Managing Diabetes During Pregnancy in the Wireless Age

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus; Gestational Diabetes Mellitus
• Intervention / Treatment: Device: Home Blood Glucose Telemonitoring System

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander G Logan, MD, FRCP(C); Phone Number: 416-586-5187; Email: logan@lunenfeld.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 3L9
      • Recruiting
      • Mount Sinai Hospital, Leadership Sinai Centre for Diabetes
      • Contact: Alexander G Logan, MD, FRCP(C); Phone Number: 416-586-5187; Email: logan@lunenfeld.ca
      • Principal Investigator: Alexander G Logan, MD, FRCP(C)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Collaborators: Ontario Ministry of Health and Long Term Care
• Investigators: Principal Investigator: Alexander G Logan, MD, FRCP(C), Mount Sinai Hospital

Publications and helpful links

General Publications

• Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
• Langer O. Type 2 diabetes in pregnancy: exposing deceptive appearances. J Matern Fetal Neonatal Med. 2008 Mar;21(3):181-9. doi: 10.1080/14767050801929497.
• HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
• Feig DS, Palda VA. Type 2 diabetes in pregnancy: a growing concern. Lancet. 2002 May 11;359(9318):1690-2. doi: 10.1016/S0140-6736(02)08599-9. No abstract available.
• Kinsley B. Achieving better outcomes in pregnancies complicated by type 1 and type 2 diabetes mellitus. Clin Ther. 2007;29 Suppl D:S153-60. doi: 10.1016/j.clinthera.2007.12.015.
• Yang J, Cummings EA, O'connell C, Jangaard K. Fetal and neonatal outcomes of diabetic pregnancies. Obstet Gynecol. 2006 Sep;108(3 Pt 1):644-50. doi: 10.1097/01.AOG.0000231688.08263.47.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 18, 2011

Study Record Updates

• Last Update Posted (Estimate): November 21, 2011
• Last Update Submitted That Met QC Criteria: November 17, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes, Gestational
• Other Study ID Numbers: AFP6075