Recruiting

Diabetes Management

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT01474525

Conditions

Gestational Diabetes Mellitus

Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Home Blood Glucose Telemonitoring System

Study Details

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.

Conditions

Gestational Diabetes Mellitus

Type 2 Diabetes Mellitus

Study ID

NCT01474525

Start date

Jan, 2010

Status verified date

Nov, 2011

Completion date

Mar, 2012

Anticipated

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telemonitoring

active comparator: Usual Care

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Alexander G Logan, MD, FRCP(C)

416-586-5187logan@lunenfeld.ca

Locations

Mount Sinai Hospital, Leadership Sinai Centre for Diabetes

Recruiting

Toronto, Ontario, Canada, M5T 3L9

Contacts

Alexander G Logan, MD, FRCP(C)

416-586-5187logan@lunenfeld.ca

Principal Investigator:

Alexander G Logan, MD, FRCP(C)

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Nov 21, 2011

Last verified

Nov, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2011-11-21.