Factory-Calibrated Continuous Glucose Monitoring: How and Why It Works, and the Dangers of Reuse Beyond Approved Duration of Wear

Forlenza, Gregory P.; Kushner, Taisa; Messer, Laurel H.; Wadwa, R. Paul; Sankaranarayanan, Sriram

doi:10.1089/dia.2018.0401

Cited by 29 publications

(21 citation statements)

References 33 publications

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“…This is consistent with Faulds and colleagues' study, which reported that adults using 670G in the first 3 months calibrated their sensor 3.2 times/day and checked BG an average of 6.5 times/day . In an era when many individuals with type 1 diabetes are using factory calibrated CGM systems, requiring BG checks and sensor calibrations may be too high a burden for sustained use of HCL.…”

Section: Discussionsupporting

confidence: 88%

Six months of hybrid closed loop in the real‐world: An evaluation of children and young adults using the 670G system

Berget¹,

Messer²,

et al. 2020

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Objective: To describe glycemic and psychosocial outcomes in youth with type 1 diabetes using a hybrid closed loop (HCL) system. Subjects: Youth with type 1 diabetes (2-25 years) starting the 670G HCL system for their diabetes care were enrolled in an observational study. Methods: Prospective data collection occurred during routine clinical care and included glycemic variables (sensor time in range [70-180 mg/dL], HbA1c), and psychosocial variables (Hypoglycemia Fear Survey [HFS]; Problem Areas in Diabetes [PAID]). Mixed models were used to analyze change across time.Results: Ninety-two youth (mean age 15.7 ± 3.6 years, 50% female, HbA1c 8.8% ± 1.8%) started HCL for their diabetes care. Youth used Auto Mode 65.5% ± 3.0% of the time at month 1, which decreased to 51.2% ± 3.4% at month 6 (P = .001). Sensor time in range increased from 50.7% ± 1.8% at baseline to 56.9% ± 2.1% at 6 months (P = .007). HbA1c decreased from 8.7% ± 0.2% at baseline to 8.4% ± 0.2% after 6 months of use (P ≤ .0001), with the greatest HbA1c decline in participants with high baseline HbA1c. Increased percent time in auto mode was associated with lower HbA1c (P = .02). Thirty percent of youth discontinued HCL in the first 6 months of use. There were no changes in the HFS or PAID scores across time.Conclusions: HCL use is associated with improved glycemic control and no change in psychosocial outcomes in this clinical sample. The decline in HCL use across time suggests that youth experience barriers in sustaining use of HCL. Further research is needed to understand reasons for HCL discontinuation and determine intervention strategies.pediatrics, artificial pancreas, automated insulin delivery, continuous glucose monitor The use of diabetes technology is a promising treatment strategy to improve diabetes outcomes in youth. Use of insulin pumps and continuous glucose monitors (CGM) are associated with reduction in HbA1c, both when used separately and together. 7 The most advanced technology currently available for diabetes care is a hybrid closed loop (HCL) insulin delivery system. HCL technology automates basal insulin delivery in response to CGM glucose trends while users deliver bolus doses for carbohydrate consumption. The MiniMed 670G is the first HCL device to be commercially available, which consists of the 670G insulin pump and the Guardian 3 CGM.The 670G operates in two modes, both as a standard insulin pump ("Manual Mode"), and as HCL ("Auto Mode"). 8 When using the 670G system in Auto Mode, the basal insulin delivery is calculated every 5 min by the pump's HCL algorithm, based on sensor glucose data. 9 To maintain Auto Mode use, the user must wear the CGM consistently, calibrate the CGM sensor at least twice per day, and respond to alerts in a timely manner. The system exits users from Auto Mode to Manual Mode if: (a) there is prolonged hyperglycemia (ie, sensor glucose >250 mg/dL for 3 h or >300 mg/dL for 1 h); (b) the pump has delivered a minimum or maximum insulin rate for 1-3 h; or (c) sensor glucose data are missing or inaccurate...

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Section: Discussionsupporting

confidence: 88%

Six months of hybrid closed loop in the real‐world: An evaluation of children and young adults using the 670G system

Berget¹,

Messer²,

et al. 2020

Self Cite

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show abstract

“…The receiver options vary by CGM type and may include a hand-held device, an insulin pump, or a mobile application on a smart phone or other device (i.e., apple watch, etc.). The CGM sensor is a glucose oxidase electrode, which generates an electrical current in the presence of glucose in the interstitial fluid and then converts that information into an estimated blood glucose value (Forlenza et al, 2019). As such, it is important to realize that CGM is not measuring blood glucose values directly, and it is not measuring capillary blood glucose levels, like SMBG.…”

Section: Overview Of Cgmmentioning

confidence: 99%

“…The most current Dexcom CGM (Dexcom G6) is factory calibrated, and therefore does not require the user to calibrate the sensor with SMBG values (Forlenza et al, 2019). The user can choose to calibrate, but generally, it is not recommended to calibrate with SMBG unless there is a reason to believe that the CGM is not reading accurately (i.e., symptoms do not match the CGM reading).…”

Section: Figure 1 Components Of Continuous Glucose Monitoringmentioning

confidence: 99%

Use of Technology in Managing Diabetes in Youth, Part 1: Continuous Glucose Monitoring: Information and Tips for the School Nurse

Berget¹,

Wykoff

2020

NASN School Nurse

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Glucose monitoring is an essential component of type 1 diabetes (T1D) treatment. Continuous glucose monitoring (CGM) systems measure glucose levels every few minutes and provide valuable trend information about the direction and speed glucose levels are changing. Use of CGM is increasing rapidly in youth with T1D and consistent use of CGM is associated with improved glycemic control. School nurses are a vital part of the care team for a student with T1D, and therefore, must be comfortable using CGM to support their students at school. This is the first article in a three-part series on the use of technology in managing diabetes in youth. The purpose of this article is to describe CGM devices, including calibration requirements and interpretation of trend arrows and provide tips for school nurses in incorporating CGM into the student’s individualized healthcare plan. Part 2 in this series will focus on insulin pumps and Part 3 will focus on special considerations and problem solving when using diabetes technology in the school setting.

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“…Although the composition of CGMS has not changed significantly, the current CGMSs (Dexcom G6 ® and Abbott FreeStyle Libre) do not require calibration anymore. Since revolutionary change in CGMS is due to advance in sensor manufacturing, Dexcom G6 ® and Abbott FreeStyle Libre do not need in vivo calibration, thus reaching zero-finger pricking glucose monitoring [41]. As a result, diabetic patients can now relieve from painful, daily, routine finger-pricking calibration.…”

Section: Semi-implantalbe Cgms With Electrochemical Sensorsmentioning

confidence: 99%

Toward Long-Term Implantable Glucose Biosensors for Clinical Use

Heo

Kim

2019

Applied Sciences

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Continuous glucose monitoring (CGM) sensors have led a paradigm shift to painless, continuous, zero-finger pricking measurement in blood glucose monitoring. Recent electrochemical CGM sensors have reached two-week lifespans and no calibration with clinically acceptable accuracy. The system with the recent CGM sensors is identified as an “integrated glucose monitoring system,” which can replace finger-pricking glucose-testing for diabetes treatment decisions. Although such innovation has brought CGM technology closer to realizing the artificial pancreas, discomfort and infection problems have arisen from short lifespans and open wounds. A fully implantable sensor with a longer-term lifespan (90 days) is considered as an alternative CGM sensor with high comfort and low running cost. However, it still has barriers, including surgery for applying and replacing and frequent calibration. If technical refinement is conducted (e.g., stability and reproducibility of sensor fabrication), fully implantable, long-term CGM sensors can open the new era of continuous glucose monitoring.

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Factory-Calibrated Continuous Glucose Monitoring: How and Why It Works, and the Dangers of Reuse Beyond Approved Duration of Wear

Cited by 29 publications

References 33 publications

Six months of hybrid closed loop in the real‐world: An evaluation of children and young adults using the 670G system

Six months of hybrid closed loop in the real‐world: An evaluation of children and young adults using the 670G system

Use of Technology in Managing Diabetes in Youth, Part 1: Continuous Glucose Monitoring: Information and Tips for the School Nurse

Toward Long-Term Implantable Glucose Biosensors for Clinical Use

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