.9 mmol/L. Multiple linear regressions further demonstrated that TBR< 3.9 mmol/L (β = -0.214, P = 0.033), TAR> 13.9 mmol/L (β = -0.216, P = 0.030) and TAR10.1–13.9 mmol/L (β = 0.206, P = 0.042) were significantly correlated with cued recall scores after adjusting for confounding factors. However, TIR, GRI, CV and MAGE showed no significant correlation with the results of neuropsychological tests (P > 0.05). Conclusions: A higher TBR< 3.9 mmol/L and TAR> 13.9 mmol/L were associated with worse cognitive functions (memory, visuospatial ability, and executive functioning). Conversely, a higher TAR of 10.1–13.9 mmol/L was associated with better memory performance in memory tasks. [ABSTRACT FROM AUTHOR]

Introduction: People with diabetes are at a higher risk for coronavirus disease-19 (COVID-19) and hence are prioritized for vaccination. The aim of the current study was to investigate the effects of COVID-19 vaccination on blood glucose control in Arabic people with type 1 diabetes (T1D). Secondary aim was to compare the responses between the two vaccines approved for use in Kuwait. Method: This retrospective study compared ambulatory glucose metrics, using a continuous glucose monitoring device, measured for 14 days before, and 7 days and 14 days after, the first and second dose of the COVID-19 vaccine in Arabic people with Type 1 diabetes (T1D). We also explored possible links with vaccine type and other clinical characteristics. Glucose metrics calculated were time in range (TIR, 3.9-10 mmol/L), time above range (TAR, 10.1-13.9 mmol/L or >13.9 mmol/L), time below range (TBR, 3-3.9 mmol/L or <3 mmol/L) and glucose variability (CV). Results: We enrolled 223 participants in the study. Over the 7 days period after the first vaccination dose there was a decrease in TIR (mean difference (SD) - 1.9% ± 14.8%; p = 0.05) and increase in TAR >10 mmol/L (2.2% ± 15.9%; p = 0.04), with no effects on TBR. These effects were not seen after the second dose or 14 days after either dose. There was a decrease in CV over the 7 days period after the first (-1.2% ± 7.4%; p = 0.02) and second vaccine doses (-1.1% ± 6.9%; p = 0.03), with no effects noted 14 days after either dose. In subgroup analysis similar effects on TIR and TAR were also seen in those who had received the viral vectorbased vaccine, but not the mRNA-based vaccine, although the decrease in CV was seen in those who had received the mRNA based vaccine but not the viral vector-based vaccine. Conclusion: We found a temporary impairment in glucose control in the first 7 days, particularly among individuals receiving viral vector vaccines. The group receiving mRNA vaccine was likely to experience an increase in glucose levels above the target range. However, the temporary change in metrics appears to return to pre-vaccination levels after one-week post-vaccination. The effects on glycemic parameters were more neutral after the second dose. [ABSTRACT FROM AUTHOR]

IntroductionPeople with diabetes are at a higher risk for coronavirus disease-19 (COVID-19) and hence are prioritized for vaccination. The aim of the current study was to investigate the effects of COVID-19 vaccination on blood glucose control in Arabic people with type 1 diabetes (T1D). Secondary aim was to compare the responses between the two vaccines approved for use in Kuwait.MethodThis retrospective study compared ambulatory glucose metrics, using a continuous glucose monitoring device, measured for 14 days before, and 7 days and 14 days after, the first and second dose of the COVID-19 vaccine in Arabic people with Type 1 diabetes (T1D). We also explored possible links with vaccine type and other clinical characteristics. Glucose metrics calculated were time in range (TIR, 3.9–10 mmol/L), time above range (TAR, 10.1- 13.9 mmol/L or >13.9 mmol/L), time below range (TBR, 3- 3.9 mmol/L or 10 mmol/L (2.2% ± 15.9%; p = 0.04), with no effects on TBR. These effects were not seen after the second dose or 14 days after either dose. There was a decrease in CV over the 7 days period after the first (−1.2% ± 7.4%; p = 0.02) and second vaccine doses (−1.1% ± 6.9%; p = 0.03), with no effects noted 14 days after either dose. In subgroup analysis similar effects on TIR and TAR were also seen in those who had received the viral vector-based vaccine, but not the mRNA-based vaccine, although the decrease in CV was seen in those who had received the mRNA based vaccine but not the viral vector-based vaccine.ConclusionWe found a temporary impairment in glucose control in the first 7 days, particularly among individuals receiving viral vector vaccines. The group receiving mRNA vaccine was likely to experience an increase in glucose levels above the target range. However, the temporary change in metrics appears to return to pre-vaccination levels after one-week post-vaccination. The effects on glycemic parameters were more neutral after the second dose.

Glucose monitoring is an important part of diabetes management. For over a century, diabetes monitoring technology has developed from the initial urine glucose test, to the later blood glucose test, and finally to the current continuous glucose monitoring (CGM), which is evolving in a more convenient, accurate, minimally invasive, and even non-invasive direction. CGM refers to the technology that continuously measures glucose concentrations in the subcutaneous interstitial fluid by glucose sensors. It can detect hyperglycemia and hypoglycemia that are not easily recognized by traditional monitoring methods. Using the huge amounts of glucose data generated by CGM technology, diabetes management is expected to be more targeted, with glucose control more accurate. In this context, novel measure of glucose control represented by time in range (TIR) has been popularized, which can provide comprehensive information including hyperglycemia, hypoglycemia, and glucose fluctuation. Hence, the modern approach to glucose control should focus not only on glycosylated hemoglobin, but also pay attention to new metrics such as TIR. In the future, more mature, minimally invasive and even non-invasive glucose monitoring technologies that are comfortable, stable and highly accurate should be further developed to greatly improve the experience and enthusiasm of the patients in blood glucose monitoring. Meanwhile, closed-loop insulin infusion system should be further developed, to truly realize individualized and automated glucose control, as well as further improvement of glucose control in the patients with diabetes. [ABSTRACT FROM AUTHOR]

Background and Objective: In recent years, there has been growing interest in glycemic variability within the scientific community, particularly regarding its potential as an independent risk factor for diabetes-related long-term complications. This narrative review aimed to provide a comprehensive overview of short-term glycemic variability in children and adolescents with type 1 diabetes (T1D)., Methods: We performed a search of published literature on the PubMed MEDLINE database using the following combination of search terms: "glycemic variability", "pediatric", "type 1 diabetes", and "children"., Key Content and Findings: The widespread use of continuous glucose monitoring (CGM) systems has facilitated the characterization and quantification of glycemic fluctuations. Over the years, several metrics for assessing glycemic variability have been developed. Children and adolescents with T1D often experience wide and frequent glycemic excursions due to behavioral and hormonal factors. Several studies suggest a potential link between glycemic variability and an increased risk of diabetes-related complications., Conclusions: Glycemic variability has become an integral aspect of the routine clinical management of youths with T1D, serving as a valuable therapeutic target. However, achieving recommended glycemic targets in this population remains challenging. Further long-term data are needed to definitively establish the role of glycemic variability in the development of complications., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tp.amegroups.com/article/view/10.21037/tp-24-114/coif). The authors have no conflicts of interest to declare., (2024 Translational Pediatrics. All rights reserved.)

Introduction: Despite significant advances in diabetes care over the last three decades, the majority of people living with T1D are not meeting established metabolic goals. Automated insulin delivery can help achieve these metabolic goals (HbA1c and TIR). Areas covered: This review examines the new features and available data regarding safety and efficacy of the MiniMed™ 780 G, a second-generation advanced hybrid closed-loop system. Reported outcomes include time in, above and below range, HbA1c, diabetic ketoacidosis and severe hypoglycemia. Expert opinion: The initial pivotal trials of the MiniMed™ 780 G have demonstrated promising clinical and safety outcomes. Real-world data and longer-term studies are still needed. The success of AID devices moving forward hinges on their ease of use and ability to reduce and relieve the burden of living with T1D. [ABSTRACT FROM AUTHOR]

Background The prevalence of gestational diabetes mellitus (GDM) is increasing globally. When diet and lifestyle modifications are inadequate for control, managing GDM often involves insulin or metformin. Metformin's oral administration option improves patient compliance and acceptance, but concerns about its use persist, necessitating careful evaluation. Comparative studies between insulin and metformin in GDM are scarce. In pregnancies complicated by diabetes, precise glucose control is crucial for maternal-fetal well-being, and continuous glucose monitoring (CGM) plays a valuable role in achieving recommended targets. CGM provides comprehensive glucose profiles, including postprandial glucose excursions and details about time spent in hypoglycemia, euglycemia, and hyperglycemia. The time-in-range (TIR) metric, when used alongside A1C, offers more actionable information than A1C alone. To the best of our knowledge, no published trials compare TIR in GDM with metformin or insulin aspart/detemir, specifically focusing on CGM metrics. This randomized controlled trial (RCT) aims to assess TIR in women with GDM treated with either metformin or insulin. Materials and methods This study was a non-inferiority randomized control trial evaluating TIR in GDM using continuous glucose monitoring with metformin or insulin. Forty-four women with GDM were enrolled. The diagnosis of GDM was based on the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria. CGM readings were collected for 14 days after sensor activation. Results In our study, 44 women with GDM completed the protocol, with 22 in the Metformin group and 22 in the Insulin group. Baseline characteristics did not differ between the groups. Age, BMI pre-gravid, BMI at 28 weeks, parity, family history of diabetes mellitus, previous history of GDM, glycated hemoglobin (HbA1c), oral glucose tolerance tests (OGTT) at zero hours, one hour, and two hours, as well as gestational weeks, did not significantly differ between the two groups. The metformin and insulin groups did not differ significantly in CGM metrics, including TIR, time above range, time below range, mean glucose, and glucose management indicator. Conclusion Based on our findings, the metformin and insulin groups did not differ in CGM metrics, including TIR, time above range, time below range, mean glucose, and glucose management indicator. In clinical practice, CGM metrics complement fasting blood glucose, postprandial glucose, and HbA1c as appropriate and useful clinical targets and outcome measurements. Metformin's oral administration option offers advantages such as improved patient compliance and acceptance in women with GDM., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Pandey et al.)

• Transitioning to telemedicine for type 1 diabetes care improves glycemic measures. • Glycemic measures that improve include HbA1c, TIR and mean sensor glucose. • This transition is also associated with improved patient reported outcome measures. • Improved glycemic measures are correlated and patient reported outcome measures. With advances in cloud-based technologies, there has been a rise in remote T1D care. We hypothesized that transitioning T1DM care to a virtual, multidisciplinary clinic could improve measures beyond HbA1c. To assess the impact of transitioning from standard to virtual T1DM care, we evaluated glycemic measures and patient reported outcomes. Sixty-one adults with T1DM were included, with mean age 40.2 ± 13.5 years and diabetes duration 16.9 ± 9.0 years. Most patients were treated with insulin pumps and CGM. The number of annual diabetes care encounters rose from 2.1 ± 4.2 to 12.8 ± 5.5. Baseline HbA1c was 7.9 ± 1.6 %(63 ± 16.9 mmol/mol), declining to 7.3 ± 1.1 %(56 ± 8.5 mmol/mol) and 7.1 ± 1.0 %(54 ± 7.7 mmol/mol) at 6 and 12 months respectively (p < 0.001 for both). In parallel, TIR improved from 63.1 ± 19.3 % to 69.2 ± 13.8 % (p < 0.001) and 67.5 ± 19.4 % (p = 0.03) at 6 and 12 months respectively, while TBR declined. Scores from validated diabetes treatment and self-management questionnaires rose significantly and these rises were associated with a reduction in HbA1c, the latter score was also associated with increased TIR. There was a trend toward a correlation between encounter frequency and improvement in HbA1c and TIR. Transitioning from standard to virtual, coordinated, multidisciplinary T1DM care is associated with increased visit frequency, improving glycemic control, treatment satisfaction and self-care behaviors. [ABSTRACT FROM AUTHOR]

Introduction: Finding a goal of time in range (%TIR) that defines good glycemic control is necessary. Previous retrospective studies suggest good concordance between HbA1c ≤7% with a TIR >70%; however, the studies that included the largest number of patients used blood glucose measurement data with a follow-up time of less than 90 days. This study defined the TIR value that best discriminates HbA1c ≤7%., Methods: We performed a prospective study of diagnostic tests based on a cohort of patients with type 1 diabetes (T1D) treated with a hybrid closed loop (HCL) followed for three months. The ability of %TIR to distinguish patients with HbA1c ≤7% was evaluated through receiver operating characteristic curve analysis. We determined the %TIR cutoff point with the best operating characteristics., Results: A total of 118 patients were included (58.1% women, 47% overweight or obese, and 33% with high glycemic variability). A moderate negative correlation ( R = -.54, P < .001) was found between %TIR and HbA1c. The discrimination ability was moderate, with an area under the curve of 0.7485 (95% confidence interval = 0.6608-0.8363). The cutoff point that best predicted HbA1c ≤7% was %TIR ≥75.5 (sensitivity 70%, specificity 67%). The findings were similar among those with a coefficient of variation (CV%) ≥36%., Conclusions: Our data suggest that the %TIR adequately identifies patients with HbA1c ≤7%. A target of TIR ≥75%, rather than the currently recommended TIR ≥70%, may be a more suitable value for optimal glycemic control., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AMG reports speaker fees from Novo Nordisk, Sanofi, Elli Lilly, Boehringer Ingelheim, Abbott, and Medtronic. DCH reports speaker fees from Novo Nordisk, Sanofi, Medtronic, and Abbott.

Background: Insulin pump use is increasing in frequency among pregnant individuals with type 1 diabetes (T1D). Automated insulin delivery (AID) technologies have not been studied extensively in pregnancy., Method: We present a retrospective case series of eight individuals with T1D who used the Tandem t:slim X2 insulin pump (Tandem Diabetes Care, Inc., CA, USA) during pregnancy. Weekly continuous glucose monitor and insulin pump data were analyzed from electronic medical records and data-sharing portals. Safety, glycemic control, and pregnancy outcomes were examined with both the control IQ (CIQ) and basal IQ (BIQ) algorithms., Results: Six CIQ and two BIQ users were studied. The mean glycated hemoglobin (A1C) during pregnancy was 6.1%, and the average time in pregnancy-recommended glycemic range (TIR; 63-140mg/dL) was 67.9%. There were no instances of diabetic ketoacidosis or severe hypoglycemia. CIQ users had a higher mean sensor glucose (127.6 mg/dL) compared to BIQ participants (118.4 mg/dL). However, the average time below range (<63 mg/dL) was 6.1% in BIQ participants compared to 1.5% in CIQ participants. CIQ participants used several strategies to achieve glycemic targets, including daytime use of sleep activity. An increased basal-to-bolus insulin ratio was negatively correlated with TIR (r=-0.415)., Conclusions: Tandem t:slim X2 insulin pumps were safely used during pregnancy in eight individuals with T1D, with variable success in achieving recommended glycemic targets. Further research is needed to understand differences in CIQ and BIQ use in pregnancy. AID device manufacturers must additionally develop further methods to target lower glucose for pregnant users., Competing Interests: The authors have declared financial relationships, which are detailed in the next section., (Copyright © 2024, Nandam et al.)

To assess features associated with glucagon prescribing and hospital admissions with hypoglycaemia in type one diabetes. Observational study of 4462 adults. Outcome measures were features associated with glucagon prescriptions and predictors of hospital admissions with hypoglycaemia and high levels of glucagon prescribing. 74 % did not collect any glucagon prescriptions and 2.7 % collected >6 over 3.5 years. Hospital admission with hypoglycaemia (P = 0.032), impaired awareness (P = 0.049) and female sex (P < 0.001) were associated with glucagon collection. More frequent prescribing of glucagon was associated with diabetes duration (P < 0.001) and socioeconomic deprivation (P < 0.001). Higher average glucose (P = 0.047), higher time above 13.9 mM (P = 0.008) and higher SD (P = 0.002) were associated with glucagon prescribing. Diabetes duration (P < 0.001) and HbA1c (P < 0.001) were higher in people with hospitalised hypoglycaemia. Higher time above 13.9 mM (P = 0.004) and SD glucose (P < 0.001) were most clearly associated with hospitalised hypoglycaemia. A minority of people with type 1 diabetes have access to glucagon suggesting more could be done to better target this treatment. Individuals with risk factors and those with frequent glucagon prescriptions should be identified for interventions known to reduce hypoglycaemia. • Diabetes duration, technology use, female sex and impaired hypoglycaemia awareness associated with glucagon prescribing. • Frequent glucagon use was associated with deprivation, diabetes duration and high glucose variability. • Hospitalised hypoglycaemia was associated with diabetes duration, deprivation, high HbA1c and high glucose variability. [ABSTRACT FROM AUTHOR]

Continuous Glucose Monitoring (CGM) has been demonstrated to be clinically valuable, reducing risks of hypoglycemia and hyperglycemia, glycemic variability (GV), and improving patient quality of life for a wide range of patient populations and clinical indications. Use of CGM can help reduce HbA1c and mean glucose. One CGM device, with accuracy (%MARD) of approximately 10%, has recently been approved for self-adjustment of insulin dosages (nonadjuvant use) and approved for reimbursement for therapeutic use in the United States. CGM had previously been used off-label for that purpose. CGM has been demonstrated to be clinically useful in both type 1 and type 2 diabetes for patients receiving a wide variety of treatment regimens. CGM is beneficial for people using either multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). CGM is used both in retrospective (professional, masked) and real-time (personal, unmasked) modes: both approaches can be beneficial. When CGM is used to suspend insulin infusion when hypoglycemia is detected until glucose returns to a safe level (low-glucose suspend), there are benefits beyond sensor-augmented pump (SAP), with greater reduction in the risk of hypoglycemia. Predictive low-glucose suspend provides greater benefits in this regard. Closed-loop control with insulin provides further improvement in quality of glycemic control. A hybrid closed-loop system has recently been approved by the U.S. FDA. Closed-loop control using both insulin and glucagon can reduce risk of hypoglycemia even more. CGM facilitates rigorous evaluation of new forms of therapy, characterizing pharmacodynamics, assessing frequency and severity of hypo- and hyperglycemia, and characterizing several aspects of GV. [ABSTRACT FROM AUTHOR]

Objectives: Flash glucose monitoring in patients with type 1 diabetes provides new glucometric data that allow for the assessment of glycemic control beyond HbA 1c . The objective of the study was to evaluate the relationship between HbA 1c , time-in-range (TIR) and glycemic variability in a cohort of paediatric and adult patients with type 1 diabetes and treatment with flash glucose monitoring., Material and Methods: This was a cross-sectional study in 195 patients with type 1 diabetes (42.6% females, 70 paediatric, 26.2% continuous subcutaneous insulin infusion, 28.7% coefficient of variation [CV]≤36%) in intensive treatment and flash glucose monitoring. Clinical, analytical and glucometric data were evaluated., Results: The relationship between the TIR and HbA 1c showed a strong negative linear correlation (R=-0.746; R 2 =0.557; P<.001), modified in those patients with CV≤36% (R=-0.852; R 2 =0.836) compared to CV>36% (R=-0.703; R 2 =0.551). A similar correlation was found when evaluating the TIR and the Glucose Management Indicator (R=-0.846; R 2 =0.715; P<.001); in patients with CV≤36% (R=-0.980; R 2 =0.960) versus CV>36% (R=-0.837; R 2 =0.701); P<.001. Both correlations remained stable in the paediatric population (R=-0.724; R 2 =0.525; P<.001) and adults (R=-0.706; R 2 =0.498; P<.001) and by type of treatment: multiple doses of insulin (R=-0.747; R 2 =0.558; P<.001) and continuous subcutaneous insulin infusion (R=-0.711; R 2 =0.506; P<.001). In a multiple regression analysis evaluating HbA 1c as dependent variable, the only parameters that maintained statistical significance were the TIR (β=-0,031; P<.001), CV (β=0.843; P<.05) and TIR-CV interaction (β=-0.017; P<.01)., Conclusions: The glycemic variability defined by the CV modifies the relationship between the TIR and HbA 1c /Glucose Management Indicator and should be taken into account when individualising TIR targets, regardless of age or the type of treatment used., (Copyright © 2021 SEEN and SED. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction : Despite significant advances in diabetes care over the last three decades, the majority of people living with T1D are not meeting established metabolic goals. Automated insulin delivery can help achieve these metabolic goals (HbA1c and TIR). Areas covered : This review examines the new features and available data regarding safety and efficacy of the MiniMed™ 780 G, a second-generation advanced hybrid closed-loop system. Reported outcomes include time in, above and below range, HbA1c, diabetic ketoacidosis and severe hypoglycemia. Expert opinion : The initial pivotal trials of the MiniMed™ 780 G have demonstrated promising clinical and safety outcomes. Real-world data and longer-term studies are still needed. The success of AID devices moving forward hinges on their ease of use and ability to reduce and relieve the burden of living with T1D.