Managing Diabetes During Pregnancy in the Wireless Age

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Samuel Lunenfeld Research Institute, Mount Sinai Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Alexander Gordon Logan, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01474525
First received: July 20, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Gestational Diabetes Mellitus
Type 2 Diabetes Mellitus
Device: Home Blood Glucose Telemonitoring System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Managing Diabetes During Pregnancy in the Wireless Age: a RCT of Glucose Telemonitoring

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    An average of 12 weeks.


Secondary Outcome Measures:
  • Mean fasting and post-prandial blood glucose by trimester [ Time Frame: from the baseline to the delivery date ] [ Designated as safety issue: Yes ]
    An average of 12 weeks.

  • Percentage of values within recommended guidelines [ Time Frame: from the baseline to the delivery date ] [ Designated as safety issue: Yes ]
    An average of 12 weeks.

  • Adherence: Percentage of values recorded over expected number of values [ Time Frame: from the baseline to the delivery date ] [ Designated as safety issue: Yes ]
    An average of 12 weeks.

  • Adherence: Average number of values per day [ Time Frame: from the baseline to the delivery date ] [ Designated as safety issue: Yes ]
    An average of 12 weeks.

  • Onset of labour and mode of delivery [ Time Frame: at exit (delivery) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at exit (delivery) ] [ Designated as safety issue: Yes ]
    An average of 1 day.

  • Perinatal complications (i.e. premature, NICU admission, jaundice, shoulder dystocia, hypoglycemia) [ Time Frame: at exit (delivery) ] [ Designated as safety issue: Yes ]
    An average of 1 week.

  • Provider usage: number of logins onto the system, average amount of time spent on the system per week [ Time Frame: for the duration of the study ] [ Designated as safety issue: No ]
    An average of 12 weeks.


Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemonitoring 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.

Active Comparator: Usual Care 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474525

Contacts
Contact: Alexander G Logan, MD, FRCP(C) 416-586-5187 logan@lunenfeld.ca

Locations
Canada, Ontario
Mount Sinai Hospital, Leadership Sinai Centre for Diabetes Recruiting
Toronto, Ontario, Canada, M5T 3L9
Contact: Alexander G Logan, MD, FRCP(C)    416-586-5187    logan@lunenfeld.ca   
Principal Investigator: Alexander G Logan, MD, FRCP(C)         
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Alexander G Logan, MD, FRCP(C) Mount Sinai Hospital, New York
  More Information

Publications:
Responsible Party: Alexander Gordon Logan, Principal Investigator, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01474525     History of Changes
Other Study ID Numbers: AFP6075
Study First Received: July 20, 2011
Last Updated: November 17, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on April 17, 2014