Use Of rtCGM Research Articles

Are we Ready for Real-Time Continuous Glucose Monitoring in the Hospital Setting? Benefits, Challenges, and Practical Approaches for Implementation : Case Vignette: Remote Real-Time Continuous Glucose Monitoring for Hospitalized Care in Quincy Koala.

While preliminary evidence for use of real-time continuous glucose monitoring (rtCGM) in the hospital setting is encouraging, challenges with currently available devices and technology will need to be overcome as part of real-world integration. This paper reviews the current evidence and guidelines regarding use of rtCGM in the hospital and suggests a practical approach to implementation. There is now a considerable body of real-world evidence on the benefits of reducing dysglycemia in the hospital using both traditional point-of-care (POC) glucose testing and rtCGM. Benefits of rtCGM include decreased frequency of hypo- and hyperglycemia with reduced need of frequent POC checks and it is both feasible and well-accepted by nursing staff and providers. If expansion to additional sites is to be considered, practical solutions will need to be offered. Recommendations for an operational workflow and tools are described to guide implementation in the non-ICU setting. Further testing in randomized controlled trials and real-world dissemination and implementation designs is needed, together with industry and technology collaborations, to further streamline the integration into health systems.

Cost-utility of real-time continuous glucose monitoring versus self-monitoring of blood glucose in people with insulin-treated Type II diabetes in France.

Aim: Clinical trials and real-world data for Type II diabetes both show that glycated hemoglobin (HbA1c) levels and hypoglycemia occurrence can be reduced by real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG). The present cost-utility study investigated the long-term health economic outcomes associated with using rt-CGM versus SMBG in people with insulin-treated Type II diabetes in France. Materials & methods: Effectiveness data were obtained from a real-world study, which showed rt-CGM reduced HbA1c by 0.56% (6.1mmol/mol) versus sustained SMBG. Analyses were conducted using the IQVIA Core Diabetes Model. A French payer perspective was adopted over a lifetime horizon for a cohort aged 64.5years with baseline HbA1c of 8.3% (67mmol/mol). A willingness-to-pay threshold of €147,093 was used, and future costs and outcomes were discounted at 4% annually. Results: The analysis projected quality-adjusted life expectancy was 8.50 quality-adjusted life years (QALYs) for rt-CGM versus 8.03QALYs for SMBG (difference: 0.47QALYs), while total mean lifetime costs were €93,978 for rt-CGM versus €82,834 for SMBG (difference: €11,144). This yielded an incremental cost-utility ratio (ICUR) of €23,772 per QALY gained for rt-CGM versus SMBG. Results were particularly sensitive to changes in the treatment effect (i.e., change in HbA1c), annual price and quality of life benefit associated with rt-CGM, SMBG frequency, baseline patient ageand complication costs. Conclusion: The use of rt-CGM is likely to be cost-effective versus SMBG for people with insulin-treated Type II diabetes in France.

Cost-utility of real-time continuous glucose monitoring versus self-monitoring of blood glucose in people with insulin-treated Type 2 diabetes in Canada.

Aim: Clinical trials and real-world data for Type 2 diabetes have shown that real-time continuous glucose monitoring (rt-CGM) lowers glycated hemoglobin (A1c) and reduces hypoglycemia relative to self-monitoring of blood glucose (SMBG). This analysis examined the long-term health and economic outcomes associated with using rt-CGM versus SMBG in people with insulin-treated Type 2 diabetes in Canada. Materials & methods: Clinical data were sourced from a real-world study, in which rt-CGM reduced A1C by 0.56% versus continued SMBG. The analysis was performed using the IQVIA Core Diabetes Model, from a Canadian payer perspective over a lifetime horizon for a cohort aged 65 years with an A1C of 8.3% at baseline. Future costs and clinical outcomes were discounted at 1.5% annually. Results: Projected total mean lifetime costs were CAD 207,466 for rt-CGM versus CAD 189,863 for SMBG (difference: CAD 17,602) and projected mean quality-adjusted life expectancy was 9.97 quality-adjusted life years (QALYs) for rt-CGM versus 9.02 QALYs for SMBG (difference: 0.95 QALYs), resulting in an incremental cost-utility ratio (ICUR) of CAD 18,523 per QALY gained for rt-CGM versus SMBG. Findings were sensitive to changes in the A1C treatment effect, annual cost and quality of life benefit associated with using rt-CGM, SMBG frequency, and baseline age, but ICURs remained below CAD 50,000 per QALY in all analyses. Conclusion: For people in Canada with insulin-treated Type 2 diabetes and poor glycemic control, use of rt-CGM is likely to be cost-effective relative to SMBG.

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.

Study protocol: glycaemic outcomes in people with type 2 diabetes initiating continuous glucose monitoring: the 2GO-CGM study

PurposeImproving glycaemic control in type 2 diabetes (T2D) is essential to reducing social and health-economic burden of diabetes-related complications. Continuous glucose monitoring (CGM) has been established as beneficial in improving glycaemic control and reducing hypoglycaemia in people with type 1 diabetes, however data in T2D is limited. This study has been designed to assess the effect of initiating real-time CGM (rtCGM) on glycaemic control in a high-risk population of adults with T2D. Secondary objectives are to assess the cost-effectiveness and safety of rtCGM, and the effects of rtCGM on diet/lifestyle and the burden of diabetic complications, including cardiovascular risk.MethodsThis multicentre randomised controlled trial (RCT) will be conducted at three sites in New Zealand (Waikato, Christchurch and Dunedin). Eighty adults with T2D on insulin with suboptimal glycaemic control (HbA1c > 8.0% or 64 mmol/mol) will be randomised 1:1 to rtCGM or routine care with self-monitoring of blood glucose levels (SMBG) for three months. This intervention phase will be followed by a three-month continuation phase where SMBG group crossover to use rtCGM. Participants will then be invited to join the extension phase with continued use of rtCGM for a further 12 months. During the extension phase, both groups will independently titrate their insulin under the remote supervision of prescribing diabetes nurse specialists following an insulin titration algorithm. The primary outcome of the study is time in target glucose range (3.9–10 mmol/L or 70–180 mg/dL; TIR). Secondary outcomes include CGM metrics as per consensus statement recommendations, and HbA1c. Additional planned analyses include cardiovascular risk profile, incremental cost-effectiveness analyses, dietary patterns, and qualitative analyses.Trial registration numberThe trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621000889853) on 8 July 2021 and the World Health Organisation International Clinical Trial Registry Platform (Universal Trial Number U1111–1264-5822).

Levelling up: should all continuous glucose monitoring systems be available on prescription in the NHS?

Dear Editor, the launch of the FreeStyle Libre intermittently scanned continuous glucose monitoring system (also known as Flash or isGCM) on prescription in November 2017 and subsequently Libre 2 has brought about a paradigm shift in the widespread availability of CGM for people living with type 1 diabetes (T1D) in the UK.1 Libre has been available for self-funding since 2014 and real-time (rt) CGM has been around commercially for a decade or so before this.2 Strong clinical leadership from Professor Partha Kar and colleagues from the Diabetes Technology Network along with campaigning from patient organisations have undoubtedly accelerated and catalysed this change with over 69% of the English population of people living with T1D being prescribed a Libre, and – with the exception of two (out of 42) integrated care systems – all other systems have at least half of their population of people living with T1D on Libre from almost zero five years earlier.3 This growth occurred prior to the publication of 2022 NICE guidance (NG17)4 recommending all forms of CGM be offered to all people living with T1D. Previous NHS England guidelines suggested about 20% of the T1D population would be eligible for FreeStyle Libre and funding for sensors up to this number of patients was available centrally for a limited time. National Diabetes Audit data for rtCGM from 2020–215 (until recently rtCGM was not available on prescription at all) show that the majority of specialist adult diabetes care providers in England had none or a miniscule percentage of their patients using rtCGM; many of these same units had large numbers of people using FreeStyle Libre. (See Figure 1.) These data would suggest that there were (and still may be) large parts of the country where, for adults with T1D, rtCGM was (or still may be) either not available or difficult to access. The data would further suggest that there is an even greater variation in the use of rtCGM than there is with FreeStyle Libre. The recent update to NG174 on the use of all forms of CGM has undoubtedly encouraged companies to include some of their rtCGM products on prescription, but not all. At present there appears to be inconsistent, non-transparent and often complicated local schemes for providing access to many rtCGM systems. This makes delivery on the promise of NG17 unnecessarily difficult -- especially in terms of giving people with T1D a genuine choice in the device they use to monitor their glucose levels. If we are to fully meet the glucose monitoring needs of our adult population of people with T1D, surely the time has come for all CGM systems to be available on prescription. This would create a level playing field for people living with diabetes and those who provide their care, thereby affording access based on NICE 2022 criteria in keeping with the founding principles of the NHS. There are no conflicts of interest declared.

Real-Time Continuous Glucose Monitoring Reduced Costly Diabetes-Related Events in Adolescents and Young Adults despite Lack of Short-Term Reduction in Hemoglobin A1c

Real-time continuous glucose monitoring (rtCGM) can directly improve patient outcomes, including decreased health care system utilization and associated costs. The purpose of this study was to evaluate the clinical benefits of rtCGM use in a high-risk, under-resourced cohort of adolescents and young adults (AYA) with type 1 diabetes (T1D) who had no prior access to rtCGM. The effects of rtCGM use on hemoglobin A1c (A1c) and the frequency of health care events (i.e., diabetes-related emergency room (ER) visits, hospitalizations, emergency medical services (EMS), and after-hour emergency calls) were evaluated regarding payor costs in 33 AYA with ≥70% rtCGM use. Secondary aims included the evaluation of a phone-based pattern management intervention. The frequency of health care events decreased at 12 and 24 weeks for all participants, and there was no significant difference by treatment group. We estimated that the use of rtCGM in this cohort results in a projected annualized cost-savings of $195,943 to $294,864 or 43–65% per year based on Medicare or list pricing for rtCGM, respectively. Results also revealed improvements in A1c at 12 weeks for all study participants, but this was not maintained at 24 weeks for the phone-based pattern management intervention group. Our findings suggest that rtCGM may be an effective tool for reducing diabetes-related events and underscores the importance of access. Future studies are needed to further examine tailored interventions and support to optimize rtCGM use and glycemic health in high-risk AYA.

Effect of switching from intermittently scanned to real-time continuous glucose monitoring in adults with type 1 diabetes: 24-month results from the randomised ALERTT1 trial

Comparing Continuous With Flash Glucose Monitoring In Adults With Type 1 Diabetes (ALERTT1) examined whether switching from first-generation intermittently scanned continuous glucose monitoring (isCGM) without alerts to real-time continuous glucose monitoring (rtCGM) with alert functionality offers additional benefits to adults with type 1 diabetes. The extension of the randomised ALERTT1 trial assessed the effect of switching from isCGM to rtCGM up to 24 months. In this 6-month, double-arm, parallel-group, non-masked, randomised, controlled trial, done across six hospitals in Belgium, 254 adults aged 18 years or older with type 1 diabetes previously using isCGM were randomly assigned (1:1) to rtCGM with alerts (intervention; n=127) or isCGM without alerts (control; n=127). Upon completion of the 6-month trial, the control group switched to rtCGM (is-rtCGM group), and the intervention group continued rtCGM (rt-rtCGM group). The extension focused on within-group changes in time in range (TIR; 3·9-10·0 mmol/L; primary outcome), HbA1c, time in clinically significant hypoglycaemia (<3·0 mmol/L), and Hypoglycaemia Fear Survey worry (HFS-worry) score (all prespecified key secondary outcomes). Mean within-group change versus the start of rtCGM is reported, with a positive value referring to a lower value at start of rtCGM. This trial is registered at ClinicalTrials.gov (NCT03772600). 119 participants were assigned to the is-rtCGM group of whom 112 (94%) completed the 24-month trial, and 123 participants were assigned to the rt-rtCGM group of whom 117 (95%) completed the 24-month trial. TIR increased from 51·8% (95% CI 49·1-54·5) at start of rtCGM (month 6) to 63·5% (60·7-66·3) at month 12 in the is-rtCGM group, and remained stable up to month 24 (change 11·7 percentage points [pp] [9·4-14·0; p<0·0001). In the rt-rtCGM group, TIR increased from 52·5% (95% CI 49·8-55·1) at start of rtCGM (month 0) to 63·0% (60·3-65·8) at month 12, also remaining stable up to month 24 (change 10·5 pp [8·2-12·8]; p<0·0001). HbA1c decreased from 7·4% (57 mmol/mol; month 6) to 6·9% (52 mmol/mol) at month 24 (change -0·54 pp [95% CI -0·64 to -0·44]; -5 mmol/mol [95% CI -6 to -4]; p<0·0001) in the is-rtCGM group, and from 7·4% (57 mmol/mol; month 0) to 7·0% (53 mmol/mol) at month 24 (change -0·43 pp [95% CI -0·53 to -0·33]; -4 mmol/mol [95% CI -5 to -3]; p<0·0001) in the rt-rtCGM group. The change in HFS-worry score was -2·67 (month 24 vs month 6; p=0·0008) in the is-rtCGM group and -5·17 points (month 24 vs month 0; p<0·0001) in the rt-rtCGM group. Time in clinically significant hypoglycaemia was unchanged in both groups after month 12. Severe hypoglycaemia decreased from 31·0 to 3·3 per 100 patient-years after switching to rtCGM. Glycaemic control and hypoglycaemia worry improved significantly up to 24 months after switching from isCGM without alerts to rtCGM with alerts, supporting the use of rtCGM in the care of adults with type 1 diabetes. Dexcom.

Continuous Glucose Monitoring in Pediatric Diabetic Ketoacidosis.

Use of real-time continuous glucose monitoring (rtCGM) in ambulatory settings improves overall glycemic control and reduces the incidence of diabetic ketoacidosis (DKA) in adults and children/adolescents with type 1 diabetes (T1D). However, the use of rtCGM in children with DKA has not been well studied. This prospective, single-arm, single-center study assessed the accuracy, reliability, and feasibility of a commercially available rtCGM device compared with point-of-care (POC) capillary and serum glucose values in pediatric patients admitted to the pediatric intensive care unit for DKA. The primary outcome was the accuracy of rtCGM glucose values compared with POC capillary and serum glucose values during standard treatment of DKA as assessed by Clarke Error Grid (CEG) analysis. Secondary outcomes were assessment of the relationship between rtCGM readings and degree of acidosis and mean length of hospital stay (LOS). Data from 35 hospitalized children (mean ± SD age, 11.9 ± 4.1 years) with DKA were included in our analysis. Five hundred twenty-four time-matched glucose values between serum glucose and rtCGM and 91 time-matched glucose values between POC capillary glucose and rtCGM were obtained. The effect of acidosis on accuracy CEG analysis showed 95.4% of the 524 matched CGM/POC pairs and 95.6% of the 91 matched CGM/serum glucose pairs in the clinically acceptable A + B zones. The average LOS was 1.32 ± 0.73 days. Serum bicarbonate level did not appear to affect the accuracy of rtCGM in the setting of DKA. Continuous glucose monitoring use in inpatient pediatric DKA treatment was found to be feasible and reliable.

Continuous Glucose Monitoring: An Opportunity for Population-Based Diabetes Management.

The increasing prevalence of prediabetes and diabetes in the United States poses a serious threat to the health of the population. Closely associated with obesity, hypertension, dyslipidemia, and cardiovascular disease, a diagnosis of diabetes or prediabetes carries with it life-altering demands. Critically important among these is the requirement for frequent glucose level checks-typically performed with blood obtained from a fingerstick. Innovative real-time continuous glucose monitoring (rtCGM) technology makes it possible for patients and their clinicians to receive continuous glucose level measurements around the clock without finger sticks. Accruing evidence shows that rtCGM is an effective tool for patients and their clinicians in managing diabetes (ie, maintaining glucose levels within the recommended target range) and in understanding how lifestyle behaviors directly influence glucose levels. In recent years, a number of large payer organizations (eg, private health insurers, employers) have incorporated rtCGM in their diabetes management programs as a means of addressing the dual challenge of achieving/maintaining control of glucose levels and preventing or delaying the onset of complications. Programmatic integrated approaches have been used successfully and cost-effectively for managing other chronic conditions. Incorporating rtCGM in similar integrated approaches in diabetes management may be of value in improving quality outcomes and reducing costs on a population level. The evidence supports broader adoption and continued study to evaluate models that incorporate the use of rtCGM.

Diabetes: the role of continuous glucose monitoring.

Diabetes mellitus is a chronic condition affecting 1 out of every 11 people worldwide. Monitoring of blood glucose allows for therapeutic lifestyle and pharmacotherapy changes to reduce the occurrence of hyperglycaemia and hypoglycaemia. Advancements in technology over the past two decades have increased patient and clinician access to glucose data and trends with continuous glucose monitoring (CGM) systems. This narrative review seeks to investigate the efficacy and safety of CGM for the management of diabetes. In type 1 diabetes (T1DM) and type 2 diabetes, efficacy studies of real-time CGM (rtCGM) or intermittently scanned CGM (isCGM) have shown a decrease in HbA1C (0.3–0.6%) over traditional self-monitoring blood glucose. Percent time in the target glucose range also improved (6.8–17.6%). Rates of hypoglycaemia, including severe hypoglycaemia, decreased in studies of rtCGM and isCGM with most available data in T1DM. In pregnant women with T1DM, rtCGM has shown modest improvements in HbA1C and time in target glucose range and decreased risk of neonatal complications. Multiple studies have shown that the use of rtCGM or isCGM increased diabetes treatment satisfaction amongst patients. Head-to-head studies of rtCGM and isCGM are limited but one study indicates that a CGM system with alarms may be preferred in T1DM to reduce the risk of hypoglycaemia. Selection of a CGM device should depend on patient-specific factors and insurance coverage. The results of one study show that the benefits of CGM device use were not sustained after discontinuing use. Increasing widespread and long-term access to CGM devices is necessary to improve the management of diabetes amongst the greater population.

70-LB: Lower A1C with Real-Time CGM than with Intermittently-Scanned CGM after One Year—The CORRIDA LIFE Study

We investigated the efficacy of real-time continuous glucose monitoring (rtCGM) and intermittently scanned continuous glucose monitoring (isCGM) on change in A1C. CORRIDA LIFE was a 12 month, real-world, non-randomized trial that assessed the impact of rtCGM (Dexcom G5 or G6) vs. isCGM (FreeStyle Libre 14-Day, Abbott) on A1C and other CGM metrics in adults with T1D. Patients on MDI therapy or CSII with no automatic functions were included. One hundred ninety-one adults with T1D (mean age 40±13 years, A1C 8.1±3.4% [65±14 mmol/mol]) participated in this study; 81 patients initiated rtCGM and 110 initiated isCGM. After 12-months, A1C was significantly lower with rtCGM vs. isCGM (7.1±3.1% [54.1±10.1 mmol/mol] vs. 7.7±3.3% [61.2±12.2 mmol/mol]) , p=0.0001. (Figure 1) The percentage of time in hypoglycemia (&amp;lt;70 mg/dL [&amp;lt;3.9 mmol/L]) was lower among rtCGM vs. isCGM participants (4.3±2.8% vs. 6.4±5.3%) , p=0.003) . Patients with rtCGM spent less time in clinically significant hypoglycemia (&amp;lt;54 mg/dL [&amp;lt;3.0 mmol/L]) (0.9±1.0% vs. 2.3±2.5%, p&amp;lt;0.0001) and more time in target range (70-180 mg/dL [3.9-10 mmol/L]) than isCGM users (67.5±14.8% vs. 57.8±17.0%) , p=0.0002. Use of rtCGM was superior to isCGM in reducing A1C and hypoglycemia and improving other glycemic outcomes. Disclosure L. Radovnická: Consultant; Medtronic, Speaker’s Bureau; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi. M. Prazny: Advisory Panel; Bayer AG, Consultant; Boehringer Ingelheim International GmbH, Speaker’s Bureau; Abbott Diabetes, Amgen Inc., Eli Lilly and Company, Medtronic, Merck Sharp &amp; Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk, Sanofi. J. Soupal: Advisory Panel; Abbott Diabetes, Roche Diabetes Care, Speaker’s Bureau; Boehringer Ingelheim International GmbH, Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk. A. Hásková: None. Q. Do: None. E. Horova: None. V. Navrátilová: None. O. Mikes: None. D. Cihlár: None. C. Parkin: Consultant; Abbott Diabetes, CeQur SA, Dexcom, Inc., LifeScan, MannKind Corporation, Novo Nordisk, Provention Bio, Inc., Roche Diabetes Care. G. Grunberger: Advisory Panel; LifeScan, Nevro Corp., Research Support; Medtronic, Speaker’s Bureau; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk. Funding Ministry of Health, Czech Republic, General University Hospital in Prague

The effect of do-it-yourself real-time continuous glucose monitoring on psychological and glycemic variables in children with type 1 diabetes: A randomized crossover trial.

BackgroundContinuous glucose monitoring (CGM) decreases fear of hypoglycemia (FOH) and improves glycemic control among those affected by type 1 diabetes (T1D). No studies to date have examined the impact of using do‐it‐yourself real‐time continuous glucose monitoring (DIY RT‐CGM) on psychological and glycemic outcomes.MethodsChild–parent dyads were recruited for a multicentre randomized crossover trial. Children with T1D were current intermittently scanned CGM (isCGM) users and aged 2–13 years. Families received either 6 weeks of DIY RT‐CGM with parental remote monitoring (intervention) or 6 weeks of isCGM plus usual diabetes care (control), followed by a 4‐week washout period, then crossed over. The primary outcome was parental FOH. Secondary outcomes were glycemic control using traditional CGM metrics, as well as a range of other psychosocial measures.FindingsFifty five child–parent dyads were recruited. The child mean age was 9.1 ± 2.8 years. Although, there was no effect on parental FOH, −0.1 (95%CI: −0.3, 0.1, p = 0.4), time‐in‐range (TIR) (%3.9‐10 mmol/L) was significantly higher with DIY RT‐CGM over isCGM (54.3% ± 13.7 vs. 48.1% ± 13.6), mean difference, 5.7% (95%CI 1.8, 9.6, p <0.004). There was no difference for time spent in hypoglycemia. Parent diabetes treatment satisfaction was significantly higher following DIY RT‐CGM compared to isCGM, mean difference 5.3 (95%CI: 2.3, 8.2, p <0.001).ConclusionThe use of DIY RT‐CGM versus isCGM did not improve parental FOH; however, TIR and parental satisfaction with diabetes treatment were significantly improved. This suggests in the short term, DIY RT‐CGM appears safe and may offer families some clinically important advantages over isCGM.

614-P: Success of CME at Improving Knowledge of Clinical Use of Real-Time CGM

We sought to determine if an online continuing medical education (CME) activity could improve knowledge and competence of diabetologists/endocrinologists (D/Es) and primary care physicians (PCPs) related to clinical use of rtCGM. The effect of an online, 15-minute, CME-certified summary of a satellite symposium was analyzed to determine efficacy. A repeated pairs pre-/post-assessment study design was used and chi-squared test (5% significance level, P &amp;lt;.05) assessed educational effect. Cramer's V was used to calculate the effect size (0.06-0.15 is a noticeable effect, 0.16-0.26 considerable, and &amp;gt;0.26 extensive). The activity posted June 22, 2020, and data were collected through October 14, 2020. Matched learner data indicate that overall, 19% of D/E learners' (N=234) and 26% of PCP learners' (N=241) responses improved from pre-to-post (both P&amp;lt;.001) with a considerable effect size of 0.164 and 0.205, respectively On a question-level: 15% of D/Es and 17% of PCPs improved at recognizing recent clinical trial data on the use of rtCGM in pregnant patients with T1D 24% of D/Es and 34% of PCPs improved at identifying appropriate TIR levels in patients with gestational diabetes Overall, 33% of D/Es and 46% of PCPs reported increased confidence in interpreting glucometric data from CGM device, for a total confidence shift of +11.4% and +23.3, respectively. Continued educational gaps: • 29% of both D/Es and PCPs did not recognize data on the use of rtCGM in pregnant T1D patients • 41% of D/Es and 49% of PCPs did not recognize appropriate TIR levels in gestational diabetes This study demonstrates the success of an online summary from a satellite symposium on improving knowledge and confidence of clinical use of rtCGM, with gaps identified for future education. Disclosure A. Larkin: None. J. Schrand: None. A. Le: None. Funding Dexcom, Inc.

62-LB: The Effect of Do-It-Yourself Real-Time Continuous Glucose Monitoring on Psychological and Glycaemic Variables in Children with Type 1 Diabetes: A Randomised Crossover Trial

Background: Continuous glucose monitoring (CGM) can decrease fear of hypoglycaemia (FOH) and improve glycaemic control among those affected by type 1 diabetes (T1D). No studies to date have examined the impact of using Do-It-Yourself Real-Time Continuous Glucose Monitoring (DIY RT-CGM) on psychological and glycaemic outcomes. The primary aim of this study was to investigate the effect of DIY RT-CGM compared to intermittently scanned CGM (isCGM) on parental FOH. Methods: Child-parent dyads were recruited for this multicentre randomised crossover trial. Children with T1D were aged 2-13 years and were current isCGM users. Families had 6 weeks of using DIY RT-CGM with parental remote monitoring (intervention) and 6 weeks of isCGM plus usual diabetes care (control) in a random order with a four-week washout period. FOH was assessed by the hypoglycaemia fear survey. Standard CGM based glycaemic variables were collected via Tidepool. Parental satisfaction was assessed by the diabetes treatment satisfaction questionnaire (DTSQ). Results: The study included 55 child-parent dyads; child mean age 9.1±2.8 years. There was no evidence of an effect on parental FOH, -0.1 (95% CI: -0.3, 0.1, p-value 0.4). Time-in-range (%3.9-10mmol/L) favoured DIY RT-CGM over isCGM (54.3%±13.7 vs. 48.1%±13.6), adjusted mean difference, 5.7% (95% CI 1.8, 9.6, p-value 0.004). There was no evidence of a difference between DIY RT-CGM and isCGM for time spent in hypoglycaemia. Parents reported higher DTSQ scores following DIY RT-CGM compared to isCGM, adjusted mean difference 5.3 (95% CI: 2.3, 8.2, p-value &amp;lt;0.001). Conclusion: The use of DIY RT-CGM versus isCGM did not improve parental FOH, however time in range and parental satisfaction with diabetes treatment were significantly improved, suggesting DIY RT-CGM with remote monitoring may offer families clinically important benefits over isCGM in regards to these aspects of T1D management. Disclosure M. Elbalshy: None. B. J. Wheeler: Research Support; Self; Dexcom, Inc., i-SENS, Inc., Medtronic, Ypsomed Group. S. Styles: None. J. J. Haszard: None. B. Galland: None. H. Crocket: None. C. A. Jefferies: None. E. Wiltshire: None. P. Tomlinson: None. M. De bock: None.

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.

Type 2 Diabetes and the Use of Real-Time Continuous Glucose Monitoring.

The role of continuous glucose monitoring (CGM) in type 1 diabetes (T1D) is well established in improving glycemic control and reducing hypoglycemia. Type 2 diabetes (T2D) is more prevalent than T1D and management of T2D is more heterogeneous, requiring treatment ranging from lifestyle modification to oral medications to intensive insulin therapy. Recent randomized controlled trials in intensively insulin-treated T2D demonstrated the efficacy and safety of real-time CGM (rtCGM) in reducing glycated hemoglobin without increasing hypoglycemia. Although evidence is limited, early studies have indicated a role for rtCGM in selected patients with non-insulin requiring T2D to improve glycemic control and/or reduce hypoglycemia. Based on literature review, we summarized current data on the use of rtCGM in T2D management and provided future research direction to generate more evidence on the utility of CGM in this population.

Remote Application and Use of Real-Time Continuous Glucose Monitoring by Adults with Type 2 Diabetes in a Virtual Diabetes Clinic.

The Onduo Virtual Diabetes Clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists. Adults with T2D (n = 594) who were evaluated by a VDC endocrinologist, remotely prescribed and mailed a real-time continuous glucose monitoring (rtCGM) device and used ≥1 sensor completed a CGM satisfaction questionnaire. The CGM satisfaction score was 4.5 ± 0.8 out of 5. Most respondents (94.7%) agreed/strongly agreed that they were comfortable inserting the sensor remotely and that rtCGM use improved understanding of the impact of eating (97.0%), increased diabetes knowledge (95.7%), and helped improve diabetes control when not wearing the sensor (79.4%). HbA1c (n = 372) decreased from 7.7% ± 1.6% to 7.1% ± 1.2% (P < 0.001; 10.2 months). These data suggest that it is feasible to provide rtCGM directly to individuals with T2D through a VDC without in-office training. Intermittent use of rtCGM was well-received by adults with T2D and was associated with improvement in HbA1c.

Outcomes and Healthcare Provider Perceptions of Real-Time Continuous Glucose Monitoring (rtCGM) in Patients With Diabetes and COVID-19 Admitted to the ICU.

We assessed the clinical utility and accuracy of real-time continuous glucose monitoring (rtCGM) (Dexcom G6) in managing diabetes patients with severe COVID-19 infection following admission to the intensive care unit (ICU). We present retrospective analysis of masked rtCGM in 30 patients with severe COVID-19. rtCGM was used during the first 24 hours for comparison with arterial-line point of care (POC) values, where clinicians utilized rtCGM data to adjust insulin therapy in patients if rtCGM values were within 20% of point-of-care (POC) values during the masked period. An investigator-developed survey was administered to assess nursing staff (n = 66) perceptions regarding the use of rtCGM in the ICU. rtCGM data were used to adjust insulin therapy in 30 patients. Discordance between rtCGM and POC glucose values were observed in 11 patients but the differences were not considered clinically significant. Mean sensor glucose decreased from 235.7 ± 42.1 mg/dL (13.1 ± 2.1 mmol/L) to 202.7 ± 37.6 mg/dL (11.1 ± 2.1 mmol/L) with rtCGM management. Improvements in mean sensor glucose were observed in 77% of patients (n = 23) with concomitant reductions in daily POC measurements in 50% of patients (n = 15) with rtCGM management. The majority (63%) of nurses reported that rtCGM was helpful for improving care for patients with diabetes patients during the COVID-19 pandemic, and 49% indicated that rtCGM reduced their use of personal protective equipment (PPE). Our findings provide a strong rationale to increase clinician awareness for the adoption and implementation of rtCGM systems in the ICU. Additional studies are needed to further understand the utility of rtCGM in critically ill patients and other clinical care settings.

Practical Approach to Using Trend Arrows on Real-Time Continuous Glucose Monitoring System in Type 1 Diabetes Adolescents Living Camp Setting Treated With Multiple Daily Injection or Continuous Subcutaneous Insulin Infusion Insulin Therapy.

The aim of the study was to determine the effect of an educational intervention on the use of trend arrows of a real-time continuous glucose monitoring (rt-CGM) to manage daily therapy decisions in a group of adolescents with type 1 diabetes attending a camp. The secondary aim was to evaluate the variations in total daily dose (TDD) of insulin requirement. Twenty patients (15-17 years) on multiple insulin injections (n = 8) or continuous subcutaneous insulin infusion (n = 12) attended a training session at the beginning of the camp to learn our algorithm for the management of therapy depending on trend arrows. TDD, time in range (TIR), time above range (TAR), and time below range (TBR) (in the 24 hours and in the three hours after breakfast) before the training session (run-in) and at the end of the camp (T1) were analyzed. Data showed a reduction of TAR (run-in 42.6%, T1 32.05%, P = .036) and an increase in TIR (run-in 52.9%, T1 62.4%, P = .013). Reduction of TBR (run-in 42.5%, T1 37.5%, P = .05) and improvement in TIR (run-in 49.0%, T1 57.0%, P = .02) were also observed in the post-breakfast period. Data showed a significant reduction in the TDD (run-in 52.02 ± 17.44 U/die, T1 46.49 ± 12.39 U/die, P = .024). Statistically significant improvement of glycemic control and reduction of TTD were observed in all patients regardless of therapy type. The improvement between run-in and T1 demonstrates the importance of patients' education on the correct use of rt-CGM with simple algorithms for the management of therapy.