Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes (AID-DM)

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Diabete Type 1
• Intervention / Treatment: Device: Automated closed-loop insulin delivery

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.

• Study Type: Interventional
• Enrollment (Estimated): 305
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lene Ringholm Chief physician, PhD, Associate Professor; Phone Number: +45 35458671; Email: lene.ringholm.02@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Center for Pregnant Women with Diabetes, Rigshospitalet
  • Aalborg
    • Aalborg, Aalborg, Denmark, 9000
      • Recruiting
      • Department of Gynecology and Obstetrics, Aalborg University Hospital
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Not yet recruiting
      • Department of Gynecology and Obstetrics, Aarhus University Hospital
    • Aarhus, Aarhus N, Denmark, 8200
      • Not yet recruiting
      • Steno Diabetes Center Aarhus
  • Gistrup
    • Aalborg, Gistrup, Denmark, 9260
      • Recruiting
      • Steno Diabetes Center Nordjylland
  • Herlev
    • Copenhagen, Herlev, Denmark, 2730
      • Not yet recruiting
      • Steno Diabetes Center Copenhagen
  • Odense C
    • Odense, Odense C, Denmark, 5000
      • Recruiting
      • Department of Gynecology and Obstetrics, Odense University Hospital
    • Odense, Odense C, Denmark, 5000
      • Recruiting
      • Steno Diabetes Center Odense, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated closed-loop insulin delivery (AID)	Device: Automated closed-loop insulin delivery; Automated closed-loop insulin delivery and The mylife CamAPS FX algorithm combined with CGM
No Intervention: Usual insulin treatment modality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range	The between group difference in time in range in pregnancy (3.5-7.8 mmol/L) between intervention and controls	From first day of last menstrual cycle (planning pregnancy) or randomization (early pregnancy) until delivery.
Neonatal outcome: Birthweight	Offspring birthweight standard deviation score adjusted for gestational age and infant gender.	At delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin and carbohydrates	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	Randomization, during pregnancy planning, study visits during pregnancy, around delivery and at one month post-delivery
System features	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)	From inclusion until one month post-delivery
HbA1c	HbA1c before pregnancy and HbA1c levels during pregnancy.	Inclusion, last before pregnancy, at 9, 21, 33 and 35 weeks
Severe hypoglycemia	The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and in the first one-month period post-delivery	2 years - if not becoming pregnant in the study period - until leaving the study
Ketoacidosis	The prevalence of diabetic ketoacidosis (positive ketones in urine or serum, pH ≤7·30 and/or bicarbonate ≤18 mmol/l)	During pregnancy planning OR during pregnancy and post-delivery
Weight	Maternal gestational weight gain and weight retention one month post-delivery OR Weight at randomization and last weight before pregnancy	At inclusion until one month post-delivery OR leaving the study
Pregnancy complications	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	9 months
Birth complications	Prevalence of shoulder dystocia, birth canal trauma, mode of delivery (vaginal delivery, instrumental delivery, planned cesarean section, emergency cesarean section), postpartum hemorrhage, maternal death	From delivery until one month post-delivery
Major congenital malformations	ICD10 Q00-Q99 or requiring medical or surgical treatment	From delivery until one month post-delivery
Lactation	The prevalence of lactation	One month post-delivery
Continuous glucose monitoring data	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	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
Fetal overgrowth	The prevalence of fetal overgrowth, defined as the offspring birth weight standard deviation score >90th percentile	At birth
Neonatal morbidity	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	At delivery until one month post-delivery
Infant growth	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	One month post-delivery

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Abbott; The Novo Nordic Foundation; mylife Diabetes Care AG

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Estimated): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications
• Other Study ID Numbers: 3080181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared if it is a requirement at our institution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No