Table 3.
Glycaemic and adverse outcomes of pregnancy trial participants
|
Baseline |
34 weeks' gestation |
p value* | ||||
|---|---|---|---|---|---|---|
| CGM | Control | CGM | Control | |||
| Direct CGM measures† | ||||||
| Hours per week‡ | 158 (143–168) | 150 (139–165) | 159 (143–177) | 156 (143-166) | ·· | |
| Glucose | 7·3 (1·2) | 7·6 (1·1) | 6·7 (0·9) | 7·0 (1·1) | 0·14 | |
| Time in target | 52% (13) | 52% (14) | 68% (13) | 61% (15) | 0·0034 | |
| Time >7·8 mmol/L | 39% (28–49) | 40% (32–51) | 27% (19–37) | 32% (25–39) | 0·0279 | |
| High blood glucose index | 4·2 (2·3–6·2) | 4·6 (2·8–6·7) | 1·8 (1·1–2·8) | 2·3 (1·5–3·4) | 0·067 | |
| Time <3·5 mmol/L | 8% (4–14) | 6% (3–11) | 3% (1–6) | 4% (2–8) | 0·10 | |
| Low blood glucose index | 2·8 (1·6–4·6) | 2·4 (1·5–3·6) | 1·7 (1·1–2·8) | 2·1 (1·4–2·8) | 0·18 | |
| Hypoglycaemia§ | 0·8 (0·6–1·0) | 0·7 (0·4–0·9) | 0·5 (0·3–0·8) | 0·5 (0·3–0·8) | 0·73 | |
| Glucose variability measures | ||||||
| Coefficient of variation | 42% (38–47) | 42% (36–47) | 32% (28–37) | 34% (29–39) | 0·058 | |
| SD (mmol/L) | 3·1 (2·6–3·6) | 3·1 (2·6–3·8) | 2·2 (1·8–2·5) | 2·4 (2·0–2·8) | 0·0359 | |
| Mean amplitude of glucose excursion (mmol/L) | 6·0 (5·1–7·1) | 6·4 (5·5–7·8) | 4·2 (3·5–4·9) | 4·6 (3·9–6·0) | 0·0455 | |
| Rate of change mmol/L per h | 2·15 (1·88–2·52) | 2·17 (1·89–2·46) | 2·02 (1·70–2·26) | 1·63 (1·31–1·96) | <0·0001 | |
| Severe hypoglycaemia¶ | ||||||
| Number of women | 7 (7%) | 4 (4%) | 11 (11%) | 12 (12%) | 1·0 | |
| Number of episodes‡ | 11 | 5 | 18 | 21 | ·· | |
| Diabetic ketoacidosis during study | ·· | ·· | 2 (2%) | 2 (2%) | 1·0 | |
| Changed to insulin pump during study | ·· | ·· | 1 (1%) | 3 (3 %) | 0·62 | |
| Total insulin dose (U/kg per day) | 0·69 (0·25) | 0·76 (0·31) | 0·99 (0·41) | 1·07 (0·42) | 0·14 | |
Values are mean (SD) and median (IQR) as appropriate.
p value for between-group difference at 34 weeks' gestation.
CGM data were obtained 1 week after completion of the 34 week visit using real-time sensors in the CGM group and masked sensors in the control group. Assessed in 107 participants in the CGM group and 107 participants in the control group at baseline, and in 77 participants in the CGM group and 77 participants in the control group at 34 weeks' gestation.
Not study outcomes.
Hypoglycaemia events are defined as CGM levels <3·5 mmol/L for at least 20 min. Distinct events were counted only if separated by at least 30 min.
Severe hypoglycaemia was defined as an episode requiring third-party assistance; assessed in 107 participants in the CGM group and 107 participants in the control group at baseline, and in 103 participants in the CGM group and 104 participants in the control group at 34 weeks' gestation.