Managing Diabetes During Pregnancy in the Wireless Age

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Unknown

Conditions

Gestational Diabetes Mellitus

Type 2 Diabetes Mellitus

Treatments

Device: Home Blood Glucose Telemonitoring System

Study type

Interventional

Funder types

Other

Identifiers

NCT01474525

AFP6075

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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