Poor glucose control during pregnancy is a significant concern for Canadian women with diabetes. This problem is magnified in First Nations women, who have among the highest rates of gestational diabetes (GDM) in the world (up to 18% of First Nations women will develop GDM during pregnancy and 70% of these will go on to develop type 2 diabetes later). Continuous glucose monitoring (CGM) technology has the potential to help women maintain tighter control during pregnancy, however, in the First Nations population, there are many unique barriers that may affect use of this technology. Such barriers include remoteness of the community, cultural apprehension, lack or difficulty of access to care, and language differences. A total of 60 participants from three participating First Nations communities in Southern Ontario will participate in the study. Participants will self-select to either the CGM group (n=30) or the control group (n=30) after consenting to participate in the study. Participants in both groups will be asked to monitor their blood glucose for 5 days for the 28th, 32nd and 36th week of gestation. Primary outcomes to be evaluated include maternal A1c and offspring birth weight. To assess the feasibility and acceptability of CGMs among First Nations women, a questionnaire will be distributed to participants to gather insight into their rationale for enrolling into either group. Recruitment rates for both groups will also be used to assess feasibility and acceptability of CGMs. Additionally, all participants will be encouraged to participate in a community lifestyle program consisting of 30-min exercise sessions offered five days a week. The community lifestyle program will be adapted to the community, linked to existing programs with support from program personnel and will include educational sessions related to diabetes and healthy lifestyles. It is hypothesized that through participation in the community lifestyle program, pregnant First Nations women with diabetes will experience a decrease in their blood glucose values post-exercise, mitigate excessive weight gain and normalize their A1c's. It is further hypothesized that an increase in women's regular physical activity levels, the number of steps taken and knowledge of diabetes will be observed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
18
Participants in the CGM group will be asked to monitor their blood glucose for 5 days for the 28th, 32nd and 36th week of gestation using the iPro2 CGM.
Participants in the control group will be asked to monitor their blood glucose for 5 days for the 28th, 32nd and 36th week of gestation using a glucose meter.
Western University
London, Ontario, Canada
Maternal HbA1c
Lab collected at the specific time periods listed above.
Time frame: 24, 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014
Offspring Birth Weight
Offspring birth weight will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
1 hour post-prandial glucose measurements (maternal)
This will be collected from the CGM or glucose meter, depending on the group the participant consents to take part in.
Time frame: 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014.
Weight gain (maternal)
Baseline weight is collected from Antenatal Record 1 and 2 (Ontario Ministry of Health and Long-Term Care forms). Follow-up weight measurements are done at each visit until delivery. Weight gain is calculated from the baseline and follow-up measurements.
Time frame: Weight is recorded at each visit from May 2012 to September 2014.
Maternal diabetes treatment
Baseline treatment will be collected from Antenatal Record 1 and 2 (Ontario Ministry of Health and Long-Term Care forms) if available.
Time frame: 28, 32, and 36 weeks of gestation. This will occur between May 2012 to September 2014.
Daily mean glucose values (maternal)
This will be calculated from the glucose measurements taken using either the CGM or the glucose meter.
Time frame: 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014.
Insulin Use (maternal)
Baseline insulin use will be collected from Antenatal Record 1 and 2 (Ontario Ministry of Health and Long-Term Care forms) if available.
Time frame: 24, 28, 32, and 36 weeks of gestation. This will occur between May 2012 to September 2014.
Neonatal gestational age
Neonatal gestational age will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
Neonatal hypoglycemia
Neonatal hypoglycemia will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2013.
Neonatal Intensive Care Unit (NICU) Admission
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
Number of days in the hospital (neonatal)
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
Birth injuries (neonatal)
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
Jaundice (neonatal)
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
Delivery in a community or teaching hospital
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
Caesarean section rate (maternal)
This will be collected from the Neonatal Examination Form/Birth Record and Maternal Discharge Summary.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
Delivery Methods
Forceps, vacuum-assisted. This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
Cephalopelvic disproportion
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
Number of days in hospital post delivery (maternal)
This will be collected from the Maternal Discharge Summary.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
Shoulder Dystocia (neonatal)
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time frame: At Delivery. This will occur between May 2012 to September 2014.
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