Dataset Information

Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial.

ABSTRACT: Introduction: Real-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study.

Methods and analysis: Open-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG). Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6-8 days. The third visit will be scheduled 8-10 days later and then every 2?weeks. At every visit, glucose measurements will be evaluated and all patients will be treated according to the standard care. The control group will receive a blinded CGM for 10 days between the second and third visit and between week 36+0?and 38+6. Cord blood will be sampled immediately after delivery. 48?hours after delivery neonatal biometry and maternal glycosylated haemoglobin A1c (HbA1c) will be assessed, and between weeks 8 and 16 after delivery all patients receive a re-examination of glucose metabolism including blinded CGM for 8-10 days.

Ethics and dissemination: This study received ethical approval from the main ethic committee in Vienna. Data will be presented at international conferences and published in peer-reviewed journals.

Trial registration number: NCT03981328; Pre-results.

SUBMITTER: Huhn EA

PROVIDER: S-EPMC7705524 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial.

Huhn Evelyn Annegret EA Linder Tina T Eppel Daniel D Weißhaupt Karen K Klapp Christine C Schellong Karen K Henrich Wolfgang W Yerlikaya-Schatten Gülen G Rosicky Ingo I Husslein Peter P Chalubinski Kinga K Mittlböck Martina M Rust Petra P Hoesli Irene I Winzeler Bettina B Jendle Johan J Fehm T T Icks Andrea A Vomhof Markus M Greiner Gregory Gordon GG Szendrödi Julia J Roden Michael M Tura Andrea A Göbl Christian S CS

BMJ open 20201130 11

<h4>Introduction</h4>Real-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences i ...[more]

PMID: 33257486

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Project description:BackgroundContinuous glucose monitoring (CGM) has shown potential in improving maternal and neonatal outcomes in individuals with type 1/2 diabetes, but data in gestational diabetes mellitus (GDM) is limited. We aimed to explore the relationship between CGM-derived metrics during pregnancy and pregnancy outcomes among women with GDM.MethodsWe recruited 1302 pregnant women with GDM at a mean gestational age of 26.0 weeks and followed them until delivery. Participants underwent a 14-day CGM measurement upon recruitment. The primary outcome was any adverse pregnancy outcome, defined as having at least one of the outcomes: preterm birth, large-for-gestational-age (LGA) birth, fetal distress, premature rupture of membranes, and neonatal intensive care unit (NICU) admission. The individual outcomes included in the primary outcome were considered as secondary outcomes. We conducted multivariable logistic regression to evaluate the association of CGM-derived metrics with these outcomes.FindingsPer 1-SD difference in time above range (TAR), glucose area under the curve (AUC), nighttime mean blood glucose (MBG), daytime MBG, and daily MBG was associated with higher risk of any adverse pregnancy outcome, with odds ratio: 1.22 (95% CI 1.08-1.36), 1.22 (95% CI 1.09-1.37), 1.18 (95% CI 1.05-1.32), 1.21 (95% CI 1.07-1.35), and 1.22 (95% CI 1.09-1.37), respectively. Time in range, TAR, AUC, nighttime MBG, daytime MBG, daily MBG, and mean amplitude of glucose excursions were positively associated, while time blow range was inversely associated with the risk of LGA. Additionally, higher value for TAR was associated with higher risk of NICU admission. We further summarized the potential thresholds of TAR (2.5%) and daily MBG (4.8 mmol/L) to distinguish individuals with and without any adverse pregnancy outcome.InterpretationThe CGM-derived metrics may help identify individuals at higher risk of adverse pregnancy outcomes. These CGM biomarkers could serve as potential new intervention targets to maintain a healthy pregnancy status among women with GDM.FundingNational Key R&D Program of China, National Natural Science Foundation of China, and Westlake Laboratory of Life Sciences and Biomedicine.

Project description:Aims/introductionWe aimed to evaluate and compare continuous glucose monitoring system (CGMS)-based glycemic parameters in women in early pregnancy (<20 weeks of gestation) who were classified as: (i) gestational diabetes mellitus (GDM) by the International Association of Diabetes and Pregnancy Study Groups (IADPSG), but normoglycemia by alternate (UK National Institute for Health and Care Excellence, Canadian Diabetes Association and Diabetes in Pregnancy Study group of India) criteria; and (ii) normoglycemia by both (IADPSG and alternate) criteria.Material and methodsIn this cross-sectional study, eligible women underwent standard 75-g oral glucose tolerance test, followed by the placement of a CGMS. Glycemia-related parameters were calculated using the standard approach for CGMS data in pregnancy.ResultsWe enrolled 96 women at 14.0 ± 3.2 weeks of gestation. Of the women diagnosed as GDM by IADPSG criteria, 34.2%, 26.3% and 44.7% were classified as normoglycemic by UK National Institute for Health and Care Excellence, Canadian Diabetes Association and Diabetes in Pregnancy Study group of India criteria, respectively. Mean 1-h postprandial glucose and time above range were significantly higher in women who were GDM by IADPSG, but normoglycemia by Canadian Diabetes Association criteria, compared with women with normoglycemia using both criteria. Similarly, mean 1-h postprandial glucose, 2-h postprandial glucose, peak postprandial glucose, 1-h postprandial glucose excursion and time above range were significantly higher in women who were not identified as GDM by the UK National Institute for Health and Care Excellence criteria. Finally, women missed by the Diabetes in Pregnancy Study group of India criteria had significantly higher mean 1-h postprandial glucose, 2-h postprandial glucose, peak postprandial glucose, postprandial glucose excursion, 24-h glucose and time above range parameters.ConclusionsMore than one-quarter of women diagnosed as GDM by IADPSG criteria are not identified by alternate criteria. Such women are significantly different from normoglycemic women in terms of several CGMS-based glycemic parameters of clinical significance.

Project description:BACKGROUND:The purpose of this study was to examine the relationships between glucose parameters obtained by continuous glucose monitoring and clinical outcomes in acute stroke patients. METHODS AND RESULTS:Consecutive patients with acute ischemic stroke or intracerebral hemorrhage within 24 hours after onset were included. A continuous glucose monitoring device (iPro2) was attached for the initial 72 hours after emergent admission. Eight glucose parameters were obtained from continuous glucose monitoring: maximum, minimum, mean, and SD of blood glucose levels, as well as area under the curve more than 8 mmol/L of blood glucose, distribution time more than 8 mmol/L of blood glucose, coefficient of variation (%CV), and presence of time less than 4 mmol/L over 72 hours. The primary outcome measure was death or dependency at 3 months (modified Rankin Scale score ?3). One hundred patients with acute ischemic stroke (n=58) or intracerebral hemorrhage (n=42) were included. Blood glucose levels varied between 5.2±1.4 and 11.4±3.2 mmol/L over 72 hours, with area under the curve more than 8 mmol/L of blood glucose of 0.7±1.4 min×mmol/L, distribution time more than 8 mmol/L of blood glucose of 31.7±32.7%, coefficient of variation of 15.5±5.4%, and presence of hypoglycemia in 20% of overall patients. Mean glucose level (adjusted odds ratio, 1.60, 95% confidence interval, 1.12-2.28/1 mmol/L), area under the curve more than 8 mmol/L of blood glucose (2.13, 1.12-4.02/1 min×mmol/L), and distribution time more than 8 mmol/L of blood glucose (1.25, 1.05-1.50/10%) were related to death or dependency for overall patients, as well as for acute ischemic stroke patients (2.05, 1.15-3.65; 2.38, 1.04-5.44; 1.85, 1.10-3.10, respectively). CONCLUSIONS:High mean glucose levels, distribution time more than 8 mmol/L of blood glucose, and areas under the curve more than 8 mmol/L of blood glucose during the initial 72 hours of acute stroke were associated with death or dependency at 3 months.

Dataset Information

Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial.

Publications

Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial.

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