A Randomized Trial of Closed-Loop Insulin Delivery Postpartum in Type 1 Diabetes
Authors' conclusion
Women randomized to closed-loop insulin delivery postpartum had less hypoglycemia than those randomized to sensor-augmented pump therapy. There were no safety concerns. These findings are reassuring for use of closed-loop insulin delivery postpartum because of its potential to reduce hypoglycemia.
Study context
- Population
- Postpartum individuals with T1D, first 12 weeks postpartum; mean ± SD age 32 ± 3.5 years, diabetes duration 22 ± 7.3 years, early pregnancy HbA1c 52 ± 6.8 mmol/mol [6.9 ± 0.9%]18 completed 24 weeks
- Comparison
- Hybrid closed-loop insulin delivery vs sensor-augmented pump therapy postpartum
Methodological detailsopen-label, followed by continuation phase with closed-loop for all until 24 weeks postpartum
- Open-label
- Followed by continuation phase with closed-loop for all until 24 weeks postpartum
Primary result
As reported in the abstract
- TIR did not differ between groups
- Closed-loop vs Sensor-augmented pump: P = 0.41
Further findings
Time <70 mg/dL (3.9 mmol/L) · randomized phase · less with closed-loop
P < 0.001
Time <54 mg/dL (3.0 mmol/L) · randomized phase · less with closed-loop
P = 0.008
- Time >180 mg/dL (10 mmol/L) · randomized phase · not different between groups
- P = 0.21
Time <70 mg/dL in those initially randomized to sensor-augmented pump, after initiation of closed-loop · continuation phase
- Less time <70 mg/dL after initiation of closed-loop (5.5 ± 3.3% vs. 3.3 ± 2.2%)
- P = 0.039
- Closed-loop group maintained similar glycemic metrics in both study phases
Safety
DKA or severe hypoglycemia · randomized and continuation phases
- Episodes of DKA or severe hypoglycemia in either group
- 0
Original publication
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