Table 1

Baseline characteristics of trial participants (N = 16)

n (%)Mean (SD)
Age (years)32.8 (5.0)
BMI (kg/m2)26.6 (4.4)
Booking HbA1c (%)8.0 (1.1)
Booking HbA1c (mmol/mol)63.7 (12.1)
Booking HbA1c >7.5% (58 mmol/mol)9 (56)
Duration of diabetes (years)19.4 (10.2)
Insulin pump use before study8 (50)
CGM use before study±3 (19)
Total daily insulin dose (units/kg/day)0.51 (0.09)
Weeks’ gestation*16.4 (4.9)
Primiparous6 (38)
Recruitment site
 Cambridge6 (38)
 Norwich8 (50)
 Ipswich2 (12)
  • †The booking HbA1c is the measurement taken at the first antenatal clinic visit after confirmed pregnancy.

  • ±None of the three participants had used CGM in the 6 months before enrollment in the study or as part of their regular diabetes management. Two had used real-time CGM (participant 6 and participant 12) and one FreeStyle Libre (participant 15).

  • *Weeks’ gestation at randomization. Randomization was performed after recruitment and at least 2–4 weeks of device training when insulin regimens were optimized and participants were competent in using the study pump and CGM devices.

  • ‡Six participants had experienced previous pregnancy losses (six miscarriages and one stillbirth). Two participants had had a termination of pregnancy for major malformation. Two participants had a history of hypertensive disorders of pregnancy.