A Single-center, Prospective, 'Open-label,' Investigator-initiated Pilot Study Evaluating the Role of Continuous Glucose Monitor (CGM) Use Either Alone or With Remote Monitoring Capabilities in Pregnancy Associated With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Changes in Glucose Variability
研究概览
简要总结
A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities during pregnancy associated with T1DM.
详细描述
A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities that enable subjects to share CGM data with family and friends (whom the investigators will call "followers" in this protocol) among women with T1DM associated with pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent before any study-related activities
- •Female aged 18 years and older
- •T1D duration >1 year
- •Pregnancy with confirmation of gestational age 13 weeks or less
- •Willingness to routinely practice at least 3-7 blood glucose measurements per day
- •Using MDI or CSII therapy
- •Willingness to provide an A1C level
- •Ability and willingness to adhere to the protocol including scheduled study visits for the duration of the pregnancy
- •Able to speak, read, and write English
- •Exclusion Criteria
- •Extensive skin changes/diseases that inhibit wearing a sensor on normal skin
- •Known allergy to adhesives
- •Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent
排除标准
- 未提供
结局指标
主要结局
Changes in Glucose Variability
时间窗: From first pregnancy visit to delivery
Glucose variability as measured by glucose excursions from CGM
Change(s) in Behavior and/or Concerns of Diabetics.
时间窗: From first pregnancy visit to delivery
Change(s) in behavior and/or concerns of diabetics as detected by the hypoglycemia fear questionnaire. Behavior sub-scale score ranges from 10-50, with higher scores indicating more behavioral changes in the participant's daily routine to avoid low blood sugar. Worry sub-scale score ranges from 17-85, with higher scores indicating more worry or concerns because of low blood sugar. Total score ranges from 27-135, with higher scores for both sub-scales indicating more fear and a worse outcome.
次要结局
- Change in A1C.(From first pregnancy visit to delivery)
- Evaluation of Maternal and Fetal Outcomes.(From first pregnancy visit to delivery)