Patients with Type 2 Diabetes and Residual Insulin Secretory Capacity Realize Glycemic Benefits from Real-Time Continuous Glucose Monitoring.
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ABSTRACT:
SUBMITTER: Puhr S
PROVIDER: S-EPMC8258531 | biostudies-literature | 2021 Jul
REPOSITORIES: biostudies-literature
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Patients with Type 2 Diabetes and Residual Insulin Secretory Capacity Realize Glycemic Benefits from Real-Time Continuous Glucose Monitoring.
Puhr Sarah S Welsh John B JB Bauza Colleen E CE Walker Tomas C TC
Journal of diabetes science and technology 20210415 4
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Project description:BackgroundThe 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.MethodsIn 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.ResultsThe 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).ConclusionIn 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: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:IntroductionDay-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.ObjectivesThis 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.MethodsThis 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.ResultsThe 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.ConclusionIntermittent 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: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:BackgroundContinuous glucose monitors (CGM) are underutilized by individuals with type 1 diabetes (T1D), particularly during the adolescent years. Little is known about perceptions of CGM benefit and burdens, and few tools exist to quantify this information.MethodsTwo questionnaires were developed and validated-Benefit of CGM (BenCGM) and Burdens of CGM (BurCGM)-in a sample of adolescents ages 12-19 years involved in the T1D Exchange Registry. We chose to start the validation process with adolescents given their low CGM uptake and high risk for suboptimal glycemic outcomes. Exploratory and confirmatory factor analyses were conducted to confirm factor structure and select items. The resultant scales were tested for internal reliability and convergent/divergent validity with critical diabetes and quality of life outcomes: age, depression, diabetes distress, self-efficacy, technology attitudes, and diabetes technology attitudes.ResultsA total of 431 adolescents with T1D completed the questionnaires (51% female, mean age 16.3 ± 2.26, 83% white non-Hispanic, 70% having used CGM). Two single factor scales emerged, and scales were reduced to 8 items each. Those who perceived higher benefit of CGM exhibited lower diabetes distress, higher self-efficacy, and more positive attitudes toward technology. Those who perceived higher burden of CGM exhibited higher diabetes distress, lower self-efficacy, and less positive technology attitudes.ConclusionThe BenCGM and BurCGM questionnaires each comprise 8-items that demonstrate robust psychometric properties for use in adolescents with T1D, and can be used to develop targeted interventions to increase CGM wear to improve diabetes management.
| S-EPMC6835174 | biostudies-literature
Project description:Continuous glucose monitoring (CGM) is a promising, minimally invasive alternative to plasma glucose measurements for calibrating physiology-based mathematical models of insulin-regulated glucose metabolism, reducing the reliance on in-clinic measurements. However, the use of CGM glucose, particularly in combination with insulin measurements, to develop personalized models of glucose regulation remains unexplored. Here, we simultaneously measured interstitial glucose concentrations using CGM as well as plasma glucose and insulin concentrations during an oral glucose tolerance test (OGTT) in individuals with overweight or obesity to calibrate personalized models of glucose-insulin dynamics. We compared the use of interstitial glucose with plasma glucose in model calibration, and evaluated the effects on model fit, identifiability, and model parameters' association with clinically relevant metabolic indicators. Models calibrated on both plasma and interstitial glucose resulted in good model fit, and the parameter estimates associated with metabolic indicators such as insulin sensitivity measures in both cases. Moreover, practical identifiability of model parameters was improved in models estimated on CGM glucose compared to plasma glucose. Together these results suggest that CGM glucose may be considered as a minimally invasive alternative to plasma glucose measurements in model calibration to quantify the dynamics of glucose regulation.
| S-EPMC11371931 | biostudies-literature
Project description:BackgroundGestational diabetes mellitus (GDM) and insulin resistance (IR) increase the risk of adverse pregnancy outcomes. We aimed to examine the relationship of interstitial glucose assessed by continuous glucose monitoring (CGM) at early gestation, and the subsequent development of IR and GDM, and to determine 24-h interstitial glucose centile distributions in women with normal (non-IR and non-GDM) and suboptimal glycemic status (IR and/or GDM).MethodsCGM measurements were taken for 3-10 days at 18-24 weeks' gestation, followed by fasting serum insulin and oral glucose tolerance testing at 24-28 weeks' gestation. IR and GDM were determined by the updated Homeostasis Model Assessment of IR score of ≥ 1.22 and 2013 World Health Organization criteria, respectively. Risks of IR and GDM were estimated using modified Poisson models, and hourly interstitial glucose centiles determined using Generalized Additive Models for Location, Scale and Shape.ResultsThis prospective cohort study involved 167 pregnant women in Singapore, with a mean age of 31.7 years, body mass index of 22.9 kg/m2, and gestation of 20.3 weeks. 25% of women exhibited IR and 18% developed GDM. After confounders adjustment, women with suboptimal glycemic control, indicated by higher mean daily glucose (risk ratio 1.42; 95% confidence interval 1.16, 1.73), glucose management indicator (1.08; 1.03, 1.12), and J-index (1.04; 1.02, 1.06), as well as those with greater glycemic variability, indicated by higher standard deviation (1.69; 1.37, 2.09), coefficient of variation (1.03; 1.00, 1.06), and mean amplitude of glycemic excursions (1.4; 1.14, 1.35) derived from CGM in early gestation were associated with higher risks of developing IR in later gestation. These associations were similarly observed for the development of GDM. Centile curves showed that, compared to those with normal glycemic status, women with suboptimal glycemic status had higher glucose levels, with greater fluctuations throughout 24 h.ConclusionsIn pregnant women who subsequently developed IR and GDM, interstitial glucose levels assessed by CGM were elevated and varied greatly. This supports the potential use of CGM to screen for glycemic changes early in pregnancy.
| S-EPMC11562738 | 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:The contribution of endogenous insulin secretion to glycemic variability (GV) may differ between patients with impaired insulin secretion and those with preserved secretion. Our objective was to determine the linearity of the relationship between fasting C-peptide (CPR) as a marker of endogenous insulin secretion and GV in type 2 diabetes (T2DM), regardless of the type of antidiabetic treatment. We conducted a prospective observational study using continuous glucose monitoring obtained from 284 Japanese outpatients with T2DM with various HbA1c values and antidiabetic treatment. We constructed a prediction curve of base-line CPR versus coefficient of variation (CV) and identified the clinical factors associated with CV using multiple regression analysis. Fasting CPR showed a significant negative log-linear relationship with CV (P < 0.0001), and the latter being strikingly high in the low-CPR group. The multiple regression analysis showed that low CPR was an independent predictor of high CV (P < 0.0001). The significant correlations were sustained in both patients with/without insulin treatment. The contribution of endogenous insulin secretion to GV depends on the extent of insulin secretion impairment. Fasting CPR may represent a useful indicator of GV instability in T2DM.
| S-EPMC8079412 | biostudies-literature
Project description:BackgroundTwo weeks of continuous glucose monitoring (CGM) sampling with >70% CGM use is recommended to accurately reflect 90 days of glycemic metrics. However, minimum sampling duration for CGM use <70% is not well studied. We investigated the minimum duration of CGM sampling required for each CGM metric to achieve representative glycemic outcomes for <70% CGM use over 90 days.MethodsNinety days of CGM data were collected in 336 real-life CGM users with type 1 diabetes. CGM data were grouped in 5% increments of CGM use (45%-95%) over 90 days. For each CGM metric and each CGM use category, the correlation between the summary statistic calculated using each sampling period and all 90 days of data was determined using the squared value of the Spearmen correlation coefficient (R2).ResultsFor CGM use 45% to 95% over 90 days, minimum sampling period is 14 days for mean glucose, time in range (70-180 mg/dL), time >180 mg/dL, and time >250 mg/dL; 28 days for coefficient of variation, and 35 days for time <54 mg/dL. For time <70 mg/dL, 28 days is sufficient between 45 and 80% CGM use, while 21 days is required >80% CGM use.ConclusionWe defined minimum sampling durations for all CGM metrics in suboptimal CGM use. CGM sampling of at least 14 days is required for >45% CGM use over 90 days to sufficiently reflect most of the CGM metrics. Assessment of hypoglycemia and coefficient of variation require a longer sampling period regardless of CGM use duration.
| S-EPMC11874234 | biostudies-literature