Managing Diabetes During Pregnancy in the Wireless Age: a RCT of Glucose Telemonitoring
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean blood glucose, based on the highest post-prandial blood glucose reading for each day, by trimester
研究概览
简要总结
This Randomized Controlled Trial (RCT) will test the efficacy of a home blood glucose telemonitoring system against usual care in women with gestational diabetes mellitus (GDM) or type 2 diabetes mellitus (T2DM) during pregnancy. We hypothesize that the system can improve glycemic control in patients, assessed using the mean blood glucose during gestation as the primary outcome measure.
详细描述
Establishing good glycemic control is crucial for the treatment of patients with gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (DM2). High levels of blood glucose in pregnancy may lead to complications during delivery and pose threat to the fetus. The self-monitoring of blood glucose (SMBG) by patients at home is used to provide clinicians with information to make adjustments to treatment plans. Patients record the values and present them at their next meeting with the physician. As such, SMBG by the patients is an important part of disease management and a method for clinicians to follow a patient's day-to-day response to a treatment regime.
The system is designed to send the blood glucose values from the patients' glucometers wirelessly to the server where they can be viewed by the patients' health care providers. The system generates automated adherence reminders to patients and alert messages to both patients and their care providers. The system will provide clinicians with better access to the patient data, so that they may better manage their case loads, make timely clinical decisions, and ultimately provide better patient care.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients must be pregnant
- •diagnosed with gestational diabetes or Type 2 diabetes
- •must be comfortable with instructions in English and be able to express themselves using simple phrases in English.
排除标准
- •unable to complete self monitoring of blood glucose (SMBG) for any reason
- •uncomfortable with the use of the telemonitoring equipment
- •develop an acute illness requiring hospitalization, where they may deviate from the normal delivery of care
- •refusal to sign consent form or to carry out the demands made by the study
结局指标
主要结局
Mean blood glucose, based on the highest post-prandial blood glucose reading for each day, by trimester
时间窗: from the baseline to the delivery date
An average of 12 weeks.
次要结局
- Mean fasting and post-prandial blood glucose by trimester(from the baseline to the delivery date)
- Percentage of values within recommended guidelines(from the baseline to the delivery date)
- Adherence: Percentage of values recorded over expected number of values(from the baseline to the delivery date)
- Adherence: Average number of values per day(from the baseline to the delivery date)
- Onset of labour and mode of delivery(at exit (delivery))
- Fetal outcomes: gestational age at delivery, birth weight (by gender), percentage of macrosomia, large for gestational age (LGA) and small for gestational age (SGA), APGAR at 1 and 5 minutes(at exit (delivery))
- Perinatal complications (i.e. premature, NICU admission, jaundice, shoulder dystocia, hypoglycemia)(at exit (delivery))
- Provider usage: number of logins onto the system, average amount of time spent on the system per week(for the duration of the study)
研究者
Alexander Gordon Logan
Principal Investigator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital