Healthy Moms, Healthy Babies

Study Overview
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Brief Summary
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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.

Official Title
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Healthy Moms, Healthy Babies: A Strategy to Improve the Care and OUtcome of Diabetes in Pregnancy in On-Reserve First Nations Women

Conditions
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Type 2 Diabetes Mellitus, Gestational Diabetes

Intervention / Treatment
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* Device: Continuous Glucose Monitoring
* Device: Glucose Meter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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. | Device: Glucose Meter<br>* 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.<br>* Other names: Lifescan One Touch Ultra Mini;|
| Experimental: Continuous Glucose Monitor (CGM) Group<br>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. | Device: Continuous Glucose Monitoring<br>* 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.<br>* Other names: iPro2 by Medtronic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal HbA1c | Lab collected at the specific time periods listed above. | 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. | At Delivery. This will occur between May 2012 to September 2014. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At Delivery. This will occur between May 2012 to September 2014. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Gestational Diabetes, Type 2 Diabetes Mellitus, Continuous Glucose Monitor, Glucose