Type 2 Diabetes Mellitus Clinical Trial
Official title:
Managing Diabetes During Pregnancy in the Wireless Age: a RCT of Glucose Telemonitoring
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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