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Determining the accuracy of continuous glucose monitoring during periods of acute glycaemic variability in pregnancy

Determining the accuracy of continuous glucose monitoring during periods of acute glycaemic variability in pregnancy (during hospital admission or during labour with or without betamethasone infusion).

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000508471
Enrollment
37
Registered
2025-05-23
Start date
2021-11-24
Completion date
2023-08-09
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Guidelines recommend continuous glucose monitoring (CGM) for all ambulatory pregnant women with Type 1 diabetes (T1 DM), and insulin-treated pregnant women with Type 2 diabetes (T2 DM) and hypoglycaemic risk. However, evidence for efficacy and safety of CGM in a hospital setting is lacking. Aim: To determine CGM accuracy and potential clinical risk of using CGM compared to the reference (capillary blood glucose level, capillary BG level) in pregnant women with T1 DM or T2 DM during acute hospitalisation. Method: Prospective cohort study. CGM glucose was compared to paired capillary BG during hospitalisation. Concordance was assessed using paired values distribution, mean absolute relative deviation (MARD), Clarke Error Grid (CEG) Analysis, and the FDA standard for new integrated Contiguous Glucose Monitoring (iCGM) accuracy.

Interventions

This study aims to assess the accuracy of continuous glucose monitoring (CGM) during periods of acute glycaemic variability in pregnancy, such as during hospital admission for acute illness or labour with or without betamethasone infusion. During hospitalisation, blood glucose monitoring will follow standard hospital protocols, which rely exclusively on capillary blood glucose measurements. While pregnant women often continue wearing their personal CGM devices during hospital stays, particularl

This study aims to assess the accuracy of continuous glucose monitoring (CGM) during periods of acute glycaemic variability in pregnancy, such as during hospital admission for acute illness or labour with or without betamethasone infusion. During hospitalisation, blood glucose monitoring will follow standard hospital protocols, which rely exclusively on capillary blood glucose measurements. While pregnant women often continue wearing their personal CGM devices during hospital stays, particularly those already using them as outpatients, CGM data will not be used to guide clinical decisions. All inpatient diabetes management, including insulin dosing, will be based solely on capillary blood glucose readings, in accordance with current standards of care. Participants were informed of this and encouraged to continue wearing their CGM devices during hospitalisation to support study data collection. Blood glucose checks will typically be performed 5–6 times daily for patients on multiple daily insulin injections (MDI), and hourly for those on intravenous insulin infusions, with increased frequency (every 30 minutes) if glucose levels fall outside target ranges. Some participants may receive betamethasone infusion during their hospital stay, independent of study involvement. Importantly, no study-related glucose monitoring will occur at home following discharge after birth.

Sponsors

Naeel Mohammad - John Hunter Hospital and The University of Newcastle
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Pregnant women at the age of 18 years old or more with T1 DM who attended the antenatal clinic at John Hunter Hospital and used their own CGM or were enrolled for CGM. 2. pregnant women at the age of 18 years old or more with T2 DM mellitus who attended the antenatal clinic at John Hunter Hospital and used their own CGM or were enrolled for CGM,

Exclusion criteria

1. Pregnant women with DM who were unable to wear CGM due to an allergy or other medical condition. 2. Pregnant women with DM who declined or were unable to give consent, despite use of an interpreter where required. 3. Pregnant women with regular paracetamol intake, as paracetamol could affect the CGM accuracy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026