Gestational diabetes & diabetes in pregnancy
Randomized Trial of Assisted Hybrid Closed-Loop Therapy Versus Sensor-Augmented Pump Therapy in Pregnancy
Authors' conclusion
CGM within group differences were seen for time <63 mg/dL favoring HCL therapy and TIR favoring SAPT (third trimester vs. baseline). Safety and adverse pregnancy outcomes were similar between groups.
Study context
- Population
- Pregnancies with T1D, enrolled in first trimester, randomised at 14–18 weeks of gestation; therapy until 4–6 weeks postpartum
- Participants
- 11 vs 12
- Comparison
- Hybrid closed-loop (HCL) vs sensor-augmented pump therapy (SAPT)
- HCLn = 11
- SAPTn = 12reference
Methodological detailspilot feasibility, investigator-initiated, two-site, single-blind, HCL group used assistive techniques, e.g. fake carbohydrate boluses and exiting HCL overnight
- Pilot feasibility
- Investigator-initiated
- Two-site
- Single-blind
- HCL group used assistive techniques, e.g. fake carbohydrate boluses and exiting HCL overnight
Primary result
As reported in the abstract
Gestational safety: severe hypoglycaemia and DKA after randomisation
- No severe hypoglycemia (SH) or diabetic ketoacidosis (DKA) episode after randomisation
Further findings
Mean sensor glucose · third trimester · lower with SAPT
P < 0.05
Time <54 mg/dL
- Did not differ between groups
Time <63 mg/dL in HCL, within-group change vs run-in · second and third trimester vs run-in
- HCL second trimester (SE 1.3%)
- 3.5%
- HCL third trimester (SE 1.3%)
- 2.8%
- HCL run-in (SE 1.3%)
- 7.9%
- Decrease vs run-in, both trimesters
- P < 0.05 for both
- Decreased in both groups, significantly in HCL
Time-in-range (TIR) (63-140 mg/dL) in SAPT, within-group change vs run-in · third trimester vs run-in
- SAPT third trimester (SE 3.1%)
- 68.2%
- SAPT run-in (SE 3.1%)
- 64.3%
- Increase vs run-in
- P < 0.05
Gestational health outcomes
- Did not differ between groups
Safety
SH and DKA · after randomisation
- SH or DKA episodes
- 0
Original publication
Randomized Trial of Assisted Hybrid Closed-Loop Therapy Versus Sensor-Augmented Pump Therapy in Pregnancy. Diabetes Technol Ther. Published 18 March 2024. doi:10.
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