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Enlite glucose sensor

Manufactured by Medtronic
Sourced in United States, Switzerland

The Enlite Glucose Sensor is a lab equipment product designed for continuous glucose monitoring. It measures glucose levels in the interstitial fluid and provides real-time data to help manage diabetes.

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9 protocols using enlite glucose sensor

1

Continuous Glucose Monitoring in CAP Patients

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Continuous glucose monitoring was performed using iPro2® as the recorder and an Enlite® glucose sensor (Medtronic, Northridge, CA). The CGM system was inserted in the abdominal area according to the manufacturer’s guidelines. Recordings by CGM were fully blinded during hospitalization and therefore not used for in-hospital diabetes management. Standard POC capillary blood glucose measurements were performed by ward glucometers FreeStyle Precision Pro® (Abbot, Berkshire, UK) three times daily before main meals (7:00 AM, 12:00 AM, and 5:00 PM) to calibrate the CGMs. CGM data were collected from study enrollment until discharge. At least 24 h of CGM data were required to be included in the analyses.
At baseline, we collected clinical data (age, gender, comorbidities, CURB-65 score as a measurement of severity of CAP, early warning score, Charlson comorbidity index, and medications before admission) and standard blood work (hemoglobin A1c (HbA1c)). For the two groups receiving GCs, CGM data were analyzed only during GC exposure which was defined as the period between the first GC dose and 24 h (six half-lives for prednisolone) after GCs were stopped. Meal registration (timing and percentage of the amount of meal consumed at breakfast, lunch, and dinner) made it possible to calculate PPGE.
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2

Continuous Glucose Monitoring During Sleep

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Interstitial glucose concentrations were assessed overnight, using a continuous glucose-monitoring device (Medtronic Guardian; Medtronic, Northridge, CA, USA). The system consists of a sensor, a transmitter, and a recording device. The sensor (Enlite Glucose Sensor; Medtronic, Northridge, CA, USA) is a thin (31-gauge), short (8.5-mm) substrate with electrode surfaces to detect glucose concentrations. The transmitter is a small oval-shaped device approximately 2 cm across and is attached to the exposed part of the sensor and covered with a waterproof dressing. The transmitter sends radio signals to the recording device, and interstitial glucose concentrations are recorded in 5 min epochs. The devices were chosen because they are minimally invasive and, once inserted, allow for continuous monitoring of glucose concentrations without disturbing the wearer, as is essential during sleep.
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3

Continuous Glucose Monitoring Protocol

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Interstitial glucose concentrations were assessed using a continuous glucose monitoring device (Medtronic Guardian; Medtronic, Northridge, CA, USA). The device consists of a sensor, a transmitter and a recording device. The sensor (Enlite Glucose Sensor; Medtronic, Northridge, CA, USA) is a thin (31-gauge), short (8.5 mm) substrate with electrode surfaces to detect glucose concentrations. The Enlite sensor was chosen as it is compatible with the Medtronic Guardian system. Only one brand of sensor was used to allow for comparisons in the glucose response between groups (data reported elsewhere). The sensor is inserted into the skin using an introducer needle which is discarded after insertion. The transmitter is a small (approximately 2 cm in diameter) flat, round device which is attached to the exposed part of the sensor and covered with a waterproof dressing. The transmitter sends radio signals depicting interstitial glucose concentrations to the recording device, where they are recorded in 5-min epochs.
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4

Glucose Variability Assessment from OGTT and CGM

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The incremental glucose peak (IGP; mmol/L), a recently validated OGTT-based index of daily glucose variability, was calculated by subtracting FPG from the maximum glucose peak value measured during a complete seven-point OGTT30 (link). At the time of analysis, data on IGP were available in a subset of participants (n = 2407). We used CGM (iPro2 and Enlite Glucose Sensor; Medtronic, Tolochenaz, Switzerland) to assess daily glucose variability during a 1-week period, which was expressed as standard deviation (mmol/L) of mean sensor glucose (mmol/L)26 (link). CGM-assessed data were available in a subset of participants (n = 622). More details on the assessment of glycemic indices with OGTT and CGM are provided in the Supplemental Methods.
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5

Continuous Glucose Monitoring Protocol

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The rationale and methodology of CGM (iPro2 and Enlite Glucose Sensor; Medtronic, Tolochenaz, Switzerland) have been described previously [14 (link)]. In brief, the CGM device was worn abdominally and recorded subcutaneous interstitial glucose values (range: 2.2–22.2 mmol/L) every five minutes for a seven-day period. For calibration purposes, participants were asked to perform self-measurements of blood glucose four times daily (Contour Next; Ascensia Diabetes Care, Mijdrecht, the Netherlands). Participants were blinded to the CGM recording, but not to self-measured values. Diabetes medication use was allowed and no dietary instructions were given. We only included individuals with at least 48h of CGM, but excluded the first 24h of CGM from analysis because of insufficient calibration. For the glucose prediction analyses, all remaining glucose data points were used. We additionally calculated mean sensor glucose, standard deviation (SD), and coefficient of variation (CV) with the use of Glycemic Variability Research Tool (GlyVaRT; Medtronic) software.
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6

Continuous Glucose Monitoring Protocol

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Continuous glucose monitoring was performed using iPro2® as the recorder and an En-lite® glucose sensor (Medtronic plc). The CGM system was placed in the abdominal area and the lateral upper arms according to the manufacturer's instructions. Standard POC capillary blood glucose measurements were carried out by Gold AQ glucometers (Sinocare Co., Ltd., Shanghai, China) for three times/day before breakfast, lunch and dinner to calibrate the CGM system. CGM data were collected from study enrollment until discharge at a week-long study session, and we analyzed average glucose level, estimated HbA1c (eHAb1c) level, glucose variability (calculated as the coefficient of variation, CV; MAGE, mean amplitude glycemic excursion; LAGE, large amplitude glycemic excursion; LBGI, low blood glucose index; HBGI, high blood glucose index), 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). The targets were set according to the international consensus guidelines on CGM as follows: TIR ≥ 70%, TAR <25%, TBR <4% and CV <36%, and target HbA1c level of <7.5% was recommended (17 (link)).
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7

Continuous Glucose Monitoring in Intervention

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Participants’ capillary blood glucose was measured before each meal and once during fasting, at the frequency of every 4–6 h, depending on their eating schedule. In addition, a Medtronic Enlite Glucose Sensor (Medtronic, Northridge, CA, USA) was used to monitor glycemia during the intervention period24 (link). Interstitial glucose levels were recorded every 5 min with a detection range of 40–400 mg/dL. Glucose levels from capillary blood and continuous glucose monitoring (CGM) were compared and calibrated at randomization and 1, 3, and 4 h after randomization. The glycemic data from CGM were used in the analyses.
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8

Unblinded Continuous Glucose Monitoring System

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An unblinded continuous glucose monitoring system (CGMS) was used during the dietary interventions (Enlite® glucose sensors combined with the Minilink® Real Time Transmitter, MedTronic®). A Minimed Paradigm Veo® insulin pump (void of insulin) was used to store and display sensor results. Patients were instructed to use the CGMS system by specialist diabetes nurses or the investigator. The sensor was placed on the abdomen, and used according to the manufacturers' specifications. Patients regularly performed capillary glucose measurements (device: Contour Next Link USB, Bayer®) to calibrate the glucose sensor (at least 3 times/ day) and to check for accurate sensor function. All patients made a capillary glucose measurement before the first meal in the morning in addition to the sensor readings. An alarm was set to warn patients in case of nocturnal hypoglycemia (threshold <2.5 mmol/l). Confirmation of hypoglycemia by a capillary glucose measurement was mandatory in case of an alarm prior to carbohydrate intake. CGMS data were downloaded with the Carelink Professional® Software (MedTronic®) for statistical analysis, and discussed with the patients.
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9

Continuous Glucose Monitoring and Hypoglycemia

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Following recording of baseline characteristics and blood sampling, the participants underwent 6-7 days of blinded continuous glucose monitoring (CGM), while they continued their usual daily activities and treatments. During the monitoring period, the participants documented episodes of symptomatic hypoglycaemia (≤3.9 mmol/l). Daily activities, food intake and insulin dosing were recorded every half hour in a diary. A detailed questionnaire was filled in by the participants regarding each episode of hypoglycaemia, including whether they had symptoms or not.
The device used for CGM was blinded iPro 2 with Enlite Glucose sensors (Medtronic MiniMed, Northridge, CA, USA), which has a reported overall mean absolute relative difference (MARD) of 13.9% and 18.4% in the hypoglycaemic range (glucose level ≤ 3.9 mmol/l), a sensitivity of 90.1% and a positive predictive value of 83.8% for hypoglycaemia [15] (link). Calibration was performed according to the manufacturer's recommendations (four times daily) with blood glucose meter measurements (Contour XT meter using Contour NEXT test strips; Bayer, Basel, Switzerland).
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