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Diabete Type 1AID-DMNCT07240012

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

A study testing Automated closed-loop insulin delivery in people with Diabete Type 1 and Pregnancy Complications, run by Copenhagen University Hospital, Rigshospitalet at 8 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Diabete Type 1, Pregnancy Complications
What is being tested?
Automated closed-loop insulin delivery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
8 sitesDenmark
Study dates
1 Dec 2025to Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
  • Women, age 18-45 years
  • Duration of type 1 diabetes ≥ 12 months
Show all 11Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lene Ringholm Chief physician, PhD, Associate Professor contact

+45 35458671

lene.ringholm.02@regionh.dk

8 sites in 1 country

Denmark8 sites, 8 recruiting

  • Department of Gynecology and Obstetrics, Aalborg University Hospital

    Aalborg, Aalborg, 9000

    Recruiting

  • Steno Diabetes Center Nordjylland

    Aalborg, Gistrup, 9260

    Recruiting

  • Department of Gynecology and Obstetrics, Aarhus University Hospital

    Aarhus, Aarhus N, 8200

    Recruiting

  • Steno Diabetes Center Aarhus

    Aarhus, Aarhus N, 8200

    Recruiting

  • Steno Diabetes Center Copenhagen

    Copenhagen, Herlev, 2730

    Recruiting

  • Center for Pregnant Women with Diabetes, Rigshospitalet

    Copenhagen, 2100

    Recruiting

  • Department of Gynecology and Obstetrics, Odense University Hospital

    Odense, Odense C, 5000

    Recruiting

  • Steno Diabetes Center Odense, Odense University Hospital

    Odense, Odense C, 5000

    Recruiting

Other trials in Denmark

About this study

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.

Read the 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.

Being tested
Automated closed-loop insulin delivery
Medical subject headings
Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automated closed-loop insulin deliveryDevice

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

Study groups in NCT07240012
Study groupRoleWhat they receive
Automated closed-loop insulin delivery (AID)ExperimentalNot described
Receives: Device: Automated closed-loop insulin delivery
Usual insulin treatment modalityNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in range

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

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

  2. Neonatal outcome: Birthweight

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

    Measured: At delivery

Secondary outcomes (14)

  1. 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

    Measured: 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

  2. 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

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

  3. 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)

    Measured: From inclusion until one month post-delivery

  4. HbA1c

    HbA1c before pregnancy and HbA1c levels during pregnancy.

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

  5. Severe hypoglycemia

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

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

  6. Ketoacidosis

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

    Measured: During pregnancy planning OR during pregnancy and post-delivery

  7. Weight

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

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

  8. Fetal overgrowth

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

    Measured: At birth

  9. 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

    Measured: 9 months

  10. 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

    Measured: From delivery until one month post-delivery

  11. 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

    Measured: At delivery until one month post-delivery

  12. Major congenital malformations

    ICD10 Q00-Q99 or requiring medical or surgical treatment

    Measured: From delivery until one month post-delivery

  13. 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

    Measured: One month post-delivery

  14. Lactation

    The prevalence of lactation

    Measured: One month post-delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start1 Dec 2025
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
305 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07240012
Sponsor's protocol ID
3080181
Acronym
AID-DM
Status last verified
Aug 2026
First submitted
16 Nov 2025
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will be shared if it is a requirement at our institution.

Questions about this trial

What is this clinical trial studying?

A study testing Automated closed-loop insulin delivery in people with Diabete Type 1 and Pregnancy Complications, run by Copenhagen University Hospital, Rigshospitalet at 8 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lene Ringholm Chief physician, PhD, Associate Professor (+45 35458671, lene.ringholm.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in range (time frame: From first day of last menstrual cycle (planning pregnancy) or randomization (early pregnancy) until delivery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07240012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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