NCT04292509已完成不适用
Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy With Predictive Stop Before Low Compared to Stop on Low: an Open-label Crossover RCT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- blood ketones > 0.6mmol/l.
研究概览
简要总结
The ROKSANA study is an open-label crossover RCT with the aim to evaluate whether sensor-augmented pump therapy (SAP) with predictive low glucose suspend technology is associated with an increased risk for ketonaemia during type 1 diabetes pregnancies.
详细描述
10 pregnant women with type 1 diabetes will be included . Participants will be randomized 1/1 between 12-30 weeks of pregnancy to SAP with predictive stop before low during two weeks or predictive stop on low. Participants will be cross-over to the other group after two weeks (from stop before low to stop on low or vice versa). During the study, participants will be asked to measure blood ketones three times per day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •type 1 diabetes
- •age 18-45 years
- •a singleton pregnancy with ultrasound-confirmed gestational age between 12- 30 weeks.
- •treated with 640 insulin pump and have a baseline HbA1c level ≤10%.
排除标准
- •a physical or psychological disease likely to interfere with the conduct of the study
- •medications known to interfere with glucose metabolism
结局指标
主要结局
blood ketones > 0.6mmol/l.
时间窗: 4 weeks
ketonaemia
次要结局
- HbA1c(4 weeks)
- frequency of CGM use >80% of time(4 weeks)
- mean glucose based on CGM(4 weeks)
- time <63 mg/dl(4 weeks)
- mean concentration of blood ketones(4 weeks)
- time >180 mg/dl(4 weeks)
- mean time of suspension of insulin delivery(4 weeks)
- frequency of hospitalization due to ketonaemia(4 weeks)
- time >140 mg/dl(4 weeks)
- time <50mg/dl(4 weeks)
- standard deviation of glycaemic measurements(4 weeks)
- coefficient of variation of glycaemic measurements(4 weeks)
- mean amplitude of glucose excursions(4 weeks)
- time 70-180 mg/dL(4 weeks)
- total insulin dose(4 weeks)
- severe hypoglycemic episodes(4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).Solid TumorsLymphomaChronic Lymphocytic LeukemiaNCT01021358Abbott12
撤回
不适用
Diabetic Cardiomyopathy and Heart FailureDiabetic CardiomyopathiesHeart FailureNCT05571865University of Louisville40
招募中
不适用
Ketohexokinase Isoforms in Endometrial Cancer.Endometrial CancerNCT03931265Far Eastern Memorial Hospital220
撤回
1 期
A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic MelanomaMalignant Melanoma, NeoplasmsNCT01765556Hoffmann-La Roche
撤回
1 期
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR CancersAdvanced Solid TumorMetastatic CancerHER2-positive Breast CancerHER2-positive Gastric CancerHER-2 Protein OverexpressionOvarian CancerEsophageal CancerEndometrium CancerNon Small Cell Lung CancerEGF-R Positive Non-Small Cell Lung CancerHead and Neck Squamous Cell CarcinomaTriple Negative Breast CancerColorectal CancerPancreatic CancerCervical CancerBladder CancerSarcomaNCT04464967NKGen Biotech, Inc.