Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Glucose variability
研究概览
简要总结
Hypothesis:
Increased contact with the diabetes care team throughout pregnancy will lead to improved glucose control during pregnancy.
详细描述
Patient will have weekly contact through the Mayo Patient On-line Services to send in their blood glucose readings and to receive recommendations back regarding insulin dose changes. Information will be analyzed regarding the magnitude of change in insulin dosing and in glycemic variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult pregnant women with type 1 diabetes utilizing either an insulin pump or multiple daily injection insulin program to manage their diabetes
- •Inclusion Criteria:
- •Female with type 1 diabetes and pregnancy
- •EDD prior to November 15, 2014
- •18 years of age and older
- •On insulin pump or multiple daily injection insulin program
- •Signed patient consent form
排除标准
- •Exclusion Criteria:
- •Female with type 1 diabetes and pregnancy under age 18 or older than age 45
- •Female with type 2 diabetes or gestational diabetes and pregnancy
研究组 & 干预措施
Single arm, remote contact.
Between visit remote contact.
干预措施: Frequent remote contact between clinic visits. (Other)
结局指标
主要结局
Glucose variability
时间窗: Baseline to 9 months
Glucose variability represented by multiple measures including mean plasma glucose with standard deviation, high blood glucose index, low blood glucose index and average daily risk range.
次要结局
- Changes is severe hypoglycemia(up to 9 months)
