Managing Diabetes During Pregnancy in the Wireless Age

Not Applicable

• Conditions: Gestational Diabetes Mellitus; Type 2 Diabetes Mellitus
• Interventions: Device: Home Blood Glucose Telemonitoring System

• Registration Number: NCT01474525
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-07-20
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-15
• Last Update Submitted: 2011-11-17
• Study First Posted: 2011-11-18
• Last Update Posted: 2011-11-21
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring	Home Blood Glucose Telemonitoring System	-
Usual Care	Home Blood Glucose Telemonitoring System	-

Primary Outcome Measures

Name	Time	Method
Mean blood glucose, based on the highest post-prandial blood glucose reading for each day, by trimester	from the baseline to the delivery date	An average of 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Mean fasting and post-prandial blood glucose by trimester	from the baseline to the delivery date	An average of 12 weeks.
Percentage of values within recommended guidelines	from the baseline to the delivery date	An average of 12 weeks.
Adherence: Percentage of values recorded over expected number of values	from the baseline to the delivery date	An average of 12 weeks.
Adherence: Average number of values per day	from the baseline to the delivery date	An average of 12 weeks.
Onset of labour and mode of delivery	at exit (delivery)	An average of 3 days.
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)	An average of 1 day.
Perinatal complications (i.e. premature, NICU admission, jaundice, shoulder dystocia, hypoglycemia)	at exit (delivery)	An average of 1 week.
Provider usage: number of logins onto the system, average amount of time spent on the system per week	for the duration of the study	An average of 12 weeks.

Trial Locations

Locations (1)

Mount Sinai Hospital, Leadership Sinai Centre for Diabetes; 🇨🇦 Toronto, Ontario, Canada