Non Inferiority Study of Glycemic Monitoring Via myDiabby Healthcare vs Conventional Diary in Patients With Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 668
- 试验地点
- 1
- 主要终点
- Assessment of the non-inferiority of the occurrence of maternal, fetal, and neonatal complications for patients of both groups
研究概览
简要总结
The purpose of the study is to demonstrate the non-inferiority of the onset of maternal, foetal, and neonatal complications for patients who had Gestational diabetes mellitus (GDM) and who had been monitored by myDiabby Healthcare compared to patients who had a classic glycemic blood monitoring by diary
详细描述
TELESUR-GDM is a descriptive and comparative study which will be compared to ERD2 study. ERD2 (personal data) was a retrospective study leaded in Rene Dubos hospital. The primary objective was to evaluate de proportion of patients who had a blood screening for type 2 diabetes after having a gestational diabetes and who gave birth between 2013 and 2015 in Rene Dubos hospital. The primary outcome was the discovery of a diabetes after the OGTT test (75g of glucose), 2 to 3 months after delivery, a fasting blood glucose rate ≥ 1,26 g/L and a plasma glucose after 2 hours ≥ 2g/L
- In ERD2 study 391 subjects were included. The patients were over 18 years old and had a gestational diabetes and were informed by a survey. The main criteria of maternal and neonatal complications were a maternal high blood pressure, a neonatal jaundice, neonatal hypocalcemia and hypoglycemia, and shoulders dystocia. In this study the patients were followed up with classic diary for glycemic blood rate.
- With TELESUR-GDM study, the objective is to prove the non-inferiority of the new method of monitoring for blood glucose rate (myDiabby Healthcare) for patients who had a gestational diabetes and who gave birth between 01/01/2021 and the 31/12/2021. The data will be collected with an informatic secured data base.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Assessment of the non-inferiority of the occurrence of maternal, fetal, and neonatal complications for patients of both groups
时间窗: At the end of the Study, an average of 8 month
Comparison, for patients with GDM, of the composite score (maternal / foetal - neonatal) between the group with remote monitoring by the myDiabby Healthcare and the group of patients with traditional monitoring (paper glycemic diaries). For each item answered "yes" count 1 point and "no" count 0 point. For information, the composite score is based on the following items: Maternal : * High blood pressure (≥140/90 mmHG) * Caesarean section * Instrumental extraction * Perineal Trauma : complete or complicated perineal tearing * Pre-eclampsia Foetal and neonatal : * birth weight ≥ 95th percentile for gestational age (neonatal macrosomia) * intrauterine growth restriction (birth weight ≤ 5th percentile) * APGAR \< 7 at 5 minutes * Fetal death in utero * Neonatal hypoglycemia * Neonatal hypocalcemia * Neonatal acidosis : pH\<7,10 and lactate \>6µmol * Shoulders dystocia * Collarbone fracture, brachial plexus * Neonatal jaundice
次要结局
- Comparison of the rate of patients put on insulin in both groups(At the end of the Study, an average of 8 month)
- Comparison, for each maternal and each Foetal/Neonatal composite items, between both groups(At the end of the Study, an average of 8 month)