Remote continuous glucose monitoring during the COVID-19 pandemic in quarantined hospitalized patients in Denmark: A structured summary of a study protocol for a randomized controlled trial.
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ABSTRACT:
SUBMITTER: Klarskov CK
PROVIDER: S-EPMC7686946 | biostudies-literature | 2020 Nov
REPOSITORIES: biostudies-literature
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Remote continuous glucose monitoring during the COVID-19 pandemic in quarantined hospitalized patients in Denmark: A structured summary of a study protocol for a randomized controlled trial.
Klarskov Carina Kirstine CK Lindegaard Birgitte B Pedersen-Bjergaard Ulrik U Kristensen Peter Lommer PL
Trials 20201125 1
<h4>Objectives</h4>Patients with diabetes are - compared to people without diabetes - at increased risk of worse outcomes from COVID-19 related pneumonia during hospitalization. We aim to investigate whether telemetric continuous glucose monitoring (CGM) in quarantined hospitalized patients with diabetes and confirmed SARS-CoV-2 infection or another contagious infection can be successfully implemented and is associated with better glycaemic control than usual blood glucose monitoring (finger pri ...[more]
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Project description:DisclaimerIn an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.PurposeInpatient diabetes management involves frequent assessment of glucose levels for treatment decisions. Here we describe a program for inpatient real-time continuous glucose monitoring (rtCGM) at a community hospital and the accuracy of rtCGM-based glucose estimates.MethodsAdult inpatients with preexisting diabetes managed with intensive insulin therapy and a diagnosis of coronavirus disease 2019 (COVID-19) were monitored via rtCGM for safety. An rtCGM system transmitted glucose concentration and trending information at 5-minute intervals to nearby smartphones, which relayed the data to a centralized monitoring station. Hypoglycemia alerts were triggered by rtCGM values of ≤85 mg/dL, but rtCGM data were otherwise not used in management decisions; insulin dosing adjustments were based on blood glucose values measured via blood sampling. Accuracy was evaluated retrospectively by comparing rtCGM values to contemporaneous point-of-care (POC) blood glucose values.ResultsA total of 238 pairs of rtCGM and POC data points from 10 patients showed an overall mean absolute relative difference (MARD) of 10.3%. Clarke error grid analysis showed 99.2% of points in the clinically acceptable range, and surveillance error grid analysis showed 89.1% of points in the lowest risk category. It was determined that for 25% of the rtCGM values, discordances in rtCGM and POC values would likely have resulted in different insulin doses. Insulin dose recommendations based on rtCGM values differed by 1 to 3 units from POC-based recommendations.ConclusionrtCGM for inpatient diabetes monitoring is feasible. Evaluation of individual rtCGM-POC paired values suggested that using rtCGM data for management decisions poses minimal risks to patients. Further studies to establish the safety and cost implications of using rtCGM data for inpatient diabetes management decisions are warranted.
| S-EPMC8767852 | biostudies-literature
Project description:Continuous glucose monitoring (CGM) has become a widely used tool in the ambulatory setting for monitoring glucose levels, as well as detecting uncontrolled hyperglycemia, hypoglycemia, and glycemic variability. The accuracy of some CGM systems has recently improved to the point of manufacture with factory calibration and Food and Drug Administration clearance for nonadjunctive use to dose insulin. In this commentary, we analyze the answers to six questions about what is needed to bring CGM into the hospital as a reliable, safe, and effective tool. The evidence to date indicates that CGM offers promise as an effective tool for monitoring hospitalized patients. During the current coronavirus disease 2019 crisis, we hope to provide guidance to healthcare professionals, who are seeking to reduce exposure to SARS-Cov-2, as well as preserve invaluable personal protective equipment. In this commentary, we address who, what, where, when, why, and how CGM can be adopted for inpatient use.
| S-EPMC7673156 | biostudies-literature
Project description:Introduction: Multiple daily injection insulin therapy frequently fails to meet hospital glycemic goals and is prone to hypoglycemia. Automated insulin delivery (AID) with remote glucose monitoring offers a solution to these shortcomings. Research Design and Methods: In a single-arm multicenter pilot trial, we tested the feasibility, safety, and effectiveness of the Omnipod 5 AID System with real-time continuous glucose monitoring (CGM) for up to 10 days in hospitalized patients with insulin-requiring diabetes on nonintensive care unit medical-surgical units. Primary endpoints included the proportion of time in automated mode and percent time-in-range (TIR 70-180 mg/dL) among participants with >48 h of CGM data. Safety endpoints included incidence of severe hypoglycemia and diabetes-related ketoacidosis (DKA). Additional glycemic endpoints, CGM accuracy, and patient satisfaction were also explored. Results: Twenty-two participants were enrolled; 18 used the system for a total of 96 days (mean 5.3 ± 3.1 days per patient), and 16 had sufficient CGM data required for analysis. Median percent time in automated mode was 95% (interquartile range 92%-98%) for the 18 system users, and the 16 participants with >48 h of CGM data achieved an overall TIR of 68% ± 16%, with 0.17% ± 0.3% time <70 mg/dL and 0.06% ± 0.2% time <54 mg/dL. Sensor mean glucose was 167 ± 21 mg/dL. There were no DKA or severe hypoglycemic events. All participants reported satisfaction with the system at study end. Conclusions: The use of AID with a disposable tubeless patch-pump along with remote real-time CGM is feasible in the hospital setting. These results warrant further investigation in randomized trials.
| S-EPMC10611957 | biostudies-literature
Project description: Not available
| S-EPMC10699474 | biostudies-literature
Project description:Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications.
The primary aim of our project is to assess the feasibility of the use of continuous glucose monitoring in measuring blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to understand the effects of stress and intraoperative interventions on the blood glucose level. The tertiary goal is to assess the predictive value of hyperglycemia for surgical site infection.
| 71713 | ecrin-mdr-crc
Project description:BackgroundGlycemic variability (GV) has only been sparsely studied in patients with community-acquired pneumonia (CAP). This study aimed to quantify in-hospital GV in CAP patients, including determining the impact of type 2 diabetes mellitus (T2DM) and glucocorticoid (GC) treatment on GV.MethodsThis is a prospective cohort study of CAP patients (N = 40) with or without T2DM and treated or not with GCs. The primary endpoint was GV measured as glucose standard deviation (SD), coefficient of variation (CV), and postprandial glucose excursions (PPGE) based on continuous glucose monitoring (CGM). Analysis of glucose data was split into daytime and nighttime when possible.ResultsPatients included had a mean age of 74 (range 55 to 91) years. SD (95%CI) increased by a factor of 1.93 (1.40 to 2.66) and 2.29 (1.38 to 3.81) in patients with T2DM and not treated with GCs during the daytime and the nighttime, respectively (both P < 0.01), and by a factor of 1.42 (1.04 to 1.97) in patients treated with GCs but without T2DM during the daytime (P = 0.031) compared to patients without T2DM and not treated with GCs. CV (95%CI) increased by 5.1 (0.0 to 10.1) and 8.1 (1.0 to 15.2) percentage points during the daytime and the nighttime, respectively, in patients with T2DM and not treated with GCs compared to patients without T2DM and not treated with GCs (P = 0.046 and P = 0.026, respectively). PPGE (95% CI) increased during lunch by 2.5 (0.7 to 4.3) mmol/L (45 (13 to 77) mg/dL) in patients with T2DM and treated with GCs compared to patients without T2DM and not treated with GCs (P = 0.018).ConclusionsCAP patients receiving GCs, especially those with T2DM, are at great risk of developing high GV and therefore require clinical attention to mitigate GV. This applies particularly during the daytime. Results support the 1 to 2-h post-lunch screening procedure for glucocorticoid-induced hyperglycemia in patients without diabetes. SD was positively correlated with hospital length of stay.
| S-EPMC8905566 | biostudies-literature
Project description:BackgroundContinuous glucose monitoring (CGM) devices are increasingly used in critical and non-critical care hospital units. The efficacy of CGM in assessing glucose control in adults with diabetic ketoacidosis (DKA) is unknown.MethodsThis single-center pilot study compared glycemic control by real-time CGM (Dexcom G6), capillary point-of-care (POC), and basic metabolic panel (BMP) during intravenous (IV) insulin treatment and after the resolution of DKA. We compared the mean absolute relative difference (MARD), median absolute relative difference (ARD) glucose values, and Diabetes Technology Society (DTS) Error Grid analyses.ResultsWe recruited 52 patients (49 ± 19 years, admission glucose: 503 ± 239.4 mg/dL) with type 1 diabetes (n = 24) and type 2 diabetes (n = 28). Compared with POC testing, the MARD was 17.4% ± 13.2%, and the median ARD was 14.2% (interquartile range [IQR]: 6.4, 28) during the initial IV insulin period and 19.8% ± 18.7% and 14.3% (7, 26.2) after DKA resolution. The DTS Error Grid analysis showed that 100% of values during the IV insulin treatment and 95% after the DKA resolution were in zones A+B. Compared with BMP glucose values, the MARD and median ARD were 18.5% ± 19.1% and 12.2% (5.4, 23.8) during the IV insulin treatment and 22.5% ± 24.7% and 15.1% (6.6, 27.6) after DKA resolution.ConclusionThis is the first report on the use of real-time CGM in adults with DKA. Our study indicates that CGM technology is a reliable tool for hospital use during acute insulin treatment and after the resolution of DKA. Future multicentre randomized studies are needed to determine the benefits of real-time CGM in facilitating diabetes care in hospitalized patients with hyperglycemic crises.
| S-EPMC11800229 | biostudies-literature
Project description:ObjectiveThe efficacy and safety of continuous glucose monitoring (CGM) in adjusting inpatient insulin therapy have not been evaluated.Research design and methodsThis randomized trial included 185 general medicine and surgery patients with type 1 and type 2 diabetes treated with a basal-bolus insulin regimen. 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 insulin dose adjusted based on POC results, while in the CGM group, insulin adjustment was based on daily CGM profile. Primary end points were differences in time in range (TIR; 70-180 mg/dL) and hypoglycemia (<70 mg/dL and <54 mg/dL).ResultsThere were no significant differences in TIR (54.51% ± 27.72 vs. 48.64% ± 24.25; P = 0.14), mean daily glucose (183.2 ± 40 vs. 186.8 ± 39 mg/dL; P = 0.36), or percent of patients with CGM values <70 mg/dL (36% vs. 39%; P = 0.68) or <54 mg/dL (14 vs. 24%; P = 0.12) between the CGM-guided and POC groups. Among patients with one or more hypoglycemic events, compared with POC, the CGM group experienced a significant reduction in hypoglycemia reoccurrence (1.80 ± 1.54 vs. 2.94 ± 2.76 events/patient; P = 0.03), lower percentage of time below range <70 mg/dL (1.89% ± 3.27 vs. 5.47% ± 8.49; P = 0.02), and lower incidence rate ratio <70 mg/dL (0.53 [95% CI 0.31-0.92]) and <54 mg/dL (0.37 [95% CI 0.17-0.83]).ConclusionsThe inpatient use of real-time Dexcom G6 CGM is safe and effective in guiding insulin therapy, resulting in a similar improvement in glycemic control and a significant reduction of recurrent hypoglycemic events compared with POC-guided insulin adjustment.
| S-EPMC9643134 | biostudies-literature
Project description:ObjectiveAdvances in continuous glucose monitoring (CGM) have transformed ambulatory diabetes management. Until recently, inpatient use of CGM has remained investigational, with limited data on its accuracy in the hospital setting.Research design and methodsTo analyze the accuracy of Dexcom G6, we compared retrospective matched-pair CGM and capillary point-of-care (POC) glucose data from three inpatient CGM studies (two interventional and one observational) in general medicine and surgery patients with diabetes treated with insulin. Analysis of accuracy metrics included mean absolute relative difference (MARD), median absolute relative difference (ARD), and proportion of CGM values within 15, 20, and 30% or 15, 20, and 30 mg/dL of POC reference values for blood glucose >100 mg/dL or ≤100 mg/dL, respectively (% 15/15, % 20/20, % 30/30). Clinical reliability was assessed with Clarke error grid (CEG) analyses.ResultsA total of 218 patients were included (96% with type 2 diabetes) with a mean age of 60.6 ± 12 years. The overall MARD (n = 4,067 matched glucose pairs) was 12.8%, and median ARD was 10.1% (interquartile range 4.6, 17.6]. The proportions of readings meeting % 15/15, % 20/20, and % 30/30 criteria were 68.7, 81.7, and 93.8%, respectively. CEG analysis showed 98.7% of all values in zones A and B. MARD and median ARD were higher in the case of hypoglycemia (<70 mg/dL) and severe anemia (hemoglobin <7 g/dL).ConclusionsOur results indicate that CGM technology is a reliable tool for hospital use and may help improve glucose monitoring in non-critically ill hospitalized patients with diabetes.
| S-EPMC8323182 | biostudies-literature
Project description:BackgroundYouth with type 1 diabetes (T1D) and public insurance have lower diabetes technology use. This pilot study assessed the feasibility of a program to support continuous glucose monitor (CGM) use with remote patient monitoring (RPM) to improve glycemia for youth with established T1D and public insurance.MethodsFrom August 2020 to June 2023, we provided CGM with RPM support via patient portal messaging for youth with established T1D on public insurance with challenges obtaining consistent CGM supplies. We prospectively collected hemoglobin A1c (HbA1c), standard CGM metrics, and diabetes technology use over 12 months.ResultsThe cohort included 91 youths with median age at enrollment 14.7 years, duration of diabetes 4.4 years, 33% non-English speakers, and 44% Hispanic. Continuous glucose monitor data were consistently available (≥70%) in 23% of the participants. For the 64% of participants with paired HbA1c values at enrollment and study end, the median HbA1c decreased from 9.8% to 9.0% (P < .001). Insulin pump users increased from 31 to 48 and automated insulin delivery users increased from 11 to 38.ConclusionsWe established a program to support CGM use in youth with T1D and barriers to consistent CGM supplies, offering lessons for other clinics to address disparities with team-based, algorithm-enabled, remote T1D care. This real-world pilot and feasibility study noted challenges with low levels of protocol adherence and obtaining complete data in this cohort. Future iterations of the program should explore RPM communication methods that better align with this population's preferences to increase participant engagement.
| S-EPMC11664559 | biostudies-literature