ArticleDiabetes technology & therapeutics2018
Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes.
Article in Diabetes technology & therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04422821 (Flash Glucose Monitoring in Gestational Diabetes Mellitus), which is not on this map. Cited by 70 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial
Who cites it
70 citing papers in PubMed, 3 syntheses or guidelines pooled it, 152 citations in OpenAlex.
- Cutaneous Complications With Continuous or Flash Glucose Monitoring Use: Systematic Review of Trials and Observational Studies.Journal of diabetes science and technology · 2020Pooled it
- Application and Utility of Continuous Glucose Monitoring in Pregnancy: A Systematic Review.Frontiers in endocrinology · 2019Pooled it
- Flash Glucose Monitoring System for People with Type 1 or Type 2 Diabetes: A Health Technology Assessment.Ontario health technology assessment series · 2019Pooled it
- Flash glucose monitoring in gestational diabetes mellitus (FLAMINGO): a randomised controlled trial.Acta diabetologica · 2023Trial
- Optimizing Blood Glucose Control through the Timing of Exercise in Pregnant Individuals Diagnosed with Gestational Diabetes Mellitus.International journal of environmental research and public health · 2023Trial
- Real-Time Flash Glucose Monitoring Had Better Effects on Daily Glycemic Control Compared With Retrospective Flash Glucose Monitoring in Patients With Type 2 Diabetes on Premix Insulin Therapy.Frontiers in endocrinology · 2022Trial
- Continuous Glucose Monitoring in Gestational Diabetes Mellitus: Evidence, Clinical Benefits and Remaining Challenges.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Review
- The Role of Continuous Glucose Monitoring in Managing Hyperglycaemia First Detected in Pregnancy: A Narrative Review.Diabetes, obesity & metabolism · 2026Review
- Review
- The role of continuous glucose monitoring for diagnosis of gestational diabetes: exploring the potential.BMC medicine · 2026Review
- Impact of Metabolic Surgery on Gestational Diabetes Mellitus: A Cohort Analysis.The Australian & New Zealand journal of obstetrics & gynaecology · 2026Article
- Diabetes Monitoring in Pregnant Women with Type 1 Diabetes: Capillary Blood Glucose or Interstitial Fluid Glucose? A Case Control Study.Nutrition and metabolic insights · 2026Article
- Performance of flash continuous glucose monitoring and glycemic marker correlations in Chinese pregnant women with non-type 1 diabetes.World journal of diabetes · 2025Article
- Continuous glucose monitoring system in diabetes in pregnancy: a narrative review.Diabetology & metabolic syndrome · 2025Review
- Article
- Effect of FSL-CGM on Maternal and Neonatal Outcomes in GDM: A Propensity Score Matching Study in Hangzhou, China.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
- The Effect of a Mobile App (eMOM) on Self-Discovery and Psychological Factors in Persons With Gestational Diabetes: Mixed Methods Study.JMIR mHealth and uHealth · 2025Article
- Quality of Life in Women With Gestational Diabetes Mellitus and Treatment Satisfaction Upon Intermittently Scanned Continuous Glucose Monitoring.Journal of Korean medical science · 2025Observational
- Accuracy and feasibility of continuous glucose monitoring system in pancreatectomy patients.Langenbeck's archives of surgery · 2025Article
- The Efficacy and Acceptability of Flash Glucose Monitoring in Pregnant Women with Gestational Diabetes Mellitus: A Systematic Review.Journal of clinical medicine · 2024Review
10 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAccuracy 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
methodsSeventy-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).
resultsClinical 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.
conclusionsGood 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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.