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NCT Number: NCT07240012

Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes

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.

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Key information

Conditions

Diabete Type 1 Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynecology and Obstetrics, Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated closed-loop insulin delivery

Device

Automated closed-loop insulin delivery and The mylife CamAPS FX algorithm combined with CGM

Primary outcomes

  1. Time in range

    Time frame: From first day of last menstrual cycle (planning pregnancy) or randomization (early pregnancy) until delivery.

    The between group difference in time in range in pregnancy (3.5-7.8 mmol/L) between intervention and controls

  2. Neonatal outcome: Birthweight

    Time frame: At delivery

    Offspring birthweight standard deviation score adjusted for gestational age and infant gender.

Secondary outcomes

  1. 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

    Mean sensor glucose, mean sensor glucose coefficient of variation, time in range in pregnancy 3.5-7.8 mmol/l, time above range in pregnancy >7.8 mmol/l and time below range in pregnancy <3.5 mmol/l between intervention and controls

  2. Insulin and carbohydrates

    Time frame: Randomization, during pregnancy planning, study visits during pregnancy, around delivery and at one month post-delivery

    Total daily insulin dose, percentage insulin administered as basal insulin, carbohydrate-to-insulin ratio, numbers of boluses (automatic and manual), daily amount of entered carbohydrates

  3. System features

    Time frame: From inclusion until one month post-delivery

    • Use of specific features as auto mode, "Ease-off" and "Boost" functions (intervention group)
    • Use of specific features as auto mode, night mode, fake carbohydrates (women in the control group using AID systems other than the CamAPS FX system)

  4. HbA1c

    Time frame: Inclusion, last before pregnancy, at 9, 21, 33 and 35 weeks

    HbA1c before pregnancy and HbA1c levels during pregnancy.

  5. Severe hypoglycemia

    Time frame: 2 years - if not becoming pregnant in the study period - until leaving the study

    The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and in the first one-month period post-delivery

  6. Ketoacidosis

    Time frame: During pregnancy planning OR during pregnancy and post-delivery

    The prevalence of diabetic ketoacidosis (positive ketones in urine or serum, pH ≤7·30 and/or bicarbonate ≤18 mmol/l)

  7. Weight

    Time frame: At inclusion until one month post-delivery OR leaving the study

    Maternal gestational weight gain and weight retention one month post-delivery OR Weight at randomization and last weight before pregnancy

  8. Fetal overgrowth

    Time frame: At birth

    The prevalence of fetal overgrowth, defined as the offspring birth weight standard deviation score >90th percentile

  9. Pregnancy complications

    Time frame: 9 months

    Prevalence of induced abortion, miscarriage, gestational hypertension, preeclampsia, need for maternal corticosteroid treatment for fetal lung maturation, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preterm pre-labour rupture of the membranes

  10. Birth complications

    Time frame: From delivery until one month post-delivery

    Prevalence of shoulder dystocia, birth canal trauma, mode of delivery (vaginal delivery, instrumental delivery, planned cesarean section, emergency cesarean section), postpartum hemorrhage, maternal death

  11. Neonatal morbidity

    Time frame: At delivery until one month post-delivery

    Neonatal hypoglycemia with plasma glucose <2.2 mmol/l two hours after birth, neonatal hypoglycemia requiring treatment with intravenous glucose, jaundice, respiratory distress, transient tachypnoea, duration of stay in neonatal intensive care unit, total number of admission days, cord blood pH, stillbirths, infant death within one month post-delivery

  12. Major congenital malformations

    Time frame: From delivery until one month post-delivery

    ICD10 Q00-Q99 or requiring medical or surgical treatment

  13. Infant growth

    Time frame: One month post-delivery

    Evaluated by weight standard deviation score and health evaluated as days with hospitalization during the first month of life after discharge in the neonatal period

  14. Lactation

    Time frame: One month post-delivery

    The prevalence of lactation

Study contacts

Contact information is provided by the study sponsor or research team.

Lene Ringholm Chief physician, PhD, Associate Professor

CONTACT

[email protected]

+45 35458671

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Abbott
  • The Novo Nordic Foundation
  • mylife Diabetes Care AG

Registry information

Acronym: AID-DM

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 20, 2025
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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