Continuous Glucose Monitors (CGM) automatically capture interstitial glucose levels every 5 minutes, 24 hours/day, allowing users to view their glucose levels in real-time and make informed decisions about how to manage diet, exercise, and medications. While CGMs are a central component in the glucose management of type 1 diabetes and insulin-dependent type 2 diabetes, less is known about the potential value of CGMs for diabetes prevention. The original Diabetes Prevention Program (DPP) demonstrated that 5-7% weight loss - an outcome reliant upon healthful eating and exercise - was more effective than medication in preventing or delaying the onset of T2D; however, subsequent DPP translations have not consistently achieved the same weight loss outcomes. CGM may represent a way to reinforce and incentivize hard-to-make health behavior changes in real-time that are crucial to the more distal (and often elusive) weight loss outcome. This small (n=7) feasibility pilot examined the preliminary effectiveness and acceptability of integrating CGM in a DPP at Scripps Health, a large, non-profit, private insurance-based health system in San Diego, CA. Following a brief introduction to the CGM and target glucose ranges, DPP participants self-inserted and wore the CGM for 2 weeks. Mean time-in-range (70-140 mg/dL) improved from 70.4% to 76.4%, and time > 140 mg/dL decreased from 29.4% to 23.1% during this period. Individual change in time-in-range ranged from -9.7% to + 38.8% (M ∆ = +6.0%). Participants reported high satisfaction with the CGM, but expressed a desire for more education on blood glucose management. Given these findings, a longer-term, randomized controlled trial is planned to investigate whether a CGM-enhanced DPP leads to greater weight loss than DPP alone. This research will also further our understanding of the potential benefit of improved glycemic control for diabetes prevention even among the subset of cases who do not ultimately achieve the targeted weight loss goal. Disclosure A.L. Fortmann: None. A. Bastian: None. S.R.S. Bagsic: None. I. Loupasi: None. K. Luu: None. A.R. Hottinger: None. K.A. Barry: None. M. Ruiz: None. C. Walker: None. A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Funding Confidence Foundation; Dexcom, Inc.
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.
Background: Glycemic control in the hospital setting is imperative for improving outcomes among patients with diabetes. Bedside point-of-care (POC) glucose monitoring has remained the gold standard for decades, while only providing momentary glimpses into a patient’s glycemic control. Continuous glucose monitoring (CGM) has been shown to improve glycemic control in the ambulatory setting. However, a paucity of inpatient experience and data remains a barrier to US Food and Drug Administration (FDA) approval and expanded/non-research use in the hospital setting. Method: Amid the COVID-19 pandemic, the FDA exercised its enforcement discretion to not object to the use of CGM systems for the treatment of patients in hospital settings to support COVID-19 health care–related efforts to reduce viral exposure of health care workers. Following this announcement, Scripps Health, a large not-for-profit health care system in San Diego, California, implemented CGM as the new “standard of care” (CGM as SOC) for glucose monitoring and management in the hospital. Results: The present report serves to (1) detail the implementation procedures for employing this new SOC; (2) describe the patients receiving CGM as SOC, their glycemic control, and hospital outcomes; and (3) share lessons learned over two years and nearly 900 hospital encounters involving CGM. Conclusions: Here, we conclude that CGM is feasible in the hospital setting by using a dedicated diabetes care team and the CGM technology with remote monitoring.
Hispanic individuals are disproportionally impacted by type 2 diabetes (T2D) and COVID-19 compared to non-Hispanic White individuals. Notably, T2D is associated with greater COVID-19 disease severity and mortality; however, with good glucose control, prognosis improves. During the COVID-19 pandemic, N=172 Hispanic patients with T2D hospitalized near the US/Mexico border in California were randomized to receive Dulce Digital-COVID Aware (DD-CA) texting platform or usual care. The DD-CA program provides culturally tailored, educational, and motivational text-messaging related to diabetes management and COVID prevention, remote glucose monitoring, and automated, tailored feedback on behavioral and glucose metrics for 6 months post-discharge. Participants were on average 58 ± 13 years, 52% male, 9.3% COVID+, with a mean BMI of 32.7 ± 8.2 and mean baseline HbA1c of 9.6% ± 2.2%. In unadjusted analyses, DD-CA did not reduce 30- or 90-day hospital readmission rates compared to usual care (28% vs 15%, p = 0.06; and 37% vs 35%, p = 0.9, respectively). Follow up HbA1c completion rates were low; however, HbA1c improvement was significantly greater among those in DD-CA compared to usual care at 3 months (n=56; −2.69% vs. −1.45%, p=0.05), with slight attenuation of effect at 6 months (n=64; −2.03% vs −0.91%, p=0.07). Given the reduction of in-person clinical care and emphasis on staying at home amid the pandemic, DD-CA represented an alternative pathway for delivering diabetes- and COVID-related education and support to high-risk individuals during this time. While the DD-CA intervention did not significantly impact readmission rates, it was effective in achieving a clinically significant, >1% greater improvement in HbA1c relative to usual care post-hospital discharge. Additional analyses will be presented on clinical and patient-reported outcomes. Disclosure S.R.Spierling bagsic: 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. O.M.Padilla neely: None. H.Sandoval: None. A.Bastian: None. R.Belasco: None. N.Orendain: None. E.Soriano: None. L.Talavera: None. A.L.Fortmann: Employee; Dexcom, Inc. Funding National Institutes of Health (R01DK112322-05S1)
Self-adjusting insulin is challenging for people with type 2 diabetes (PWT2D). Mobile health technologies (mHealth) can help PWT2D track blood glucose more easily, but it remains unclear whether an mHealth-enabled digital therapeutic tool can effectively support basal insulin (BI) titration in a large multispecialty health care setting. We randomized 242 PWT2D on BI (baseline HbA1c 7.5% - 12.5%) to use either an app-based self-titration tool [Mobile Insulin Dosing System (MIDS)] or an enhanced paper titration tool based on a stepped algorithm with diabetes educator support (control) for 16 weeks. Cohort characteristics for the intent to treat sample (MIDS n = 117; control n = 120) were: median age 61 years [IQR: 53 - 69], 41.7% female, 75.9% non-Hispanic White, 11.4% new to insulin, median duration of diabetes 11 years [IQR: 7 - 18], and median baseline HbA1c of 8.7% [IQR: 8.0 - 9.6]. Improvements in HbA1c (-1.3% [IQR: -2.2 - -.5] and -1.2% [IQR: -1.9 - -.5]; both Ps < .05) with increased median insulin dose (+8 IU [IQR: 2 - 22] and +10 IU [IQR: 2 - 25.5]; both Ps < .05) and no change in hypoglycemia were observed at 16 weeks in both the MIDS and control groups, respectively. No differences in HbA1c (P = .48) or insulin dose change (P = .34) were observed between the groups. Among SMBG readings recorded during the study, the mean proportion of readings between 70-180 mg/dL (76.8% ± 22.0; 70.0% ± 26.7; p<0.05) and >250 mg/dL (4.9% ± 9.2; 9.2% ± 18.4; p<0.05) both favored the MIDS group. The use of MIDS and the enhanced paper-based tool for BI self-titration both resulted in higher insulin dose and significantly improved glycemic control among PWT2D who were relatively uncontrolled despite most already being treated with insulin. An mHealth-enabled digital therapeutic tool such as MIDS may offer an effective alternative option for PWT2D and their HCPs for titrating BI to non-mHealth approaches; future RCTs will more clearly elucidate the efficacy of MIDS compared to usual care. Disclosure A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. A.L. Fortmann: None. A. Bastian: None. A. Kanchi: Employee; Self; Glooko, Inc. Stock/Shareholder; Self; Glooko, Inc. R. Abad: Employee; Self; Glooko, Inc. T. Sheng: Employee; Self; Glooko, Inc. L. Parks: Employee; Self; Glooko, Inc. M. Greenfield: Consultant; Self; Glooko, Inc. M.A. Clements: Consultant; Self; Glooko, Inc. Other Relationship; Self; Glooko, Inc.
Concordance between continuous glucose monitoring (CGM) and point-of-care testing (POCT) in research studies has been promising; however, the accuracy of using CGM for glucose management in real-world settings requires evaluation. Amid the COVID-19 pandemic, the CGM as “standard of care” (CGM as SOC) program was implemented at Scripps Mercy Hospital in San Diego, CA. In this real-world setting, concordance between the Dexcom G6 CGM system and POCT was evaluated among hospitalized adult patients with diabetes requiring insulin from May 2020-July 2022. For N=880 admissions, CGM readings over the first 24 hours of wear were analyzed relative to POCT conducted within 5 minutes. Patients had a median of 3 CGM-POCT data pairs, and the first CGM-POCT pair occurred a median of 2.75 hours after CGM device placement. Mean absolute relative difference (MARD) decreased over the first 24 hours of wear (B= -0.09%, p=0.0005; Figure 1A). Following the %20/20 rule, 62% of CGM readings were concordant upon the first measured POCT; 15.8% did not meet criteria at all during the first 24-hours. Using the Clarke Error Grid to describe concordance between CGM-POCT pairs (n=3015), only 0.7% (n=22) of CGM readings would have led to incorrect treatment decisions indicated by zones D/E (Figure 1B). These findings provide support for the accuracy of CGM for glucose management in the hospital. Disclosure S.R.Spierling bagsic: 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. R.Belasco: None. A.Ritko: None. S.Lohnes: Consultant; Dexcom, Inc. H.Sandoval: None. M.Chichmarenko: None. E.Soriano: None. A.Bastian: None.
Continuous glucose monitors (CGM) are an integral aspect in the glucose management of many individuals with type 1 diabetes, and a growing number of people with insulin-requiring type 2 diabetes (T2D). A 2019 meta-analysis of 7 randomized controlled trials that investigated CGMs for T2D reported that CGM users had significantly lower HbA1c and shorter time spent with hypoglycemia compared with self-monitoring blood glucose comparison groups. However, little is known about optimal, real world approaches for integrating CGM in the routine management of patients with T2D. A pragmatic, feasibility pilot (n=6) was conducted to document the preliminary effectiveness and acceptability of introducing CGM in the context of a 5-class diabetes self-management education (DSME) series at Scripps Health, a large, non-profit, private insurance-based health system in San Diego, CA. Prior to class 2, English- (n = 3) and Spanish-speaking (n = 3) adults with T2D self-inserted the CGM and received enough sensors to wear the CGM until 6 weeks post-DSME (10 weeks total). During classes 3-5, time was devoted to reviewing the past week’s CGM data report and participants were encouraged to make associations between glucose trends and eating and exercise patterns. CGM wear ranged from 5 to 10 weeks (M =7.8 ± 1.7 weeks). Time-in-range (70-180 mg/dL) and mean average glucose improved from 54% and 185.1 ± 67.9 mg/dL at baseline to 74% and 159.1 ± 50.5 mg/dL by the end of DSME, and to 84% and 142.7 ± 30.6 mg/dL at 4-weeks post-DSME. Self-report surveys indicated improvements in healthful eating and physical activity over this time, and participants reported very high satisfaction with the CGM; the majority expressed a desire to continue CGM use post-study. Findings highlight DSME as a promising environment for effectively integrating CGM in the management of T2D. Future research should pinpoint the duration and frequency of CGM use for optimal clinical benefit in the general T2D population. Disclosure A.L. Fortmann: None. A. Bastian: None. C.J. Lensing: Employee; Self; UnitedHealth Group. Employee; Spouse/Partner; UnitedHealth Group. S. Hoversten: Employee; Self; UnitedHealth Group. K. Luu: None. K. Barger: None. L. Talavera: None. A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Funding UnitedHealth Group; Dexcom, Inc.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.