Summary: In a single-centre randomised trial of 80 pregnant women with type 2 or gestational diabetes, a continuous glucose monitoring (CGM)-guided individualised strategy was compared with self-monitoring of blood glucose (SMBG). Fasting and 2-hour postprandial glucose fell significantly within both groups (P<0.001), and anxiety, pregnancy-related anxiety and quality-of-life scores improved within the CGM group (P<0.05). No between-group glycaemic superiority, HbA1c outcome or formal safety comparison was reported.
PICO Summary
| Element | Detail |
|---|---|
| Population | 80 pregnant women with type 2 diabetes complicating pregnancy or gestational diabetes; single-centre randomised controlled trial, China (ChiCTR2200060719). |
| Intervention | CGM-guided individualised strategy: 14-day glucose monitoring informing insulin titration plus structured lifestyle modification (diet, physical activity). CGM arm. |
| Comparison | Self-monitoring of blood glucose (SMBG) with the same individualised titration framework. SMBG arm. |
| Outcome | Within-group pre/post change: fasting blood glucose and 2-hour postprandial glucose decreased significantly in both arms (P<0.001). Within the CGM arm, scores improved for anxiety (SAS 39.59±7.10 to 37.15±6.28), pregnancy-related anxiety (PAQ 24.15±6.45 to 22.59±5.65) and diabetes-specific quality of life (DSQL 47.44±9.01 to 43.20±9.00), all P<0.05. No between-group effect estimate, 95% CI, HbA1c outcome, ARR/NNT or adverse-event comparison was reported. |
Expert Commentary
This small single-centre randomised trial is best read as exploratory and hypothesis-generating rather than as evidence that CGM is superior to structured self-monitoring in diabetic pregnancy. The headline figures are reassuring but modest, and a critical reading is required: the significant fasting and postprandial glucose reductions reported as P<0.001 are within-group pre-versus-post changes seen in both arms, so they reflect the individualised titration protocol shared by both groups rather than an effect attributable to CGM. The psychological improvements (anxiety, pregnancy-related anxiety and quality of life) were likewise reported as within-CGM-group changes; no adjusted between-arm comparison, effect size or confidence interval was provided, and no HbA1c or neonatal outcome was assessed. The single limitation most worth weighing is the absence of a head-to-head between-group analysis, which leaves the core question of incremental CGM benefit unanswered. The sample of 80 is small, follow-up was short, and the open-label monitoring design cannot be blinded, all of which inflate the risk of bias toward the more intensively monitored arm. Can I use this with my patients? Not yet as a reason to favour CGM over diligent SMBG on glycaemic grounds; it is fair to say a structured, individualised titration plan helps both, and CGM may support psychological wellbeing. Adequately powered trials with between-group and neonatal endpoints are needed before practice changes.
References
Liu M, Chen T, Wang S, Li N, Liu D. To assess the impact of individualized strategy and continuous glucose monitoring on glycemic control and mental health in pregnant women with diabetes. Front Endocrinol (Lausanne). 2025;16:1470473. doi:10.3389/fendo.2025.1470473