Intermittently Scanned Continuous Glucose Monitoring Research Articles

Cost-effective analysis focused on hypoglycemia of intermittent-scanning continuous glucose monitoring in type 1 diabetes adults: a ISCHIA randomized clinical trial

Cost-effective analysis focused on hypoglycemia of intermittent-scanning continuous glucose monitoring in type 1 diabetes adults: a ISCHIA randomized clinical trial

Differences Between Glycated Hemoglobin and Glucose Management Indicator in Real-Time and Intermittent Scanning Continuous Glucose Monitoring in Adults With Type 1 Diabetes.

This study demonstrates the difference between glucose management indicator (GMI) and glycated hemoglobin (HbA1c) according to sensor mean glucose and HbA1c status using 2 continuous glucose monitoring (CGM) sensors in people with type 1 diabetes. A total of 275 subjects (117 Dexcom G6 [G6] and 158 FreeStyle Libre 1 [FL]) with type 1 diabetes was included. The G6 and FL sensors were used, respectively, over 90 days to analyze 682 and 515 glycemic profiles that coincide with HbA1c. The mean HbA1c was 6.6% in Dexcom G6 and 7.2% in FL profiles. In G6 profiles, GMI was significantly higher than HbA1c irrespective of mean glucose (all P < .001, mean difference: 0.58% ± 0.49%). The GMI was significantly higher than the given HbA1c when HbA1c was below 8.0% (all P < .001). The discordance was the highest at 0.9% for lower HbA1c values (5.0%-5.9%). The proportion of discordance >0.5% improved from 60.1% to 30.9% when using the revised GMI equation in G6 profiles. In FL profile, the overall mean difference between GMI and HbA1c was 0 (P = .966). The GMI was significantly lower by 0.9% than HbA1c of 9.0% to 9.9% and higher by 0.5% in HbA1c of 5.0% to 5.9% (all P < .001). The GMI is overestimated in G6 users, particularly those with well-controlled diabetes, but the GMI and HbA1c discordance improved with a revised equation from the observed data. The FL profile showed greater discordance for lower HbA1c levels or higher HbA1c levels.

Effectiveness of the flash glucose monitoring system in preventing severe hypoglycemic episodes and in improving glucose metrics and quality of life in subjects with type 1 diabetes at high risk of acute diabetes complications

AimsTo assess the effectiveness of the intermittent-scanned continuous glucose monitoring (isCGM) system in preventing severe hypoglycemic episodes and in improving glucose parameters and quality of life.MethodsFour hundred T1D individuals were enrolled in a prospective real-word study with an intermittently scanned continuous glucose monitoring device during the 12-months follow-up. The primary endpoint was the incidence of severe hypoglycemic events.Results82% of subjects were naïve to the use of the device (group A) and 18% were already wearing the system (group B). The cumulative incidence of severe hypoglycemia (SH) at 12 months was 12.06 per 100 person-year (95% CI: 8.35–16.85) in group A and 10.14 (95% CI: 4.08–20.90) in group B without inter-group differences. In group A there was a significant decrease in SH at 12 months compared to 3 months period (p = 0.005). Time in glucose range significantly increased in both groups accompanied with a significant decrease in glucose variability. HbA1c showed a progressive significant time-dependent decrease in group A. The use of the device significantly improved the perceived quality of life.ConclusionThis study confirmed the effectiveness of the isCGM in reducing hypoglycemic risk without glucose deterioration, with potential benefits on adverse outcomes in T1D individuals.Trial registration: ClinicalTrials.gov registration no. NCT04060732.

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.

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 &lt; 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 European Cost-Utility Analysis of the MiniMed™ 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes.

Background: Advanced hybrid closed-loop (AHCL) automated insulin delivery systems are the most effective therapy in terms of assisting people with type 1 diabetes (T1D) to achieve glycemic targets; however, the cost can represent a barrier to uptake. In this study, a cost-utility analysis of the MiniMed™ 780G AHCL system (MM780G) versus intermittently scanned continuous glucose monitoring (is-CGM) plus multiple daily insulin injections (MDI) in people with T1D not achieving glycemic goals was performed across six European countries. Methods: Clinical input data were sourced from the ADAPT trial. Assuming a baseline HbA1c of 9.04%, HbA1c reductions of 1.54% for AHCL and 0.2% for is-CGM+MDI were modeled. The analyses were performed from a payer perspective over a time horizon of 40 years and an annual discount rate of 3% was applied. Results: Across all countries, the use of AHCL was projected to result in an incremental gain in quality-adjusted life expectancy of >2 quality-adjusted life years (QALYs) versus is-CGM+MDI. Lifetime direct costs were higher with AHCL resulting in incremental cost-utility ratios for AHCL versus is-CGM+MDI ranging from EUR 11,765 per QALY gained in Austria to EUR 43,963 per QALY gained in Italy. Conclusions: For people with T1D managed with is-CGM+MDI not achieving glycemic targets, initiation of the MM780G system was projected to improve long-term clinical outcomes; however, due to differences in health care costs between countries, the health economic outcomes differed. In all included countries, AHCL is likely to be cost-effective relative to is-CGM+MDI for people not achieving glycemic goals with is-CGM+MDI. The ADAPT trial is registered with ClinicalTrials.gov, NCT04235504.

Recovery of hypoglycemic confidence using intermittently scanned continuous glucose monitoring among adults with type 1 diabetes with level 3 hypoglycemia: A prospective, single-center, single-arm study

AimTo investigate whether the FreeStyle Libre, an intermittent scanning continuous glucose monitoring (isCGM) system, influences confidence in managing hypoglycemia in adults with type 1 diabetes. Materials and MethodsThis longitudinal, observational study conducted at one facility included 121 adults with type 1 diabetes. Participants used the conventional finger-prick method for self-testing glucose before using isCGM. At baseline and 12 months after initiating isCGM, the Hypoglycemic Confidence Scale (HCS), Diabetes Treatment Satisfaction Questionnaire (DTSQ), and HbA1c were performed. At 12 months, the percentage of individuals utilizing isCGM trend arrows for glucose management was observed. The primary endpoint was hypoglycemic confidence change attributed to using isCGM. ResultsAfter using isCGM, HCS scores improved significantly from 2.89 (2.56, 3.22) to 3.00 (2.20, 3.33) (p < 0.001); median (25%, 75%). Among participants with level 3 hypoglycemia at baseline, hypoglycemic confidence during sleep (p < 0.05), in social situations (p < 0.05), and in avoiding serious hypoglycemia-related problems (p < 0.05) were improved. Despite hypoglycemia risk, participants could continue daily activities by using isCGM (p < 0.05), and sixty-nine percent utilized trend arrows effectively. ConclusionUsing isCGM improved hypoglycemic confidence among adults with type 1 diabetes. Data analysis indicated that people with type 1 diabetes could live more freely and better manage hypoglycemia using isCGM.

Impact of glucose variability on the assessment of the glycemia risk index (GRI) and classic glycemic metrics

ObjectiveTo evaluate the impact of glucose variability on the relationship between the GRI and other glycemic metrics in a cohort of pediatric and adult patients with type 1 diabetes (T1D) using intermittent scanning continuous glucose monitoring (isCGM).MethodsWe performed a cross-sectional study of 202 patients with T1D under intensive insulin treatment (25.2% CSII) using isCGM. Clinical, metabolic, and glycemic metrics were collected, and the GRI was calculated with its hypoglycemia (CHypo) and hyperglycemia (CHyper) components. The correlation between the GRI and other classical glycometrics in relation to the coefficient of variation (CV) was evaluated.ResultsA total of 202 patients were included (53% male; 67.8% adults) with a mean age of 28.6 ± 15.7 years and 12.5 ± 10.9 years of T1D evolution (TIR 59.0 ± 17.0%; CV 39.8 ± 8.0%; GMI 7.3 ± 1.1%). The mean GRI was 54.0 ± 23.3 with a CHypo and CHyper component of 5.7 ± 4.8 and 23.4 ± 14.3, respectively. A strong negative correlation was observed between the GRI and TIR (R = −0.917; R2 = 0.840; p < 0.001), showing differences when dividing patients with low glycemic variability (CV < 36%) (R = −0.974; R2 = 0.948; p < 0.001) compared to those with greater CV instability (≥36%) (R = −0.885; R2 = 0.784; p < 0.001). The relationship of GRI with its two components was strongly positive with CHyper (R = 0.801; R2 = 0.641; p < 0.001) and moderately positive with CHypo (R = 0.398; R2 = 0.158; p < 0.001). When the GRI was evaluated with the rest of the classic glycemic metrics, a strong positive correlation was observed with HbA1c (R = 0.617; R2 = 0.380; p < 0.001), mean glucose (R = 0.677; R2 = 0.458; p < 0.001), glucose standard deviation (R = 0.778; R2 = 0.605; p < 0.001), TAR > 250 (R = 0.801; R2 = 0.641; p < 0.001), and TBR < 54 (R = 0.481; R2 = 0.231; p < 0.001).ConclusionsThe GRI correlated significantly with all the glycemic metrics analyzed, especially with the TIR. Glycemic variability (GV) significantly affected the correlation of the GRI with other parameters and should be taken into consideration.

Intermittent scanning continuous glucose monitoring is safe and useful in postsurgical glucose monitoring after pancreatoduodenectomy

AimsIntermittently scanned continuous glucose monitoring (isCGM) systems have not been thoroughly evaluated during in-hospital stay, and there are concerns about accuracy during various conditions. Patients undergoing pancreatoduodenectomy have an increased risk of hyperglycaemia after surgery which is aggravated by parenteral nutrition therapy. This study aims to evaluate glycaemic control and safety during insulin infusion in a surgical non-ICU ward, using a hybrid glucose monitoring approach with isCMG and periodic point-of-care (POC) testing.MethodsWe prospectively included 100 patients with a resectable pancreatic tumour. After surgery, continuous insulin infusion was initiated when POC glucose was > 7 mmol/l and titrated to maintain glucose between 7 and 10 mmol/l. Glucose was monitored with isCGM together with intermittent POC, every 3–6 h. Median absolute relative difference (MARD) and hypoglycaemic events were evaluated. Mean glucose was compared with a historic control (n = 100) treated with multiple subcutaneously insulin injections, monitored with POC only.ResultsThe intervention group (isCGM/POC) had significantly lower POC glucose compared with the historic control group (8.8 ± 2.2 vs. 10.4 ± 3.4 mmol/l, p < 0.001). MARD was 17.8% (IQR 10.2–26.7). isCGM readings were higher than POC measurements in 91% of the paired cases, and isCGM did not miss any hypoglycaemic event. About 4.5% of all isCGM readings were < 3.9 mmol/l, but only six events were confirmed with POC, and none was < 3.0 mmol/l.ConclusionsA hybrid approach with isCGM/POC is a safe and effective treatment option in a non-ICU setting after pancreatoduodenectomy.

738-P: Lifestyle Intervention Program with Smartphone App Augmented by Intermittently Scanned Continuous Glucose Monitoring for People at High Risk of Diabetes—Randomized Controlled Trial

We examined the effects of a lifestyle intervention program with a smartphone app augmented by intermittently scanned continuous glucose monitoring (isCGM) of persons at high risk of developing diabetes in a 12-week randomized open-label trial (UMIN00004640). The program monitored blood glucose fluctuations and lifestyle habits and displayed them in an easy-to-understand interface as well as provided personalized lifestyle intervention messages. The primary endpoint was the change in time in range (TIR) of 70-140 mg/dL between intervention (App) and control (C) groups. Among 168 patients (mean age 48.1 y, mean BMI 26.6 kg/m2, and male 80.4%), 82 and 86 were assigned to the App group and C group, respectively. After 12 weeks, TIR of 70-140 mg/dL significantly improved in the App group compared to the C group (-2.6 min/day vs. +31.5 min/day, p=0.03). Changes in time above range (&amp;gt;140 mg/dL; -20.9 min/day vs. -22.6 min/day, p=0.86) did not differ, whereas time below range (&amp;lt;70 mg/dL; +23.5 min/day vs. -8.9 min/day, p=0.02) improved in App compared to C. BMI (-0.26 vs. -0.59, p=0.017) and carbohydrate intake (-4.4 kcal/day vs. -22.7 kcal/day, p=0.049) also improved in App compared to C. Intervention with a smartphone app and isCGM increased glycemic control with a decrease in carbohydrate intake and weight loss. Disclosure M.Kitazawa: None. H.Sone: Research Support; Novo Nordisk, Astellas Pharma Inc., Kyowa Kirin Co., Ltd., Taisho Pharmaceutical Holdings Co., Ltd., Ono Pharmaceutical Co., Ltd., Eisai Co., Ltd., Takeda Pharmaceutical Co., Ltd. H.Suzuki: None. C.Horikawa: None. Y.Takeda: None. I.Ikeda: None. M.Hatta: None. M.Iwanaga: None. T.Yamada: None. K.Fujihara: None.

142-LB: Cost-Effectiveness of Real-Time Continuous Glucose Monitoring (rt-CGM) vs. Intermittent-Scanning Continuous Glucose Monitoring (is-CGM) in Patients with Type 2 Diabetes on Multiple Daily Injections of Insulin (T2D MDI) in Canada

Rt-CGM systems provide real-time glucose values, hypo- and hyperglycemia alerts, and predictive “urgent low soon” alerts that have been shown to improve glycemic outcomes and reduce severe hypoglycemic events (SHEs) in patients with T2D, without the need for periodic scanning. The economic value of rt-CGM vs is-CGM is unknown for patients with T2D MDI in Canada. We conducted a cost-effectiveness analysis comparing the two systems for this patient population using the INESSS Canadian payer perspective. ­ A 30-year analysis was performed using the validated ECHO-T2DM. Patient characteristics were sourced from Karter (2021). Efficacy and safety were derived from the DIAMOND T2D and REPLACE RCTs. The HbA1c difference of -0.33 (favoring rt-CGM) was derived using Bucher's adjusted indirect comparison, SHE rates were 0.014 and 0 Per Person-Year (PPY) for is-CGM and rt-CGM, respectively, and severe hyperglycemia/DKA rates were proxied by the difference in time above range (0.0313 and 0 PPY, respectively). Costs and disutility weights were sourced from published Canadian literature and discounted at 1.5% annually. A reduction in fear of hypoglycemia (FOH) utility was sourced from the ALERTT1 RCT. Sensitivity analyses were performed. Rt-CGM was associated with quality-adjusted life year gains of 0.346 and incremental costs of CAD 5,737, with an incremental cost-effectiveness ratio (ICER) of CAD 16,598. No DKA events for is-CGM and a 50% reduction in FOH utility increased the ICERs to CAD 30,987 and CAD 29,116, respectively. ICER was CAD 2,278 when both CGM costs were reduced by 50% and rt-CGM became cost-saving (dominant) at a 65% reduction. These results suggest rt-CGM is cost-effective vs is-CGM in patients with T2D MDI in Canada. These findings can inform government and commercial healthcare decision-makers when considering reimbursement of CGM systems. Disclosure H. Alshannaq: Employee; Dexcom, Inc., Other Relationship; Vertex Pharmaceuticals Incorporated. G. J. Norman: Employee; Dexcom, Inc. M. Willis: None. A. Nilsson: None. Funding Dexcom, Inc.

141-LB: Cost-Effectiveness of Real-Time Continuous Glucose Monitoring (rt-CGM) vs. Intermittent-Scanning Continuous Glucose Monitoring (is-CGM) from a U.S. Payer Perspective in Patients with Type 2 Diabetes on Multiple Daily Injections of Insulin (PwT2D on MDI)

Diabetes management for PwT2D on MDI requires access to timely glucose readings to inform treatment decisions and avoid acute events like severe hypoglycemia (SHE) and Diabetic Ketoacidosis (DKA). CGM systems have different features that can impact glycemic outcomes and disease complications and costs. There is a gap in the literature on the cost-effectiveness of rt-CGM vs is-CGM systems. We conducted lifetime projections of disease outcomes and costs from a US payer perspective using the IQVIA Core Diabetes Model v9.5+. Cohort characteristics and clinical inputs were sourced from the DIAMOND T2D and REPLACE RCTs. Applying Bucher's adjusted indirect comparison method resulted in an HbA1c effect of -0.33 favoring rt-CGM, SHE incidence rates of 0.014 and 0 Per Person-Year (PPY) for is-CGM and rt-CGM, respectively, and DKA rates were estimated using Time-Above-Range (0.0313 and 0 PPY, respectively). The cost of both CGM systems is based on Medicare pricing and 80% reimbursement (HCPCS code A4239). A utility for fear of hypoglycemia (FoH) reduction was applied from the ALERTT1 RCT. The model associates rt-CGM use with reduced eye (-5.64%), renal (-7.42%), neural (-4.08%), and cardiovascular (-2.56%) complications compared to is-CGM. It projects rt-CGM users to have higher quality-adjusted life years (QALYs) by 0.454 with cost savings of -$1,355, and an incremental cost-effectiveness ratio of -$2,983/QALY. Rt-CGM remained cost-effective under the $50,000 willingness-to-pay threshold even when its cost was increased by 70% (+$1,713). Scenario analysis with 50% lower FoH utility, SHE, and DKA rates reduced QALYs gained to 0.264. Our analysis suggests that rt-CGM is cost-saving and cost-effective vs is-CGM in PwT2D on MDI in the US and can inform US payers of the economic value of different CGM systems. Disclosure H. Alshannaq: Employee; Dexcom, Inc., Other Relationship; Vertex Pharmaceuticals Incorporated. G. J. Norman: Employee; Dexcom, Inc. P. M. Lynch: Employee; Dexcom, Inc., Stock/Shareholder; Dexcom, Inc.

Prevention of hypoglycemia by intermittent-scanning continuous glucose monitoring device combined with structured education in patients with type 1 diabetes mellitus: A randomized, crossover trial

AimsWe conducted a randomized, crossover trial to compare intermittent-scanning continuous glucose monitoring (isCGM) device with structured education (Intervention) to self-monitoring of blood glucose (SMBG) (Control) in the reduction of time below range. MethodsThis crossover trial involved 104 adults with type 1 diabetes mellitus (T1DM) using multiple daily injections. Participants were randomly allocated to either sequence Intervention/Control or sequence Control/Intervention. During the Intervention period which lasted 84 days, participants used the first-generation FreeStyle Libre (Abbott Diabetes Care, Alameda, CA, USA) and received structured education on how to prevent hypoglycemia based on the trend arrow and by frequent sensor scanning (≥10 times a day). Confirmatory SMBG was conducted before dosing insulin. The Control period lasted 84 days. The primary endpoint was the decrease in the time below range (TBR; <70 mg/dL). ResultsThe time below range was significantly reduced in the Intervention arm compared to the Control arm (2.42 ± 1.68 h/day [10.1 %±7.0 %] vs 3.10 ± 2.28 h/day [12.9 %±9.5 %], P = 0.012). The ratio of high-risk participants with low blood glucose index >5 was significantly reduced (8.6 % vs 23.7 %, P < 0.001). ConclusionsThe use of isCGM combined with structured education significantly reduced the time below range in patients with T1DM.

The Impact of Baseline User Characteristics on the Benefits of Real-Time Versus Intermittently Scanned Continuous Glucose Monitoring in Adults With Type 1 Diabetes: Moderator Analyses of the ALERTT1 Trial.

ALERTT1 showed that switching from intermittently scanned continuous glucose monitoring (isCGM) without alerts to real-time CGM (rtCGM) with alert functionality improved time in range (TIR; 70-180 mg/dL), glycated hemoglobin (HbA1c), time <54 mg/dL, and Hypoglycemia Fear Survey version II worry subscale (HFS-worry) score after six months in adults with type 1 diabetes (T1D). Moderator analyses aimed to identify certain subgroups that would benefit more from switching to rtCGM than others. Post hoc analyses of ALERTT1 evaluated the impact of 14 baseline characteristics on the difference (delta) in mean TIR, HbA1c, time <54 mg/dL, and HFS-worry score at six months between rtCGM and isCGM. Therefore, the delta was allowed to depend on each of these variables by including interactions in the moderator analysis model. Analyses were performed separately for each variable; variables with P < .10 in the univariable analysis were combined into a single model. Univariable analyses showed no dependency of delta TIR, HbA1c, or time <54 mg/dL on variables other than CGM type. Only delta HFS-worry score depended on baseline HbA1c (P = .0059), indicating less worries with rtCGM in people with baseline HbA1c <6.5% or ≥8%. Given P < .10 for dependency of delta TIR on insulin therapy type (favoring multiple daily injections), baseline HbA1c, and baseline TIR, these variables were combined into a multivariable analysis; interactions were not statistically significant. Except for HFS-worry score, no interactions between 14 baseline characteristics and the six-month intervention effect of rtCGM on TIR, HbA1c, or time <54 mg/dL were observed, supporting the conclusion of ALERTT1 that switching from isCGM without alerts to rtCGM with alert functionality is beneficial for a wide range of people with T1D.

The Effects of Imeglimin on the Daily Glycemic Profile Evaluated by Intermittently Scanned Continuous Glucose Monitoring: Retrospective, Single-Center, Observational Study.

IntroductionImeglimin is a novel antidiabetic drug that amplifies glucose-stimulated insulin secretion (GSIS) and improves insulin sensitivity. Several randomized clinical studies have shown the efficacy of imeglimin for glycemic control in patients with type 2 diabetes (T2D). We aimed to evaluate the short-term effects and safety of imeglimin in terms of glycemic control, as assessed by intermittently scanned continuous glucose monitoring (isCGM).MethodsThis retrospective and observational study of 32 patients who were administered imeglimin in addition to existing treatment regimens was designed to evaluate glycemic profiles. The patients were monitored for more than 4 weeks, including the day of starting imeglimin. The changes in glycemic indices, including mean glucose level, coefficient of variation (CV), time in range (TIR) and time above range (TAR), before and after imeglimin administration were analyzed, and data on adverse effects were collected by interview.ResultsImeglimin administration significantly improved the mean values of glucose (from 159.0 ± 27.5 mg/dL to 141.7 ± 22.1 mg/dL; p < 0.001), TIR (from 67.9 ± 17.0% to 79.5 ± 13.3%; p < 0.001) and TAR (from 29.4 ± 17.5% to 17.9 ± 13.7%; p < 0.001) and tended to improve CV (from 29.0 ± 6.1 to 27.4 ± 5.58; p = 0.058). The curves of 24-h mean glucose level for all 32 subjects were shifted downward from the baseline after imeglimin administration. The high mean glucose level, high TAR, low TIR, low body mass index and low C-peptide were related to the efficacy of imeglimin for glycemic control. The main adverse effects were gastrointestinal disorders, and the incidence of hypoglycemia was increased in cases receiving a combination of imeglimin plus insulin or a glinide agent.ConclusionImeglimin clearly shifted the daily glucose profile into an appropriate range in Japanese T2D patients, indicating improvement of short-term glycemic control. Imeglimin is thought to be a promising therapeutic agent for T2D patients, especially those with a low insulin secretory capacity, which is a common phenotype in East-Asian subjects with glucose intolerance.

647-P: Improved Glycemic Control and Continuous Glucose Monitoring (CGM) Utilization: A Comparison of Real-Time CGM and Intermittent Scanning CGM

Evolution of CGM technology has equipped the market with different systems. This study compared two types of CGM devices, real-time (rt) CGM and intermittently scanned (is) CGM on clinical outcomes among persons with diabetes using intensive insulin therapy. A retrospective analysis was performed using Optum Clinformatics® Database comprised of administrative claims data. CGM naïve patients with type 1 or type 2 diabetes initiated rtCGM (Dexcom G6®) or isCGM (FreeStyle Libre®) between 8/1/2018 through 3/31/2020 (index date = earliest observed pharmacy claim) . Patients with continuous health plan enrollment 12-months pre and post index date, age ≥18 years, with ≥1 sensor pharmacy claim, with A1C lab values during baseline and follow up were included in the study. Outcomes were the proportion reaching a target A1C of &amp;lt; 7% and the change in number of severe hypoglycemia (SH) inpatient/ER visits. A total of 272 rtCGM (average age = 47.3 (sd = 13.1) years, 46.7% female) and 467 isCGM (average age = 50.9 (sd = 12.7) years, 37.5% female) patients on intensive insulin therapy met inclusion criteria. After adjusting for baseline, rtCGM users were nearly twice as likely, compared to isCGM users, to reach an A1C of &amp;lt; 7% (OR = 1.97, 95% CI, 1.32 to 2.95, p&amp;lt;0.01) . A significant reduction was found in SH events from 40 to 13 after rtCGM initiation (baseline mean = 0.15, sd=0.49; and follow up mean = 0.05, sd=0.23, p&amp;lt;0.01) . For isCGM users SH events reduced from 42 to 32 (mean = 0.09, sd=0.44; and follow up mean 0.07, sd=0.35, p=0.239) . Findings suggest CGM naïve patients benefit from rtCGM compared to isCGM through significantly greater numbers achieving A1C &amp;lt; 7%. Improved access to rtCGM should help more patients achieve optimal glycemic control and reduce health care encounters due to SH. Disclosure K.Hannah: Employee; Dexcom, Inc. P.Nemlekar: None. D.A.Price: Employee; Dexcom, Inc. G.J.Norman: Employee; Dexcom, Inc.

Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment: Does It Impact Time in Glucose Target and Treatment Preference? The QUEST Randomized Crossover Study.

ObjectiveTo compare glycemic control and treatment preference in children with type 1 diabetes (T1D) using sensor augmented pump (SAP) with predictive low glucose suspend (SmartGuard®) or pump with independent intermittent scanning continuous glucose monitoring (iscCGM, Freestyle libre ®).MethodsIn this open label, cross-over study, children 6 to 14 years of age, treated with insulin pump for at least 6 months, were randomized to insulin pump and iscCGM (A) or SAP with SmartGuard® (B) for 5 weeks followed by 5 additional weeks. The difference in percentages of time in glucose target (TIT), (3.9 – 8.0 mmol/l), <3 mmol/l, > 8 and 10 mmol/l, were analyzed using linear mixed models during the final week of each arm and were measured by blinded CGM (IPro2®).Results31 children (15 girls) finished the study. With sensor compliance > 60%, no difference in TIT was found, TIT: A 37.86%; 95% CI [33.21; 42.51]; B 37.20%; 95% CI [32.59; 41.82]; < 3 mmol/l A 2.27% 95% CI [0.71; 3.84] B 1.42% 95% CI [-0.13; 2.97]; > 8 mmol/l A 0.60% 95% CI [0.56, 0.67]; B 0.63% [0.56; 0.70]. One year after the study all participants were on CGM compared to 80.7% prior to the study, with a shift of 13/25 participants from iscCGM to SAP.ConclusionsIn this study, no significant difference in glycemic control was found whether treated with SAP (SmartGuard®) or pump with iscCGM. The decision of all families to continue with CGM after the study suggests a positive impact, with preference for SmartGuard®.Clinical Trial Registration[clinicaltrials.gov], identifier NCT03103867.

Effect of divergent continuous glucose monitoring technologies on glycaemic control in type 1 diabetes mellitus: A systematic review and meta-analysis of randomised controlled trials.

AimsWe aimed to conduct a systematic review and meta‐analysis of randomised controlled clinical trials (RCTs) assessing separately and together the effect of the three distinct categories of continuous glucose monitoring (CGM) systems (adjunctive, non‐adjunctive and intermittently‐scanned CGM [isCGM]), compared with traditional capillary glucose monitoring, on HbA1c and CGM metrics.MethodsPubMed, Web of Science, Scopus and Cochrane Central register of clinical trials were searched. Inclusion criteria were as follows: randomised controlled trials; participants with type 1 diabetes of any age and insulin regimen; investigating CGM and isCGM compared with traditional capillary glucose monitoring; and reporting glycaemic outcomes of HbA1c and/or time‐in‐range (TIR). Glycaemic outcomes were extracted post‐intervention and expressed as mean differences and 95%CIs between treatment and comparator groups. Results were pooled using a random‐effects meta‐analysis. Risk of bias was assessed using the Cochrane Rob2 tool.ResultsThis systematic review was conducted between January and April 2021; it included 22 RCTs (15 adjunctive, 5 non‐adjunctive, and 2 isCGM)). The overall analysis of the pooled three categories showed a statistically significant absolute improvement in HbA1c percentage points (mean difference (95% CI): −0.22% [−0.31 to −0.14], I 2 = 79%) for intervention compared with comparator and was strongest for adjunctive CGM (−0.26% [−0.36, −0.16]). Overall TIR (absolute change) increased by 5.4% (3.5 to 7.2), I 2 = 71% for CGM intervention compared with comparator and was strongest with non‐adjunctive CGM (6.0% [2.3, 9.7]).ConclusionsFor individuals with T1D, use of CGM was beneficial for impacting glycaemic outcomes including HbA1c, TIR and time‐below‐range (TBR). Glycaemic improvement appeared greater for TIR for newer non‐adjunctive CGM technology.

Real-World Use of Continuous Glucose Monitoring Systems Among Adolescents and Young Adults With Type 1 Diabetes: Reduced Burden, but Little Interest in Data Analysis.

Since 2016, German health insurance companies reimburse continuous glucose monitoring (CGM) systems for persons with insulin-dependent diabetes, leading to a tremendous increase of CGM use. This study assessed the use of CGM, the satisfaction with, and the data analysis behavior among young people. During a diabetes camp for young people from all over Germany, participants anonymously answered a questionnaire on their method of glucose monitoring, satisfaction and quality of CGM use, HbA1c, and diabetes distress (Problem Areas in Diabetes Scale [PAID]-5). A total of 308 participants (age 21.4 ± 3.5 years; 73% female; diabetes duration 10.1 ± 5.9 years) completed the questionnaire. Approximately, 25% used self-monitoring of blood glucose (SMBG), 46% intermittent-scanning continuous glucose monitoring (iscCGM), and 30% real-time continuous glucose monitoring (rtCGM). Mean HbA1c was slightly, but not significantly, higher among SMBG users compared with CGM users (8.0% ± 1.9% vs. 7.7% ± 1.4%; P = .791). Diabetes distress was not associated with the method of glucose monitoring (SMBG 5.6 vs. iscCGM 6.2 vs. rtCGM 6.5; P = .386). Overall, satisfaction with CGM use was very high; 98% of the CGM users reported better well-being with CGM compared with previous SMBG use. Only 19% of CGM users reported regular data analyses; their HbA1c was lower compared with other CGM users (7.2% ± 1.2% vs. 7.7% ± 1.4%; P = .039). In this large sample of young people, 75% were using a CGM system. Treatment satisfaction was very high, but CGM use was not associated with reduced diabetes distress or better glycemic control. However, young people who regularly analyzed their CGM data reported lower HbA1c levels.

Evaluation of Accuracy and Performance of isCGM Sensors during Experimentally Induced Glucose Excursions. Comment on Moser et al. Performance of the Intermittently Scanned Continuous Glucose Monitoring (isCGM) System during a High Oral Glucose Challenge in Adults with Type 1 Diabetes-A Prospective Secondary Outcome Analysis. Biosensors 2021, 11, 22.

A 2021 publication in Biosensors from Moser and colleagues [...].