The Effect of Professional Continuous Glucose Monitoring on Diabetes Management,Hypoglycemia and Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Glycemic Control by Measurement of HbA1c
研究概览
简要总结
The purpose of this study is to determine if professional Continuous glucose monitoring improves glycemic control with less hypoglycaemia in insulin-requiring Gestational Diabetes Mellitus
详细描述
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OBJECTIVES
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To determine if professional CGM improves glycemic control with less hypoglycaemia in insulin- requiring GDM
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To determine if professional CGM use alters management of insulin-requiring GDM
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To determine if professional CGM improves pregnancy outcomes in insulin-requiring GDM.
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To determine patient attitudes toward CGMS.
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HYPOTHESES
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Professional CGMS improves glycaemic control in women with insulin-requiring GDM with less hypoglycaemia
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Professional CGM use will alter management of insulin-requiring GDM
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Professional CGMS will reduce perinatal morbidity and mortality in patients with insulin- requiring GDM
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Third trimester CGMS parameters will correlate better with perinatal outcomes compared with conventional measures of glycaemic control in pregnancy i.e. fructosamine/ A1c/ FBS/ 2hrs PP glucose
STUDY DESIGN
- This is a prospective, open-label, randomized controlled trial. We plan to recruit 80 women with gestational diabetes at 28 weeks gestation or less from the UMMC antenatal clinic. These women should be insulin-naïve but require insulin therapy. 40 subjects (Group 1) will be selected to undergo professional CGM at weeks 28, 32, and week 36 and another 40 subjects individually matched with regards, to age, baseline A1c, BMI will be recruited to undergo usual antenatal care without CGMS (Group 2). The CGMS data will be uploaded and reviewed at weeks 29, 33, and 37 and changes made to the therapeutic regimen as required by the endocrinologist. All mothers will be required to measure their glucose levels at 7 standardized points in a day daily. These glucose readings will be recorded in a diary together with a food log. All subjects will also be required to keep a hypoglycaemia diary.
- The primary outcomes will be glycaemic control in the third trimester and maternal hypoglycaemia. We also plan to assess changes to management made by the endocrinologist based on the additional information on glycemic control obtained from professional CGM use. We also plan to compare hypoglycaemia and hyperglycaemia detection rates using the CGMS and fingerstick methods of glucose evaluation. Patient satisfaction in both groups will also be assessed. Written and informed consent will be obtained in accordance with the principles of the Helsinki Declaration
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with gestational diabetes
- •aged >18 years
- •less than or equal to 28 weeks gestation of pregnancy
- •singleton pregnancy
- •insulin naive , but requiring insulin therapy
排除标准
- •pregestational type 1 or 2 diabetes mellitus
- •newly diagnosed overt diabetes in pregnancy ( HbA1c > 6.5)
- •hypothyroidism
- •Cushing's syndrome/ using exogenous steroids
- •chronic infection ( HIV, Hepatitis B/C, Tuberculosis)
- •any active chronic systemic disease ( except essential hypertension)
- •assisted conception
- •pregnancies with fetal anomalies / where imminent or preterm delivery is likely because of maternal disease ( besides gestational diabetes)
结局指标
主要结局
Glycemic Control by Measurement of HbA1c
时间窗: From 28 weeks until delivery
次要结局
- Hypoglycemia(28 weeks until delivery)
研究者
Shireene Vethakkan
Associate Professor and Consultant Endocrinologist
University of Malaya