Closed-loop Insulin Delivery by Glucose Responsive Computer Algorithms In Type 1 Diabetes Pregnancies (CIRCUIT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 23
- 主要终点
- Glycemic control as reflected by percent glucose time-in-range
研究概览
简要总结
This trial will assess the efficacy of the Tandem t:slim X2 insulin pump with Control IQ technology compared with standard insulin delivery plus CGM in pregnant women with type 1 diabetes.
详细描述
Pregnant women with type 1 diabetes (T1D) require normal or near normal glucose in order to reduce the risks of birth defects, stillbirth, increased birthweight, neonatal hypoglycemia, neonatal death, preterm delivery and preeclampsia. Reducing maternal glucose is extremely difficult due to an increased risk of maternal hypoglycemia. Only 14% of T1D pregnancies achieve pregnancy guideline recommended glucose control, leading to complications related to high maternal glucose exposure in roughly half of newborns.
Maintaining recommended maternal glucose levels during pregnancy reduces the risk of adverse neonatal outcomes to those similar in pregnancies unaffected by T1D. Most insulin pumps in use today are open-loop systems, which means that the user must program the pump to deliver a pre-set amount of insulin. These insulin delivery methods (MDI and open-loop pumps) are usually inadequate to achieve the optimal glucose control necessary for T1D pregnancies and they impart a large time, effort and emotional burden.
Closed-loop systems have been found to be effective in improving glucose control outside of pregnancy when studied in children and adults. A new hybrid closed-loop system, the Tandem t:slim X2 insulin pump with Control IQ technology, recently became commercially available. Trials have demonstrated the efficacy of the Control IQ algorithm for non-pregnant adults and children. Pregnant women were not included in these trials.
The investigators propose the first randomized controlled trial to evaluate the Tandem t:slim X2 insulin pump with Control IQ technology versus standard insulin delivery (MDI or pump) and CGM in pregnant women with T1D. In this trial, the investigators will assess the efficacy of the Tandem t:slim X2 insulin pump with Control IQ technology compared with standard insulin delivery plus CGM in pregnant women with type 1 diabetes.
We are grateful to Tandem Diabetes Care and Dexcom for in-kind donations to this investigator initiated study.
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
- •Between 18 and 45 years of age (inclusive)
- •A diagnosis of type 1 diabetes, as defined by Diabetes Canada, for at least 12 months
- •A viable singleton pregnancy confirmed by ultrasound, less than 14 weeks gestation
- •Currently on intensive insulin therapy (≥ 3 injections, or Continuous subcutaneous insulin infusion (CSII)
- •Willingness to use the study devices throughout the trial
- •A1c ≥ 6.2% and <10% measured any time during pregnancy prior to enrollment
- •Able to provide informed consent
- •Have access to email
排除标准
- •Non-type 1 diabetes
- •Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
- •Known or suspected allergy to insulin
- •Women with nephropathy (estimated glomerular filtration rate [eGFR] <45), severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy, as judged by the investigator, that is likely to interfere with the normal conduct of the study and interpretation of study results
- •Total daily insulin dose <8 or >250 units/day at screening
- •Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
- •Unable to communicate effectively in English or French as judged by the investigator
- •Current use of Tandem Control IQ, DIY looping system, 670G in Auto Mode, or alternate closed-loop system as judged by the investigator
- •Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results
结局指标
主要结局
Glycemic control as reflected by percent glucose time-in-range
时间窗: 16 weeks until 34 weeks gestation
Time in range (3.5 to 7.8 mmol/L) per day assessed by CGM glucose measurement
次要结局
- Percent time spent above target range per day (+/-SD)(16 weeks gestation until delivery of neonate)
- Proportion of babies born large for gestational age (>90th percentile)(Delivery of neonate)
- Mean blood glucose measurement at 24 and 34 weeks (+/-SD)(24 and 34 weeks gestation)
- Proportion of participants who experience maternal hypoglycemic events(16 weeks gestation until delivery of neonate)
- Sleep quality(7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum)
- Health-related quality of life(7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum)
- Proportion of babies born with neonatal hypoglycemia(Delivery of neonate)
- Proportion of participants who experienced pregnancy loss or miscarriage (< 20 weeks, stillbirth ≥20 weeks, neonatal loss up to 28 days)(7-13 weeks until delivery of neonate + up to 28 days)
- Proportion of participants who experience episodes of severe hypoglycemia(7-13 weeks + 6 days gestation until delivery of neonate)
- Proportion of participants who experience episodes of diabetic ketoacidosis(7-13 weeks + 6 days gestation until delivery of neonate)
- Fear of hyperglycemia(7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum)
- Work productivity(7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum)
- Proportion of participants who experience gestational hypertension events(16 weeks gestation until delivery of neonate)
- Proportion of babies born small for gestational age (<10th percentile)(Delivery of neonate)
- Percent time spent below target range per day (+/-SD)(16 weeks gestation until delivery of neonate)
- Glycemic variability reflected by the coefficients of variation and standard deviations of CGM data(16 weeks gestation until delivery of neonate)
- Diabetes-related distress to the participant(7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum)
- Fear of hypoglycemia(7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum)
- Diabetes-related distress to the partners(7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum)
- Proportion of participants who experience preeclampsia events(16 weeks gestation until delivery of neonate)
- Proportion of participants who have caesarean deliveries(16 weeks gestation until delivery of neonate)
- Mean neonatal birthweight (+/-SD)(Delivery of neonate)
- Proportion of participants who experience worsening chronic hypertension events(16 weeks gestation until delivery of neonate)
- Proportion of participants who experience preterm births(Delivery of neonate to 6 weeks postpartum)
- Comparison of birthweight z-score(Delivery of neonate)
- Proportion of neonates admitted to intensive care unit admission(Delivery of neonate to 6 weeks postpartum)
- Proportion of participants who experience device-related adverse events(7-13 weeks + 6 days gestation until delivery of neonate)