CTRI/2024/07/071323尚未招募2/3 期
Evaluating the utility of continuous glucose monitoring system for behavioral modification in high risk women enrolled in early pregnancy for the prevention of gestational diabetes mellitus a pilot Randomized Control Trial
Dr Yashdeep Gupta1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年6月2日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Difference in the incidence of gestational diabetes mellitus between the intervention and control groups
研究概览
简要总结
In this study we wish to evaluate the utility of tailored behavioral modification based on information provided by a continuous glucose monitoring device compared to usual care in which participants will be given a diet chart and advised physical activity. We wish to see the difference between the incidence of gestational diabetes mellitus in between these two groups as well as observe the differences between various maternal and neonatal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Month(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women 18 years or older in early pregnancy with period of gestation less than 14 weeks.
- •The patient should have a BMI more than equal to 25 kilogram per meter square or BMI more than or equal to 23 Kilogram per meter square with hypertension or history of PCOS or previous history of gestational diabetes mellitus or family history of diabetes in first degree relative or age more than 35 years.
- •The patient should have a singleton pregnancy confirmed by ultrasonography and should be enrolled either in the Department of Endocrinology and Metabolism or Department of Obstetrics and Gynaecology AIIMS Delhi.
- •The participant should also be willing to comply with the study protocol.
排除标准
- •Women with Type 1 diabetes mellitus secondary diabetes or overt and pre-existing diabetes or gestational diabetes defined as per WHO 2019 criteria.
- •The participant should not have any systemic illness with major organ dysfunction and should not be on steroids.
- •Women with eczema or with a skin condition which precludes using a continuous glucose monitoring device will also be excluded.
- •Women who do not have a smartphone as diet pictures have to be shared on real time basis.
结局指标
主要结局
Difference in the incidence of gestational diabetes mellitus between the intervention and control groups
时间窗: At 28 weeks period of gestation
次要结局
- Difference in between the two groups in appropriate gestational weight gain both total and per week.(At baseline, between 24 to 28 weeks period of gestation, between 34-38 weeks period of gestation and at delivery.)
- Difference in composite pregnancy outcome which will be a composite of neonate born large for gestational age(gestational hypertension or pre-eclampsia, small for gestational age, Apgar score less than 7, hyperbilirubinemia, respiratory distress syndrome, clinically significant neonatal hypoglycemia, preterm birth, perinatal mortality, NICU admission for more than 24 hours)
- Percentage of women who wore CGMS for the entire duration of two weeks(At baseline and between 24 to 28 weeks period of gestation)
- Percentage of women who shared the data of their diet for at least 70% of their meals(At baseline and between 24 to 28 weeks period of gestation)
- Percentage of women who scanned periodically and provided more than 70% of the CGMS data(At baseline and between 24 to 28 weeks period of gestation)
- Percentage of women adherent to all six assessment visits.(At delivery.)
- Participant satisfaction with full intervention process(At delivery)
- Perceived benefit of tailored behavioral modification advice by the participant(At delivery)
- Participant satisfaction with the use of CGMS(At baseline and between 24-28 weeks)
- Likely recommendation for use in other pregnant women by the participant(At delivery)
研究者
Dr Yashdeep Gupta
All India Institute of Medical Sciences, New Delhi
研究点 (1)
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