Healthy Moms, Healthy Babies

NCT ID: NCT01578460

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-08-29

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.

Conditions

Type 2 Diabetes Mellitus; Gestational Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control Group

Participants will self-select which group they wish to participate in at time of consent. The control group will use standard glucose meter testing to monitor their glucose levels.

Group Type: ACTIVE_COMPARATOR

Glucose Meter

Intervention Type: DEVICE

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.

Continuous Glucose Monitor (CGM) Group

Participants will self-select which group they wish to participate in at time of consent. The CGM group will utilize the iPro2 CGM to monitor their glucose levels during their 28, 32, and 36 week of gestation.

Group Type: EXPERIMENTAL

Continuous Glucose Monitoring

Intervention Type: DEVICE

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.

Interventions

Continuous Glucose Monitoring

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.

Intervention Type: DEVICE

Glucose Meter

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.

Intervention Type: DEVICE

Other Intervention Names

iPro2 by Medtronic; Lifescan One Touch Ultra Mini

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Stewart Harris

OTHER

Sponsor Role: lead

Responsible Party

Stewart Harris

Professor, CDA Chair in Diabetes Management, Ian McWhinney Chair of Family Medicine Studies

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stewart Harris, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

Western University

London, Ontario, Canada

Countries

Canada

Other Identifiers

17686

Identifier Type: OTHER

Identifier Source: secondary_id

R-11-223

Identifier Type: -

Identifier Source: org_study_id