Phase
Condition
Pregnancy Complications
Diabetes And Hypertension
Diabetes Prevention
Treatment
Faster-acting Aspart insulin Fiasp
Control (insulin Novorapid)
Clinical Study ID
Ages 18-65 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria
Women, age ≥ 18 years
Duration of type 1 diabetes (or mature onset of diabetes in the young) ≥ 12 months
Type 2 diabetes (any duration)
Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks
Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or Neutral Protamine Hagedorn insulin and willing to continue routine treatment modality
Women with type 1 diabetes using an insulin pump compatible with trial products
Women with type 2 diabetes treated with diet, oral antidiabetic therapy or pre-mixed insulin before pregnancy and willing to change to trial medication according to randomization or to an appropriate long-acting insulin analogue, as indicated
Proficiency in Danish to understand oral and written information
Exclusion criteria
• Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator
Study Design
Connect with a study center
Center for Pregnant Women with Diabetes, Rigshospitalet
Copenhagen,
DenmarkSite Not Available
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