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| Name | Class |
|---|---|
| The Novo Nordic Foundation | OTHER |
| mylife Diabetes Care AG | INDUSTRY |
| Abbott | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated closed-loop insulin delivery (AID) | Experimental |
| |
| Usual insulin treatment modality | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated closed-loop insulin delivery | Device | Automated closed-loop insulin delivery and The mylife CamAPS FX algorithm combined with CGM |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria during pregnancy planning
Inclusion during pregnancy:
Exclusion criteria during pregnancy planning and during pregnancy:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lene Ringholm Chief physician, PhD, Associate Professor | Contact | +45 35458671 | lene.ringholm.02@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology and Obstetrics, Aalborg University Hospital | Recruiting | Aalborg | Aalborg | 9000 | Denmark | |
IPD will be shared if it is a requirement at our institution.
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| 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 |
| 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 |
| Fetal overgrowth | The prevalence of fetal overgrowth, defined as the offspring birth weight standard deviation score >90th percentile | At birth |
| 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 |
| 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 |
| Major congenital malformations | ICD10 Q00-Q99 or requiring medical or surgical treatment | From 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 |
| Lactation | The prevalence of lactation | One month post-delivery |
| Department of Gynecology and Obstetrics, Aarhus University Hospital |
| Not yet recruiting |
| Aarhus |
| Aarhus N |
| 8200 |
| Denmark |
| Steno Diabetes Center Aarhus | Not yet recruiting | Aarhus | Aarhus N | 8200 | Denmark |
| Steno Diabetes Center Nordjylland | Recruiting | Aalborg | Gistrup | 9260 | Denmark |
| Steno Diabetes Center Copenhagen | Not yet recruiting | Copenhagen | Herlev | 2730 | Denmark |
| Department of Gynecology and Obstetrics, Odense University Hospital | Recruiting | Odense | Odense C | 5000 | Denmark |
| Steno Diabetes Center Odense, Odense University Hospital | Recruiting | Odense | Odense C | 5000 | Denmark |
| Center for Pregnant Women with Diabetes, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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