Gestational diabetes & diabetes in pregnancy
Faster-acting insulin aspart versus insulin aspart in the treatment of type 1 or type 2 diabetes during pregnancy and post-delivery (CopenFast): an open-label, single-centre, randomised controlled trial
Primary result · Birthweight SD scoreResult — go to the resultEstimated treatment difference −0.22 CI −0.58 to 0.14Authors' conclusion
Treatment with faster aspart resulted in similar fetal growth and HbA1c, relative to insulin aspart, in women with type 1 or type 2 diabetes. Faster aspart can be used in women with type 1 or type 2 diabetes during pregnancy and post-delivery with no additional safety issues.
Study context
- Population
- Women aged ≥18 years with T1D or T2D, randomised at 8+0 to 13+6 weeks of gestation, followed until 3 months post-delivery; Rigshospitalet, Copenhagen, Denmark203 analysed
- Participants
- 216 women
- Comparison
- Faster aspart vs insulin aspart
- Faster aspartn = 109
- Insulin aspartn = 107reference
- Primary endpoint
- Infant birthweight SD score
Methodological detailsopen-label, single-centre, superiority, stratified by diabetes type and insulin treatment modality
- Open-label
- Single-centre
- Superiority
- Stratified by diabetes type and insulin treatment modality
Primary result
Birthweight SD score
Estimated treatment difference
−0.22
CI −0.58 to 0.14
P = 0.23
By group
Faster aspart
1.0
mean · SD 1.4
Insulin aspart
1.2
mean · SD 1.3
Faster aspartvs Insulin aspart
estimated treatment difference −0.22 (CI −0.58 to 0.14); P = 0.23
As reported in the abstract
Secondary outcomes
| Outcome | Faster aspart | Insulin aspart | Estimated treatment difference (CI) | P value | |
|---|---|---|---|---|---|
| HbA1c · 33 weeks of gestationMean, mmol/mol | 42 (SD 6) | 43 (SD 7) | −1.01 (−2.86 to 0.83) | P = 0.28 | |
| HbA1c % | 6.0% [SD 0.9%] | 6.1% [SD 1.2%] | |||
| −4−202Difference (linear scale) |
Safety
- Participants discontinuing treatment
- 0
- No additional safety issues with faster aspart vs insulin aspart
Original publication
Faster-acting insulin aspart versus insulin aspart in the treatment of type 1 or type 2 diabetes during pregnancy and post-delivery (CopenFast): an open-label, single-centre, randomised controlled trial. Lancet Diabetes Endocrinol. Published 4 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →