Budapest: CGM traces (Guardian REAL-Time, Medtronic Minimed, Northridge, California) from 4 infants receiving 3 hourly enteral breast milk feeds of 20mL or more were available from Semmelweis University, Department of Paediatrics, Hungary. Demographic data are in Table 2. According to the local ethical codes this analysis of retrospective CGM data is considered as a clinical data audit, requiring only the depersonalization of the data collected.
Guardian real time
Manufactured by Medtronic
Sourced in United States
The Guardian® REAL-Time is a continuous glucose monitoring (CGM) system manufactured by Medtronic. It is designed to monitor glucose levels in the interstitial fluid of the body and provides real-time data to the user.
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Lab products found in correlation
4 protocols using guardian real time
1
Continuous Glucose Monitoring in Infants
2
CGM Monitoring in Subcutaneous Tissue
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Interstitial glucose level was monitored by Guardian® REAL Time (Medtronic®, USA) CGM. The flexible platinum Enlite® sensor was inserted in the subcutaneous tissue of the left or right lateral thigh and covered by transparent dressing. Each measurement was started after 2 hours of equilibration period. The initial calibrations were performed at the beginning of the CGM measurement and four hours afterwards. Further calibrations were done regularly at least two times daily. Additional calibrations were repeated as clinically needed. The calibration was not allowed immediately after enteral nutrition or during rapid changes of subcutaneous glucose (more than 1 mg/dL/min, alerted by the display). The range of the glucose measurement by Guardian® REAL Time is 40–400 mg/dL. Reference glucose values were obtained from blood gas analyzer (GEM 3000 Premier™, Instrumentation Laboratory®) or point-of-care glucose testing (DCONT Ideal, 77 Elektronika®). Reference blood gas measurements were taken from arterial (77 samples), central venous (184) or capillary (276) sites.
3
Continuous Glucose Monitoring Protocol
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Interstitial glucose level was monitored by Guardian® REAL-Time (Medtronic®, USA) CGM. The flexible platinum Enlite® sensor was inserted in the subcutaneous tissue of the left or right lateral thigh and covered by transparent dressing. The calibration protocol can be found in our previous publication [14 (link)]. The study was approved by the Research Ethical Committee (number: TUKEB 2012/4) of the Semmelweis University, Budapest.
4
Continuous Glucose Monitoring in Pregnant T1D
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Pregnant CGM users were approached about potential participation in the study during their third trimester. Those who wished to participate provided informed consent for themselves and assent for their neonate, with parental written consent for neonates confirmed within 24 hours of delivery. Inclusion criteria included maternal familiarity with masked or real-time CGM, intensive insulin therapy using either multiple daily injections of insulin (MDI) or insulin pump therapy, and singleton pregnancy. Exclusion criteria included known congenital anomaly or neonates with severe respiratory distress.
Pregnant women with T1D had a CGM sensor inserted 2-3 days prior to anticipated delivery.
Participants already using the Guardian® REAL-Time or MiniMed Minilink® CGM (both Medtronic, Northridge, CA) continued their usual CGM. Participants using the Freestyle Navigator II (Abbott Diabetes Care) were fitted with an additional masked CGM sensor for measurements used in this study (iPro™ 2 Professional CGM, Medtronic, Northridge, CA, USA). Participants were asked to measure capillary glucose concentration using their routine glucometer and to record at least 4 daily readings.
Pregnant women with T1D had a CGM sensor inserted 2-3 days prior to anticipated delivery.
Participants already using the Guardian® REAL-Time or MiniMed Minilink® CGM (both Medtronic, Northridge, CA) continued their usual CGM. Participants using the Freestyle Navigator II (Abbott Diabetes Care) were fitted with an additional masked CGM sensor for measurements used in this study (iPro™ 2 Professional CGM, Medtronic, Northridge, CA, USA). Participants were asked to measure capillary glucose concentration using their routine glucometer and to record at least 4 daily readings.
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