Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes
- Conditions
- Type1 Diabetes
- Registration Number
- NCT04520971
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
Multi-centric open-label randomized controlled trial (RCT) with 11 Belgian centers and one Dutch center in pregnant women with type 1 diabetes to assess safety, efficacy, feasibility and cost-effectiveness of 780 MiniMed Medtronic hybrid closed-loop insulin system (intervention group) compared to standard of care therapy (control group).
- Detailed Description
Women will be recruited with a singleton pregnancy up to 12 weeks gestation. Participants will be randomized 1/1 to 780 pump or standard of care (continue with current treatment of insulin pump without closed-loop or multiple daily insulin injections). Participants will be stratified according to study center, baseline Hba1c, and method of insulin delivery (pump or injections). Participants will be followed-up till delivery. To account for differences in the type of continuous glucose monitoring (CGM) used between the intervention group and the control group, the same CGM system as in the 780 insulin pump group (Guardian™ Sensor 3 and once available the Guardian 4 sensor) will be used in a blinded manner in the control group to collect CGM data during at least four different time points in pregnancy: at 14-17 weeks, 20-23 weeks, 26-29 weeks and 33-36 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 95
- Women with type 1 diabetes (T1DM), diagnosed with T1DM at least 1 year before pregnancy
- Age 18-45 years
- A singleton pregnancy confirmed by b-HCG in blood and/or ultrasound-confirmed gestational age up to 11 weeks and 6 days.
- Treated with intensive insulin treatment (either MDI or insulin pump). A closed-loop system can only be used in manual mode.
- Have a booking HbA1c (measurement taken at the first antenatal clinic visit after confirmed pregnancy) level ≤10%.
- Participants need to speak and understand Flemish, French or English and have e-mail access.
- The use of a closed-loop insulin delivery system in auto mode.
- A twin (multiple) pregnancy
- A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician)
- Medications known to interfere with glucose metabolism
- An insulin dose of ≥1.5 units/kg
- Known allergy to adhesives due to infusion set and/or CGM
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method time in range from 14 weeks to 36 weeks time between 63-140mg/dl (pregnancy glycemic target range)
- Secondary Outcome Measures
Name Time Method time in range during the night from 14 weeks to 36 weeks time in range (63-140mg/dl) from midnight till 6am
type of labor delivery spontaneous, induced or cesarean section before labor
time in range early pregnancy from 9 weeks to 12 weeks time in range (63-140mg/dl) 9-12 weeks
time below target (50mg/dl) from 14 weeks to 36 weeks time \<50mg/dl
CGM compliance from 14 weeks to 36 weeks % of time use of CGM
glycemic variability from 14 weeks to 36 weeks standard deviation glucose values based on CGM
duration hospitalization delivery delivery length of hospital stay (days)
time in range during each trimester from 9 weeks to 36 weeks time in range (63-140mg/dl) during each trimester
time above target (180mg/dl) from 14 weeks to 36 weeks time \>180mg/dl
variation glucose values from 14 weeks to 36 weeks coefficient of variation based on CGM
severe hypoglycemia from 9 weeks to 36 weeks hypoglycemia requiring third-part assistance
rate of stillbirth >20 weeks mors in utero \>20 weeks
rate of neonatal death 1 month after delivery death \<1 months after delivery
rate of respiratory distress delivery respiratory failure or distress
number with very large gestational age infants delivery gestational age adjusted birth weight \>97th percentile according to the standardized Flemish birth charts adjusted for parity and sex
cord blood ph delivery cord blood gas ph
rate of neonatal hypoglycemia up to 5 days after delivery neonatal hypoglycemia requiring intravenous dextrose
duration NICU admission up to 30 days after delivery duration of NICU admission (days or weeks)
overnight time low from 14 weeks to 36 weeks time \<63mg/dl from midnight till 6am
time in range during the day from 14 weeks to 36 weeks time in range (63-140mg/dl) during the day
mean glucose from 14 weeks to 36 weeks mean glucose based on CGM
MAGE (mean amplitude of glycemic excursions) from 14 weeks to 36 weeks mean amplitude of glucose variations based on CGM
rate of preterm delivery delivery delivery \<37 weeks
rate of preeclampsia from 20 weeks to delivery onset of new hypertension and proteinuria and/or end-organ dysfunction after 20 weeks of gestation
rate of IUGR (intra-uterine growth restriction) from 20 weeks to delivery intra-uterine growth restriction
rate of miscarriage <20 weeks fetal loss \<20 weeks gestations
rate of termination of pregnancy up to 24 weeks induced abortion
birth weight delivery birth weight (Kg and g)
rate of macrosomia delivery birth weight \>4 Kg
rate with high birth weight delivery birth weight \>4.5 Kg
rate of SGA infant (small for gestational age) delivery gestational age adjusted birth weight \<10th percentile according to the standardized Flemish birth charts adjusted for parity and sex
time below low day and night from 14 weeks to 36 weeks time \<63mg/dl day and night
HbA1c during each trimester from 9 weeks to 36 weeks HbA1c (% and mmol/mol) during each trimester
time above target (140mg/dl) from 14 weeks to 36 weeks time \>140mg/dl
duration of hypoglycemia from 14 weeks to 36 weeks low blood glucose index
time in nonpregnant target range from 14 weeks to 36 weeks time 70-180mg/dl
rate of diabetic keto-acidosis from 9 weeks to 36 weeks metabolic keto-acidosis with decreased ph and/or decreased bicarbonate in blood
gestational duration delivery duration of pregnancy (weeks)
rate of eclampsia from 20 weeks to delivery generalized convulsions and/or coma
time below target (54mg/dl) from 14 weeks to 36 weeks time \<54mg/dl
insulin dose from 14 weeks to 36 weeks total insulin dose
nocturnal hypoglycemia from 9 weeks to 36 weeks glucose \<50mg/dl from 23-07hour
type of delivery delivery vaginal, forceps or vacuum, cesarean section during labor or planned cesarean section
rate of gestational hypertension from 20 weeks to delivery blood pressure of 140/90 mmHg or higher starting after 20 weeks of gestation
rate of shoulder dystocia delivery one or both of a baby's shoulders get stuck inside the mother's pelvis during labor.
rate of birth trauma delivery fracture, damage to nerves...
rate of LGA infant (large for gestational age) delivery gestational age adjusted birth weight \>90th percentile according to the standardized Flemish birth charts adjusted for parity and sex
rate of fetal hyperinsulinemia delivery cord blood c-peptide
skinfolds newborn up to 3 days after delivery sum of skinfolds (triceps, scapula and flank)
number with composite neonatal outcome delivery pregnancy loss (miscarriage, still birth or neonatal death), LGA (large for gestational age), respiratory distress syndrome, birth trauma, shoulder dystocia, neonatal hypoglycemia and NICU admission
rate of worsening of chronic hypertension from 9 weeks to delivery blood pressure of 140/90 mmHg or higher start is present before 20 weeks of gestation
rate of HELLP syndrome from 20 weeks to delivery hemolysis, elevated liver enzymes and a low platelet count
rate of fetal malformation up to 24 weeks congenital malformation
sex of infant delivery boy or girl
rate of hyperbilirubinaemia delivery hyperbilirubinaemia with need of treatment with phototherapy
rate of NICU admission up to 30 days after delivery Neonatal intensive care unit (NICU) admission defined as requiring a duration of at least 24 h
neonatal fat mass up to 3 days after delivery fat mass calculated by the formula of Catalano et al.
Trial Locations
- Locations (12)
OLV Aalst-Asse
🇧🇪Aalst, Oost-Vlaanderen, Belgium
Imelda Bonheiden
🇧🇪Bonheiden, Belgium
AZ St Jan Brugge
🇧🇪Brugge, Belgium
UCLouvain
🇧🇪Brussels, Belgium
UZ Brussel
🇧🇪Brussel, Belgium
UZ Gent
🇧🇪Gent, Belgium
AZ Groeninge Kortrijk
🇧🇪Kortrijk, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
AZ Roeselare
🇧🇪Roeselare, Belgium
AZ Nikolaas
🇧🇪Sint-Niklaas, Belgium
Scroll for more (2 remaining)OLV Aalst-Asse🇧🇪Aalst, Oost-Vlaanderen, Belgium