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临床试验/NCT02315274
NCT02315274已完成不适用

Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes.

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年6月最近更新:
适应症
干预措施

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

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.

Experimental

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)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yogish C. Kudva

PI

Mayo Clinic

研究点 (2)

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