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 = 100 | No. of resources* | No. of mother/infant dyads n = 102 | |
| Antenatal 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 trial10 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.