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Managing Diabetes During Pregnancy in the Wireless Age

NCT01474525 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-11-21

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Home Blood Glucose Telemonitoring System

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.

Sponsors & Collaborators

  • Ontario Ministry of Health and Long Term Care

    collaborator OTHER_GOV

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Alexander G Logan, MD, FRCP(C) · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01474525 on ClinicalTrials.gov