Managing Diabetes During Pregnancy in the Wireless Age: a RCT of Glucose Telemonitoring
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes Mellitus
- Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Mean blood glucose, based on the highest post-prandial blood glucose reading for each day, by trimester
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Alexander Gordon Logan
Principal Investigator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mean blood glucose, based on the highest post-prandial blood glucose reading for each day, by trimester
Time Frame: from the baseline to the delivery date
An average of 12 weeks.
Secondary Outcomes
- 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)