Sensor Glucose Research Articles

The Association of High and Low Glycation With Incident Diabetic Retinopathy in Adults With Type 1 Diabetes.

We investigated the risk of incident diabetic retinopathy (DR) among high glycator compared to low glycator patients based on the hemoglobin glycation index (HGI). Visit-to-visit variations in HGI also were assessed. Glycated hemoglobin (HbA1c) and continuous glucose monitoring data were collected up to 7 years prior to the date of eye examination defining incident DR or no retinopathy (control). Hemoglobin glycation index was calculated as difference in measured HbA1c and an estimated A1c from sensor glucose (eA1c) to define high (HbA1c - eA1c >0%) or low (HbA1c - eA1c <0%) glycator. Stable glycators were defined as ≥75% of visits with same HGI category. Logistic regression was used to assess the association between glycation category and incident DR. Of 119 adults with type 1 diabetes (T1D), 49 (41%) were stable low glycator (HbA1c - eA1c <0%), 36 (30%) were stable high glycator (HbA1c - eA1c >0%), and 34 (29%) were unstable glycator. Using alternate criteria to define high vs low glycator (consistent difference in HbA1c - eA1c of > 0.4% or <0.4%, respectively), 53% of the adults were characterized as unstable glycator. Compared to low glycators, high glycators did not have a significantly higher risk for incident DR over time when adjusted for age, T1D duration and continuous glucose monitoring (CGM) sensor type (odds ratio [OR] = 1.31, 95% confidence interval [CI] = 0.48-3.62, P = .15). The risk of diabetic retinopathy was not found to differ significantly comparing high glycators to low glycators in adults with T1D. Moreover, HbA1c - eA1c relationship was not stable in nearly 30% to 50% adults with T1D, suggesting that discordance in HbA1c and eA1c are mostly related either HbA1c measurements or estimation of A1c from sensor glucose rather than physiological reasons.

Efficacy and safety of advanced hybrid closed loop systems in children with type 1 diabetes younger than 6 years.

Tight glycemic control is essential for the normal growth and development of preschool children. The aim of our study was to evaluate the impact of advanced hybrid closed loop (AHCL) systems in a real-life setting in children younger than 6 years. We conducted a two-center prospective study. We enrolled 19 patients with a median age at disease onset of 2.6 years [interquartile range (IQR) 1.6; 4.4] and a median disease duration of 1.4 years (IQR 0.9; 2.8) who were switched to AHCL from multiple daily injections or open-loop insulin therapy and with a 6-month follow-up. Clinical data, sensor glycemic metrics, and pump settings were collected and analyzed. After 6 months of follow-up, there was a significant reduction in median HbA1c (p = 0.0007) and glucose management indicator (p = 0.03). A reduction in both mild (>180 mg/dL) (p = 0.04) and severe (>250 mg/dL) (p = 0.01) hyperglycemia was observed after 1 month of auto mode, and in mild hyperglycemia, it persisted up to 6 months (p = 0.02). A small increase in time below range (<70 mg/dL) was observed (p = 0.04) without a significant difference in time <54 mg/dL (p = 0.73). Time in range increased significantly, reaching a 10% increment (p = 0.03) compared with baseline. A significant reduction in the average sensor glucose was observed (p = 0.01) while coefficient of glucose variability (CV%) remained stable (p = 0.12). No episodes of ketoacidosis or severe hypoglycemia have been recorded. AHCL systems are effective and safe for children younger than 6 years and should be considered as a valid therapeutic option from diabetes onset.

Cross-sectional association of continuous glucose monitoring-derived metrics with cerebral small vessel disease in older adults with type 2 diabetes.

To examine cross-sectional associations between continuous glucose monitoring (CGM)-derived metrics and cerebral small vessel disease (SVD) in older adults with type 2 diabetes. In total, 80 patients with type 2 diabetes aged ≥70 years were analysed. Participants underwent CGM for 14 days. From the CGM data, we derived mean sensor glucose, percentage glucose coefficient of variation, mean amplitude of glucose excursion, time in range (TIR, 70-180 mg/dl), time above range (TAR) and time below range metrics, glycaemia risk index and high/low blood glucose index. The presence of cerebral SVD, including lacunes, microbleeds, enlarged perivascular spaces and white matter hyperintensities, was assessed, and the total number of these findings comprised the total cerebral SVD score (0-4). Ordinal logistic regression analyses were performed to examine the association of CGM-derived metrics with the total SVD score. The median SVD score was 1 (interquartile range 0-2). Higher hyperglycaemic metrics, including mean sensor glucose, TAR >180 mg/dl, TAR >250 mg/dl, and high blood glucose index and glycaemia risk index, were associated with a higher total SVD score. In contrast, a higher TIR (per 10% increase) was associated with a lower total SVD score (odds ratio 0.73, 95% confidence interval 0.56-0.95). Glycated haemoglobin, percentage glucose coefficient of variation, mean amplitude of glucose excursions, time below range and low blood glucose index were not associated with total cerebral SVD scores. The hyperglycaemia metrics and TIR, derived from CGM, were associated with cerebral SVD in older adults with type 2 diabetes.

Automated insulin delivery in children with type 1 diabetes during physical activity: a meta-analysis.

The aim of this study was to evaluate the performance of the automated insulin delivery (AID) in adolescents, and children with type 1 diabetes (T1D) during physical activity. Relevant studies were searched electronically inthe Cochrane Library, PubMed, and Embase utilizing the key words "Child", "Insulin Infusion Systems", and "Diabetes Mellitus" from inception to 17th March 2024 to evaluate the performance of the AID in adolescents, and children with T1D during physical activity. Twelve studies involving 514 patients were identified. AID did not show a beneficial effect on duration of hypoglycemia<70 mg/dL during study period (p>0.05; I2=96 %) and during the physical activity (p>0.99). Percentage of sensor glucose values in TIR was higher in AID than the non-AID pumps during study period (p<0.001; I2=94 %). The duration of hyperglycemic time was significantly decreased in AID group compared to the non-AID pumps group during study period (p<0.05; I2>50 %). AID improved TIR and decreased the duration of hyperglycemic time, but did not appear to have a significant beneficial effect on the already low post-exercise duration of hypoglycemia achievable by open loop or sensor-augmented pumps in adolescents and children with T1D during physical activity; further research is needed to confirm the beneficial effect of AID on duration of hypoglycemia.

The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT

Background We assessed whether a sustained period of intensive glucose control with hybrid closed-loop for 12 months following diagnosis of type 1 diabetes in children and adolescents can preserve C-peptide secretion compared to standard insulin therapy. Methods In an open-label, multicentre, randomised, parallel trial, youth aged 10–16.9 years were randomised within 21 days of type 1 diabetes diagnosis to hybrid closed-loop or standard insulin therapy (control). Primary end point was the difference in mixed-meal C-peptide area under the curve 12 months post diagnosis. Key secondary end points included time spent in target glucose range, glycated haemoglobin and time spent below target glucose range at 12 months. Analysis was by intention to treat. The Closed Loop from Onset in Type 1 Diabetes consortium secured external funding for participants to continue on beyond 12 months, but the funding by National Institute for Health and Care Research and the results reported here refer only to the 12 months follow-up. Results We randomised 97 participants (mean ± standard deviation age 12 ± 2 years), 51 to closed-loop and 46 to control therapy. There was no difference in C-peptide area under the curve at 12 months between groups [geometric mean (interquartile range) closed-loop (n = 46): 0.35 pmol/ml (0.16, 0.49) vs. control (n = 37): 0.46 pmol/ml (0.22, 0.69); mean adjusted difference –0.06 (95% confidence interval –0.14 to 0.03); p = 0.19]. The proportion of time in target range 3.9–10.0 mmol/l based on 14-day masked LibrePro (Abbott Diabetes Care, Maidenhead, UK) sensor glucose data at 12 months was 10 percentage points (95% confidence interval 2 to 17) higher in the closed-loop group (64 ± 14%) compared to control group (54 ± 23%). Arithmetic mean glycated haemoglobin A1c was lower in the closed-loop group by 4 mmol/mol (0.4%) [95% confidence interval 0 to 8 mmol/mol (0.0% to 0.7%)] at 12 months. The mean difference in time spent &lt; 3.9 mmol/l between groups was 0.9 percentage points (95% confidence interval –1.0 to 2.8). Three severe hypoglycaemic events occurred in the closed-loop group (two participants), and one in the control group; one diabetic ketoacidosis occurred in the closed-loop group. Conclusions A sustained period of hybrid closed-loop glucose control following diagnosis of type 1 diabetes in children and adolescents does not slow down the decline in residual C-peptide secretion compared with standard insulin therapy. Despite the lack of effect on C-peptide, glycaemic control was sustained in the closed-loop group, whereas glycaemic control deteriorated in the control group 6 to 9 months after diagnosis and closed-loop safely accommodated the variability in exogenous insulin requirements which occur with beta-cell recovery post diagnosis. Limitations of the study included no central measurement of auto-antibodies at diagnosis. There was imbalance in the rate of diabetic ketoacidosis at diagnosis which is associated with a more rapid decline in C-peptide secretion, but this was adjusted for in the analyses. This highlights the need for improved therapies to allow youth to achieve recommended glycaemic targets from onset of type 1 diabetes irrespective of the lack of effect on residual C-peptide secretion. Future work includes ongoing follow-up of the study population for up to 4 years after diagnosis to observe how any differences in glycaemic control between treatment groups develop over time. Trial registration This trial is registered as Clinicaltrials.gov NCT02871089. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 14/23/09), the Helmsley Trust (2016PG-T1D045 and 2016PG-T1D046), and JDRF (22-2013-266 and 2-RSC-2019-828-M-N), and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 8. See the NIHR Funding and Awards website for further award information. Additional support for the artificial pancreas work was from the NIHR Cambridge Biomedical Research Centre and NIHR Oxford Biomedical Research Centre. Abbott Diabetes Care supplied free glucose monitoring devices, and Dexcom supplied discounted continuous glucose monitoring devices. Medtronic supplied discounted insulin pumps, phone enclosures, continuous glucose monitoring devices, and pump consumables.

Impact of macronutrients intake on glycemic homeostasis of preterm infants: evidence from continuous glucose monitoring

Nutritional intake could influence the blood glucose profile during early life of preterm infants. We investigated the impact of macronutrient intake on glycemic homeostasis using continuous glucose monitoring (CGM). We analyzed macronutrient intake in infants born ≤ 32 weeks gestational age (GA) and/or with birth weight ≤ 1500 g. CGM was started within 48 h of birth and maintained for 5 days. Mild and severe hypoglycemia were defined as sensor glucose (SG) < 72 mg/dL and <47 mg/dL, respectively, while mild and severe hyperglycemia were SG > 144 mg/dL and >180 mg/dL. Data from 30 participants were included (age 29.9 weeks (29.1; 31.2), birthweight 1230.5 g (1040.0; 1458.6)). A reduced time in mild hypoglycemia was associated to higher amino acids intake (p = 0.011) while increased exposure to hyperglycemia was observed in the presence of higher lipids intake (p = 0.031). The birthweight was the strongest predictor of neonatal glucose profile with an inverse relationship between the time spent in hyperglycemia and birthweight (p = 0.007). Conclusions: Macronutrient intakes influence neonatal glucose profile as described by continuous glucose monitoring. CGM might contribute to adjust nutritional intakes in preterm infants.What is Known:• Parenteral nutrition may affect glucose profile during the first days of life of preterm infants.What is New:• Continuous glucose monitoring describes the relationship between daily parenteral nutrient intakes and time spent in hypo and hyperglycemic ranges.

Associations Between HbA1c and Glucose Time in Range Using Continuous Glucose Monitoring in Type 1 Diabetes: Cross-Sectional Population-Based Study.

Continuous glucose monitoring (CGM) introduces novel indicators of glycemic control. This cross-sectional study, based on the Swedish National Diabetes Register, examines 27,980 adults with type 1 diabetes. It explores the relationships between HbA1c (glycated hemoglobin) and various CGM-derived metrics, including TIR (time in range, representing the percentage of time within the range of 4-10mmol/l for 2weeks), TAR (time above range), TBR (time below range), mean glucose, standard deviation (SD), and coefficient of variation (CV). Pearson correlation coefficients and linear regression models were utilized for estimation. The analysis included 46% women, 30% on insulin pump, 7% with previous coronary heart disease and 64% with retinopathy. Mean ± SD values were age 48 ± 18years, diabetes duration 25 ± 16years, HbA1c 58.8 ± 12.8mmol/mol, TIR 58.8 ± 19.0%, TAR 36.3 ± 20.0%, TBR 4.7 ± 5.4%, mean sensor glucose 9.2 ± 2.0mmol/l, SD 3.3 ± 1.0mmol/l, and CV 36 ± 7%. The overall association between HbA1c and TIR was -0.71 (Pearson's r), with R2 0.51 in crude linear regression and 0.57 in an adjusted model. R2values between HbA1c and CGM mean glucose were 0.605 (unadjusted) 0.619 (adjusted) and TAR (unadjusted 0.554 and fully adjusted 0.568, respectively), while fully adjusted R2values were 0.458, 0.175 and 0.101 between HbA1c and CGM SD, CGM CV and TBR, respectively. This descriptive study demonstrates that the degree of association between HbA1c and new and readily available CGM-derived metrics, i.e., time in range (TIR), time above range (TAR), and CGM mean glucose, is robust in assessing the management of individuals with type 1 diabetes in clinical settings. Metrics from CGM that pertain to variability and hypoglycemia exhibit only weak correlations with HbA1c.

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

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. 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. 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. 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.

Impact of early-morning administration of rapid-acting insulin on the increase in blood glucose levels related to the dawn phenomenon in individuals with type 1 diabetes.

An early-morning elevation of blood glucose levels known as the dawn phenomenon and consequent postbreakfast hyperglycemia occur in some individuals with type 1 diabetes (T1D). Whereas insulin pump therapy can mitigate this phenomenon, some individuals prefer or are limited to alternative treatments. We have now assessed the effectiveness of early-morning administration of rapid-acting insulin for amelioration of the dawn phenomenon in individuals with T1D. Thirteen individuals with T1D who experienced the dawn phenomenon as determined by continuous glucose monitoring (CGM) and who received a small dose of rapid-acting insulin on waking were included in this retrospective study. We evaluated the change in sensor glucose levels during a 2-h period from before to after breakfast consumed at 0700h. The change in blood glucose levels during additional time intervals, average daily sensor glucose values, CGM indices, and insulin dose were also evaluated. The early-morning administration of 0.5-1 unit of rapid-acting insulin was associated with a significant reduction in 2-h glucose variability between before (0700h) and after breakfast from a median of 90.7-51.0mg/dL. The glucose variability from 0300 to 0700 or 0900h was also significantly decreased, from 67.7 to 29.0mg/dL and from 172.5 to 78.3mg/dL, respectively. Average sensor glucose levels throughout the day were significantly reduced (from 192.7 to 156.7mg/dL), as was the daily total insulin dose. Early-morning administration of rapid-acting insulin effectively managed the dawn phenomenon and subsequent postbreakfast hyperglycemia in individuals with T1D. The online version contains supplementary material available at 10.1007/s13340-024-00709-6.

During an 18-month course of automated insulin delivery treatment, children aged 2 to 6 years achieve and maintain a higher time in tight range.

To investigate whether the positive effects on glycaemic outcomes of 3-month automated insulin delivery (AID) achieved in 2- to 6-year-old children endure over an extended duration and how AID treatment affects time in tight range (TITR), defined as 3.9-7.8 mmol/L. We analysed 18 months of follow-up data from a non-randomized, prospective, single-arm clinical trial (n = 35) conducted between 2021 and 2023. The main outcome measures were changes in time in range (TIR), glycated haemoglobin (HbA1c), time above range (TAR), TITR, and mean sensor glucose (SG) value during follow-up visits (at 0, 6, 12 and 18 months). The MiniMed 780G AID system in SmartGuard Mode was used for 18 months. Parental diabetes distress was evaluated at 3 and 18 months with the validated Problem Areas in Diabetes-Parent, revised (PAID-PR) survey. Between 0 and 6 months, TIR and TITR increased, and HbA1c, mean SG value and TAR decreased significantly (p < 0.001); the favourable effect persisted through 18 months of follow-up. Between 3 and 18 months, PAID-PR score declined significantly (0 months: mean score 37.5; 3 months: mean score 28.6 [p = 0.06]; 18 months: mean score 24.6 [p < 0.001]). Treatment with AID significantly increased TITR and TIR in young children. The positive effect of AID on glycaemic control observed after 6 months persisted throughout the 18 months of follow-up. Similarly, parental diabetes distress remained reduced during 18 months follow-up. These findings are reassuring and suggest that AID treatment improves glycaemic control and reduces parental diabetes distress in young children over an extended 18-month follow-up.

Randomized Trial of Assisted Hybrid Closed-Loop Therapy Versus Sensor-Augmented Pump Therapy in Pregnancy.

Objective: Examine gestational safety, glycemic and health outcomes, of a hybrid closed-loop (HCL) system without pregnancy-specific glucose targets. Research Design: This was a pilot feasibility investigator-initiated, two-site, single-blind, randomized controlled trial of sensor-augmented pump therapy (SAPT) versus HCL therapy in type 1 diabetes pregnancies. Participants were enrolled in the first trimester and randomized at 14-18 weeks of gestation and used SAPT or HCL until 4-6 weeks postpartum. We compared continuous glucose monitoring (CGM) metrics, severe hypoglycemia (SH), diabetic ketoacidosis (DKA), adverse skin reactions, and pregnancy outcomes between groups. Results: Baseline characteristics were similar between groups (n = 11 HCL and n = 12 SAPT). There was no SH or DKA episode after randomization. Time spent <54 mg/dL did not differ between groups. Time spent <63 mg/dL decreased in both groups, significantly in the HCL group (3.5% [1.3% standard error] second trimester and 2.8% [1.3%] third trimester vs. 7.9% [1.3%] run-in phase, P < 0.05 for both). Mean sensor glucose was lower with SAPT compared to HCL therapy in the third trimester (119 [4] mg/dL SAPT vs. 132 [4] mg/dL HCL, P < 0.05). Third trimester time-in-range (TIR; 63-140 mg/dL) increased with SAPT (68.2% [3.1%] vs. 64.3% [3.1%] run-in phase, P < 0.05). Gestational health outcomes did not differ between groups. The HCL group used assistive techniques, such as fake carbohydrate boluses and exiting HCL overnight. Conclusions: CGM within group differences were seen for time <63 mg/dL favoring HCL therapy and TIR favoring SAPT (third trimester vs. baseline). Safety and adverse pregnancy outcomes were similar between groups.

Assessment of the Impact of Subcutaneous Catheter Change on Glucose Control in Patients with Type 1 Diabetes Treated by Insulin Pump in Open- and Closed-Loop Modes.

Introduction: Most continuous subcutaneous insulin infusion (CSII) catheters (KT) are changed every 3 days. This study aims at evaluating whether KT changes impact glucose control while under open-loop (OL) or automated insulin delivery (AID) modes. Methods: We included patients with type 1 diabetes who used Tandem t:slim x2 insulin pump and Dexcom G6 glucose sensor for 20 days in OL, then as AID. CSII and sensor glucose data in OL and for the past 20 days of 3-month AID were retrospectively analyzed. The percentage of time spent with sensor glucose above 180 mg/dL (%TAR180) was compared between the calendar day of KT change (D0), the next day (D1), and 2 days later (D2). Values were adjusted for age, gender, body mass index (BMI), hemoglobin A1c (HbA1c) at inclusion, and %TAR180 for the 2 h before KT change. Results: A total of 1636 KT changes were analyzed in 134 patients: 72 women (54%), age: 35.6 ± 15.7 years, BMI: 25.2 ± 4.7 kg/m2, and HbA1c: 7.5 ± 0.8%. %TAR180 in the 2 h before the KT change was 51.3 ± 37.0% in OL and 33.2 ± 30.0% in AID mode. In OL, significant absolute increases of %TAR180 at D0 versus D1 (+6.9%; P < 0.0001) or versus D2 (+6.8%; P < 0.0001) were observed. In AID, significant absolute increases of %TA180R at D0 versus D1 (+4.8%; P < 0.0001) or versus D2 (+4.2%; P < 0.0001) were also observed. Conclusion: This study shows an increase in time spent in hyperglycemia on the day of the KT change both in OL and AID modes. This additional information should be taken into account to improve current AID algorithms. ClinicalTrials.gov: NCT04939766.

A Randomized Clinical Trial for Meal Bolus Decision Using Learning-based Control in Adults With Type 2 Diabetes.

We propose an artificial-pancreas-like algorithm (AP-A) that could automatically determine the preprandial insulin dose based on intermittently scanned continuous glucose monitoring (isCGM) data trajectories in multiple dose injection (MDI) therapy. We aim to determine whether preprandial insulin dose adjustments guided by the AP-A are as effective and safe as physician decisions. We performed a randomized, single-blind, clinical trial at a tertiary, referral hospital in Beijing, China. Type 2 diabetes participants were eligible if they were aged 18 years or older, with a glycated hemoglobin A1c of 8.0% or higher. Eligible participants were randomly assigned (1:1) to the AP-A arm supervised by physician and the conventional physician treatment arm. The primary objective was to compare percentage time spent with sensor glucose level in 3.9 to 10.0 mmol/L (TIR) between the 2 study arms. Safety was assessed by the percentage time spent with sensor glucose level below 3.0 mmol/L (TBR). A total of 140 participants were screened, of whom 119 were randomly assigned to the AP-A arm (n = 59) or physician arm (n = 60). The TIR achieved by the AP-A arm was statistically noninferior compared with the control arm (72.4% [63.3%-82.1%] vs 71.2% [54.9%-81.4%]), with a median difference of 1.33% (95% CI, -6.00 to 10.94, noninferiority margin -7.5%). TBR was also statistically noninferior between the AP-A and control arms (0.0% [0.0%-0.0%] vs 0.0% [0.0%-0.0%]), respectively; median difference (95% CI, 0.00% [0.00%-0.00%], noninferiority margin 2.0%). The AP-A-supported physician titration of preprandial insulin dosage offers noninferior glycemic control compared with optimal physician care in type 2 diabetes.

Reducing Diabetes Burden in Medtronic's Automated Insulin Delivery Systems.

Background: The MiniMed™ 780G advanced hybrid closed-loop system (MM780G) builds on the basal automation and low-glucose protection features of the MiniMed™ 670G and 770G systems. While previous publications have focused on glycemic control improvements with MM780G, burden reduction has not been fully described. Methods: Data from two 3-month pivotal trials for the MM670G with Guardian™ Sensor 3 (GS3) (104 adults; 125 children) and MM780G with Guardian™ 4 Sensor (G4S) (67 adults;109 children) were compared. Real-world data (RWD) from United States users (N = 3851) transitioning from MM770G+GS3 to MM780G+G4S were also analyzed. Analyses included a new metric for diabetes management burden (i.e., pentagon composite metric), glycemic outcomes and system burden (e.g., closed-loop exits and fingersticks per day). Results: Diabetes burden metric (-22.8% and -28.5%), time in range (+3.1% [*P = 0.035] and +6.4% [P < 0.001]) and time below range (-1.8% [*P < 0.001] and -0.7% [*P < 0.001]) significantly improved, compared to MM670G for adult and pediatric participants, respectively. The pediatric mean sensor glucose (SG) reduced by -8.6 mg/dL (*P < 0.001), while the adults' saw no change. Closed-loop use significantly increased for both cohorts (+17.1% [*P < 0.001] and +20.5% [*P < 0.001]). Closed-loop exits were significantly reduced to about 1 per week (-0.5 [*P < 0.001] and -0.7 [*P < 0.001]); fingerstick tests were also reduced (-6.2 [*P < 0.001] and -6.9 [*P < 0.001]). Similar outcomes were observed from U.S. RWD. Conclusions: MiniMed™ 780G with G4S use was associated with significant reduction in diabetes management burden with fewer closed-loop exits, fingersticks and other interactions, and improvements in glycemic control when compared to the MiniMed™ 670G with GS3.

Predictors of the effectiveness of isCGM usage in adults with type 1 diabetes mellitus: post-hoc analysis of the ISCHIA study.

The Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus (ISCHIA) study was a randomized, crossover trial that reported the decrease in time below range (TBR) by the use of intermittent-scanning continuous glucose monitoring (isCGM) combined with structured education in adults with type 1 diabetes (T1D) treated by multiple daily injections. The participants were instructed to perform frequent scanning of the isCGM sensor (10 times a day or more) and ingest sugar when impending hypoglycemia is suspected by tracking the sensor glucose levels and the trend arrow. We conducted post-hoc analysis to identify factors affecting difference in TBR (∆TBR), in time in range (∆TIR), and in time above range (∆TAR). Data from 93 participants who completed the ISCHIA study were used. Multiple regression analyses were performed to identify factors affecting CGM metrics. Pearson's correlation analysis showed the negative association between log-transformed scan frequency and with ∆TBR (r = -0.255, P = 0.015), while there was no significant association of log-transformed scan frequency with ∆TIR (r = 0.172, P = 0.102) and ∆TAR (r = 0.032, P = 0.761), respectively. The log-transformed scan frequency was an independent predictor of ∆TBR (Beta = -7.712, P = 0.022), but not of ∆TIR(Beta = 7.203, P = 0.091) and of ∆TAR (Beta = 0.514, P = 0.925). Our findings suggest that more frequent scanning of isCGM may be beneficial to reduce TBR in T1D adults.

Separable Microneedle for Integrated Hyperglycemia Sensing and Photothermal Responsive Metformin Release.

Microdevices that offer hyperglycemia monitoring and controllable drug delivery are urgently needed for daily diabetes management. Herein, a theranostic separable double-layer microneedle (DLMN) patch consisting of a swellable GelMA supporting base layer for glycemia sensing and a phase-change material (PCM) arrowhead layer for hyperglycemia regulation has been fabricated. The Cu-TCPP(Fe)/glucose oxidase composite and 3,3',5,5'-tetramethylbenzidine coembedded in the supporting base layer permit a visible color shift at the base surface in the presence of glucose via a cascade reaction, allowing for the in situ detection of glucose in interstitial fluid. The PCM arrowhead layer is encapsulated with water monodispersity melanin nanoparticles from Sepia officinalis and metformin that is imparted with a near-infrared ray photothermal response feature, which is beneficial to the controllable release of metformin for suppression of hyperglycemia. By applying the DLMN patch to the streptozotocin-induced type 2 diabetic Sprague-Dawley rat model, the results demonstrated that it can effectively extract dermal interstitial fluid, read out glucose levels, and regulate hyperglycemia. This DLMN-integrated portable colorimetric sensor and self-regulated glucose level hold great promise for daily diabetes management.

Study protocol for a randomised open-label clinical trial examining the safety and efficacy of the Android Artificial Pancreas System (AAPS) with advanced bolus-free features in adults with type 1 diabetes: the ‘CLOSE IT’ (Closed Loop Open SourcE In Type 1 diabetes) trial

IntroductionMultiple automated insulin delivery (AID) systems have become commercially available following randomised controlled trials demonstrating benefits in people with type 1 diabetes (T1D). However, their real-world utility may be undermined...

Tandem T:Slim X2 Insulin Pump Use in Clinical Practice Among Pregnant Individuals With Type 1 Diabetes: A Retrospective Observational Cohort Study.

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. 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. 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). 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.

Quickest detection of bias injection attacks on the glucose sensor in the artificial pancreas under meal disturbances

Modern glucose sensors deployed in closed-loop insulin delivery systems, so-called artificial pancreas use wireless communication channels. While this allows a flexible system design, it also introduces vulnerability to cyberattacks. Timely detection and mitigation of attacks are imperative for device safety. However, large unknown meal disturbances are a crucial challenge in determining whether the sensor has been compromised or the sensor glucose trajectories are normal. We address this issue from a control-theoretic security perspective. In particular, a time-varying Kalman filter is employed to handle the sporadic meal intakes. The filter prediction error is then statistically evaluated to detect anomalies if present. We compare two state-of-the-art online anomaly detection algorithms, namely the χ2 and CUSUM tests. We establish a robust optimal detection rule for unknown bias injections. Even if the optimality holds only for the restrictive case of constant bias injections, we show that the proposed model-based anomaly detection scheme is also effective for generic non-stealthy sensor deception attacks through numerical simulations.

Difference in the accuracy of the third-generation algorithm and the first-generation algorithm of FreeStyle Libre continuous glucose monitoring device.

FreeStyle Libre uses the algorithm to calculate the sensor glucose (SG) levels. The manufacturer announced that they had changed the algorithm from the first generation (Gen. 1) to the third generation (Gen. 3). To assess the difference, we conducted an observational study to analyze the characteristics of the measurements by these two algorithms compared to the capillary blood glucose (BG) levels. Participants with type 1 diabetes wore two FreeStyle Libre sensors, one on the left arm used with Gen. 3 algorithm, and another on the right arm used in combination with the FreeStyle Libre Reader with Gen. 1 algorithm. Data were collected from 11 participants. The Bland-Altman analysis of the measurements by Gen. 3 algorithm showed bias of 7.4 mg/dl and no proportional bias was observed (r=0.130). In contrast, the Bland-Altman analysis of the measurements by Gen. 1 algorithm showed bias of 4.4 mg/dl and proportional bias was observed (r=0.424). The MARD of Gen. 3 algorithm and Gen. 1 algorithm was 11.9±9.0% and 9.7±8.3%, respectively (P=0.053). No proportional bias in the measurements by Gen. 3 algorithm was observed, but in those by Gen. 1 algorithm. J. Med. Invest. 71 : 225-231, August, 2024.