The Study of Recommendation System DiaCompanion With Personalized Dietary Recommendations for Women With Gestational Diabetes Mellitus (DiaCompanion I)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Percentage of postprandial capillary glucose values above target (>7.0 mmol/L)
研究概览
简要总结
This is a randomized controlled trial of a recommendation system implementation in the treatment of women with gestational diabetes mellitus (GDM). The trial assesses the aspects of system effects on maternal glucose control, the fetus and pregnancy outcomes. This study is an interventional, randomized controlled trial, open-labeled.
详细描述
The study aims to clarify the effect of using DiaCompanion I (a mobile-based personalized recommendations system) on glycemic levels and pregnancy outcomes in women with GDM. Women with GDM are randomized to 2 treatment groups (utilizing and not utilizing the developed mobile-based system with data-driven personal recommendations focused primarily on postprandial glycemic response prediction). Data on glycemic levels during the study and consumption of major macro- and micronutrients will be collected using the mobile app with electronic report forms. The app provides women in the intervention group with the resulting data-driven prognosis of a 1-hour postprandial glucose level every time they input their meal data. The app also provides participants of the intervention group with a set of reminders and recommendations on the diet and lifestyle.
Apart from the assessment of the outcomes described below, biobanking of serum, plasma; cord fluid, HUVECs, faeces, and meconium will be performed. The samples may be used for further analyses in ancillary studies, which could be beneficial for GDM care based on evolution in scientific knowledge.
This biological collection is optional [Time Frame: within 15 years after the end of the study]:
- The blood samples will be collected at the same time as the sample routinely collected
- Maternal faeces will be collected within 5 days after inclusion and at gestational weeks 35-36
- Cord fluid will be collected
- HUVECs will be isolated from the cord after delivery
- Meconium will be collected within 24 hours after birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with GDM according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e. fasting plasma glucose between 5.1 mmol/L and 6.9 mmol/L after the 6th week of gestation and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 10.0 mmol/L and/or 2-hour plasma glucose value between 8.5 mmol/L and 11.0 mmol/L at the 24-31st week of gestation
- •Age >18 years
- •Gestational age >= 12 and < 32 weeks
- •No more than 4 weeks after confirmation of GDM diagnosis
- •Singleton pregnancy
- •The ability to navigate an app
- •Provided informed consent
排除标准
- •Preexisting diabetes of any type before the current pregnancy
- •Need for insulin therapy at the time of screening
- •Heart failure
- •Chronic kidney disease
- •History of bariatric surgery
- •Use of long-term systemic corticosteroids
- •Impaired mobility
- •Known fetal malformations
- •Concomitant participation in other clinical trials
结局指标
主要结局
Percentage of postprandial capillary glucose values above target (>7.0 mmol/L)
时间窗: from randomization up to delivery
The women will be asked to perform 6 measures a day. Capillary glucose values will be retrieved from the glucose meter, and if not available, from the woman's diary.
次要结局
- Proportion of women with glucose values within target(within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery)
- Fasting glucose, mmol/L(at gestational weeks 35-37)
- The level of HbA1c, %(at gestational weeks 35-37)
- Capillary glucose values(within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery)
- Fasting insulin, mIU/mL(at gestational weeks 35-37)
- Cesarean delivery rate(At any time during pregnancy up to delivery)
- Pregnancy-induced hypertension in women with no known hypertension before pregnancy(At any time during pregnancy up to delivery)
- The number of in-patient visits to endocrinologists(from randomization to delivery)
- Rate of patients requiring insulin therapy during pregnancy(At any time during pregnancy up to delivery)
- Mean incremental area under the blood glucose curve 2 hours after meals (iAUC120) according to continuous glucose monitoring (time period: 7 days)(1-2 weeks after randomization and 35-37th gestational week)
- HOMA-IR index(at gestational weeks 35-37)
- Birth weight ≥ 4000 g; ≥ 4500 g(At delivery)
- Hypoglycemia(from randomization to delivery)
- Gestational weight change(by the time of delivery)
- Neonatal hypoglycemia(At delivery)
- Low Apgar score: 5-min Apgar score < 7(At delivery)
- Need for operative vaginal delivery rate(At any time during pregnancy up to delivery)
- Preeclampsia(At any time during pregnancy up to delivery)
- Results of oral glucose tolerance test(3 months after delivery)
- Patient satisfaction evaluated through a questionnaire(at gestational weeks 35-36)
- Small for gestational age (< 10th percentile) infant(At delivery)
- Birth weight, kg(At delivery)
- Apgar score at 1 and 5 minutes from birth(At delivery)
- Induction of labor rate(At any time during pregnancy up to delivery)
- Acceptance/satisfaction of 2 strategies: score(at gestational weeks 35-36)
- Serum triglyceride levels, mmol/L(at gestational weeks 35-37)
- Large (>90th percentile) for gestational age infant(At delivery)
- Shoulder dystocia(At delivery)
- Birth injury, any of the following: plexus injury, clavicle, humeral, or skull fracture(At delivery)
- Preterm delivery(At delivery)
- Jaundice requiring phototherapy(At delivery)
- Admission to neonatal intensive care unit during the three days following birth(At delivery)
- Umbilical cord blood C-peptide, ng/mL(At delivery)
- Neonatal respiratory distress syndrome(At delivery)
研究者
Polina Popova
Head of the research laboratory of methabolic disorders and microbiota
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health