Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Automated closed-loop insulin delivery.
- Who it may be relevant to
- Registry conditions: Diabete Type 1, Pregnancy Complications. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This is a national multi-center open-label randomized controlled trial investigating whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy (\<14 completed weeks) improves maternal glycemic control in women with type 1 diabetes during pregnancy, delivery and post-delivery and leads to more appropriate fetal growth compared to usual insulin treatment modality (multiple day injections or insulin pump) combined with continuous glucose monitoring.
Women planning pregnancy will initiate the automated insulin delivery system CamAPS FX or continue usual insulin treatment modality combined with a compatible continuous glucose monitoring, as per randomisation allocation before conception and throughout pregnancy until one month post-delivery or for up to 52 weeks if not becoming pregnant. Women who become pregnant during the 52-week study period will be referred to their local center for pregnant women with diabetes and followed during pregnancy until one month post-delivery. Women who do not become pregnant during the 52-week study period will leave the study and continue usual diabetes care at their usual diabetes center.
Women who are pregnant at randomisation will initiate the automated insulin delivery system CamAPS FX or continue usual insulin treatment modality combined with a compatible continuous glucose monitoring as per randomisation allocation, throughout the pregnancy period until one month post-delivery.
Interventions
- Device Automated closed-loop insulin delivery
Automated closed-loop insulin delivery and The mylife CamAPS FX algorithm combined with CGM
Primary outcome measures
- Time in range [Time frame: From first day of last menstrual cycle (planning pregnancy) or randomization (early pregnancy) until delivery.]
- Neonatal outcome: Birthweight [Time frame: At delivery]
Secondary outcome measures (12)
- Continuous glucose monitoring data [Time frame: From randomisation during pregnancy planning until delivery or leaving study after 52 weeks (randomized during pregnancy planning) or from randomization in early pregnancy to delivery]
- Insulin and carbohydrates [Time frame: Randomization, during pregnancy planning, study visits during pregnancy, around delivery and at one month post-delivery]
- System features [Time frame: From inclusion until one month post-delivery]
- HbA1c [Time frame: Inclusion, last before pregnancy, at 9, 21, 33 and 35 weeks]
- Severe hypoglycemia [Time frame: 2 years - if not becoming pregnant in the study period - until leaving the study]
- Ketoacidosis [Time frame: During pregnancy planning OR during pregnancy and post-delivery]
- Weight [Time frame: At inclusion until one month post-delivery OR leaving the study]
- Fetal overgrowth [Time frame: At birth]
- Pregnancy complications [Time frame: 9 months]
- Birth complications [Time frame: From delivery until one month post-delivery]
- Neonatal morbidity [Time frame: At delivery until one month post-delivery]
- Major congenital malformations [Time frame: From delivery until one month post-delivery]
Eligibility criteria
Inclusion 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
Exclusion criteria 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 8 centers
- Department of Gynecology and Obstetrics, Aalborg University Hospital — Aalborg
- Department of Gynecology and Obstetrics, Aarhus University Hospital — Aarhus
- Steno Diabetes Center Aarhus — Aarhus
- Steno Diabetes Center Nordjylland — Aalborg
- Steno Diabetes Center Copenhagen — Copenhagen
- Department of Gynecology and Obstetrics, Odense University Hospital — Odense
- Steno Diabetes Center Odense, Odense University Hospital — Odense
- Center for Pregnant Women with Diabetes, Rigshospitalet — Copenhagen
Identifiers
NCT: NCT07240012 · 3080181