Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial
Open accessAbstract
OBJECTIVE: To evaluate the effectiveness of continuous glucose monitoring during pregnancy on maternal glycaemic control, infant birth weight, and risk of macrosomia in women with type 1 and type 2 diabetes. DESIGN: Prospective, open label randomised controlled trial. SETTING: Two secondary care multidisciplinary obstetric clinics for diabetes in the United Kingdom. PARTICIPANTS: 71 women with type 1 diabetes (n=46) or type 2 diabetes (n=25) allocated to antenatal care plus continuous glucose monitoring (n=38) or to standard antenatal care (n=33). INTERVENTION: Continuous glucose monitoring was used as an educational tool to inform shared decision making and future therapeutic changes at intervals of 4-6 weeks during pregnancy. All other aspects of antenatal care were equal between the groups. MAIN OUTCOME MEASURES: The primary outcome was maternal glycaemic control during the second and third trimesters from measurements of HbA(1c) levels every four weeks. Secondary outcomes were birth weight and risk of macrosomia using birthweight standard deviation scores and customised birthweight centiles. Statistical analyses were done on an intention to treat basis. RESULTS: Women randomised to continuous glucose monitoring had lower mean HbA(1c) levels from 32 to 36 weeks' gestation compared with women randomised to standard antenatal care: 5.8% (SD 0.6) v 6.4% (SD 0.7). Compared with infants of mothers in the control arm those of mothers in the intervention arm had decreased mean birthweight standard deviation scores (0.9 v 1.6; effect size 0.7 SD, 95% confidence interval 0.0 to 1.3), decreased median customised birthweight centiles (69% v 93%), and a reduced risk of macrosomia (odds ratio 0.36, 95% confidence interval 0.13 to 0.98). CONCLUSION: Continuous glucose monitoring during pregnancy is associated with improved glycaemic control in the third trimester, lower birth weight, and reduced risk of macrosomia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84461581.
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A 5-7% higher TIR during the second and third trimesters is associated with decreased risk of LGA and neonatal outcomes, including macrosomia, shoulder dystocia, neonatal hypoglycemia and NICU admissions.
“Taken together, the Swedish and CONCEPTT data confirm that a 5-7% higher TIR during the second and third trimesters is associated with decreased risk of LGA and neonatal outcomes, including macrosomia, shoulder dystocia, neonatal hypoglycemia and NICU admissions.”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [64]
The Results > Birth weight section reports fewer macrosomic infants in the continuous-glucose-monitoring arm (35% versus 60%). But this trial does not report a 5–7% difference in time in range (TIR) or establish the claimed association across the second and third trimesters. Results > Pregnancy outcomes reports no significant between-group differences in neonatal hypoglycaemia or neonatal-care admissions, and does not report a reduction in shoulder dystocia. (LLM, conf=0.88)
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- Authors
- Murphy, H. R., Rayman, G., Lewis, K., Kelly, S., Johal, B., Duffield, K., Fowler, D., Campbell, P. J., & Temple, R. C.
- Affiliations
- National Health Service (GB)
- Ipswich Hospital (GB)
- Norfolk and Norwich University Hospital (GB)
- Wellcome Sanger Institute (GB)
- Corresponding author
- Murphy, H. R
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2008-09-25
- Volume
- 337
- Issue
- sep25 2
- Pages
- a1680-a1680
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC2563261
- OpenAlex
- W2084809043
- Cited by
- 358
- References
- 39
- Citations by year
- 2026: 10 · 2025: 20 · 2024: 16 · 2023: 21 · 2022: 13 · 2021: 26 · 2020: 15 · 2019: 21 · 2018: 28 · 2017: 16 · 2016: 24 · 2015: 16 · 2014: 14 · 2013: 24 · 2012: 24
- FWCI
- 26.85
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- BMJ (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- UEA Digital Repository (University of East Anglia) (submittedVersion, cc-by)
- Funders
- Diabetes UK
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Keywords
- continuous glucose monitoring, pregnancy, type 1 diabetes, type 2 diabetes, maternal glycaemic control, HbA1c, birth weight, macrosomia, prenatal care, shared decision-making, gestational diabetes mellitus
- MeSH terms
- Adolescent, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Female, Fetal Macrosomia, Glycated Hemoglobin, Humans, Hyperglycemia, Middle Aged, Pregnancy, Pregnancy in Diabetics, Pregnancy Outcome, Prenatal Care, Prenatal Diagnosis, Prospective Studies, Time Factors, Blood Glucose Self-Monitoring
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