Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes: a Randomized Controlled Trial: the CRISTAL Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 21
- 主要终点
- time in range
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
time in range
时间窗: from 14 weeks to 36 weeks
time between 63-140mg/dl (pregnancy glycemic target range)
次要结局
- insulin dose(from 14 weeks to 36 weeks)
- time in range during the night(from 14 weeks to 36 weeks)
- type of labor(delivery)
- time in range early pregnancy(from 9 weeks to 12 weeks)
- time below target (50mg/dl)(from 14 weeks to 36 weeks)
- CGM compliance(from 14 weeks to 36 weeks)
- glycemic variability(from 14 weeks to 36 weeks)
- duration hospitalization delivery(delivery)
- rate of neonatal death(1 month after delivery)
- time in range during each trimester(from 9 weeks to 36 weeks)
- time above target (180mg/dl)(from 14 weeks to 36 weeks)
- variation glucose values(from 14 weeks to 36 weeks)
- severe hypoglycemia(from 9 weeks to 36 weeks)
- rate of stillbirth(>20 weeks)
- rate of respiratory distress(delivery)
- number with very large gestational age infants(delivery)
- cord blood ph(delivery)
- rate of neonatal hypoglycemia(up to 5 days after delivery)
- duration NICU admission(up to 30 days after delivery)
- rate of preterm delivery(delivery)
- overnight time low(from 14 weeks to 36 weeks)
- time in range during the day(from 14 weeks to 36 weeks)
- mean glucose(from 14 weeks to 36 weeks)
- MAGE (mean amplitude of glycemic excursions)(from 14 weeks to 36 weeks)
- rate of preeclampsia(from 20 weeks to delivery)
- rate of IUGR (intra-uterine growth restriction)(from 20 weeks to delivery)
- rate of miscarriage(<20 weeks)
- rate of termination of pregnancy(up to 24 weeks)
- birth weight(delivery)
- rate of macrosomia(delivery)
- rate with high birth weight(delivery)
- rate of SGA infant (small for gestational age)(delivery)
- time below low day and night(from 14 weeks to 36 weeks)
- HbA1c during each trimester(from 9 weeks to 36 weeks)
- time above target (140mg/dl)(from 14 weeks to 36 weeks)
- duration of hypoglycemia(from 14 weeks to 36 weeks)
- time in nonpregnant target range(from 14 weeks to 36 weeks)
- rate of diabetic keto-acidosis(from 9 weeks to 36 weeks)
- gestational duration(delivery)
- rate of eclampsia(from 20 weeks to delivery)
- time below target (54mg/dl)(from 14 weeks to 36 weeks)
- nocturnal hypoglycemia(from 9 weeks to 36 weeks)
- type of delivery(delivery)
- rate of gestational hypertension(from 20 weeks to delivery)
- rate of shoulder dystocia(delivery)
- rate of birth trauma(delivery)
- rate of LGA infant (large for gestational age)(delivery)
- rate of fetal hyperinsulinemia(delivery)
- skinfolds newborn(up to 3 days after delivery)
- number with composite neonatal outcome(delivery)
- rate of worsening of chronic hypertension(from 9 weeks to delivery)
- rate of HELLP syndrome(from 20 weeks to delivery)
- rate of fetal malformation(up to 24 weeks)
- sex of infant(delivery)
- rate of hyperbilirubinaemia(delivery)
- rate of NICU admission(up to 30 days after delivery)
- neonatal fat mass(up to 3 days after delivery)