None listed
Conditions
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, 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
Eligibility
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.