Clinical trial NCT01578460: Healthy Moms, Healthy Babies
Official title: Healthy Moms, Healthy Babies: A Strategy to Improve the Care and OUtcome of Diabetes in Pregnancy in On-Reserve First Nations Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Gestational Diabetes
Keywords: Pregnancy
Gestational Diabetes
Type 2 Diabetes Mellitus
Continuous Glucose Monitor
Glucose
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2012-04-17
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* First Nations (self-identified)
* On-reserve (living or receiving care)
* Informed consent to participate
* Adults aged 18 years or older
* Diagnosed with gestational diabetes (GDM) or type 2 diabetes (T2DM)
* Pregnant (less than or equal to 36 weeks o gestation)
* Consent to have primary care giver informed of participation in teh project
* Willingness to perform required study and data collectin procedures and adhere to the operating requirements of the iPro2 and/or the glucose meter
* Willingness to wear the iPro 2 continuous glucose monitor (CGM) for 5 days for the 28th, 32nd, 36th week of pregnancy (for participants in the CGM group)
* Willingness to perform at least 4 finger prick testing per day during the Monitoring Week of the 28th, 32nd, 36th week of pregnancy (for CGM and control group)

Exclusion Criteria:

* Lack of decision making capacity to provide consent
* Participating in another diabetes and/or lifestyle improvement research project
* Non-First Nations descent
* Pregnant diagnosed with type 1 diabetes
* Pregnant not diagnosed with GDM or T2DM
* Pregnant women past 36th week of gestation
* Participants who do not consent to have their primary care giver informed of project participation
* The participant has a history of tape allergies that have not been resolved
* The participant has any skin abnormality (e.g. Psoriasis, rash, staphylococcus infection) that has not been resolved and would inhibit her from wearing the sensor
* Any other condition (s) that in the Investigator's opinion would warrant exclusion from the study or prevent the participant from completing the project

Primary outcomes:
measure: Maternal HbA1c
timeFrame: 24, 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014
measure: Offspring Birth Weight
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
Secondary outcomes:
measure: 1 hour post-prandial glucose measurements (maternal)
timeFrame: 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014.
measure: Weight gain (maternal)
timeFrame: Weight is recorded at each visit from May 2012 to September 2014.
measure: Maternal diabetes treatment
timeFrame: 28, 32, and 36 weeks of gestation. This will occur between May 2012 to September 2014.
measure: Daily mean glucose values (maternal)
timeFrame: 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014.
measure: Insulin Use (maternal)
timeFrame: 24, 28, 32, and 36 weeks of gestation. This will occur between May 2012 to September 2014.
measure: Neonatal gestational age
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
measure: Neonatal hypoglycemia
timeFrame: At Delivery. This will occur between May 2012 to September 2013.
measure: Neonatal Intensive Care Unit (NICU) Admission
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
measure: Number of days in the hospital (neonatal)
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
measure: Birth injuries (neonatal)
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
measure: Jaundice (neonatal)
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
measure: Delivery in a community or teaching hospital
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
measure: Caesarean section rate (maternal)
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
measure: Delivery Methods
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
measure: Cephalopelvic disproportion
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
measure: Number of days in hospital post delivery (maternal)
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
measure: Shoulder Dystocia (neonatal)
timeFrame: At Delivery. This will occur between May 2012 to September 2014.
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Stewart Harris, MD
role: PRINCIPAL_INVESTIGATOR
References: