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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The system is designed to send the measured blood glucose values directly to a hospital server. Values recorded by the glucometer are sent to the Blackberry® cell phone. A special removable Bluetooth® adapter unit is required for data transmission from the glucometer to the Blackberry®. The patient must then select on the Blackberry® the meal period the last measurement corresponds. The cellular phone serves as the platform for data-transmission to the central server. The threshold number of readings can be set for each patient individually through the web-interface. The system can be accessed by both the patients and the care providers through a secure web-interface. Apart from collecting values the system generates automated adherence reminders to patients and high/low blood glucose alert messages to both patients and their care providers.
Mount Sinai Hospital, Leadership Sinai Centre for Diabetes
Toronto, Ontario, Canada
RECRUITINGMean blood glucose, based on the highest post-prandial blood glucose reading for each day, by trimester
An average of 12 weeks.
Time frame: from the baseline to the delivery date
Mean fasting and post-prandial blood glucose by trimester
An average of 12 weeks.
Time frame: from the baseline to the delivery date
Percentage of values within recommended guidelines
An average of 12 weeks.
Time frame: from the baseline to the delivery date
Adherence: Percentage of values recorded over expected number of values
An average of 12 weeks.
Time frame: from the baseline to the delivery date
Adherence: Average number of values per day
An average of 12 weeks.
Time frame: from the baseline to the delivery date
Onset of labour and mode of delivery
An average of 3 days.
Time frame: 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
An average of 1 day.
Time frame: at exit (delivery)
Perinatal complications (i.e. premature, NICU admission, jaundice, shoulder dystocia, hypoglycemia)
An average of 1 week.
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Time frame: at exit (delivery)
Provider usage: number of logins onto the system, average amount of time spent on the system per week
An average of 12 weeks.
Time frame: for the duration of the study