Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injection in Pregnant Women With Type 2 Diabetes: A Single-center Open Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time in range (TIR) at 34 weeks of gestation
研究概览
简要总结
The primary objective of the study is to determine if continuous subcutaneous insulin infusion (CSII) can improve glycemic control in women with type 2 diabetes (T2D) who are pregnant.
详细描述
In women with diabetes, hyperglycemia is associated with increased rates of maternal and fetal adverse outcomes. Mothers are at increased risk of preeclampsia, deterioration of proteinuria and caesarean sections. Infants of mothers with diabetes have increased rates of congenital anomalies, premature delivery, macrosomia, stillbirth and NICU admissions, as well as increased risks of shoulder dystocia, birth injury, hypoglycemia, hyperbilirubinemia, respiratory distress syndrome, asphyxia and death in the neonatal period. Several studies have shown that pregnancy outcomes can be improved along with better glycemic control. Theoretically CSII could achieve better glycemic control due to its flexibility in adjusting both basal rate and bolus insulin infusion. Several randomized controlled studies have compared the ability of CSII with multiple daily injection (MDI) in glycemic control and improvement of pregnancy outcomes in patients with type 1 diabetes (T1D). However, there is a lack of similar studies in women with T2D. We hypothesize that CSII will assist women with T2D achieve better glycemic control during pregnancy compared to MDI users.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 40 years old
- •Patients with confirmed history of T2D or patients who are newly diagnosed with T2D by oral glucose tolerance test (OGTT) during pregnancy (diagnostic criteria refer to ADA 2020 guideline for T2D).
- •Women with singleton pregnancy at 4 to 20 weeks of gestation, whose blood glucose fails to achieved glucose target after adequate lifestyle intervention with or without the prescription of basal insulin (i.e. fasting blood glucose above 5.3 mmol/L, or one hour postprandial blood glucose above 7.8 mmol/L, or two hour postprandial blood glucose above 6.7 mmol/L), and need to start intensive insulin therapy (MDI or insulin pump) according to the evaluation of endocrinologists.
- •Patients who are willing be followed up by the Third Hospital of Peking University in the whole process of pregnancy until 6 weeks of postpartum, and promise that they will provide the results of relative prenatal examinations and perinatal medical records if they are transferred to another hospital for special reasons.
- •Patients who can pass the compliance test and agree to conduct self-monitoring of blood glucose (SMBG) at least 7 times a day during pregnancy.
- •Patients who volunteer to participate the trial and agree to sign informed consent.
排除标准
- •Patients with T1D, special type of diabetes and gestational diabetes.
- •Patients who have received intensive insulin therapy (MDI or insulin pump) or premixed fixed doses of insulin before enrollment in this trial.
- •Patients who refuse to use insulin pump or CGM devices.
- •Patients who are not recommended by obstetrician to continue their pregnancy due to comorbidity and high risk of pregnancy. The comorbidities include but not limited to the following diseases: proliferative retinopathy, chronic kidney disease (eGFR less than 60 ml /min/1.73 with or without heavy proteinuria), known coronary heart disease and cerebrovascular disease, autoimmune disease, other diseases requiring exogenous glucocorticoid or immunosuppressive therapy.
- •Patients who received inpatient psychiatric treatment within 6 months before enrollment or still using psychiatric drugs.
- •Participated in other intervention studies.
结局指标
主要结局
Time in range (TIR) at 34 weeks of gestation
时间窗: 34 weeks of gestation
Glycemic control as measured by time in range (TIR) acquired from retrospective continuous glucose monitoring devices (r-CGM) at 34 weeks of gestation among women with type 2 diabetes mellitus.
Time in range (TIR) at 28 weeks of gestation
时间窗: 28 weeks of gestation
Glycemic control as measured by time in range (TIR) acquired from retrospective continuous glucose monitoring devices (r-CGM) at 28 weeks of gestation among women with type 2 diabetes mellitus.
Time in range (TIR) at 24 weeks of gestation
时间窗: 24 weeks of gestation
Glycemic control as measured by time in range (TIR) acquired from retrospective continuous glucose monitoring devices (r-CGM) at 24 weeks of gestation among women with type 2 diabetes mellitus.
次要结局
- Glycosylated hemoglobin (HbA1c) and glycosylated serum albumin(24, 28, 34 weeks of gestation and 6 weeks of postpartum)
- TIR calculated by patients' SMBG data(At 4 weeks after randomization, and at 24, 28, 34 and 38 weeks of gestation)
- The AUC of blood glucose within 24 hours before delivery(Within 24 hours before delivery)
- Hypertension during pregnancy(From randomization, up to 42 weeks of gestation)
- Maternal hospital stay(From admission to discharge from hospital due to delivery)
- TAR and TBR(At 24, 28 and 34 weeks of gestation)
- Gestational weight gain(24, 28, 34 weeks of gestation and 6 weeks of postpartum)
- Infant birthweight(At delivery)
- Insulin requirements(4 weeks after randomization, 24, 28, 34 weeks of gestation and 6 weeks of postpartum.)
- Caesarean sections at delivery(At delivery)
- Infant Outcomes (Up to f first 7 days of life)(Up to first 7 days of infants' life)
- Blood glucose fluctuation index(At 24, 28 and 34 weeks of gestation)
- Hypoglycemic events(From randomization, up to 42 weeks of gestation)
- Infant Outcomes (Apgar score)(At birth)
- Infant Outcomes (Up to first 7 days of infants' life)(Up to first 7 days of infants' life)
- The composite endpoint of infants(Up to first 7 days of infants' life)
- Questionnaires (Self-rated Anxiety Scale, SAS)(At randomization, 34 weeks of gestation and 6 weeks of postpartum)
- Pregnancy loss(From randomization, up to 28 days after delivery)
- Infant Outcomes (Gestational week of delivery)(At birth)
- Questionnaires (Self-efficacy scale for diabetes mellitus)(At randomization, 34 weeks of gestation and 6 weeks of postpartum)
- Questionnaires (WHO-5 physical and mental health index)(At randomization, 34 weeks of gestation and 6 weeks of postpartum)
- Questionnaires (Self-manage behavior scale)(At randomization, 34 weeks of gestation and 6 weeks of postpartum)
- Questionnaires (Self-rated Depression Scale, SDS)(At randomization, 34 weeks of gestation and 6 weeks of postpartum)