Effects of intermittently scanned continuous glucose monitoring on blood glucose control and the production of urinary ketone bodies in pregestational diabetes mellitus

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Abstract

Objective

To investigate the effects of intermittently scanned continuous glucose monitoring (isCGM) on blood glucose control, clinical value of blood glucose monitoring and production of urinary ketone bodies in pregestational diabetes mellitus.

Method

A total of 124 patients with pregestational diabetes mellitus at 12–14 weeks of gestation admitted to the gestational diabetes clinic of our hospital from December 2016 to December 2018 were selected and randomly divided into two groups. Sixty patients adopted self-monitoring of blood glucose (SMBG) were taken as the control group, and the other 64 patients adopted isCGM system by wearing the device for 14 days. Blood sugar control, glycosylated albumin level, ketone production in urine, the maximum and minimum of blood sugar value measured by different monitoring methods and their occurrence time were observed in the two groups.

Result

(1) No statistically significant differences were found between the groups in terms of maternal age, gestational age at first visit, family history, duration of diabetes, education level, total insulin dose, chronic hypertension, abortion history, nulliparity, assisted reproductive technology, history of macrosomia childbirth, pre-pregnancy BMI, and overweight (%) at the first visit and hypoglycemia, (2) the value of Glycated Albumin was lower in the CGM group compared to the control group at 2ed weeks (14.6 ± 2.2 vs. 16.8 ± 2.7, p < 0.001). The women in the CGM group spent increased time in the recommended glucose control target range of 3.5–7.8 mmol/L (69 ± 10% vs. 62 ± 11%, p < 0.001) and reduced time above target compared with those in the control group at 2 weeks (25 ± 7% vs. 31 ± 8%, p < 0.001). In the second week of the study, the positive rate of urinary ketone body in isCGM group was lower than that in the control group (42 ± 5 vs. 54 ± 5, p < 0.001), and (3) the minimum blood glucose of 31.2% (20/64) cases in isCGM group appeared during 0:00–2:59 at night, and 26.6% (17/64) cases appeared during 3:00–5:59 at night. The minimum values of 40.0% (24/60) cases in the control group appeared within the 30 min before lunch, 23.3% (14/60) within the 30 min before breakfast, and 11.7% (7/60) within the 30 min before dinner. The cases of minimum of blood sugar before meals accounted for 75% of all the minimum values, and the cases of minimum at night only accounted for 8.3%.

Conclusion

Intermittently scanned continuous glucose monitoring can reduce hyperglycemia exposure and ketone body formation in pregestational diabetes mellitus. In addition, isCGM is better than SMBG in detecting nocturnal hypoglycemia.

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Most cited references 21

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Global estimates of the prevalence of hyperglycaemia in pregnancy.

L Guariguata, U Linnenkamp, J Beagley … (2014)

We estimated the number of live births worldwide and by IDF Region who developed hyperglycaemia in pregnancy in 2013, including total diabetes in pregnancy (known and previously undiagnosed diabetes) and gestational diabetes. Studies reporting prevalence of hyperglycaemia first-detected in pregnancy (formerly termed gestational diabetes) were identified using PubMed and through a review of cited literature. A simple scoring system was developed to characterise studies on diagnostic criteria, year study was conducted, study design, and representation. The highest scoring studies by country with sufficient detail on methodology for characterisation and reporting at least three age-groups were selected for inclusion. Forty-seven studies from 34 countries were used to calculate age-specific prevalence of hyperglycaemia first-detected in pregnancy in women 20-49 years. Adjustments were then made to account for heterogeneity in screening method and blood glucose diagnostic threshold in studies and also to align with recently published diagnostic criteria as defined by the WHO for hyperglycaemia first detected in pregnancy. Prevalence rates were applied to fertility and population estimates to determine regional and global prevalence of hyperglycaemia in pregnancy for 2013. An estimate of the proportion of cases of hyperglycaemia in pregnancy due to total diabetes in pregnancy was calculated using age- and sex-specific estimates of diabetes from the IDF Diabetes Atlas and applied to age-specific fertility rates. The global prevalence of hyperglycaemia in pregnancy in women (20-49 years) is 16.9%, or 21.4 million live births in 2013. An estimated 16.0% of those cases may be due to total diabetes in pregnancy. The highest prevalence was found in the South-East Asia Region at 25.0% compared with 10.4% in the North America and Caribbean Region. More than 90% of cases of hyperglycaemia in pregnancy are estimated to occur in low- and middle-income countries. These are the first global estimates of hyperglycaemia in pregnancy and conform to the new WHO recommendations regarding diagnosis and also include estimates of live births in women with known diabetes. They indicate the importance of the disease from a public health and maternal and child health perspective, particularly in developing countries. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

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Prevalence Estimates of Gestational Diabetes Mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007–2010

Carla L. DeSisto, Shin Y. Kim, Andrea Sharma (2014)

Introduction The true prevalence of gestational diabetes mellitus (GDM) is unknown. The objective of this study was 1) to provide the most current GDM prevalence reported on the birth certificate and the Pregnancy Risk Assessment Monitoring System (PRAMS) questionnaire and 2) to compare GDM prevalence from PRAMS across 2007–2008 and 2009–2010. Methods We examined 2010 GDM prevalence reported on birth certificate or PRAMS questionnaire and concordance between the sources. We included 16 states that adopted the 2003 revised birth certificate. We also examined trends from 2007 through 2010 and included 21 states that participated in PRAMS for all 4 years. We combined GDM prevalence across 2-year intervals and conducted t tests to examine differences. Data were weighted to represent all women delivering live births in each state. Results GDM prevalence in 2010 was 4.6% as reported on the birth certificate, 8.7% as reported on the PRAMS questionnaire, and 9.2% as reported on either the birth certificate or questionnaire. The agreement between sources was 94.1% (percent positive agreement = 3.7%, percent negative agreement = 90.4%). There was no significant difference in GDM prevalence between 2007–2008 (8.1%) and 2009–2010 (8.5%, P = .15). Conclusion Our results indicate that GDM prevalence is as high as 9.2% and is more likely to be reported on the PRAMS questionnaire than the birth certificate. We found no statistical difference in GDM prevalence between the 2 phases. Further studies are needed to understand discrepancies in reporting GDM by data source.

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Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial

Denice Feig, Lois Donovan, Rosa Corcoy … (2017)

Summary Background Pregnant women with type 1 diabetes are a high-risk population who are recommended to strive for optimal glucose control, but neonatal outcomes attributed to maternal hyperglycaemia remain suboptimal. Our aim was to examine the effectiveness of continuous glucose monitoring (CGM) on maternal glucose control and obstetric and neonatal health outcomes. Methods In this multicentre, open-label, randomised controlled trial, we recruited women aged 18–40 years with type 1 diabetes for a minimum of 12 months who were receiving intensive insulin therapy. Participants were pregnant (≤13 weeks and 6 days' gestation) or planning pregnancy from 31 hospitals in Canada, England, Scotland, Spain, Italy, Ireland, and the USA. We ran two trials in parallel for pregnant participants and for participants planning pregnancy. In both trials, participants were randomly assigned to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone. Randomisation was stratified by insulin delivery (pump or injections) and baseline glycated haemoglobin (HbA1c). The primary outcome was change in HbA1c from randomisation to 34 weeks' gestation in pregnant women and to 24 weeks or conception in women planning pregnancy, and was assessed in all randomised participants with baseline assessments. Secondary outcomes included obstetric and neonatal health outcomes, assessed with all available data without imputation. This trial is registered with ClinicalTrials.gov, number NCT01788527. Findings Between March 25, 2013, and March 22, 2016, we randomly assigned 325 women (215 pregnant, 110 planning pregnancy) to capillary glucose monitoring with CGM (108 pregnant and 53 planning pregnancy) or without (107 pregnant and 57 planning pregnancy). We found a small difference in HbA1c in pregnant women using CGM (mean difference −0·19%; 95% CI −0·34 to −0·03; p=0·0207). Pregnant CGM users spent more time in target (68% vs 61%; p=0·0034) and less time hyperglycaemic (27% vs 32%; p=0·0279) than did pregnant control participants, with comparable severe hypoglycaemia episodes (18 CGM and 21 control) and time spent hypoglycaemic (3% vs 4%; p=0·10). Neonatal health outcomes were significantly improved, with lower incidence of large for gestational age (odds ratio 0·51, 95% CI 0·28 to 0·90; p=0·0210), fewer neonatal intensive care admissions lasting more than 24 h (0·48; 0·26 to 0·86; p=0·0157), fewer incidences of neonatal hypoglycaemia (0·45; 0·22 to 0·89; p=0·0250), and 1-day shorter length of hospital stay (p=0·0091). We found no apparent benefit of CGM in women planning pregnancy. Adverse events occurred in 51 (48%) of CGM participants and 43 (40%) of control participants in the pregnancy trial, and in 12 (27%) of CGM participants and 21 (37%) of control participants in the planning pregnancy trial. Serious adverse events occurred in 13 (6%) participants in the pregnancy trial (eight [7%] CGM, five [5%] control) and in three (3%) participants in the planning pregnancy trial (two [4%] CGM and one [2%] control). The most common adverse events were skin reactions occurring in 49 (48%) of 103 CGM participants and eight (8%) of 104 control participants during pregnancy and in 23 (44%) of 52 CGM participants and five (9%) of 57 control participants in the planning pregnancy trial. The most common serious adverse events were gastrointestinal (nausea and vomiting in four participants during pregnancy and three participants planning pregnancy). Interpretation Use of CGM during pregnancy in patients with type 1 diabetes is associated with improved neonatal outcomes, which are likely to be attributed to reduced exposure to maternal hyperglycaemia. CGM should be offered to all pregnant women with type 1 diabetes using intensive insulin therapy. This study is the first to indicate potential for improvements in non-glycaemic health outcomes from CGM use. Funding Juvenile Diabetes Research Foundation, Canadian Clinical Trials Network, and National Institute for Health Research.

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Author and article information

Contributors

Li-ming Chen: xfx22081@vip.163.com

Journal

Journal ID (nlm-ta): Diabetol Metab Syndr

Journal ID (iso-abbrev): Diabetol Metab Syndr

Title: Diabetology & Metabolic Syndrome

Publisher: BioMed Central (London )

ISSN (Electronic): 1758-5996

Publication date (Electronic): 9 April 2021

Publication date PMC-release: 9 April 2021

Publication date Collection: 2021

Volume: 13

Electronic Location Identifier: 39

Affiliations

[1 ]Department of Endocrinology, Tianjin Xiqing Hospital, Tianjin, China

[2 ]GRID grid.265021.2, ISNI 0000 0000 9792 1228, NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, , Tianjin Medical University Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, ; Tianjin, 300134 China

Article

Publisher ID: 657

DOI: 10.1186/s13098-021-00657-0

PMC ID: 8034123

PubMed ID: 33836817

SO-VID: 637f37d0-e794-4437-8c9f-fbbe2121bea1

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 1 November 2020

Date accepted : 25 March 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100001809, National Natural Science Foundation of China;

Award ID: 81470187

Award Recipient : Li-ming Chen

Funded by: Science and Technology Project of Tianjin

Award ID: no.18ZXZNSY00280

Award Recipient : Jing Li

Funded by: Tianjin Health Commission Science and Technology Talent Cultivation Project

Award ID: KJ20022

Award Recipient : Hang Guo

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ScienceOpen disciplines: Nutrition & Dietetics

Keywords: pregestational diabetes mellitus,intermittently scanned continuous glucose monitoring,blood glucose control

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ScienceOpen disciplines: Nutrition & Dietetics

Keywords: pregestational diabetes mellitus, intermittently scanned continuous glucose monitoring, blood glucose control

Effects of intermittently scanned continuous glucose monitoring on blood glucose control and the production of urinary ketone bodies in pregestational diabetes mellitus

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Conclusion

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Karger: Nutrition and Dietetics

Most cited references 21

Global estimates of the prevalence of hyperglycaemia in pregnancy.

Prevalence Estimates of Gestational Diabetes Mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007–2010

Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial

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