rtCGM System Research Articles

Clinical application of real-time continuous glucose monitoring system during postoperative enteral nutrition therapy in esophageal cancer patients.

Enteral nutrition (EN) support therapy increases the risk of abnormal blood glucose (BG). The aim of this study is to evaluate the clinical value of a real-time continuous glucose monitoring (rt-CGM) system in BG monitoring during postoperative EN support therapy in patients with esophageal cancer. Patients without diabetes mellitus (DM) with esophageal cancer who planned to receive postoperative EN were enrolled. With the self-monitoring of BG value as the reference BG, the accuracy of rt-CGM was evaluated by the mean absolute relative difference (MARD) value, correlation efficient, agreement analysis, and Parkes and Clarke error grid plot. Finally, paired t tests were used to compare the differences in glucose fluctuations between EN and non-EN days and slow and fast days. The total MARD value of the rt-CGM system was 13.53%. There was a high correlation between interstitial glucose and fingertip capillary BG (consistency correlation efficient = 0.884 [95% confidence interval, 0.874-0.894]). Results of 15/15%, 20/20%, 30/30% agreement analysis were 58.51%, 84.71%, and 99.65%, respectively. The Parkes and Clarke error grid showed that the proportion of the A and B regions were 100% and 99.94%, respectively. The glucose fluctuations on EN days vs non-EN days and on fast days vs slow days were large, and the difference was statistically significant (P < 0.001). The rt-CGM system achieved clinical accuracy and can be used as a new option for glucose monitoring during postoperative EN therapy. The magnitude of glucose fluctuation during EN therapy remains large, even in the postoperative population without DM.

63-LB: Real-Time Continuous Glucose Monitoring (rtCGM) Is Associated with Improved Clinical and Psychosocial Health in People with Type 2 Diabetes on Basal Insulin (T2D-BI)

Background and Aims: Introduction of basal insulin (BI) can be an intimidating treatment escalation due to increased risk of hypoglycemia and weight gain for people with type 2 diabetes (T2D). There is growing evidence supporting the glycemic and quality of life benefits of rtCGM in T2D. We analyzed survey and rtCGM data for T2D-BI users of the Dexcom G6 rtCGM system to investigate the impact on sensor metrics, self-reported body weight, and psychosocial health. Methods: Three hundred T2D-BI Dexcom G6 users completed online surveys regarding their demographics and diabetes health. Participants’ sensor metrics were analyzed for duration of wear and glycemic changes from CGM initiation onwards (14-day time periods with ≥70% data available). Changes in variables were evaluated for clinical significance (weight loss ≥5%, transition to A1C &amp;lt;7%, ΔTIR ≥5%) and statistical significance (p&amp;lt;0.05 from paired t-tests). Results: Data from 150 CGM-naïve (prior to Dexcom G6 initiation) T2D-BI users were analyzed. Mean (IQR) age=60 years (53, 70), 45% female, 81% White, 50% reported annual household income &amp;lt;$75K. CGM duration was 11 months (4, 13). Body weight at baseline=235 pounds (190, 270), A1C=8.4% (7, 9.3), TIR= 69% (58, 86). Reported weight loss averaged 13 (-20, 0) pounds, A1C decrease averaged 1.6 (-2.5, 0) percentage points (both p&amp;lt;0.001) with no increase in hypoglycemia. Overall, 53 users experienced clinically significant weight loss (5% of total body weight), 48 improved their A1C to &amp;lt;7%, and 46 improved TIR by ≥ 5%. Participants reported healthier eating patterns, simplified diabetes management routines, and increased peace of mind using Dexcom G6. Conclusions: These real-world outcomes demonstrate clinically valuable improvements in T2D-BI on Dexcom G6 with respect to glycemic control, body weight, diabetes behaviors, and psychosocial health. Disclosure M. A. Crawford: Employee; Dexcom, Inc. C. Hicks: Employee; Dexcom, Inc. T. Zhou: Employee; Pfizer Inc. A. Kleinhanzl: Employee; Dexcom, Inc. H. Singh: Employee; Tandem Diabetes Care, Inc., Dexcom, Inc.

Utilising a Real-Time Continuous Glucose Monitor as Part of a Low Glycaemic Index and Load Diet and Determining Its Effect on Improving Dietary Intake, Body Composition and Metabolic Parameters of Overweight and Obese Young Adults: A Randomised Controlled Trial.

A randomised controlled trial to measure the effects of integrating real-time continuous glucose monitor (rtCGM) into a low glycaemic index (GI) and glycaemic load (GL) dietary intervention on dietary intake, body composition and specific metabolic parameters was carried out. A total of 40 overweight young adults [(means ± SD) age: 26.4 ± 5.3 years, BMI: 29.4 ± 4.7 kg/m2] were randomised into an intervention and control groups for a period of eight weeks. Both groups received nutrition education on low GI and GL foods. The intervention group also received an rtCGM system to monitor their glucose levels 24 h a day. While controlling for physical activities and GI and GL nutrition knowledge, the results indicated that the rtCGM system further improved body weight, BMI, fat mass, fasting plasma glucose, HbA1c, total cholesterol, HDL cholesterol and LDL cholesterol in the intervention group (p < 0.05). This trial unveils the robustness of the rtCGM where non-diabetic overweight and obese young adults can benefit from this device and utilise it as a management tool for overweight and obesity and a primary prevention tool for type 2 diabetes, as it provides real-time and personalised information on physiological changes.

134-OR: Cost-Effectiveness of a Real-Time Continuous Glucose Monitoring System vs. Self-Monitoring of Blood Glucose in Type 2 Diabetes Patients on Insulin in Canada

A health economic analysis was conducted to determine the cost-effectiveness of a real-time continuous glucose monitoring (rt-CGM) system versus self-monitoring of blood glucose (SMBG) in Type 2 diabetes (T2D) patients treated with insulin. The IQVIA CORE diabetes model was utilized for the analysis. Clinical data were sourced from a US retrospective cohort study of adult T2D patients on insulin and adapted to Canada. The baseline mean age (SD) of the cohort was 61 years (13.2) and proportion of male 49%. Mean baseline HbA1c for the cohort was 8.3% (67 mmol/mol) . Patients using rt-CGM were assumed to have a reduction in HbA1c of -0.56% based on the mean difference between groups after 12-months follow-up. A quality-of-life (QoL) benefit associated with reduced finger-stick testing was applied. The analysis was conducted from the Canadian Agency for Drugs and Technologies in Health perspective over a lifetime horizon. The rt-CGM system was associated with an incremental gain of 0.97 quality-adjusted life years (QALYs) compared with SMBG (mean [SD] 10.35 [3.08] versus 9.375 [2.85] QALYs) . Total mean [SD] lifetime costs were CAN$ 17,223 higher with rt-CGM (CAN$ 206,284 [121,493] versus 189,061 [129.680]) , resulting in an incremental cost-effectiveness ratio of CAN$ 17,652 per QALY gained. Sensitivity analyses demonstrated findings were sensitive to changes in QoL, HbA1c, younger patient cohorts, and rt-CGM cost. Varying rt-CGM cost to -25% of base case yielded an ICER of CAN$ 3,512, and varying rt-CGM cost to -50% of base case the ICER becomes dominant over SMBG. For T2D patients on insulin, rt-CGM was associated with significant clinical outcomes and is a cost-effective management option relative to SMBG based on a willingness-to-pay threshold of CAN$ 50,000 per QALY gained. Disclosure J.J.Isitt: Consultant; Dexcom, Inc. S.Roze: None. G.Cogswell: None. P.M.Lynch: Employee; Dexcom, Inc., Stock/Shareholder; Dexcom, Inc.

Practical implementation of remote continuous glucose monitoring in hospitalized patients with diabetes.

PurposeInpatient diabetes management involves frequent assessment of glucose levels for treatment decisions. Here we describe a program for inpatient real-time continuous glucose monitoring (rtCGM) at a community hospital and the accuracy of rtCGM-based glucose estimates.MethodsAdult inpatients with preexisting diabetes managed with intensive insulin therapy and a diagnosis of coronavirus disease 2019 (COVID-19) were monitored via rtCGM for safety. An rtCGM system transmitted glucose concentration and trending information at 5-minute intervals to nearby smartphones, which relayed the data to a centralized monitoring station. Hypoglycemia alerts were triggered by rtCGM values of ≤85 mg/dL, but rtCGM data were otherwise not used in management decisions; insulin dosing adjustments were based on blood glucose values measured via fingerstick blood sampling. Accuracy was evaluated retrospectively by comparing rtCGM values to contemporaneous point-of-care (POC) blood glucose values.ResultsA total of 238 pairs of rtCGM and POC data points from 10 patients showed an overall mean absolute relative difference (MARD) of 10.3%. Clarke error grid analysis showed 99.2% of points in the clinically acceptable range, and surveillance error grid analysis showed 89.1% of points in the lowest risk category. It was determined that for 25% of the rtCGM values, discordances in rtCGM and POC values would likely have resulted in different insulin doses. Insulin dose recommendations based on rtCGM values differed by 1 to 3 units from POC-based recommendations.ConclusionrtCGM for inpatient diabetes monitoring is feasible. Evaluation of individual rtCGM-POC paired values suggested that using rtCGM data for management decisions poses minimal risks to patients. Further studies to establish the safety and cost implications of using rtCGM data for inpatient diabetes management decisions are warranted.

The Quality of Life and Satisfaction with Continuous Glucose Monitoring Therapy in Children under 7 Years of Age with T1D Using the rtCGM System Integrated with Insulin Pump-A Caregivers Point of View.

Quality of life (QoL) is an important parameter that affects the choice of therapy. Assessment of QoL and satisfaction with therapy using the rtCGM in children with T1D aged < 7 years was conducted. The study group consisted of 38 children with T1D aged < 7 years (34% aged 2–4, 66% aged 5–7 years), HbA1c: 6.53 ± 0.63%, duration of diabetes: 2.6 ± 1.6 years, treated with an rtCGM-augmented insulin pump for 1.92 ± 1.15 years. Two anonymous surveys were conducted: a. PedsQL3.0 diabetes standardized questionnaire—QoL assessment among age groups: 2–4/5–7 years. b. An original survey assessing the CGM use satisfaction. The mean scores in PedsQL3.0: communication 75%, worries 30%, treatment 70%, and problems associated with diabetes 65%. The QoL scale is: 0–19% very low, 20–39% low, 40–59% moderate, 60–79% high, 80–100% very high. The most frequently reported concerns were long-term diabetes complications and prick pain. Satisfaction with CGM use was high (68% in group aged 5–7 and 92% 2–4 years). Twenty-seven (71%) caregivers confirmed the positive effect of CGM on sleep. During the use of rtCGM a high quality of life was reported, and the quality of sleep in their caregivers was increased.

Evaluation of the SPECTRUM training programme for real-time continuous glucose monitoring: A real-world multicentre prospective study in 120 adults with type 1 diabetes.

Comprehensive knowledge, specific skills and data-analysis competences are prerequisites for the successful use of continuous glucose monitoring (CGM) systems. SPECTRUM is a structured training programme for real-time CGM (rtCGM) consisting of a web-based introduction and six group sessions of 90min each. The 'CGM-TRAIN study' evaluated the efficacy and acceptance of SPECTRUM and rtCGM systems among adults with insulin therapy. Participants (n=120) were recruited from 10 German diabetes centres in which they were treated under usual care conditions. Outcome measures were rtCGM knowledge, practical skills, satisfaction with the training programme, satisfaction and acceptance of rtCGM system and glycaemic control. Data were collected at study entry, after training completion and at 6-month follow-up. All participants were diagnosed with type 1 diabetes (56% women, mean age 42.4±13.4years, diabetes duration 21.6±11.6years), 110 participants completed the course. After training completion, rtCGM-specific knowledge had improved by 43% (scale: 0-40 points) from 21.2±7.6 to 30.4±4.5 points; p<0.001. The knowledge-level persisted until follow-up (29.4±4.5). Participants were able to master nearly all the practical requirements of the technology. In addition, rtCGM was highly accepted, and participants were motivated to use their systems continuously. HbA1c improved slightly from 61±14mmol/mol (7.7±1.3%) before training to 60±14mmol/mol (7.6±1.3%) at follow-up (p=0.04). The training programme itself was favourably rated by participants. Under usual out-patient daily care conditions, the training programme SPECTRUM improved knowledge and skills about rtCGM in adults with type 1 diabetes. This was associated with a reduced HbA1c , high satisfaction and acceptance of rtCGM (Clinical Trials Registry no.: DRKS00014380).

338-OR: Evaluation of the Spectrum Training Program for Real-Time Continuous Glucose Monitoring: A Multicenter Prospective Study in 120 Adults with Type 1 Diabetes

Comprehensive knowledge, specific skills, and data-analysis competences are prerequisites of successful use of continuous glucose monitoring systems (CGM). SPECTRUM is a structured and manufacturer-independent training-program for real time CGM (rtCGM) comprising one web-based introduction and six modules (each 90 minutes) of face-to-face group sessions. SPECTRUM was evaluated longitudinally among adults with type 1 diabetes from 10 diabetes centers. Outcome parameters were rtCGM-knowledge and -skills (rtCGM-Profi-Check), satisfaction with the course, technology acceptance and metabolic control. Initially 120 participants with type 1 diabetes were included (mean age 42.4±13.4 years, diabetes duration 21.6±11.6 years, 56% female, mean HbA1c 7.70±1.34%). Data were collected at study entry, after the final group session, and at 6 months follow-up. The study was completed by 108 patients (10% dropped out, mainly due to scheduling problems). After training rtCGM knowledge (scale 0-40) improved by 43% (from 21.2±7.6 to 30.4±4.5; p&amp;lt;0.001) and persisted until 6 months follow-up (29.6±4.6). After 6 months HbA1c decreased to 7.58±1.32% (p=0.036). On a scale from 0-14, practical skills were 13.1±1.3 after the program. Satisfaction with SPECTRUM was 1.4±0.5 (1 is good - 6 is bad). Satisfaction with the rtCGM system was 4.2±0.5 (scale from 1 (low) to 5 (high)) and acceptance of the rtCGM system was 87.6±8.2 (scale from 14 (low) to 98 (high)) after the training and 87.0±9.7 at follow up. This indicates a high acceptance, positive attitude, and intension to use rtCGM continuously. SPECTRUM was shown to be effective in increasing the knowledge and skills about rtCGM in adults with type 1 diabetes. The effect was sustainable and independent from diabetes center and rtCGM-system used. Training participants showed an improvement in glycemic control and improved satisfaction and acceptance of rtCGM. Disclosure G. Freckmann: Advisory Panel; Self; Abbott, Sensile Medical AG. Consultant; Self; Beurer, iSens, Metronom Health, Pharmasens, Profusa, Inc., Roche Diabetes Care. Speaker’s Bureau; Self; Novo Nordisk A/S. S. Schlueter: Advisory Panel; Self; A. Menarini Diagnostics, Abbott. Consultant; Self; Roche Diabetes Care. Speaker’s Bureau; Self; Ascensia Diabetes Care, AstraZeneca, Berlin-Chemie AG, Dexcom, Inc., Medtronic, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Ypsomed AG. Other Relationship; Self; Springer Publishing Company, Verlag Kirchheim &amp; Co. GmbH. P. Wintergerst: None. L. Heinemann: Consultant; Self; Becton, Dickinson and Company, LifeCare, Inc., Roche Diabetes Care. Stock/Shareholder; Self; Profil Institute for Clinical Research. T. Rückert: None. A. Hinz: Research Support; Self; Institut for Diabetestechnologie Ulm, Novo Nordisk A/S. Speaker’s Bureau; Self; AstraZeneca, Berlin-Chemie AG, Eli Lilly and Company. M. Wernsing: Advisory Panel; Self; Abbott. Research Support; Self; Roche Diabetes Care. F. Thienel: Research Support; Self; Roche Diabetes Care. Speaker’s Bureau; Self; Abbott. T. Biester: Advisory Panel; Self; AstraZeneca. Speaker’s Bureau; Self; Dexcom, Inc., Medtronic, Roche Diabetes Care, Sanofi, Ypsomed AG. P. von Blanckenburg: None. W. Keuthage: Advisory Panel; Self; Deutschland GmbH, Novo Nordisk A/S, Roche Diabetes Care. Board Member; Self; Abbott, Berlin-Chemie AG. R. Ziegler: Advisory Panel; Self; Abbott, Lilly Diabetes, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Novo Nordisk A/S, Roche Diabetes Care. Speaker’s Bureau; Self; Abbott, Dexcom, Inc., Novo Nordisk A/S, Roche Diabetes Care. E. Martin: None. M. Holder: None. D. Deiss: Advisory Panel; Self; Abbott, Roche Diabetes Care. Consultant; Self; Senseonics. G. Buchal: None. L. van den Boom: Advisory Panel; Self; Medtronic. K. Lange: Consultant; Self; Abbott, Dexcom, Inc., Medtronic. Funding Dexcom, Inc.; Roche Diabetes Care; Sanofi; Menarini Group; Kirchheim Verlag; Medtronic

279-OR: How to Use rtCGM Data to Predict Future Severe Hypoglycemia?

We combined rtCGM-baseline-data of the HypoDE and DIAMOND study to predict future severe hypoglycemia (SH; third party assistance for recovery). At baseline, in both studies, the rtCGM system (Dexcom G4) was masked. We analyzed the data of 127 study participants in the control groups with type 1 diabetes (age 46.0 ±11.5 years; diabetes duration 22.4 ±14.1 years, A1c 7.9 ±1.0%) using SMBG during the trials. According to the consensus statement we used the following hypoglycemia-specific predictors: % of glucose values &amp;lt; 70mg/dl and &amp;lt;54 mg/dl, the number of such events, Low Blood Glucose Index (LBGI), and the coefficient of variation (CV). After baseline, a total of 44 severe hypoglycemic events were observed during the following 6-months; with 12.6% affected participants. We analyzed the area under the Receiver Operating Characteristics (ROC) curves and determined cut-off values with an optimal sensitivity and specificity (Table). All hypoglycemia-related parameters, except CV, were able to predict SH during the next 6 months significantly better than prediction by chance; e.g., if ≥ 7% of glucose values were &amp;lt; 70 mg/dl, the probability for SH in the next 6-months was 23.4%. CGM-derived hypoglycemic outcome parameters might help to identify people with diabetes who have an increased risk for future hypoglycemia. These results should be corroborated by non-masked use of rtCGM but might also be useful in patients using SMBG. Disclosure N. Hermanns: Advisory Panel; Self; Abbott. Board Member; Self; Eli Lilly and Company. Research Support; Self; Abbott, Berlin-Chemie AG, Dexcom, Inc., Roche Diabetes Care. Speaker's Bureau; Self; Berlin-Chemie AG, Dexcom, Inc., Novo Nordisk A/S. D. Ehrmann: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Abbott, Berlin-Chemie AG, Dexcom, Inc. P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. G. Freckmann: Advisory Panel; Self; Abbott, Novo Nordisk Pharma GmbH, Sensile Medical AG. Consultant; Self; Metronom Health Europe, Roche Diabetes Care, Sanofi. Speaker's Bureau; Self; Ascensia Diabetes Care, Dexcom, Inc., Ypsomed AG. L. Heinemann: Consultant; Self; Roche Diabetes Care. Research Support; Self; Dexcom, Inc. Stock/Shareholder; Self; Profil Institute for Metabolic Research, ProSciento. Funding Dexcom, Inc.

Comparison of flash glucose monitoring with real time continuous glucose monitoring in children and adolescents with type 1 diabetes treated with continuous subcutaneous insulin infusion

AimsIn 2016 intermittently scanned continuous glucose monitoring (isCGM) became the first reimbursed CGM system in Belgium. Many children with type 1 diabetes (T1D) treated with multiple daily injections as well as with continuous subcutaneous insulin infusion (CSII) switched from self-monitoring of blood glucose to isCGM to monitor their treatment. In 2017 the Enlite® real-time CGM (rtCGM) system was reimbursed enabling its use with the Minimed® 640G insulin pump with integrated SmartGuard technology. In this study we compared the metabolic control during CSII with isCGM with that during rtCGM. Patient’s satisfaction and side effects of the rtCGM system were also evaluated. Methods20 children with T1D, aged 5–16 years, were included. Metabolic control during the last month of isCGM use was compared to that during the 3rd and 6th month of rtCGM. ResultsThree patients stopped early rtCGM mainly due to calibration burden. The HbA1c level and the mean glucose value in the other patients did not change after switching to the rtCGM system. Glucose variability was smaller (46.2% vs 38.4% and 36.4%, p = 0.000). Time in hypoglycemia (<70 mg/dl) was lower (7.4% vs 1.6% and 1.5%, p = 0.000). The main patient inconvenience was the sensor calibration. ConclusionsOur data show that during Enlite® rtCGM with the Minimed® 640G pump system glucose variability was smaller and the patients spent less time in hypoglycemia than during isCGM. The need for timely calibrations is considered as the main drawback of the system.

Clinical Practice Recommendations on the Routine Use of Eversense, the First Long-Term Implantable Continuous Glucose Monitoring System.

Background: The use of real-time continuous glucose monitoring (rtCGM) systems has proved to positively impact the management of type 1 diabetes with the potential to lower HbA1c, reduce frequency and time spent in hypoglycemia, and lower glycemic variability. Nevertheless, the acceptance of rtCGM remains below expectations and the dropout rate within the first year has been reported to be 27%. Besides financial reasons due to limited reimbursement, reasons include the need for frequent sensor replacement, the discomfort of wearing a sensor, the presence of adverse skin reactions, or privacy. Thus, novel approaches to rtCGM are desired to overcome these barriers. The first long-term implantable rtCGM system diversifies the field of glucose monitoring further. However, due to its novelty, there are no published clinical practice guidelines available.Aims: The aim of this article is to set the foundation for a best clinical practice for the everyday clinical care using a long-term implantable CGM system.Methods: An international expert panel for the long-term implantable CGM system developed this best practice guidance. All participants were certified and experienced in the use of the Eversense® long-term implantable CGM system. The workflows from the respective clinics were presented, discussed and are summarized in an ideal care workflow outlined in these practice recommendations.Results: The participants agreed on the following aspects: definition of the patient population that will benefit from a long-term implantable CGM device; real-world experience on safety and accuracy of a long-term CGM; definition of the ideal sensor position; description of the optimal process for sensor insertion, removal, and replacement.

Real-World Hypoglycemia Avoidance With a Predictive Low Glucose Alert Does Not Depend on Frequent Screen Views.

Frequent real-time continuous glucose monitoring (rtCGM) data viewing has been associated with reduced mean glucose and frequent scanning of an intermittently scanned continuous glucose monitoring (isCGM) system has been associated with reduced hypoglycemia for patients with diabetes. However, requiring patients to frequently interact with their glucose monitoring devices to detect actual or impending hypoglycemia is burdensome. We hypothesized that a predictive low glucose alert, which forecasts glucose ≤55 mg/dL within 20 minutes and is included in a new rtCGM system, could mitigate hypoglycemia without requiring frequent device interaction. We analyzed estimated glucose values (EGVs) from an anonymized convenience sample of 15,000 patients who used Dexcom G6 (Dexcom, Inc, San Diego, CA, USA) and its mobile app for at least 30 days with or without the "Urgent Low Soon" alert (ULS) enabled. Screen view frequency was determined as the frequency with which the trend screen was accessed on the app. Multiple screen views within any 5-minute interval were counted as one. Hypoglycemia exposure for patients in the top and bottom quartiles of screen view frequency (>8.25 and <3.30 per day, respectively) was calculated as the percentage of EGVs below various thresholds. Over 93% of users enabled the ULS alert; its use was associated with significantly reduced hypoglycemia <55 and <70 mg/dL, independent of screen view frequency. Use of the G6 ULS alert may disencumber rtCGM users by promoting significant reductions in hypoglycemia without requiring frequent device interactions.

Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert.

Background: Programmable and fixed auditory and/or vibratory threshold alerts are essential features of real-time continuous glucose monitoring (rtCGM) systems that provide users time to intervene before the onset of clinical hypoglycemia or hyperglycemia. A sixth-generation rtCGM system from Dexcom, Inc. (G6) includes a new alert that is triggered when an algorithm predicts that an estimated glucose value ≤55 mg/dL will occur within 20 min, allowing users more time to act to avoid hypoglycemia. We examined whether this predictive low glucose alert provided added benefit to traditional low threshold alerts.Methods: We analyzed glucose values from an anonymized sample of 1424 patients who transitioned to G6 from the preceding fifth-generation system (G5) with no predictive alert. Users with the low threshold alert setting of 70 or 80 mg/dL were evaluated separately. Receiver users, those who disabled the predictive low glucose alert, or those with <30 days of data immediately before or after the transition to G6 were excluded.Results: Percent time <54, ≤55, <70, and >250 mg/dL fell significantly after the transition to G6, independent of low threshold alert setting. Time in range improved for G6 users with a low threshold alert setting of 70 mg/dL.Conclusions: Advance warning provided by predictive low glucose alerts may further reduce hypoglycemia among rtCGM-experienced users.

PMD78 - COST-EFFECTIVENESS ANALYSIS OF REAL TIME CONTINOUS GLUCOSE MONITORING (RT-CGM) VS SELF MONITORING BLOOD GLUCOSE (SMBG) IN PATIENTS WITH TYPE 1 DIABETES IN SPAIN

To evaluate the cost-effectiveness of real-time Continuous Glucose Monitoring (rt-CGM) compared to Self Monitoring Blood Glucose (SMBG) alone in Type 1 Diabetes (T1DM) patients using Multiple Daily Injections (MDI) from the Spanish payer perspective. Sensitivity analysis was included for factory-calibrated rt-CGM. The IQVIA CORE Diabetes Model (CDM) (v. 9.0) was used to assess the long-term (50-year) cost-effectiveness of rt-CGM compared to SMBG alone. Treatment effects and base-line patient characteristics are based on the DIAMOND Study (RW Beck et al, JAMA, 2017). Risk for diabetes complications and costs were sourced from other published sources. The accuracy and clinical effectiveness of rt-CGM is equivalent to that observed in the rt-CGM system used in the DIAMOND trial. Base case assumptions included a) starting HbA1c: 8.6%; b) change in HbA1c: -1.0% for rt-CGM group, -0.4% for SMBG alone; c) 50% reduction in severe hypoglycemic events (SHEs) and 33% reduction in non-severe hypoglycemic events (NSHEs) for the rt-CGM group; d) dis-utilities of -0.014 for NSHEs and SHEs not requiring medical intervention, and -0.047 for SHEs requiring medical resources. Treatment costs and outcomes were discounted at 3%. The Incremental Cost-Effectiveness Ratio (ICER) for rt-CGM vs. SMBG was €44,747/QALY in the base-case, needing two calibrations per day. Sensitivity analyses were performed using rt-CGM no-calibration device. When there is no need for calibration the ICER was €21,144/QALY for factory-calibrated rt-CGM. rt-CGM has the potential to improve clinical outcomes, quality of life and healthcare resource consumption for MDI-treated T1DM patients in Spain. The results of this evaluation show that rt-CGM has an impact on patients’ quality of life and health outcomes and that factory-calibrated rt-CGM can be cost-effective within the MDI-treated T1DM population in Spain, assuming a willingness-to-pay threshold of €30,000 per QALY in Spain.

RtCGM Usage Is Associated with a Significant Reduction of Time Spent in Hypoglycemia in Patients with Type 1 Diabetes Treated with Multiple Daily Injections—Results of the HypoDE Study

In this randomized multi-center study, performed in 12 specialized diabetes practices in Germany, we examined the impact of rtCGM use (Dexcom G5) on the duration of time spent in hypoglycemia. In total, 149 MDI-treated patients with type 1 diabetes and hypoglycemia problems (age 47±20 years, HbA1c 7.5±1.0%, 60.4% with at least one recent severe hypoglycemic event, unawareness score 4.9±1.2) used a masked rtCGM system for 4 weeks. After this baseline phase, 75 patients were randomized to rtCGM use and 74 were randomized to the control group with continuation of SMBG for the next 26 weeks. From week 22 till 26 after randomization, the control group had a masked rtCGM system again. The CGM group continued their use of rtCGM. Six-month follow-up data could be obtained from 141 participants. In the CGM group, the duration of time per day spent ≤70 mg/dl was lower compared to the Control group (42.6 vs. 112.0 min/day; adjusted Δ 69.4 min/day, 95% CI 52.4 to 86.4 min/day, p&amp;lt;0.0001). The time per day spent in &amp;lt;55 mg/dl showed the same pattern (11.2 vs. 53.2 min/day; adjusted Δ 41.9 min/day, 95% CI 31.4 to 52.2 min/day, p&amp;lt;0.0001). Time in range per day was longer in the CGM group than in the Control group (850.5 vs. 805.6 min/day; adjusted Δ 44.9 min/day, 95% CI -0.3 to 90.0 min/day, p=0.051). Time per day spent in hyperglycemia (&amp;gt;180 mg/dl) was slightly higher in the CGM group than in the Control group (544.2 vs. 525.5 min/day; adjusted Δ -18.7 min/day, 95% CI -70.3 to 32.9 min/day, p=0.474). HbA1c at follow-up was comparable between CGM and Control group (7.3% vs. 7.3%; adjusted Δ 0.0%, 95% CI -0.1 to 0.2%, p=0.665). The use of rtCGM in MDI-treated type 1 diabetic patients with hypoglycemia problems can significantly reduce exposure to hypoglycemic glucose values without compromising glycemic control. Given the rather higher costs of CSII treatment compared to MDI, these results are of high clinical as well as health-economic relevance. Disclosure L. Heinemann: Stock/Shareholder; Self; Profil Institute for Metabolic Research, ProSciento. Consultant; Self; Roche Diabetes Care Health and Digital Solutions. G. Freckmann: Speaker's Bureau; Self; Ascensia Diabetes Care. Research Support; Self; Ascensia Diabetes Care. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Abbott, Novo Nordisk Inc.. Consultant; Self; Sensile Medical AG. Speaker's Bureau; Self; Ypsomed AG. D. Waldenmaier: None. D. Ehrmann: Speaker's Bureau; Self; Berlin-Chemie AG. N. Hermanns: Speaker's Bureau; Self; Berlin-Chemie AG. Advisory Panel; Self; Abbott. Research Support; Self; Abbott. Speaker's Bureau; Self; Abbott. Research Support; Self; Berlin-Chemie AG. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Ypsomed AG, Dexcom, Inc.. Speaker's Bureau; Self; Novo Nordisk Inc..

A Novel Continuous Glucose Monitoring System Accurately Detects Existing and Impending Hypoglycemia

Autonomous real-time continuous glucose monitors (rtCGM), unlike intermittently scanned continuous glucose monitors (isCGM), can proactively warn users of impending hypoglycemia. This study assessed the likelihood of realized hypoglycemia when an alert is triggered in the novel factory-calibrated rtCGM system ("G6 FC" Dexcom). Subjects wearing a G6 rtCGM participated in 1 to 3 in-clinic sessions where venous YSI plasma glucose measurements were sampled every 15 minutes. Three types of hypoglycemic alerts were assessed: “Low” (&amp;lt;70 mg/dL), “Urgent Low” (&amp;lt;55 mg/dL), and the new “Urgent Low Soon” (≤55 mg/dL within 30 minutes). YSI glucose values were linearly interpolated to give estimated glucose values between YSI glucose measurements. The first “Low” and “Urgent Low” alerts were matched with actual and interpolated YSI values within ±15 minutes. The first “Urgent Low Soon” alerts were matched with actual and interpolated YSI values within 30 minutes after the alert. The Table shows 77% of “Low” alerts and 86% of “Urgent Low” alerts correctly warned of a hypoglycemic event (YSI reading below 70 mg/dL) within ±15 minutes. There were 480 “Urgent Low Soon” alerts, 86% of which correctly predicted a hypoglycemic event in the next 30 minutes. The G6 FC CGM System provides accurate alerts to patients which could facilitate actions to prevent or minimize hypoglycemia. Table.Hypoglycemic rates during a "Low" or "Urgent Low" alertType of alertNumber of alertsNumber (%) of alert events with a nadir YSI&amp;lt;55 mg/dL&amp;lt;70 mg/dL&amp;lt;90 mg/dLLow620185 (29.8%)478 (77.1%)596 (96.1%)Urgent Low410249 (60.7%)353 (86.1%)394 (96.1%) Disclosure P. Calhoun: Employee; Self; Dexcom, Inc.. Stock/Shareholder; Self; Dexcom, Inc. T. Johnson: Employee; Self; Dexcom, Inc. A. Balo: Employee; Self; Dexcom, Inc. D.A. Price: Employee; Self; Dexcom, Inc..

Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial

The effectiveness of real-time continuous glucose monitoring (rtCGM) in avoidance of hypoglycaemia among high-risk individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) is unknown. We aimed to ascertain whether the incidence and severity of hypoglycaemia can be reduced through use of rtCGM in these individuals. The HypoDE study was a 6-month, multicentre, open-label, parallel, randomised controlled trial done at 12 diabetes practices in Germany. Eligible participants had type 1 diabetes and a history of impaired hypoglycaemia awareness or severe hypoglycaemia during the previous year. All participants wore a masked rtCGM system for 28 days and were then randomly assigned to 26 weeks of unmasked rtCGM (Dexcom G5 Mobile system) or to the control group (continuing with self-monitoring of blood glucose). Block randomisation with 1:1 allocation was done centrally, with the study site as the stratifying variable. Masking of participants and study sites was not possible. Control participants wore a masked rtCGM system during the follow-up phase (weeks 22-26). The primary outcome was the baseline-adjusted number of hypoglycaemic events (defined as glucose ≤3·0 mmol/L for ≥20 min) during the follow-up phase. The full dataset analysis comprised participants who wore the rtCGM system during the baseline and follow-up phases. The intention-to-treat analysis comprised all randomised participants. This trial is registered with ClinicalTrials.gov, number NCT02671968. Between March 4, 2016, and Jan 12, 2017, 149 participants were randomly assigned (n=74 to the control group; n=75 to the rtCGM group) and 141 completed the follow-up phase (n=66 in the control group, n=75 in the rtCGM group). The mean number of hypoglycaemic events per 28 days among participants in the rtCGM group was reduced from 10·8 (SD 10·0) to 3·5 (4·7); reductions among control participants were negligible (from 14·4 [12·4] to 13·7 [11·6]). Incidence of hypoglycaemic events decreased by 72% for participants in the rtCGM group (incidence rate ratio 0·28 [95% CI 0·20-0·39], p<0·0001). 18 serious adverse events were reported: seven in the control group, ten in the rtCGM group, and one before randomisation. No event was considered to be related to the investigational device. Usage of rtCGM reduced the number of hypoglycaemic events in individuals with type 1 diabetes treated by MDI and with impaired hypoglycaemia awareness or severe hypoglycaemia. Dexcom Inc.