Health TrialsbyHealthPanel

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

ConditionsDiabete Type 1Pregnancy Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Automated closed-loop insulin delivery

    Device

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

Treatment groups

305 Participants
are divided into 2 treatment groups
Group A: Automated closed-loop insulin delivery (AID)Experimental treatment 1 intervention
Group B: Usual insulin treatment modalityNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time in range

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

Time frame
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.

Time frame
At delivery

Secondary outcomes

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

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
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

Time frame
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)

Time frame
From inclusion until one month post-delivery
4

HbA1c

HbA1c before pregnancy and HbA1c levels during pregnancy.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

The Novo Nordic Foundation

Collaborator

mylife Diabetes Care AG

Collaborator

Abbott

Collaborator

Source ClinicalTrials.gov
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