Advanced Hybrid Closed-Loop Therapy Compared With Standard Insulin Therapy Intrapartum and Early Postpartum in Women With Type 1 Diabetes: A Secondary Observational Analysis From the CRISTAL Randomized Controlled Trial
Authors' conclusion
AHCL is effective in maintaining tight glycemic control intrapartum and early postpartum and can be safely continued during periods of rapidly changing insulin requirements.
Study context
- Population
- Pregnant women with T1D, Belgium and the Netherlands43 and 46 completed
- Participants
- 95 women
- Comparison
- Intrapartum and early postpartum advanced hybrid closed-loop (AHCL) vs standard insulin therapy
- AHCLn = 46
- Standard insulin therapyn = 49reference
Methodological detailsprespecified, secondary observational analysis, open-label, double-arm
- Prespecified
- Secondary observational analysis
- Open-label
- Double-arm
Primary result
As reported in the abstract
Time in range 3.5-7.8 mmol/L · intrapartum
P = 0.030
Further findings
Time above range >7.8 mmol/L · intrapartum · numerically lower with AHCL
P = 0.054
Tight glycemic control 3.9-10.0 mmol/L · early postpartum · similar
P = 0.124
Continuation of assigned therapy
- AHCL continued intrapartum
- 27 (62.8%)
- Standard insulin therapy continued intrapartum
- 45 (97.8%)
- AHCL continued early postpartum
- 37 (86.0%)
- Median increase in insulin-to-carbohydrate ratios early postpartum with AHCL
- 67% (IQR −14 to 126)
Safety
Intrapartum TBR <3.5 mmol/L · no increase with AHCL
P = 0.146
Severe hypoglycaemia or DKA
- No severe hypoglycemia or DKA reported in either group
Original publication
Advanced Hybrid Closed-Loop Therapy Compared With Standard Insulin Therapy Intrapartum and Early Postpartum in Women With Type 1 Diabetes: A Secondary Observational Analysis From the CRISTAL Randomized Controlled Trial. Diabetes Care. Published 27 September 2024. doi:10.
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