Managing Diabetes During Pregnancy in the Wireless Age

Study Overview
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Brief Summary
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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
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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.

Official Title
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Managing Diabetes During Pregnancy in the Wireless Age: a RCT of Glucose Telemonitoring

Conditions
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Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: Home Blood Glucose Telemonitoring System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring<br> | Device: Home Blood Glucose Telemonitoring System<br>* 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.<br>|
| Active Comparator: Usual Care<br> | Device: Home Blood Glucose Telemonitoring System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean fasting and post-prandial blood glucose by trimester | An average of 12 weeks. | from the baseline to the delivery date | 
| Percentage of values within recommended guidelines | An average of 12 weeks. | from the baseline to the delivery date | 
| Adherence: Percentage of values recorded over expected number of values | An average of 12 weeks. | from the baseline to the delivery date | 
| Adherence: Average number of values per day | An average of 12 weeks. | from the baseline to the delivery date | 
| Onset of labour and mode of delivery | An average of 3 days. | 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. | at exit (delivery) | 
| Perinatal complications (i.e. premature, NICU admission, jaundice, shoulder dystocia, hypoglycemia) | An average of 1 week. | 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. | for the duration of the study |