Single vs Multi-Dose Insulin for Glycemic Control (SUGAR): A Randomized Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 3
- 主要终点
- Composite outcome
研究概览
简要总结
The goal of this clinical trial is to see if diabetes in pregnancy can be treated with once daily dosing of insulin instead of once daily dosing plus insulin with meals. The main question this study aims to answer is:
- Can a once daily dose of long-acting insulin control blood sugars as well as long-acting insulin plus meal-time insulin?
- Do babies born to mothers who take one dose of long-acting insulin have more complications after birth than babies born to mothers who take long-acting and meal-time insulin? Researchers will compare one dose of long-acting insulin per day to this plus three doses of short-acting insulin with each meal to see if blood sugars are controlled.
Participants will send their blood sugar logs to the study staff weekly, instead of to their OB/GYN, for adjustments to their insulin dosing.
详细描述
Purpose/Specific Aims
The purpose of this study is to determine if a single dose of long-acting insulin is non-inferior to long-acting insulin plus prandial insulin to manage diabetes in pregnancy, measured by a composite neonatal outcome of NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia, stillbirth, and neonatal death.
A. Objectives:
This study aims to compare neonatal outcomes of patients with diabetes in pregnancy to determine if a single dose of long-acting insulin is non-inferior to long-acting insulin plus prandial insulin.
B. Hypotheses / Research Question(s):
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes mellitus or A2 gestational diabetes mellitus requiring insulin use during pregnancy
- •Aged between 18-50
- •Speak English or Spanish
排除标准
- •Pre-existing use of insulin
- •Gestational Age > or = 35w0d
- •Planning to follow-up with a doctor not associated with RWJ Barnabas or NYU Langone Health and/or deliver at a hospital other than RWJUH or NYU
- •Unwilling or unable to upload or email weekly blood sugar logs
- •Contraindication to Lispro or Lantus insulin, or patient chooses to not utilize insulin therapy
- •Fetal anomaly present
研究组 & 干预措施
Insulin glargine + Insulin lispro
Once daily dosing of insulin glargine plus three times per day dosing of insulin lispro with each meal
干预措施: Insulin glargine + insulin lispro (Drug)
Insulin glargine alone
Once daily dosing of insulin glargine
干预措施: Insulin glargine alone (Drug)
结局指标
主要结局
Composite outcome
时间窗: From enrollment to delivery
NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia stillbirth, and neonatal death
次要结局
- Compliance with medication(From enrollment to delivery)
- % of patients in experimental group who are able to remain on insulin glargine only(From enrollment to delivery)
- Maternal complication rates(From enrollment to maternal discharge from delivery hospitalization)
- Birth complications(Delivery to discharge of infant from birth hospitalization)
- Neonatal complications(Delivery to discharge during birth hospitalization)
- Birthweight(Delivery, first weight recorded)
- APGAR Scores(Delivery to 5 minutes after delivery)
- Neonatal hospital stay(Delivery of neonate to discharge from birth hospitalization)
- Patient satisfaction(From enrollment to delivery)
研究者
Emily B. Rosenfeld, DO
Principal Investigator
Rutgers, The State University of New Jersey