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Compares treatment options for Diabete Type 1
Official title Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
ClinicalTrials.gov ID: NCT07240012
What this study is testing
- What it's testing
- A national multi-center open-label randomized controlled trial that investigates whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy improves maternal time in glycemic targets and fetal growth in women with type 1 diabetes compared to usual insulin treatment modality combined with Continuous Glucose Monitoring.
- Time commitment: about 52 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- during pregnancy planning
- Women, age 18-45 years
- Duration of type 1 diabetes ≥ 12 months
- Women who are not pregnant confirmed by a negative pregnancy test on the day of randomization
- Planning pregnancy within 52 weeks Inclusion during pregnancy:
You likely can't join if
- during pregnancy planning and during pregnancy:
- No proficiency in Danish to understand oral and written information
- Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator
See the full eligibility criteria
- during pregnancy planning
- Women, age 18-45 years
- Duration of type 1 diabetes ≥ 12 months
- Women who are not pregnant confirmed by a negative pregnancy test on the day of randomization
- Planning pregnancy within 52 weeks Inclusion during pregnancy:
- Women, age 18-45 years
- Duration of type 1 diabetes ≥ 12 months
- Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks
- Accepting participation in the DDBR2 study during pregnancy, delivery and until one month after delivery
- during pregnancy planning and during pregnancy:
- No proficiency in Danish to understand oral and written information
- Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Aalborg, Denmark
- Aarhus, Aarhus N, Denmark
- Aalborg, Gistrup, Denmark
- Copenhagen, Herlev, Denmark
- Odense, Odense C, Denmark
- Copenhagen, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Aalborg, Denmark; Aarhus, Aarhus N, Denmark; Aalborg, Gistrup, Denmark; Copenhagen, Herlev, Denmark; Odense, Odense C, Denmark; Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.