Real-time Continuous Glucose Monitoring Research Articles

538-P: Use of Real-Time Continuous Glucose Monitoring Supports Behavior Modification in Gestational Diabetes Mellitus—Results from an Ongoing Pilot Study

Gestational diabetes mellitus (GDM) is common, with 14% of women developing GDM. Although real-time continuous glucose monitoring (RT-CGM) has been shown to support behavioral/lifestyle modifications in patients living with type 1 and type 2 diabetes, no studies to date have assessed RT-CGM as a behavior modification tool for patients with GDM. Participants diagnosed with GDM [prior to gestational age 24 weeks (early) or between 24-30 weeks (typical)] were randomized to use RT-CGM or continue self-monitoring of blood glucose (SMBG) using finger-sticks and wore 3 serial blinded CGM over the remainder of the pregnancy. Both groups continued their routine obstetric care. After delivery, RT-CGM participants completed a 44-question survey adapted from the Joslin Diabetes Center CGM questionnaire plus our published 8-question survey on behavior modification and CGM use. To date, 70 participants have enrolled; 31 were randomized to RT-CGM. Twenty-four (4 early and 20 typical) have completed the post-delivery surveys. Demographics: 42% were Caucasian, 63% reported annual incomes of >$50,000, and 79% had achieved at least a bachelor’s degree. From RT-CGM use: 71% excluded or limited sugared beverages (29% never drank sugared beverages), 78% excluded or limited white rice (13% never ate white rice), 67% started reading labels for fiber content (17% of participants already read labels for fiber content), and 92% would walk or increase activity after a meal if they saw their glucose rising. Overall, 92% of participants felt like RT-CGM contributed to a healthier lifestyle during pregnancy. Sixty-three percent wanted to continue using RT-CGM. Our study suggests that women with GDM perceive that RT-CGM supports improved lifestyle choices during pregnancy. Studies are ongoing to assess whether RT-CGM improves maternal and/or fetal outcomes, but advocacy is needed now to improve accessibility of RT-CGM in GDM. Disclosure B.Cedeno: None. E.Fay: None. N.M.Ehrhardt: Advisory Panel; Novo Nordisk, Dexcom, Inc., Consultant; Nestlé Health Science. S.J.Fonda: Research Support; Dexcom, Inc. Funding Dexcom, Inc. (IIS-2019-101)

945-P: Effect of Real-Time Continuous Glucose Monitoring vs. Flash Glucose Monitoring on Glycemic Control and Glycemic Variability in Patients with Type 1 Diabetes—A Systematic Review and Meta-analysis

Objectives: Previous studies have shown that real-time continuous glucose monitoring (rtCGM) and flash glucose monitoring (FGM) led to different impacts on glycemic control and glycemic variability in patients with T1D. This meta-analysis aimed to summarize data and compare the effect of the rtCGM and FGM in patients with T1D. Methods: A systematic literature searches of all relevant studies comparing the clinical effectiveness of rtCGM and FGM in T1D on Cochrane Library, PubMed, Embase, Web of Science, and Scopus before October 2022 were performed. Two independent reviewers searched and assessed all literatures according to the standard of Cochrane systematic review. Data extraction and quality assessment were conducted. Stata 15.1 software was used for data analysis. The random effects model was used since there was heterogeneity between studies. Results: Eight studies including three randomized controlled trials and five observational studies conducting in 1649 TID patients were enrolled in this meta-analysis. It was found that there was no difference in reduction of HbA1c levels between rtCGM and FGM. In terms of indexes of glycemic variability, compared to FGM, rtCGM led to better TIR (3.9~10 mmol/L) (SMD = 0.721, 95%CI: 0.438 ~ 1.003, P<0.001), lower TBR (<3.9mmol/L) (SMD = -1.441, 95%CI: -2.090 ~ -0.791, P<0.001), lower TAR (TAR>10.0mmol/L: SMD = -0.299, 95%CI: -0.583 ~ -0.015, P = 0.039; TAR>13.9 mmol/L: SMD = -0.395, 95%CI: -0.702 ~ -0.088, P = 0.012), lower standard deviation (SMD = -0.769, 95%CI: -1.097 ~ -0.442, P<0.001), and lower glucose coefficient of variation (SMD = -0.859, 95%CI: -1.159 ~ -0.559, P<0.001) as well. However, there was no difference between rtCGM and FGM in lowering mean glucose and TBR (<3.0mmol/L). Conclusions: rtCGM accounted for favorable outcomes on improving glycemic variability indices but not HbA1c reduction compared to FGM in patients with T1D. Disclosure D.Chen: None. Z.Liu: None. B.Lin: None. Y.Yang: None. D.Yang: None. J.Yan: None. W.Xu: None. Funding SHMHDF (DMRFP_II_14)

591-P: Elite Cyclists with Type 1 Diabetes (T1D) Show Acceptable Glycemic Excursions during a Time-Trial Performance under High-Definition Transcranial Direct-Current Stimulation (HD-tDCS)

Patients with T1D are typically challenged by glycemic fluctuations during exercise. We recently applied HD-tDCS - a neuromodulation enhancer - both in healthy and T1D elite cyclists to improve endurance performance. Here, in a double-blind, counterbalanced, randomized order, nine elite cyclists (28 ± 3.5 years; BMI: 20.8 ± 1.3 kg/m2; VO2peak: 65.3 ± 1.7 mL/min/kg) with T1D (no complications) underwent either HD-tDCS (F3, F4) or control (SHAM) and completed a constant-load trial (CLT) at 75% of the 2nd ventilatory threshold plus a 15-km cycling time-trial (TT). Comparing the two conditions by real-time continuous glucose monitoring (CGM), subjects showed similar glycemic variability in any part of the session (Figure: bold line = mean; dotted lines = min & max), with a significant effect of time (F=26.32; P<0.0001), but no interaction stimulation x time (F=0.08; P>0.99) nor effect of stimulation (F=0.077; P=0.79). Further, CGM data were stable for the 3 days preceding and following the tests. Given that glycemic control becomes of critical interest not only for health but also for performance goals, these findings suggest that HD-tDCS can be safely used as a performance improvement device in athletes with T1D, and possibly in a wider population of active T1D-subjects. Disclosure R.Codella: None. G.Gallo: None. A.Meloni: None. L.Luzi: Advisory Panel; Eli Lilly and Company, Medtronic, Research Support; Gelesis, Speaker's Bureau; A. Menarini Diagnostics, Amgen Inc., Boehringer Ingelheim and Eli Lilly Alliance, Eli Lilly and Company, Novo Nordisk, Novartis. L.Filipas: None.

1200-P: A1C and Neonatal Outcomes Improved with Real-Time Continuous Glucose Monitoring in Pregnant Women with Preexisting Type 2 Diabetes

Preexisting type 2 diabetes (T2D) in pregnancy is increasing and confers significant health risks to the mother and fetus. Continuous glucose monitoring (CGM) systems provide real-time feedback for patients and allow for remote monitoring and therapeutic adjustments. CGM is ideal for pregnancy where insulin requirements and glucose levels are rapidly changing throughout the pregnancy and postpartum. Previous studies have demonstrated improved maternal and neonatal outcomes with the use of CGM in the context of T1D. This study used the Dexcom G6 CGM in pregnant women with preexisting T2D to determine if there is a reduction of A1C and neonatal hypoglycemia compared to preexisting T2D in women using self-monitored blood glucose (SMBG) to manage their diabetes. Women aged 18-40 years with preexisting T2D, using multiple daily insulin injections, and <14 weeks pregnant were enrolled in the study. Participants were randomly assigned to use G6 or SMBG during pregnancy. Mann Whitney U Test, Wilcoxon Signed Rank Test, and Chi-square tests were used to analyze gestational age (GA), A1C at baseline and at 34 weeks, and occurrence of neonatal hypoglycemia. Fourteen participants completed the study. In the G6 group (n=7, median age 28 years, GA 37 weeks), A1c decreased from 7.0% to 6.1% (p=0.045). In the SMBG group (n=7, median age 36 years, GA 38 weeks), A1c decreased from 6.3% to 6.1% (p=NS). There was no significant difference in the GA between the groups. None of the 7 infants in the G6 group had perinatal hypoglycemia compared to 4 out of 7 infants in the SMBG group (p=0.005). This study suggests that use of the DexcomG6 CGM in preexisting T2D during pregnancy can lower A1C and reduce neonatal hypoglycemia. Disclosure G.Nunlee-bland: Research Support; Dexcom, Inc. P.Cofie: None. Funding Dexcom, Inc. (11S-2019-037)

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 <7%, ΔTIR ≥5%) and statistical significance (p<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 <$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<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 <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.

991-P: Reduction in Diabetes-Related Hospitalizations and Medical Costs after Real-Time Continuous Glucose Monitor (rtCGM) Initiation in Patients with Type 2 Diabetes (PWT2D) on Intensive Insulin Therapy (IIT)

This study evaluated changes in diabetes-related hospitalizations and healthcare resource utilization (HCRU) costs after rtCGM initiation in PWT2D on IIT. Retrospective analysis of US healthcare claims data using Optum’s Clinformatics® database was conducted. The cohort included CGM naïve PWT2D on IIT who initiated rtCGM (Dexcom G6) between 8/1/2018 through 3/31/2021 (index date=earliest observed pharmacy claim). Diabetes-related (e.g., diabetic ketoacidosis, hyperglycemia and hypoglycemia) hospitalizations (ER and inpatient visits) and associated HCRU costs were assessed 12-months pre- and post-index. Hospitalizations were expressed as changes in the number of visits. Changes in diabetes-related HCRU costs were reported as per-person-per-month (PPPM) costs. Hospitalizations and HCRU costs were defined as claims with a diabetes-related diagnosis code in the 1st or 2nd position on the claim. A total of 790 PWT2D (average age=52.8 (sd=10.5) years, 46.7% female) rtCGM users on IIT with commercial health insurance met inclusion criteria. A 50% reduction (p<0.0001) in the number of diabetes-related inpatient visits after rtCGM initiation was observed (baseline n=132, follow-up n=66). Similarly, after rtCGM initiation, a 47% reduction (p<0.05) in the number of diabetes-related ER visits occurred (baseline n=85, follow up n=45). Average PPPM diabetes-related hospitalization medical costs decreased by $329.53 (p<0.05). HCRU cost reductions were driven by reduced diabetes-related inpatient medical costs (-$308.46 PPPM). Payer claims showed that hyperglycemia and ketoacidosis were the most common reasons for hospitalizations 12-months pre- and post-device initiation. Findings suggest that rtCGM initiation may contribute to reduced HCRU for PWT2D on IIT by way of improving glycemic control. Disclosure K.Hannah: Employee; Dexcom, Inc. P.Nemlekar: Employee; Dexcom, Inc. G.J.Norman: Employee; Dexcom, Inc. Funding Dexcom, Inc.

949-P: Hypoglycemia Detection during Real-Time Continuous Glucose Monitoring in a Real-World Hospital Setting

Continuous glucose monitoring (CGM) in the hospital can detect hypoglycemia that may go unnoticed by point-of-care testing (POCT). Following the non-objection of the FDA to the use of CGM in the hospital, using the Dexcom G6 CGM system, the “CGM as Standard of Care” (CGM as SOC) program was implemented at Scripps Mercy Hospital San Diego with a 24/7 remote-monitoring team (RMT) using a Digital Dashboard (DD). The DD alerts for glucose ≤80mg/dL and prioritizes patients by clinical risk. Using these alerts, the RMT notifies on-site bedside nurses (RN). Hypoglycemic events, defined as >15 minutes of consecutive glucose readings <70mg/dL, identified in retrospective evaluation of CGM data were analyzed to 1) evaluate appropriateness of response to events and 2) assess the accuracy of the events. 86/745 (12%) unique admissions enrolled in the CGM as SOC program between January 2021-June 2022 experienced a hypoglycemic event during the RMT period. These patients averaged 60.2 years of age, 62% male, 48% Hispanic and 87% with a type 2 diabetes diagnosis. Median number of events per admission = 1.90, for a total of 163 events. All alerts were acknowledged by the RMT, documentation that bedside RN was alerted was found on 134/163 (82%) events. It is possible that the RMT neglected to document RN outreach in the remaining 29 (18%). 90/163 events (55%) were treated as appropriate clinically, with insulin dosing changes as needed. In the remaining 69/163 (42%) events, patients were determined to not be (or no longer be) in an actionable hypoglycemia range that warranted treatment when evaluated by the RN. A small portion (10/69, 14%) were caused by documented compression on device resulting in artificially low CGM values. There were 4 (3%) events with insufficient documentation. These findings provide preliminary support of the value of an RMT in hypoglycemia surveillance in a real-world hospital setting. Additional data and recommendations for process refinements will be presented. Disclosure R.Belasco: None. L.Talavera: None. A.Philis-tsimikas: Advisory Panel; Dexcom, Inc., Novo Nordisk A/S, Sanofi, Other Relationship; Medtronic, Research Support; Novo Nordisk A/S, Lilly, Viking Therapeutics, NIH - National Institutes of Health. A.L.Fortmann: Employee; Dexcom, Inc. S.R.Spierling bagsic: None. A.Bastian: None. S.Lohnes: Consultant; Dexcom, Inc. A.Ritko: None. H.Sandoval: None. M.Chichmarenko: None. E.C.Soriano: None.

941-P: Improved Glycemic Control with Real-Time CGM in Adults with Type 2 Diabetes Not Treated with Insulin

Background: Little is known about real-time continuous glucose monitoring (rt-CGM) in adults with T2D who are not using insulin. We analyzed real-world data to evaluate the association of rt-CGM use and glycemic control in this population. Methods: Data from US-based adults who reported a T2D diagnosis, age ≥18 years, not using insulin and who first uploaded Dexcom G6 data from the Dexcom app between 9/2021 and 6/2022 were analyzed. Individuals with follow-up data at 3 months and baseline time in range (TIR, 70-180 mg/dL) <70% were included. Outcomes included change in CGM metrics and percentage of users with TIR ≥70% at follow-up. Results: CGM users (n=3,505) were [mean (SD)] 52.2 (11.2) years of age and 46% female. TIR increased by 16.2 percentage points from 40.2% (21.7) at baseline to 56.4% (28.2) at 3 months (p <0.001), which was largely attributable to reduced hyperglycemia (Table). The proportion of CGM users meeting the consensus target of TIR ≥70% increased from 0% to 37%. Over the course of 3 months, CGM was worn 91.7% of the time. Most CGM users (77.6%) accessed Clarity summary reports of CGM data and most (80.2%) enabled the optional high glucose alert. Conclusion: In adults with T2D not using insulin and not meeting treatment targets, use of rt-CGM was associated with clinically meaningful improvements in glycemic control. Ongoing use of rt-CGM may result in further improvements in glycemic control. Disclosure L.H.Jepson: Employee; Dexcom, Inc., Stock/Shareholder; Dexcom, Inc. J.Welsh: Employee; Dexcom, Inc. C.R.Green: Employee; Dexcom, Inc. R.Thomas: Employee; Dexcom, Inc. J.E.Layne: Employee; Dexcom, Inc., Verily Life Sciences. Funding Dexcom, Inc.

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.

358-OR: Better Adherence to Real-Time Continuous Glucose Monitoring (rtCGM) than to Intermittently Scanned CGM (isCGM) among People with Type 2 Diabetes (PWT2D) on Intensive Insulin Therapy (IIT)

Background: For PWT2D, medication regimen adherence is associated with improved glycemic control and reduced health care utilization. However, little is known about CGM adherence for managing T2D, and how it varies by type of CGM. Materials and Methods: A retrospective analysis of Merative’s MarketScan® US healthcare claims data was conducted. The cohort included CGM-naïve PWT2D on IIT who initiated rtCGM or isCGM between 1/1/2017 through 12/31/2020 (index date=earliest observed pharmacy claim). Adherence was defined as having ≥80% proportion of days covered (PDC) by pharmacy claims. Inclusion criteria were adults ≥30 years of age with T2D, using bolus insulin, with continuous health plan enrollment coverage 12 months before (baseline) and 12 months after the index date (follow-up), and no evidence of prior CGM use. The association between CGM adherence and change in A1C was examined in a subset of 663 patients with 6-month baseline and 6-month follow-up laboratory values. Results: The rtCGM group (n=2,349) was [mean (SD)] 49.2 (8.0) years of age and 48% female, while the isCGM group (n=8,881) was 50.4 (8.0) years of age and 48% female. Average PDC was 85% (26%) for the rtCGM group and 68% (32%) for the isCGM group. A total of 76.2% of the rtCGM group and 50.6% of the isCGM group met the ≥80% PDC level of adherence. A multivariate logistic regression model showed the odds of adherence were three times greater for rtCGM compared to isCGM (OR=3.2, 95% CI 2.8-3.5, p<0.001). Those adherent to CGM, regardless of device type, had a greater decrease in A1C (-0.94%) compared to those who did not meet the adherence criterion (-0.54%) (p<0.001). Conclusions: These findings indicate that for PWT2D on IIT, adherence to rtCGM is higher than to isCGM. The association between adherence and reduced A1C suggests patients can improve glycemic control with consistent use of CGM. Disclosure P.Nemlekar: Employee; Dexcom, Inc. K.Hannah: Employee; Dexcom, Inc. G.J.Norman: Employee; Dexcom, Inc. Funding Dexcom, Inc.

228-OR: Accuracy and Reliability of Real-Time Continuous Glucose Monitoring in the Intensive Care Unit after Major Abdominal Surgery

Introduction: Blood glucose control in patients requiring intensive care remains a therapeutic challenge; however, recent advancements in glucose sensing technologies have sparked interest in the potential use of real-time continuous glucose monitoring in the subcutaneous compartment (rtCGM) also in the intensive care unit (ICU) setting. We performed a clinical trial assessing the accuracy and reliability of rtCGM in postoperative ICU patients after major abdominal surgery. Methods: Patients undergoing pancreatic surgery, liver transplantation, pancreas (or pancreatic islets) and kidney transplantation were enrolled in the trial. Dexcom G6 (Dexcom, Inc., San Diego, USA) was used for rtCGM. Arterial blood glucose measured by the amperometric principle (ABL 800, Radiometer, Copenhagen, Denmark) served as reference and to calibrate the Dexcom G6 (every 6 hours on day 1, once daily day 2 and 3). Sensor accuracy was assessed by computing mean absolute relative difference (MARD), bias, modified Bland-Altman plot and surveillance error grid for paired samples of glucose values from CGM and ABL. Results: Sixty-one patients after major abdominal surgery staying in ICU post-operatively were included into this analysis. Median monitoring length was 7 days with a 97.1 ± 6.5% proportion of active CGM use. Overall, 1566 paired glucose values measured with CGM and ABL were obtained. MARD for CGM compared with ABL-measured glucose was 9.7% with a bias of 0.9% and coefficient of variation of 14%. In the surveillance error grid analysis, 90.9% of pairs were in the 0 risk zone and 7.9% in the risk zone 1 (out of 7). Throughout the study 3 sensors needed to be replaced due to technical problems. Conclusion: Our results show a clinically applicable accuracy and reliability of the Dexcom G6 continuous glucose monitoring system in postoperative ICU. This opens up new possibilities in intensifying ICU glucose control, lowering hypoglycaemia risk and reducing nursing staff workload. Disclosure B.Hagerf (voglová): None. M.Protus: None. L.Nemetova: None. M.Mraz: None. M.Haluzik: Advisory Panel; Novo Nordisk, Lilly Diabetes, Boehringer-Ingelheim, Research Support; Sanofi, Speaker's Bureau; Abbott, AstraZeneca. P.Girman: None. J.Franekova: None. V.Svirlochova: None. A.Jabor: None. Funding Charles University; Czech Ministry of Health; Institute for Clinical and Experimental Medicine (IKEM, IN00023001); National Institute for Research of Metabolic and Cardiovascular Diseases (EXCELES, LX22NPO5104)

1026-P: Impact of Online CME on Planned and Actual Practice Changes Related to CGM Use

Objective: Assess impact of online education to prompt changes in practice of diabetologists/endocrinologists (D/Es), PCPs and CDEs related to use of real-time continuous glucose monitoring (rtCGM) in practice. Method: Online summary of a symposium presented at the ADA 2021 Conference. Faculty presentation was reinforced with synchronized slides presenting supportive data. The impact of the education measured with a survey immediately post-education to assess planned changes in clinician practice as a result of participation in CME activity. Survey participants were contacted 8 weeks later to assess self-reported actual changes in practice. The activity launched August 3, 2021 and data were collected through June 29, 2022. Results: A total of 324 clinicians in the target audience completed the survey immediately post-education. • 74 D/Es, 141 PCPs, and 109 CDEs • 33% of D/Es, 10% of PCPs, and 17% of CDEs treat more than 30 patients per week with diabetes • 92% of respondents indicated an average of 3.1 planned practice changes each When re-engaged with the follow up survey, 15 completed the survey. • 6 D/Es and 9 PCPs • 67% of D/Es and 56% of PCPs treat more than 30 patients per week with diabetes • Of those, 93% reported making an average of 4.8 changes in practice as a result of this activity • Changes in practice include: o Recommending CGM in patients who want to improve time in range and minimize hypoglycemia (100% D/Es and 78% PCPs) o Recommending CGM in patients with diabetes on insulin (100% D/Es and 67% PCPs) o Increasing familiarity with clinical trial data related to CGM use (83% D/Es and 67% PCPs) o Target time in range with diabetes-related treatment goals (83% D/Es and 44% PCPs) Conclusion: The outcomes gathered in this assessment provide compelling evidence that participation in online CME prompts both planned and actual changes in practice related to CGM use. Future education is needed for PCPs regarding time in range goals as part of a diabetes treatment plan. Disclosure A.Larkin: None. J.Schrand: None. A.Le: None. Funding Dexcom, Inc.

360-OR: Continuous Glucose Monitoring–Guided Insulin Administration in Subjects with Type 2 Diabetes in Long-Term Care Facilities—A Randomized Clinical Trial

The efficacy of real-time continuous glucose monitoring (rt-CGM) in adjusting insulin therapy in long-term care facilities (LTCF) has not been evaluated. Accordingly, we randomized 100 insulin-treated subjects with T2D in LTCF. All subjects underwent point-of-care (POC) capillary glucose testing before meals and bedtime. Patients in the standard of care (POC group) wore a blinded Dexcom G6 CGM with treatment adjusted based on POC results; while in the rt-CGM group (Dexcom G6), treatment adjustment was based on daily CGM profile. Treatment adjustment was performed by the LTC medical team, with a target glucose of 140-180 mg/dL, and a duration of intervention up to 60 days. Primary endpoint was difference between groups in time in range (TIR, 70-180 mg/dL). Results: There were no significant differences in TIR (53.38%±30.16 vs 48.81%±28.03, p=0.40), mean daily glucose (185±44 vs 191 ±47 mg/dL, p=0.72), patients with % CGM values <54 mg/dL (0.23±0.8% vs 0.56±2.2 %, p=0.88), with a trend in reducing time below range (TBR <70 mg/dL) (0.83±2.6 % vs 1.18±3.5%, p= 0.51), between CGM and POC group. Conclusion: The results of this pilot randomized study indicate that the use of Dexcom G6 rtCGM is safe and effective in guiding diabetes therapy in long-term care facilities, resulting in a similar improvement in glycemic control (TIR) without differences in hypoglycemia. Disclosure T.Idrees: None. T.M.Johnson: Consultant; Astellas Pharma Inc., Research Support; Dexcom, Inc. L.Peng: None. G.Umpierrez: Research Support; Abbott, Dexcom, Inc., Baxter. I.A.Castro-revoredo: None. H.Oh: None. M.D.Gavaller: None. Z.Zabala: None. E.M.Moreno: None. B.Moazzami: None. R.J.Galindo: Consultant; Novo Nordisk, Eli Lilly and Company, Sanofi, Pfizer Inc., Bayer Inc., WW (Weight Watchers), Research Support; Novo Nordisk, Eli Lilly and Company, Dexcom, Inc. E.Cabb: None. Funding Dexcom, Inc. (IIS-2020-119_6X)

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.

112-LB: Proof-of-Concept Testing of an Artificial Intelligence–Based Fully Closed-Loop System in Hospitalized Patients with Diabetes

Objective: Achieving tight glucose control safely and effectively is challenging in the Intensive Care Unit (ICU). We conducted the first-in-human test of an artificial intelligence (AI)-based fully autonomous glucose control system in a simulated ICU setting. Methods: We admitted seven participants with type1 and type 2 (n=6) diabetes mellitus for 24-hour closed-loop glucose control sessions that included three unannounced meals. The AI-based system uses glucose control software that controls intravenous insulin and glucose infusions based on real-time continuous glucose monitoring derived data from two real-time CGM devices. The primary efficacy endpoint was the percentage of glucose values within the range of 70-180 mg/dL. The primary safety endpoint was the percentage of glucose values < 70 mg/dL. Results: Participants were on average 48±9.7 years-old, 71% female, and BMI 36±7.8 m/kg2. Mean time in the target range (70-180 mg/dl) was 87.8%. Mean time in the hypoglycemic range (< 70 mg/dL) was 0.2%, Figure. No adverse events occurred. Conclusion: This first in-human results show this novel fully autonomous closed-loop glucose control system designed for the ICU setting has the potential to achieve unparalleled glycemic control with minimal risk of hypoglycemia and paves the way for further research in the actual ICU setting. Disclosure F. Zahedi tajrishi: None. F. J. Pasquel: Consultant; Dexcom, Inc., Medscape, Research Support; Dexcom, Inc., Ideal Medical Technologies. G. Davis: Consultant; Medscape, Research Support; Insulet Corporation. M. Perez-guzman: None. L. I. Guerrero arroyo: None. G. Blanco: None. J. Varghese: None. S. Zahid: None. J. Dejournett: Stock/Shareholder; Ideal Medical Technologies. L. Dejournett: Employee; Ideal Medical Technologies. Funding Ideal Medical Technologies; Dexcom, Inc.

952-P: The Accuracy and Feasibility of Continuous Glucose Monitoring in COVID-19 Non-Critically Ill Hospitalized Patients—A Pilot Study

Background: Optimal glycemic control is associated with favorable outcomes in COVID-19 hospitalized patients. Frequent capillary blood glucose (CBG) monitoring is difficult to perform. Using continuous glucose monitoring (CGM) system to assist glycemic care can reduce the exposure of healthcare personnel and PPE usage. However, data on the accuracy of CGM in this setting are limited. Objective: To evaluate the accuracy and feasibility of real-time CGM (rt-CGM) in non-ICU hospitalized adult COVID-19 patients. Methods: This is a single-center prospective study of non-ICU hospitalized adult patients with COVID-19 infection who had hyperglycemia requiring insulin therapy during admission. Medtronic Guardian Connect rt-CGM sensor and transmitter were placed on the patient’s abdomen. Paired CBG and sensor glucose values were analyzed for accuracy of CGM using mean absolute relative difference (MARD) and Clarke Error Grid Analysis (CEGA). Results: Fifteen patients were enrolled. Mean age was 48.6 ± 17.9 years. Thirteen patients (86.7%) had pre-existing diabetes. Mean HbA1c was 10.6± 3.6%. Mean duration of CGM use was 6 ± 1.2 days and mean calibration was 2.6 ± 0.7 times/day. There were 253 paired CBG and CGM measurements. The overall MARD was 9.9 ± 9.3%. The lowest MARD was observed in the CBG range of 70-180 mg/dl (9.6 ± 9.0%). The percentages of glucose readings within ±15%/15 mg/dL, ±20%/20 mg/dL, and ±30%/30 mg/dL were 80.2%, 89.7%, and 95.3%, respectively. A total of 99.2% of the data points were in zone A and B of CEGA, and none were in zone E. Percent time in range on day 1 was 57.9 ± 22.9 and improved to 64.9 ± 18.1 in the last 72 hours of sensor wear. No adverse events from the CGM were observed. CGM reduced POC testing by 30%. Conclusions: Rt-CGM use in hospitalized patients with COVID-19 infection demonstrates high accuracy and potentially improves glucose control, reduces the frequency of CBG testing, and preserves medical resources. Disclosure C.Sakjirapapong: None. S.Sirinvaravong: None. L.Preechasuk: None. N.Thongtang: None. Funding Specific League Funds (R016421005)

230-OR: Hybrid Continuous Glucose Monitoring Protocols in the Intensive Care Unit—Multicenter Experience

There is limited experience with continuous glucose monitoring (CGM) in intensive care units (ICUs). We assessed the effectiveness, safety, and accuracy of real-time CGM use in COVID-19 ICUs. We pooled data from three academic centers using hybrid protocols combining point of care (POC) blood glucose (BG) with non-adjunctive CGM. At hospitals A and B, CGM was used non-adjunctively with POC at least every 6 hours. At hospital C, POC BG was performed every two hours. We also examined CGM performance during lowest pAO2, oxygen saturation, pH, and mean arterial pressure. Of 169 patients, mean age was 60.9±12.2 years, and 82%, 93%, and 62% received corticosteroids, mechanical ventilation, and vasopressors respectively. Median duration of IV insulin was 118, 156, and 50 hours at hospitals A, B, and C respectively. Mean POC BG frequency was 10.2±6.1, 7.0±5.2, and 16±6.5 times/day on day 1 of IV insulin and 6.7±3.1, 6.0±3.5, and 12.2±5.8 times/day thereafter. The median percent CGM time in range (TIR, 70-180mg/dl) was 72%, 70% and 46% during IV insulin. Median time <70mg/dl was <0.1% for all hospitals. The absolute relative difference between CGM and POC did not correlate with hemodynamic instability, Figure. This data indicates hybrid monitoring can reduce POC frequency while safely maintaining glucose. Sensor-meter agreement was not associated with abnormal physiologic parameters and requires further study. Disclosure E.R.Faulds: Advisory Panel; Dexcom, Inc., Other Relationship; A1Control, LLC, Research Support; Dexcom, Inc., Speaker's Bureau; Dexcom, Inc., Medscape. M.Garcia: None. S.Chandra: None. F.J.Pasquel: Consultant; Dexcom, Inc., Medscape, Research Support; Dexcom, Inc., Ideal Medical Technologies. K.M.Dungan: Board Member; Elsevier, Consultant; Eli Lilly and Company, Dexcom, Inc., Other Relationship; UpToDate, Research Support; Dexcom, Inc., Abbott, ViaCyte, Inc., Sanofi, Speaker's Bureau; Academy for Continued Healthcare Learning, Cardiometabolic Health Congress, Medscape, Integritas. Y.Badakhshi: None. A.Boutsicaris: None. M.C.Exline: Other Relationship; Abbott Nutrition. J.Hester: None. L.G.Jones: None. M.Mcnett: Research Support; Dexcom, Inc., National Institutes of Health. J.D.Miller: Advisory Panel; MannKind Corporation, Employee; Medtronic, Research Support; Dexcom, Inc. R.Shah: None.

252-OR: Continuous Glucose Monitoring in Patients with Post-bariatric Hypoglycemia Reduces Hypoglycemia and Glycemic Variability

Post-bariatric hypoglycemia (PBH) is an increasingly recognized complication of bariatric surgery, with prevalence of up to 36% after gastric bypass. Hypoglycemia typically follows postprandial glycemic spikes. Continuous glucose monitors (CGM) can alert patients to high or low sensor glucose (SG), allowing treatment and prevention of severe hypoglycemia. The aim of this study (NCT03353415) was to determine whether CGM, currently indicated only for diabetes, could reduce hypoglycemia in PBH. In an open label, nonrandomized, pre-post design, sensor glucose data were collected using Dexcom CGM in two sequential phases: (1) masked (no access to SG or alarms); and (2) unmasked (access to SG and alarms for low or rapidly declining SG). Data were available for paired analysis for 22 individuals with PBH (mean±SD age 51.1±13.0 yrs, 20F/2M, BMI 30.6±6.2 kg/m2, 82% with level 3 hypoglycemia and 100% with neuroglycopenia). Participants with PBH spent a lower percentage of time in hypoglycemia with unmasked vs masked CGM (<60 mg/dL, median [MAD]: 0.7 [0.8] vs 1.4 [1.7]%, p=0.03; <70 mg/dL: 2.9 [2.5] vs 4.7 [4.8]%, p=0.04), with similar trends overnight. Likewise, there was more time between 70-180 mg/dL (94.8 [3.9] vs 90.8 [5.2]%, p=0.004), and lower glycemic variability (mean amplitude of glycemic excursion: 74.0 [17.7] vs 79.6 [17.8] mg/dL, p=0.04) during unmasked wear. During the day (6:00 AM-11:59 PM), participants spent more time in normoglycemia with unmasked CGM (94.2 [4.8] vs 90.9 [6.2]%, p=0.005), largely due to reduced hyperglycemia (>180 mg/dL: 1.9 [2.2] vs 3.9 [3.6]%, p=0.02). Availability of real-time CGM data and alarms is associated with reductions in low SG, elevated SG, and glycemic variability. This suggests CGM helps patients detect hyperglycemic peaks and imminent hypoglycemia, allowing dietary modification and self-treatment to reduce hypoglycemia. CGM may thus improve safety in PBH, particularly for patients with hypoglycemia unawareness. Disclosure C.J.Cummings: None. A.Jiang: None. A.L.Sheehan: None. R.Ferraz-bannitz: None. A.Puleio: None. D.C.Simonson: Stock/Shareholder; Phase V Technologies, Inc., GI Windows. J.Dreyfuss: None. M.Patti: Consultant; MBX Biosciences, AstraZeneca, Hanmi Pharm. Co., Ltd., Other Relationship; Fractyl Health, Inc. Funding Diabetes Research Center (P30DK036836)

1040-P: Feasibility and Performance of Continuous Glucose Monitoring (CGM) to Guide Computerized Insulin Infusion Therapy in Cardiovascular Intensive Care Unit (CV-ICU)

We evaluated the utility of real-time CGM for titrating intravenous (IV) insulin via a validated institutional computerized insulin infusion (CII) algorithm in the CV-ICU. We used a hybrid approach of combining CGM with periodic point-of-care blood glucose (POC-BG) tests to validate the continued accuracy of CGM. We also surveyed nurses on this care change. Dexcom G6 CGMs were applied to 61 post-surgical patients with hyperglycemia (34% with diabetes) receiving IV insulin. CGM values were validated with POC-BG every(Q) 1-2 h per the CII protocol. Once validated (i.e., within 20% of POC-BG values if BG ≥100 mg/dL or within 20 mg/dL if BG <100 mg/dl), sensor values were then used to titrate IV insulin doses per CII algorithm. POC-BG checks were then reduced to Q6h validation. Among 857 paired POC-BG and CGM values analyzed, the mean and median average relative difference between POC-BG and CGM values were 13.2% and 9.8%, respectively. 99.6% of paired CGM and POC-BG were in Zone A and B of the Clarke Error Grid (Figure). Thirty nurse respondents found CGM very or quite convenient (n=28; 93%) and favored it over POC-BG testing (n=28; 93%). This pilot study demonstrates that using CGM via a hybrid approach for CII titration protocol is feasible, has high accuracy, and higher nursing convenience. Disclosure L.Ang: None. Y.Qu: None. R.Freeman: None. N.H.Esfandiari: None. R.Busui: Board Member; American Diabetes Association, Consultant; Averitas Pharma, Inc., Lexicon Pharmaceuticals, Inc., Nevro Corp., Novo Nordisk, Roche Diagnostics, Procter & Gamble, Research Support; Novo Nordisk, Medtronic, National Institutes of Health. R.Gianchandani: None. F.Akanbi: None. L.F.Schroeder: None. Y.Lin: None. C.A.Degeorge: None. P.Arnold: None. S.Knotts: None. E.Dubois: None. N.Desbrough: None.

677-P: Exploring the Impact of CGM on Perceived Control of Non-Intensive Insulin Treated Type 2 Diabetes—“I liked keeping my line with as few spikes as possible”

Background and Aims: Progression of type 2 diabetes (T2D) demands complex treatment modalities, which may impair patients’ confidence and psychological health. Technologies allowing improved understanding of the dynamic disease process may improve engagement with therapy. Methods: As part of a larger observational study, we previously reported findings highlighting the impact of using Dexcom G6 real-time CGM (rtCGM) with T2D adults (diverse therapies) and prediabetes over a 12-week period. We now explored qualitative data generated from a subsample of T2D participants (N=38) on non-intensive insulin therapy (Basal only=24%, No insulin=76%). Participants answered open-ended questions about their experiences using CGM including self-reported learnings and changes in behavior. Primary themes from qualitative data were derived using content analysis and confirmed with inter-coder reliability. Results: Overall, most participants (>90%) ended the study with high levels of perceived control (PC) of their diabetes. For further analysis, participants’ change in PC at study end were plotted based on low, medium, or high PC before CGM use. Interesting group differences emerged wherein fewer participants reporting medium PC at baseline reported high PC at study end (vs. others with low and high baseline PC). Qualitative themes around perceived illness severity, depressive symptoms, and self-efficacy along with differences in demographics and glycemic metrics helped translate these meaningful findings. Conclusions: rtCGM use provided valuable improvements in participants’ engagement and understanding of their diabetes with potential for long-term clinical benefits. Future studies exploring relationships between perceived control of diabetes and progression of T2D may indicate potential areas for improved engagement with diabetes technology. Disclosure M.A.Crawford: Employee; Dexcom, Inc. C.Hicks: Employee; Dexcom, Inc. P.Genge: Employee; Dexcom, Inc. K.Greenawald: Employee; Dexcom, Inc. M.Tressler: Employee; Dexcom, Inc. D.R.Cherñavvsky: None. H.Singh: Employee; Tandem Diabetes Care, Inc., Dexcom, Inc. Funding Dexcom, Inc.