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| ID | Type | Description | Link |
|---|---|---|---|
| 17686 | Other Identifier | Research Ethics Board |
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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | 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. |
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| Continuous Glucose Monitor (CGM) Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | 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. |
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stewart Harris, MD | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western University | London | Ontario | N6G 4X8 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Glucose Meter | 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. |
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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. |
| D004700 | Endocrine System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |