Carelink ipro

Dynamic glucose profiles were generated from the blinded CGM system (iPro2 with Enlite sensor, Medtronic MiniMed, Northridge, CA, USA). The glucose sensor of the CGM system (MMT-7008A) was inserted on the lateral upper arm and removed after 5-7 days, yielding a maximum daily record of 288 continuous sensor glucose values. With CGM, the participants were required to perform self-monitoring of blood glucose (SMBG) at least 4 times a day for calibration purposes. The CGM data were exported and analyzed using M-Smart software (CareLink iPro, Medtronic).
The time in range (TIR) was defined as the percentage of time spent in the normoglycemic range (3.9-10.0 mmol/L). Glycemic variability parameters included the standard deviation (SD), mean amplitude of glucose excursions (MAGE) and %CV (%CV= [(SD of glucose)/(mean glucose)]×100).

In order to detect a difference of 10% in the primary outcome variable of 24 h MBG with a power >0.8 and a type I error of 5% in a crossover design, a group of 10 participants was used. Data from the CGM were revised in the CareLink™ iPro software (Medtronic Inc., Northridge, CA, USA) and four capillary glucose calibrations per day were integrated before being downloaded and exported to Excel. To determine the different GV indexes, EasyGV 6.0 software was used. Time-course data were analyzed by two-way repeated measures ANOVA to assess the effects of treatment, time, and the interaction of treatment and time. One-way repeated measures ANOVA or Student’s t-tests were used to compare the effects of treatments on fasting parameters or GV indexes. Incremental glucose values during CGM were calculated by subtracting concentrations at time = 0 from those at the following time points. Data were expressed as mean ± standard deviation (SD), unless otherwise specified. The D’Agostino–Pearson normality test was performed to assess whether the data were consistent with a Gaussian distribution. Differences were considered statistically significant at p < 0.05. Data were processed and analyzed using the GraphPad Prism Software version 7.0 (San Diego, CA, USA).

Continuous glucose monitoring (CGM) (iPro™2 Professional CGM-Medtronic MiniMed, Northbridge, CA, USA) was used to measure glycaemic response, defined as the primary outcome. The insertion was performed on Day 1 at 17:00 and the sensor was removed on Day 3 of the study at 9:00. Data was collated and processed using online software (Medtronic Diabetes CareLink iPro; carelink.minimed.eu). The data reported in this paper represent 24 h interstitial glucose readings recorded every 5 min from 6:00 on Day 2 to 6:00 on Day 3. During each test session, the CGM sensor was calibrated against finger-stick blood glucose measurements four times a day before every meal and before sleeping using the OneTouch®Ultra®2 blood glucose meter (LifeScan, Inc., Milpitas, CA, USA). A cross-over design with a minimum of 8 subjects would be sufficient to detect a 15% change in area under the glucose curve (24 h) with a power of 0.85 at a significance level of 0.05 as adapted from Brynes et al. [25 (link), 26 (link)].

Clinical data was obtained from the hospital's obstetric database (Supplementary material 2). Data from the iPro 2 was uploaded to web-based software (CareLink iPro, Medtronic) and exported for analysis [20 ]. Statistical analysis was performed using Microsoft Excel (Microsoft, WA, USA), SPSS (SPSS Inc., IL, USA), and MATLAB (version R2019a, MathWorks Inc., Natick, MA, USA) [21 , 22 ]. Glycaemic reports generated for each patient in Microsoft Excel were individually considered to determine validity for analysis. CGM data were excluded if the 24 hour CGM and SMBG mean differed by more than 28%, as suggested by the accuracy data reported by the CGM manufacturer [23 ]. Of the seven complete continuous days of CGM, only the first three consecutive days (excluding the day of the OGTT), containing the full 288 CGM measurements per day, were considered valid and analyzed. The CGM parameters considered in our analysis are outlined in Table 1. Day time values were considered from 06: 00 to 23 : 59 hrs and night-time values from 00 : 00 to 05 : 59 hrs. The follow up ended at birth. To be included in final data analysis, OGTT date and results must have been available.

As described previously, the continuous glucose monitoring (CGM) sensor Enlite™ (Medtronic, Northridge, CA, USA) was inserted into the subcutaneous tissue of the abdomen or the upper arm and was worn for 5 days (24 (link)). The capillary finger blood glucose was monitored four times daily for calibration. To generate data from the sensors, the software Medtronic Carelink™ iPro™ was used. To quantify glycaemic variability, coefficient of variation (CV), standard deviation (SD), continuous overall net glycaemic action, and mean amplitude of glucose excursions were used. Time spent in hypoglycaemia (<3.0 mmol/L), euglycaemia (≥3.0; ¾10.0 mmol/L), and hyperglycaemia (>10.0 mmol/L) were calculated and presented in minutes and percentage.

CGM was performed for 3 consecutive days before PCI, and the daily glucose profile was analyzed using data obtained on days 2 and 3 to avoid any bias due to insertion or removal of the sensor. In all patients, CGM analysis software (CareLink iPro, Medtronic, Northridge, CA) calculated the median of the variables measured on days 2 and 3: 24-h mean glucose levels, time in hyperglycemia/hypoglycemia, and MAGE. Time in hyperglycemia and hypoglycemia was defined as the time when blood glucose levels were above 140 mg/dL and under 70 mg/dL, respectively. All patients received optimal meals (25–28 kcal/kg of ideal body weight; 60 % carbohydrate, 15–20 % protein, and 20–25 % fat) during CGM.

CGM was performed for 7 consecutive days in all patients, and the daily glucose profiles were analyzed using data obtained from day 2 to day 6 to avoid any bias due to either insertion or removal of the sensor. The CGM analysis software (CareLink iPro, Medtronic, Northridge, California) calculated the measured variables: 120-h mean glucose levels, the time in hyperglycemia/hypoglycemia and the mean amplitude of glycemic excursions (MAGE) [12 (link)], which represents fluctuations in blood glucose levels over a 24-h period and was calculated from the daily variations in blood glucose level, measured continuously by CGM over a period of 5 days. Times in hyperglycemia and hypoglycemia were defined as the times when blood glucose levels were ≥ 200 and < 70 mg/dl, respectively [13 (link)]. All patients had daily meals during CGM.