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Enlite

Manufactured by Medtronic
Sourced in United States

The Enlite is a lab equipment product manufactured by Medtronic. It is a continuous glucose monitoring (CGM) sensor designed to measure glucose levels in the interstitial fluid. The Enlite provides real-time glucose data to help healthcare professionals and patients manage diabetes.

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10 protocols using enlite

1

Continuous Glucose Monitoring and Lifestyle Factors

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To obtain insight into everyday glycemic control, a continuous glucose sensor (Enlite, Medtronic, Friedly, MN, United States) was inserted into the abdominal subcutaneous adipose tissue of all participants. The sensor was connected to a CGM monitor (iPro2, Medtronic) and calibrated four times daily with a glucometer (Contour, Bayer, Basel, Switzerland). The obtained data were analyzed for mean amplitude glycemic excursions (MAGE) a marker for glycemic variability (Service et al., 1970 ). Self-reported dietary intake was registered over 3 days before and after the intervention. Average daily calorie intake was calculated using madlog-vita.dk. Free-living physical activity was assessed using accelerometry (AX3, Newcastle, United Kingdom), sampling frequency 100 Hz, over 4 days before and after the intervention (Treuth et al., 2004 (link)).
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2

Continuous Glucose Monitoring Protocol

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The CGM sensor Enlite™ (Medtronic, Northridge, CA) was inserted into the subcutaneous tissue of the abdomen or alternatively the upper arm. Subsequently the iPro2™ (Medtronic, Northridge, CA) recorder was attached. The sensors should be worn for 5 days and the capillary finger blood glucose monitored four times daily for calibration. The software Medtronic CareLink™ iPro™ was used to generate data from the sensors. Participants were excluded from the study if there were not enough measurements of the capillary blood glucose to run the Medtronic CareLink™ iPro™ software. CV, standard deviation (SD), continuous overall net glycemic action (CONGA), and mean amplitude of glucose excursions (MAGE) were used to quantify GV (38 (link)). Time spent in hypo- (<3.0 mmol/l), eu- (≥3.0; ≤10.0 mmol/l), and hyperglycemia (>10.0 mmol/l) were calculated (38 (link)) and presented in minutes and percentage.
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3

Subcutaneous Glucose Monitoring Protocol

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The iPro2 system (Medtronic Inc, Northridge, CA, USA) was used for subcutaneous interstitial glucose monitoring. The sensor (Enlite, Medtronic Inc) recorded glucose levels every 5 min for seven consecutive days, and was inserted on the first day and removed after 7 days, generating a daily record of 288 continuous sensor values. At least two capillary blood glucose readings per day were measured by using a Sure Step blood glucose meter (LifeScan, Milpitas, CA, USA) to calibrate the CGM system. TIR was defined as the percentage of time in the target glucose range of 3.9 to 10.0 mmol/L during the 7 days. Intraday glycemic variability (GV) parameters included the standard deviation (SD) of sensor glucose values, glucose coefficient of variation (CV), and mean amplitude of glycemic excursions (MAGE). CV was determined as SD divided by the mean glucose level. In addition, the arithmetic mean of the differences between consecutive nadirs and peaks was computed to determine the MAGE value. During the 7-day CGM period, all subjects adhered to the original therapy regimen and standard diet.
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4

Continuous Glucose Monitoring in Type 1 DM

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After an overnight fast, the Type 1 DM group underwent 72-h CGM with the Ipro2 System (Medtronic, Northridge, CA), and a subcutaneous sensor (Enlite; Medtronic, Northridge, CA) for CGM was applied on the same day of SD-OCT analysis. From CGM data, the following indexes of GV were calculated [18 (link)]: standard deviation (SD); mean amplitude of glucose excursion (MAGE); J-index; mean absolute glucose (MAG); continuous overall net glycemic action (CONGA-1, -2 and -4); low blood glucose (LBGI) and high blood glucose index (HBGI); M value.
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5

Continuous Glucose Monitoring in Diabetes

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CGM was performed using iPro2® as the recorder and an Enlite® glucose sensor (Medtronic, Northridge, CA). The CGM system was inserted in the arm or abdominal area according to the manufacturer’s guidelines. Standard POC capillary blood glucose measurements were performed using Gold AQ glucometers (Sinocare, China) three times daily before breakfast, lunch, and dinner to calibrate the CGMs. CGM data were collected from study enrollment until discharge during a week-long study session, and all participants were instructed to adhere to a standard diet. The patients were instructed to keep a regular diet, avoid strenuous exercise, and maintain detailed records of diet, exercise, and insulin dose. In the present study, we analyzed average glucose, estimated HbA1c (eHAb1c), glucose variability (calculated as the coefficient of variation (CV); mean amplitude of glycemic excursions (MAGE); mean of daily differences (MODD); continuous glucose overlapping net glycemic action (CONGA); low blood glucose index (LBGI); high blood glucose index (HBGI); and postprandial glucose excursions (PPGE)), time in range (TIR, 3.9-10.0 mmol/l), time above range (TAR, > 10.0 mmol/l), and time below range (TBR, < 3.9 mmol/l).
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6

Continuous Glucose Monitoring Deployment

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CGM (Medtronic Enlite) was placed on the lateral side of the thigh preceded by adequate containment and analgesia with the use of pacifier and 0.3 ml 24% sucrose 2 min before the procedure. The device was calibrated as per manufacturer instructions.
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7

Retrospective CGM Glucose Monitoring

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Retrospective CGM systems (iPro 2; Medtronic Inc, Northridge, CA, USA) were used for subcutaneous interstitial glucose monitoring. All participants had the sensor inserted (Enlite; Medtronic Inc) on the first day of hospital admission and removed after 7 days, generating a daily record of 288 glucose values. At least four capillary blood glucose levels per day were measured using SureStep blood glucose meter (LifeScan, Milpitas, CA, USA) to calibrate the CGM systems. AUC for glucose >10.0 mmol/L, between 3.9 and 10.0 mmol/L, and <3.9 mmol/L were calculated according to the trapezoidal rule. AucIR was defined as the average percentage of AUC for glucose between 3.9 and 10.0 mmol/L, in the sum of AUC above, between and below these thresholds during a 24‐h period (Figure 1b). TIR was defined as the average percentage of time for glucose between 3.9 and 10 mmol/L during a 24‐h period. Glucose management indicator was calculated from the mean sensor glucose by the equation: glucose management indicator (%) = 3.31 + 0.023923 × mean glucose (mg/dL)14. Within‐day glycemic variability metrics including coefficient of variation, standard deviation (SD) and mean amplitude of glycemic excursions were also calculated. High blood glucose index and low blood glucose index were calculated to reflect the risk of hyperglycemia and hypoglycemia, respectively15.
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8

Real-World Continuous Glucose Monitoring

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No specific visit was necessary for the study: Patients were followed up as usual and data were recorded at the study-inclusion visit (M0) and at the follow-up visit 4 months later (M4).
Patients (and their parents) agreed to insert a sensor at both M0 and M4. Sensors used were either Enlite® sensors (with a Medtronic pump as monitor) or Dexcom G4® sensors (with an Animas pump as monitor) according to the physician's decision. A nurse employed by VitalAire France, a homecare provider, instructed the family on sensor use (insertion, calibration, display interpretation including trends) and was in charge of potential technical issues, as we previously reported [14] . There was no alarm setting. The patients and their parents also filled out a satisfaction questionnaire both at M0 and M4 either in the waiting room or at home right after the visit; questionnaires were returned with a prepaid envelope.
An additional visit (M+), 7-15 days after M0 and the first CGM period, could be planned to interpret data and change the treatment for one of three predefined choices according to the pediatrician, the youth, and the parents' shared decision.
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9

Continuous Glucose Monitoring Protocol

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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.
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10

Comprehensive Diabetes Monitoring Protocol

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The baseline screening (i.e., blood draws and urine) was performed after an overnight fast between 5 and 21 days after diagnosis (Δ) to allow metabolic stabilization. After the initial hospitalization, the outpatient clinical follow-up in diabetes care centers was organized throughout routine visits at Δ+3, Δ+6, Δ+9, and Δ+12 months, during which an array of data was collected (i.e., raw CGM, demographic and clinical parameters [i.e., TDD, HbA1c, and IDAA1c], and insulin administration regimen [i.e., pump or multiple daily injections (MDI)]). All patients >4 years old were recommended to wear CGM devices (FreeStyle Libre, Abbott Laboratories; DexCom, DexCom, Inc.; and Enlite, Medtronic MiniMed). Data from the medical records of participants were gathered and registered inside the Research Electronic Data Capture (REDCap) system (14 (link)) provided by Vanderbilt University (Nashville, TN) and hosted at CUSL.
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