Type 2 Diabetes Mellitus Clinical Trial
Official title:
Healthy Moms, Healthy Babies: A Strategy to Improve the Care and OUtcome of Diabetes in Pregnancy in On-Reserve First Nations Women
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.
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