Use of a real time continuous glucose monitoring system as an educational tool for patients with gestational diabetes

Alfadhli, Eman; Osman, Eman Naguib; Basri, Taghreed

doi:10.1186/s13098-016-0161-5

Cited by 38 publications

(61 citation statements)

References 14 publications

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“…The number of study participants with type 2 diabetes among existing studies (31,32) is small (total n = 56). Moreover, a number of small randomized controlled trials performed among GDM women have reported reduced gestational weight gain (33) and higher detection rates for those who required medication therapy (34) but have found no improvement in glycemic control or pregnancy outcomes with CGMS use (33,35). Conversely, a cohort study performed among 340 GDM women showed better pregnancy outcomes in the CGMS group (36).…”

Section: Clinical Use Of Cgms During Pregnancymentioning

confidence: 99%

A Perspective on the Accuracy of Blood Glucose Meters During Pregnancy

Simmons

2018

Diabetes Care

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Blood glucose monitoring is fundamental for hyperglycemia management during pregnancy, but are the devices up to the job? Studies assessing the accuracy of 10 commercially available glucose meters during pregnancy showed that although >98–99% of the meter values were in the acceptable zones of the error grid for the majority of the meters, the meter performance varied, with the majority showing positive bias and a few showing minimal negative bias. The mean difference between meter and laboratory plasma values varied between −0.33 and 0.73 mmol/L. Three meters showed deviations from laboratory results with a change in maternal hematocrit levels. No meters had a total analytical error <5%, and no studies evaluated meters using recent International Organization for Standardization 15197:2013 criteria. The Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT) recently showed that an antenatal continuous glucose monitoring system (CGMS), as an adjunct to capillary monitoring, was associated with a lower incidence of large-for-gestational-age babies, fewer neonatal intensive care unit admissions (>24 h), and a lower incidence of neonatal hypoglycemia. The flash glucose monitoring system shows good accuracy in pregnant women but has not been marketed widely in the U.S. We suggest that meters cannot be assumed to be sufficiently accurate during pregnancy and that manufacturers should ensure a total error <5%, with bias and imprecision <2% during pregnancy. Large studies are needed to evaluate the usefulness of CGMS among pregnant women with type 2 diabetes and gestational diabetes mellitus.

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Section: Clinical Use Of Cgms During Pregnancymentioning

confidence: 99%

A Perspective on the Accuracy of Blood Glucose Meters During Pregnancy

Simmons

2018

Diabetes Care

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“… 10 , 15–18 Reported barriers to CGM use include technical challenges, calibration, skin irritation, frequent alarms (especially during sleep), differences between sensor and SMBG measurements, and cost. 10 , 17 , 19 Despite the positive outcomes in the recent Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes (CONCEPTT) study, more than 80% of the women experienced frustrations with CGM, such as connectivity issues, alarms, and calibration errors, and 48% of participants experienced skin reactions following sensor use. 20 With the limited evidence of improved clinical outcomes, combined with the lack of published accuracy data for continuous sensing during pregnancy and the high cost of such systems, use of continuous glucose sensing is generally underutilized in the pregnant population.…”

Section: Introductionmentioning

confidence: 99%

Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes

Scott

Bilous

Kautzky‐Willer

2018

Diabetes Technology & Therapeutics

119

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Background: Accuracy of the FreeStyle Libre™ Flash Glucose Monitoring System has not been evaluated in pregnant women with diabetes. The aim of this study was to determine accuracy (compared to self-monitoring of blood glucose [SMBG]), clinical safety, and acceptability of the FreeStyle Libre System when used at home by this population.Materials and Methods: Seventy-four participants, with type 1 (T1D, n = 24), type 2 (T2D, n = 11), or gestational (n = 39) diabetes, were enrolled across 13 sites (9 in United Kingdom, 4 in Austria). Average gestation was 26.6 ± 6.8 weeks (mean ± standard deviation), age was 30.5 ± 5.1 years, diabetes duration was 13.1 ± 7.3 years for T1D and 3.2 ± 2.5 years for T2D, and 49/74 (66.2%) used insulin to manage their diabetes. Sensors were worn for up to 14 days. Sensor glucose values (masked) were compared with capillary SMBG values (made at least 4 times/day).Results: Clinical accuracy of sensor results versus SMBG results was demonstrated, with 88.1% and 99.8% of results within Zone A and Zones A and B of the Consensus Error Grid, respectively. Overall mean absolute relative difference was 11.8%. Sensor accuracy was unaffected by the type of diabetes, the stage of pregnancy, whether insulin was used, age or body mass index. User questionnaires indicated high levels of satisfaction with sensor wear, system use, and comparison to SMBG. There were no unanticipated device-related adverse events.Conclusions: Good agreement was demonstrated between the FreeStyle Libre System and SMBG. Accuracy of the system was unaffected by patient characteristics, indicating that the system is safe and accurate to use by pregnant women with diabetes.

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“…They used a similar real-time CGM for 3 to 7 days (mean of 67 hours). 18 They did not see a difference in glycemic control or perinatal outcomes.…”

Section: Resultsmentioning

confidence: 94%

Real-Time Continuous Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial

et al. 2019

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Objective To evaluate whether real-time continuous glucose monitoring improves glycemic control over intermittent self-monitoring of blood glucose in gestational diabetes. Study Design We performed a single-institution randomized controlled trial. Patients with gestational diabetes were randomized to use either real-time or blinded continuous glucose monitoring. The primary outcome was mean sensor glucose level during the fourth week of continuous glucose monitoring use. Secondary outcomes included glycemic control and a composite of obstetric and neonatal outcomes. Results Of the 40 enrolled patients, 12 (60%) patients in the blinded continuous glucose monitoring group and 11 (55%) in the real-time continuous glucose monitoring group completed 4 weeks of monitoring and were included in the final analysis. There was no significant difference in mean sensor glucose level between the blinded continuous glucose monitoring group (98.9 ± 8.9 mg/dL) and the real-time continuous glucose monitoring group (107.5 ± 11.4 mg/dL). There were also no significant differences in the time spent in glycemic target, maternal, or neonatal outcomes. Conclusion Our study shows that the use of continuous glucose monitoring with real-time feedback did not significantly decrease mean glucose values compared with intermittent self-monitoring of blood glucose after 4 weeks of continuous glucose monitoring use.

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Use of a real time continuous glucose monitoring system as an educational tool for patients with gestational diabetes

Cited by 38 publications

References 14 publications

A Perspective on the Accuracy of Blood Glucose Meters During Pregnancy

A Perspective on the Accuracy of Blood Glucose Meters During Pregnancy

Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes

Real-Time Continuous Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial

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