Article Figures & Tables
Tables
- Table 1:
Health care resources consumed by pregnant women with type 1 diabetes and their infants, from CONCEPTT trial randomization until hospital discharge after delivery
Health care resource CGM SMBG No. of resources* No. of mother/infant dyads
n = 100No. of resources* No. of mother/infant dyads
n = 102Antenatal assessments or visits Total unscheduled contacts† 1510 96 1025 91 For diabetes management 844 89 858 87 For CGM issue 211 63 8 6 For diabetes and CGM issues 269 42 25 14 For other reasons not specified 186 51 134 46 Maternal antenatal hospitalizations ≥ 24 h not for delivery No. of admissions 25 22 21 17 Total length of hospital stay, d 54 42 Maternal obstetrical day unit No. of visits 9 7 8 8 Total length of visits (assumed 6 h/visit), h 54 48 Delivery Pregnancy termination ≥ 20 wk 0 0 1 1 Stillbirth 0 0 1 1 Inductions (assumed 1 induction per participant) 49 49 42 42 Spontaneous vaginal delivery (excludes 1 termination) 28 28 18 18 Operative vaginal delivery (excluding 1 stillbirth) 9 9 8 8 Elective or planned cesarean delivery 26 26 30 30 Emergency or unplanned cesarean delivery 37 37 44 44 Hospital length of stay for delivery Total maternal hospital length of stay for delivery, d (h) 474.9 (11 396.8) 100 560.9 (13 461.4) 102 Total antenatal ward duration‡, h 2306.0 100 4078.1 102 Participants with hypertensive symptoms or preeclampsia 18 29 Total labour and delivery ward duration, h 1301.3 100 1600.8 102 Total operating room ward duration§, h 93.8 72 108.4 84 Total postpartum ward duration¶, h 7789.6 100 7782.5 102 NICU Total length of stay in high level NICU for any high level NICU admission, d (h) 180.0 (4320.6) 30 391.6 (9398.0) 45 Total length of stay in high level NICU for physician care, d 208 30 430 45 Adjudicated NICU Level 2 physician care, d 88 19 230 30 Adjudicated NICU Level 3 physician care, d 120 11 200 15 NICU level 2 hospital ward duration, d (h) 71.3 (1711.7) 19 205.1 (4922.5) 30 NICU Level 3 hospital ward duration, d (h) 108.7 (2608.9) 11 186.5 (4475.5) 15 CGM and SMBG usage** No. of days used Total, d 18 511.2 100 18 238.6 102 Per patient, mean ± SD 185.1 ± 17.1 178.8 ± 20.1 No. of patients using Medtronic CGM devices Total no. of Medtronic CGM devices 42 42 NA NA Medtronic Pump VEO 30 30 NA NA Medtronic Veo Kit Pump 10 10 NA NA Medtronic Pump 640G 2 2 NA NA No. of patients using Guardian CGM devices 58 58 NA NA No. of CGM sensors used (estimated) NA Total 3134 100 NA NA Per patient, mean ± SD 31.3 ± 2.9 NA NA Total no. of glucometers used (estimated) 100 100 102 102 No. of SMBG strips used (estimated) Total 129 630 100 127 722 102 Per patient, mean ± SD 1296.3 ± 119.5 1252.2 ± 140.7 Note: CGM = continuous glucose monitoring, NA = not applicable, NICU = neonatal intensive care unit, SD = standard deviation, SMBG = self-monitoring blood glucose.
↵* Unless indicated otherwise.
↵† Unscheduled contacts refer to patient visits or contacts that were not already planned in the trial schedule of study visits, including clinic visits or appointments via phone, email or text, with the nurse, doctor, research staff or CGM helpline.
↵‡ Participants with hypertensive symptoms or adjudicated preeclampsia had 24 hours added to their labour and delivery ward duration and removed from postnatal ward duration.
↵§ Estimated from Early External Cephalic Version 2 trial (10) by parity for cesarean delivery and operative vaginal delivery, including for 1 stillbirth and 1 termination ≥ 20 weeks.
↵¶ Total postpartum ward duration (includes reduction in postnatal ward time given increased labour and delivery ward duration of 24 hours if hypertensive symptoms or adjudicated preeclampsia).
↵** CGM and SMBG usage is estimated from the total number of participant days from randomization to infant birth date. Guardian CGM devices were used for non-Medtronic pump users or multiple daily injection users.
- Table 2:
Difference in mean total costs of all services and wards used by pregnant women with type 1 diabetes and their infants during the CONCEPTT trial
Analysis* Province CGM
n = 100 mother/infant dyadsSMBG
n = 102 mother/infant dyadsDifference between CGM and SMBG Mean, $ SEM, $ Mean, $ SEM, $ Mean, $ SEM, $ 95% CI†, $ Primary outcome: total costs excluding glucose monitoring Ontario 13 270.25 1122.61 18 465.21 1758.01 −5194.96 2112.07 −9841 to −1395 British Columbia 13 480.57 1154.21 18 762.17 1786.67 −5281.60 2154.34 −9964 to −1382 Alberta 13 294.39 1141.15 18 674.45 1808.81 −5380.06 2165.35 −10 216 to −1490 Secondary outcome: total costs including glucose monitoring Ontario 17 881.01 1107.80 19 699.65 1752.10 −1818.64 2099.14 −6424 to 1942 British Columbia 18 091.32 1139.41 19 996.61 1780.73 −1905.29 2141.33 −6588 to 1957 Alberta 17 905.15 1126.42 19 908.89 1802.87 −2003.74 2152.47 −6747 to 1844 Ad hoc analysis: maximum costs of CGM to be < SMBG costs Ontario 14 546.61 1118.35 19 699.65 1752.10 −5153.04 2102.01 −9801 to −1372 British Columbia 14 756.92 1149.96 19 996.61 1780.73 −5239.69 2145.74 −9961 to −1386 Alberta 14 570.75 1136.89 19 908.89 1802.87 −5338.14 2155.59 −10 152 to −1473 Note: BCA = bias-corrected and accelerated, CGM = continuous glucose monitoring, CI = confidence interval, SEM = standard error of the mean, SMBG = self-monitoring blood glucose.
↵* The primary outcome is the total cost of all services, excluding cost of CGM devices, CGM sensors, glucometers and SMBG strips. The secondary outcome is the total cost of all services, including cost of CGM devices, CGM sensors, glucometers and SMBG strips. The ad hoc analysis estimates the maximum total cost per patient (including cost of CGM devices, CGM sensors, glucometers and SMBG strips) for CGM to remain significantly cheaper than SMBG during type 1 diabetes pregnancy. Negative value favours less costly CGM group.
↵† The 95% CIs were estimated using the BCA method.