Managing Diabetes During Pregnancy in the Wireless Age

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01474525
• Other study ID #: AFP6075
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2011
• Last updated: November 17, 2011
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2011
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: Alexander G Logan, MD, FRCP(C)
• Phone: 416-586-5187
• Email: logan[@]lunenfeld.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital, Leadership Sinai Centre for Diabetes	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. Epub 2005 Jun 12. — View Citation

Feig DS, Palda VA. Type 2 diabetes in pregnancy: a growing concern. Lancet. 2002 May 11;359(9318):1690-2. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Mean fasting and post-prandial blood glucose by trimester	An average of 12 weeks.	from the baseline to the delivery date	Yes
Secondary	Percentage of values within recommended guidelines	An average of 12 weeks.	from the baseline to the delivery date	Yes
Secondary	Adherence: Percentage of values recorded over expected number of values	An average of 12 weeks.	from the baseline to the delivery date	Yes
Secondary	Adherence: Average number of values per day	An average of 12 weeks.	from the baseline to the delivery date	Yes
Secondary	Onset of labour and mode of delivery	An average of 3 days.	at exit (delivery)	Yes
Secondary	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)	Yes
Secondary	Perinatal complications (i.e. premature, NICU admission, jaundice, shoulder dystocia, hypoglycemia)	An average of 1 week.	at exit (delivery)	Yes
Secondary	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	No