Determination of Postprandial Glycemic Responses by Continuous Glucose Monitoring in a Real-World Setting.
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SUBMITTER: Rohling M
PROVIDER: S-EPMC6835966 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background: The GoBolus study investigated the real-world effectiveness of faster aspart in patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems. Methods: This 24-week, multicenter, single-arm, noninterventional study investigated adults with T1D (HbA1c, 7.5%-9.5%) receiving multiple daily injections (MDI) of insulin and using iscCGM within local healthcare settings for ?6 months before switching to faster aspart at study start (week 0; baseline). Primary endpoint was HbA1c change from baseline to week 24. Exploratory endpoint was change in iscCGM metrics from baseline to week 24. Results: Overall, 243 patients were included (55.6% male), with mean age/diabetes duration, 49.9/18.8 years; mean HbA1c, 8.1%. By week 24, HbA1c had decreased by 0.19% (-2.1?mmol/mol, P?<?0.0001) with no mean change in insulin doses or basal/bolus insulin ratios. For patients with sufficient available iscCGM data (n?=?92): "time in range" (TIR; 3.9-10.0?mmol/L) increased from 46.9% to 50.1% (P?=?0.01), corresponding to an increase of 46.1?min/day; time in hyperglycemia decreased from 49.1% to 46.1% (>10.0?mmol/L, P?=?0.026) and 20.4% to 17.9% (>13.9?mmol/L, P?=?0.013), corresponding to 43.5 (P?=?0.024) and 35.6 (P?=?0.015) fewer minutes per day on average spent in these ranges, respectively; no change for time in hypoglycemia (<3.9 and <3.0?mmol/L). Mean interstitial and postprandial glucose improved from 10.4 to 10.1?mmol/L (P?=?0.035) and 11.9 to 11.0?mmol/L (P?=?0.002), respectively. Conclusion: Real-world switching to faster aspart in adults with T1D on MDI improved HbA1c, increased TIR, and decreased time in hyperglycemia without affecting time in hypoglycemia. The GoBolus study: NCT03450863.
| S-EPMC7906866 | biostudies-literature
Project description:AimsTo determine the magnitude of the peripheral glucose gradient in patients with Type 1 diabetes in a real world setting and to explore its relationship with insulin dose and macronutrient intake.MethodsAll patients used mealtime analogue insulin. The glucose gradient was assessed using antecubital fossa venous and finger-stick capillary samples, collected concurrently at room temperature. Baseline sampling occurred before the administration of an insulin dose and breakfast of the patient's choosing. Breakfast was consumed an average of 15 min after baseline. The macronutrient content of breakfast was documented. Sampling was repeated 1 and 2 h after baseline.ResultsThe mean (95% CI) plasma capillary-venous glucose gradient values for 43 patients were: pre-breakfast, 0.21 (0.08-0.34) mmol/l; 1 h after baseline, 0.87 (0.66-1.07) mmol/l; and 2 h after baseline, 0.52 (0.33-0.71) mmol/l. Glucose gradient and dietary carbohydrate intake (g/kg body weight) were positively correlated at both 1 h (P < 0.01) and 2 h after baseline (P < 0.01). No relationship was observed between this gradient and mealtime insulin dose, or the glucose concentration at either time point.ConclusionsIn patients with Type 1 diabetes, a clinically significant glucose gradient is present after the ingestion of a carbohydrate-rich meal. As postprandial capillary and venous plasma glucose concentrations are not equivalent, defining the site of sample collection is important.
| S-EPMC5064751 | biostudies-literature
Project description:The validity of continuous glucose monitoring (CGM) is well established in diabetic patients. CGM is also increasingly used for research purposes in normo-glycemic individuals, but the CGM validity in such individuals is unknown. We studied the accuracy of CGM measurements in normo-glycemic individuals by comparing CGM-derived versus venous blood-derived glucose levels and measures of glycemia and glycemic variability.In 34 healthy participants (mean age 65.7 years), glucose was simultaneously measured every 10 minutes, via both an Enlite® CGM sensor, and in venous blood sampled over a 24-hour period. Validity of CGM-derived individual glucose measurements, calculated measures of glycemia over daytime (09:00h-23:00h) and nighttime (23:00h-09:00h), and calculated measures of glycemic variability (e.g. 24h standard deviation [SD]) were assessed by Pearson correlation coefficients, mean absolute relative difference (MARD) and paired t-tests.The median correlation coefficient between CGM and venous glucose measurements per participant was 0.68 (interquartile range: 0.40-0.78), and the MARD was 17.6% (SD = 17%). Compared with venous sampling, the calculated measure of glycemia during daytime was 0.22 mmol/L higher when derived from CGM, but no difference was observed during nighttime. Most measures of glycemic variability were lower with CGM than with venous blood sampling (e.g., 24h SD: 1.07 with CGM and 1.26 with venous blood; p-value = 0.004).In normo-glycemic individuals, CGM-derived glucose measurements had good agreement with venous glucose levels. However, the measure of glycemia was higher during the day and most measures of glycemic variability were lower when derived from CGM.
| S-EPMC4596806 | biostudies-literature
Project description:INTRODUCTION:Day-long fasting creates considerable metabolic stress that poses challenges in people with diabetes and those who have undergone bariatric surgery. Clinical knowledge of glucose fluctuations and the risks for such patients during fasting is limited. OBJECTIVES:This study examined the effect of intermittent fasting on glucose excursions, hypoglycemia, and hyperglycemia in people with or without diabetes who had sleeve gastrectomy compared with healthy individuals. METHODS:This open-label, prospective study compared interstitial glucose profiles measured with continuous glucose monitoring system for 72 h during fasting and non-fasting periods between four groups comprising 15 participants each: people with obesity and medicine-treated type 2 diabetes (T2D) only, obesity and T2D treated with sleeve gastrectomy, obesity without T2D treated with sleeve gastrectomy, and healthy, normal-weight non-diabetic controls. RESULTS:The mean 72-h glucose concentration was significantly lower during the fasting period for all groups (p???0.041), with the highest glucose concentrations in the medicine-treated T2D-only group and the lowest concentrations in the sleeve gastrectomy in non-T2D group. The mean glucose profiles of all the groups showed a marked increase in interstitial glucose on breaking the fast, which was exaggerated in the two diabetes groups. The mean amplitude of glycemic excursions did not differ significantly within each group between fasting and non-fasting. No significant difference was noted in the fraction of time in the hypoglycemic range between the fasting and non-fasting periods in any group. CONCLUSION:Intermittent fasting had no adverse effect on glycemic control in people with or without diabetes who had undergone sleeve gastrectomy.
| S-EPMC7467959 | biostudies-literature
Project description:AimWe aimed to address the potential impact of COVID-19 on glycemic patterns in a small pilot study.Method13 patients with mild COVID-19 who were confirmed without diabetes and another group of 18 healthy individuals with available CGM data were well matched and enrolled into the final analysis.ResultsWe noticed significantly higher TARs of >140 mg/dL (median 13.9% vs. 2.3%, P = 0.006), >160 mg/dL (median 4.7% vs. 0.0%, P = 0.011) and >180 mg/dL (median 1.9% vs. 0.0%, P = 0.007) among non-diabetic patients with COVID-19 than those among healthy individuals. There was no significant difference in TBR of <70 mg/dL or <54 mg/dL (all P > 0.1). Consequently, the TIR of 70 mg/dL to 140 mg/dL was significantly lower in non-diabetic patients with COVID-19 than that in healthy individuals (median 80.1% vs. 93.1%, P = 0.001). Significant postprandial glycemic fluctuations were observed among patients with COVID-19. There was a remarkable difference in CV in non-diabetic patients with COVID-19 compared to healthy individuals (median 25.6% vs. 15.7%, P < 0.001).ConclusionSignificant higher glycemic fluctuation and exposure to hyperglycemia was associated with COVID-19 among previously normoglycemic individuals, characterized with potentially impaired glucose tolerance.
| S-EPMC7884232 | biostudies-literature
Project description:BackgroundAmong self-care measures, the self-monitoring of blood glucose (SMBG) is a critical component for checking blood glucose levels. In addition, there is growing evidence suggesting that digital technologies are being adopted as an additional method for health care systems to increase patient contact. However, for patients with non-insulin-treated diabetes mellitus type 2 (DMT2), the value of SMBG was inconsistent among studies, and the evidence for digital technologies from real-world clinical practice is still limited.ObjectiveOur study aimed to assess patients with non-insulin-treated DMT2 who were receiving care from a single clinic and analyze whether the use of a diabetes management app and SMBG behavior would affect glycemic control in a real-world clinical setting.MethodsWe collaborated with a large clinic focused on diabetes care in Taiwan that had been using the Health2Sync mobile app and web-based Patient Management Platform to collect the data. The patients were divided into 2 groups (app-engaged-user group and only-data-uploader group) according to different activities in the app, and blood glucose was recorded every month from 1 to 6 months after registration in the app. A sample of 420 patients was included in the analysis, and a linear mixed model was built to investigate which factors affected the patients' blood glucose percentage change.ResultsUsing the mixed model coefficient estimates, we found that the percentage change was significantly negative when the only-data-uploader group was set as the baseline (t=-3.873, df=1.81 × 104; P<.001 for the patients of the app-engaged-user group). We found that for patients with shorter diabetes duration, their blood glucose decreased more than patients with longer diabetes duration (t=2.823, df=1.71 × 104; P=.005 for the number of years of diabetes duration). In addition, we found that for younger patients, their blood glucose decreased more than older patients (t=2.652, df=1.71 × 104; P=.008 for the age of the patients). Furthermore, the patients with an education level of junior high school or lower saw a significantly greater decrease in blood glucose percentage change than the patients with an education level of senior high school or higher (t=4.996, df=1.72 × 104; P<.001 for the patients with an education level of senior high school or higher). We also found that the count of blood glucose measured enlarged the decrease along the interaction months (t=-8.266, df=1.97 × 104; P<.001 for the nth month × the count of blood glucose in the nth month). Lastly, the gender of the patients did not significantly affect the percentage change (t=0.534, df=1.74 × 104; P=.59 for female patients).ConclusionsOur analysis showed the following: the blood glucose percentage change of the patients in the app-engaged-user group dropped more than that in the only-data-uploader group; shorter diabetes duration is associated with a steeper decrease in the patients' blood glucose percentage change; the percentage decrease in blood glucose change in younger patients is greater than older patients; the blood glucose percentage change of the patients with an education level of junior high school or lower dropped more than those with an education level of senior high school or higher; and the more frequently the patients test SMBG each month, the greater the decrease in the patients' blood glucose percentage. Further studies can be performed to consider the differences in daily behaviors such as exercise and diet across the patients and whether these factors could have vital effects on glycemic control.
| S-EPMC9244648 | biostudies-literature
Project description:Continuous Glucose Monitoring (CGM) has been demonstrated to be clinically valuable, reducing risks of hypoglycemia and hyperglycemia, glycemic variability (GV), and improving patient quality of life for a wide range of patient populations and clinical indications. Use of CGM can help reduce HbA1c and mean glucose. One CGM device, with accuracy (%MARD) of approximately 10%, has recently been approved for self-adjustment of insulin dosages (nonadjuvant use) and approved for reimbursement for therapeutic use in the United States. CGM had previously been used off-label for that purpose. CGM has been demonstrated to be clinically useful in both type 1 and type 2 diabetes for patients receiving a wide variety of treatment regimens. CGM is beneficial for people using either multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). CGM is used both in retrospective (professional, masked) and real-time (personal, unmasked) modes: both approaches can be beneficial. When CGM is used to suspend insulin infusion when hypoglycemia is detected until glucose returns to a safe level (low-glucose suspend), there are benefits beyond sensor-augmented pump (SAP), with greater reduction in the risk of hypoglycemia. Predictive low-glucose suspend provides greater benefits in this regard. Closed-loop control with insulin provides further improvement in quality of glycemic control. A hybrid closed-loop system has recently been approved by the U.S. FDA. Closed-loop control using both insulin and glucagon can reduce risk of hypoglycemia even more. CGM facilitates rigorous evaluation of new forms of therapy, characterizing pharmacodynamics, assessing frequency and severity of hypo- and hyperglycemia, and characterizing several aspects of GV.
| S-EPMC5467105 | biostudies-literature
Project description:ImportanceContinuous glucose monitoring (CGM) is recommended for patients with type 1 diabetes; observational evidence for CGM in patients with insulin-treated type 2 diabetes is lacking.ObjectiveTo estimate clinical outcomes of real-time CGM initiation.Design, setting, and participantsExploratory retrospective cohort study of changes in outcomes associated with real-time CGM initiation, estimated using a difference-in-differences analysis. A total of 41 753 participants with insulin-treated diabetes (5673 type 1; 36 080 type 2) receiving care from a Northern California integrated health care delivery system (2014-2019), being treated with insulin, self-monitoring their blood glucose levels, and having no prior CGM use were included.ExposuresInitiation vs noninitiation of real-time CGM (reference group).Main outcomes and measuresTen end points measured during the 12 months before and 12 months after baseline: hemoglobin A1c (HbA1c); hypoglycemia (emergency department or hospital utilization); hyperglycemia (emergency department or hospital utilization); HbA1c levels lower than 7%, lower than 8%, and higher than 9%; 1 emergency department encounter or more for any reason; 1 hospitalization or more for any reason; and number of outpatient visits and telephone visits.ResultsThe real-time CGM initiators included 3806 patients (mean age, 42.4 years [SD, 19.9 years]; 51% female; 91% type 1, 9% type 2); the noninitiators included 37 947 patients (mean age, 63.4 years [SD, 13.4 years]; 49% female; 6% type 1, 94% type 2). The prebaseline mean HbA1c was lower among real-time CGM initiators than among noninitiators, but real-time CGM initiators had higher prebaseline rates of hypoglycemia and hyperglycemia. Mean HbA1c declined among real-time CGM initiators from 8.17% to 7.76% and from 8.28% to 8.19% among noninitiators (adjusted difference-in-differences estimate, -0.40%; 95% CI, -0.48% to -0.32%; P < .001). Hypoglycemia rates declined among real-time CGM initiators from 5.1% to 3.0% and increased among noninitiators from 1.9% to 2.3% (difference-in-differences estimate, -2.7%; 95% CI, -4.4% to -1.1%; P = .001). There were also statistically significant differences in the adjusted net changes in the proportion of patients with HbA1c lower than 7% (adjusted difference-in-differences estimate, 9.6%; 95% CI, 7.1% to 12.2%; P < .001), lower than 8% (adjusted difference-in-differences estimate, 13.1%; 95% CI, 10.2% to 16.1%; P < .001), and higher than 9% (adjusted difference-in-differences estimate, -7.1%; 95% CI, -9.5% to -4.6%; P < .001) and in the number of outpatient visits (adjusted difference-in-differences estimate, -0.4; 95% CI, -0.6 to -0.2; P < .001) and telephone visits (adjusted difference-in-differences estimate, 1.1; 95% CI, 0.8 to 1.4; P < .001). Initiation of real-time CGM was not associated with statistically significant changes in rates of hyperglycemia, emergency department visits for any reason, or hospitalizations for any reason.Conclusions and relevanceIn this retrospective cohort study, insulin-treated patients with diabetes selected by physicians for real-time continuous glucose monitoring compared with noninitiators had significant improvements in hemoglobin A1c and reductions in emergency department visits and hospitalizations for hypoglycemia, but no significant change in emergency department visits or hospitalizations for hyperglycemia or for any reason. Because of the observational study design, findings may have been susceptible to selection bias.
| S-EPMC8173463 | biostudies-literature
Project description:BACKGROUND:The I-HART CGM study has shown that real-time continuous glucose monitoring (rtCGM) has greater beneficial impact on hypoglycemia than intermittently scanned continuous glucose monitoring (iscCGM) in adults with type 1 diabetes at high risk (Gold score ?4 or recent severe hypoglycemia using insulin injections). In this subanalysis, we present the impact of rtCGM and iscCGM on glycemic variability (GV). METHODS:Forty participants were recruited to this parallel group study. Following two weeks of blinded rtCGM (DexcomG4), participants were randomized to rtCGM (Dexcom G5; n = 20) or iscCGM (Freestyle Libre; n = 20) for eight weeks. An open-extension phase enabled participants on rtCGM to continue for a further eight weeks and those on iscCGM to switch to rtCGM over this period. Glycemic variability measures at baseline, 8- and 16-week endpoints were compared between groups. RESULTS:At the eight-week endpoint, between-group differences demonstrated significant reduction in several GV measures with rtCGM compared to iscCGM (GRADE%hypoglycemia, index of glycemic control [IGC], and average daily risk range [ADRR]; P < .05). Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM (P < .05). At 16 weeks, the iscCGM group switching to rtCGM showed significant improvement in GRADE%hypoglycemia, personal glycemic status, IGC, and ADRR. CONCLUSION:Our data suggest most, but not all, GV measures improve with rtCGM compared with iscCGM, particularly those measures associated with the risk of hypoglycemia. Selecting appropriate glucose monitoring technology to address GV in this high-risk cohort is important to minimize the risk of glucose extremes and severe hypoglycemia. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov NCT03028220.
| S-EPMC7576953 | biostudies-literature
Project description:Tight glycemic control can potentially reduce morbidity and mortality in the intensive care unit but increases the risk of hypoglycemia. The most effective means to avoid hypoglycemia is to obtain frequent blood glucose samples, but this increases the burden to nursing staff. The objective of this study was to assess the ability of a real-time continuous glucose monitor to reduce hypoglycemia (blood glucose <60 mg/dL [3.3 mmol/L]) during standard care or tight glycemic control effected with a proportional integral derivative insulin titration algorithm.Real-time continuous glucose monitor profiles obtained from an ongoing prospective randomized trial of tight glycemic control were retrospectively analyzed to determine whether the continuous glucose measure had prevented instances of hypoglycemia.Cardiac intensive care unit.Children 3 yrs of age or younger undergoing cardiac surgery were studied.Intravenous insulin infusion and rescue glucose guided by the real-time continuous glucose monitor and the proportional integral derivative algorithm in the tight glycemic control arm (n = 155; target glucose 80-110 mg/dL [4.4-6.1 mmol/L]) and the real-time continuous glucose monitor in the standard care arm (n = 156).No reduction in hypoglycemia was observed with real-time continuous glucose monitor alarms set at 60 mg/dL (3.3 mmol/L) (zero of 19 occurrences of blood glucose <60 mg/dL [3.3 mmol/L] detected); 18 of 40 subsequent incidences of hypoglycemia were detected after the alarm threshold was increased to 70 mg/dL (3.9 mmol/L). In the tight glycemic control arm, eight incidences were reduced in duration and an additional eight events were prevented with intravenous glucose. In the standard care arm, three of nine occurrences of hypoglycemia were detected with the duration reduced in all cases. On average, one to two false hypoglycemia alarms were observed in each patient.The real-time continuous glucose monitor in combination with proportional integral derivative control can reduce hypoglycemia during tight glycemic control. The real-time continuous glucose monitor can also reduce hypoglycemia during standard care. However, false alarms increase the overall nursing workload.
| S-EPMC3705721 | biostudies-literature