Biochemical analyses and you may study collection
Ambulatory CGM (using a FreeStyle Libre Pro sensor; Abbott Diabetes Care, Alameda, CA, USA) was performed for 14 consecutive days. The CGM data remained blinded for patients and physicians because the CGM system used was a professional version that permitted blinded CGM. Thus, patients were not able to access any real time information on their GV that might have influenced their lifestyle behaviors, including their dietary choices, during the study. After the monitoring period, we excluded data collected during the first and last days of wearing the device, considering possible inaccuracies relating to its attachment and removal 15 . We analyzed the CGM data for the remaining period using GlyCulator2 software 16 . Because an international consensus statement recommends the coefficient of variation (CV) as the primary measure of GV 17 , we analyzed the CV as an index of GV using the following formula: 100 ? [SD of glucose]/[mean glucose]. The standard deviation (SD) glucose concentration, the mean amplitude of glycemic excursions (MAGE) 18 , and the mean glucose concentration were also analyzed as secondary indices of GV. The low blood glucose index (LBGI) and high blood glucose index (HBGI), which increase with the frequency and extent of hypoglycemia and hyperglycemia, respectively, were also analyzed 19 . Furthermore, we calculated three key CGM-related indices: the percentage of readings and time per day within the target glucose range (TIR: 3.9–10.0 mmol/L), time below target glucose range (TBR: < 3.9 mmol/L), and time above the target glucose range (TAR: > 10.0 mmol/L), as recommended by the international consensus statement 20 .
Bloodstream examples was in fact amassed after an overnight quick. Accelerated plasma glucose (FPG), CPR, HbA1c, and you will estimated glomerular filtration https://hookupdaddy.net/lesbian-hookup/ rate (eGFR) was indeed mentioned having fun with simple procedure. You lbs and you will peak of the clients were measured having fun with a good calibrated level. Bmi (BMI) are calculated because the weight (inside the kg) separated of the level (inside yards dos ). Almost every other study, including ages, gender, the fresh new diabetic issues medicines being used, and you will health background have been accumulated playing with a survey which was given from the planning physicians.
To define the relationship between endogenous insulin secretion and GV instability, we constructed a scatter plot of fasting CPR versus CV. The prediction formula for CPR versus CV was estimated after both CPR and CV were logarithmically transformed. The clinical factors related to GV, including CPR, were determined after CPR was logarithmically transformed. Bivariate analyses of CGM-based metrics of GV and categorical variables, such as sex, were performed using the Mann–Whitney test. The results are shown as the median (interquartile range). Multiple regression analysis was performed using variables identified in previously published research 11 and those that were significant (P < 0.05) in the univariate analysis. We have demonstrated that these items had linear relationships with CGM-based metrics of GV (Supplementary Figs. S1, S2).
To further evaluate the contribution of CPR to CV, the patients were allocated to three subgroups according to whether they had low (CPR < 1 ng/mL), moderate (1 ng/mL ? CPR < 2 ng/mL), or high (CPR ? 2 ng/mL) CPR concentrations, based on our prediction curve for CPR versus CV. Then, the biochemical and anthropometric characteristics of the three subgroups were compared using one-way analysis of variance, the chi-square test, or the Kruskal–Wallis test, as appropriate. Because the international consensus statement defines stable GV using a CV < 36% and unstable GV using a CV ? 36% 17 , the number of patients with CV ? 36% was compared among the three subgroups using the CV distribution and the chi-square test. Next, to determine whether insulin and antidiabetic treatment use modified the association of interest, the patients were allocated to two subgroups according to whether they received insulin and antidiabetic treatments or not. Additionally, to investigate whether the use of a basal-only or basal-bolus insulin regimen modified the association of interest, we allocated the patients on insulin to two subgroups, according to their insulin regimen, and a similar stratified analysis was carried out.