Managing Diabetes During Pregnancy in the Wireless Age
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 20, 2011
CompletedFirst Posted
Study publicly available on registry
November 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedNovember 21, 2011
November 1, 2011
2.2 years
July 20, 2011
November 17, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Mean fasting and post-prandial blood glucose by trimester
from the baseline to the delivery date
Percentage of values within recommended guidelines
from the baseline to the delivery date
Adherence: Percentage of values recorded over expected number of values
from the baseline to the delivery date
Adherence: Average number of values per day
from the baseline to the delivery date
Onset of labour and mode of delivery
at exit (delivery)
- +3 more secondary outcomes
Study Arms (2)
Telemonitoring
EXPERIMENTALUsual Care
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital, Leadership Sinai Centre for Diabetes
Toronto, Ontario, M5T 3L9, Canada
Related Publications (6)
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.
PMID: 18463375BACKGROUNDCrowther 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.
PMID: 15951574BACKGROUNDFeig 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.
PMID: 12020549BACKGROUNDLanger O. Type 2 diabetes in pregnancy: exposing deceptive appearances. J Matern Fetal Neonatal Med. 2008 Mar;21(3):181-9. doi: 10.1080/14767050801929497.
PMID: 18297573BACKGROUNDKinsley 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.
PMID: 18191067BACKGROUNDYang 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.
PMID: 16946226BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander G Logan, MD, FRCP(C)
MOUNT SINAI HOSPITAL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 20, 2011
First Posted
November 18, 2011
Study Start
January 1, 2010
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
November 21, 2011
Record last verified: 2011-11