Healthy Moms, Healthy Babies (HMHB)
Primary Purpose
Type 2 Diabetes Mellitus, Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Continuous Glucose Monitoring
Glucose Meter
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes Mellitus focused on measuring Pregnancy, Gestational Diabetes, Type 2 Diabetes Mellitus, Continuous Glucose Monitor, Glucose
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
Sites / Locations
- Western University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Continuous Glucose Monitor (CGM) Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Maternal HbA1c
Lab collected at the specific time periods listed above.
Offspring Birth Weight
Offspring birth weight will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Secondary Outcome Measures
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.
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.
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.
Daily mean glucose values (maternal)
This will be calculated from the glucose measurements taken using either the CGM or the glucose meter.
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.
Neonatal gestational age
Neonatal gestational age will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Neonatal hypoglycemia
Neonatal hypoglycemia will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Neonatal Intensive Care Unit (NICU) Admission
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Number of days in the hospital (neonatal)
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Birth injuries (neonatal)
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Jaundice (neonatal)
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Delivery in a community or teaching hospital
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Caesarean section rate (maternal)
This will be collected from the Neonatal Examination Form/Birth Record and Maternal Discharge Summary.
Delivery Methods
Forceps, vacuum-assisted. This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Cephalopelvic disproportion
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Number of days in hospital post delivery (maternal)
This will be collected from the Maternal Discharge Summary.
Shoulder Dystocia (neonatal)
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Full Information
NCT ID
NCT01578460
First Posted
April 5, 2012
Last Updated
March 9, 2017
Sponsor
Stewart Harris
Collaborators
Juvenile Diabetes Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01578460
Brief Title
Healthy Moms, Healthy Babies
Acronym
HMHB
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
August 29, 2014 (Actual)
Study Completion Date
August 29, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stewart Harris
Collaborators
Juvenile Diabetes Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Gestational Diabetes
Keywords
Pregnancy, Gestational Diabetes, Type 2 Diabetes Mellitus, Continuous Glucose Monitor, Glucose
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Continuous Glucose Monitor (CGM) Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring
Other Intervention Name(s)
iPro2 by Medtronic
Intervention Description
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
Intervention Name(s)
Glucose Meter
Other Intervention Name(s)
Lifescan One Touch Ultra Mini
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal HbA1c
Description
Lab collected at the specific time periods listed above.
Time Frame
24, 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014
Title
Offspring Birth Weight
Description
Offspring birth weight will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Secondary Outcome Measure Information:
Title
1 hour post-prandial glucose measurements (maternal)
Description
This will be collected from the CGM or glucose meter, depending on the group the participant consents to take part in.
Time Frame
28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014.
Title
Weight gain (maternal)
Description
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.
Time Frame
Weight is recorded at each visit from May 2012 to September 2014.
Title
Maternal diabetes treatment
Description
Baseline treatment will be collected from Antenatal Record 1 and 2 (Ontario Ministry of Health and Long-Term Care forms) if available.
Time Frame
28, 32, and 36 weeks of gestation. This will occur between May 2012 to September 2014.
Title
Daily mean glucose values (maternal)
Description
This will be calculated from the glucose measurements taken using either the CGM or the glucose meter.
Time Frame
28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014.
Title
Insulin Use (maternal)
Description
Baseline insulin use will be collected from Antenatal Record 1 and 2 (Ontario Ministry of Health and Long-Term Care forms) if available.
Time Frame
24, 28, 32, and 36 weeks of gestation. This will occur between May 2012 to September 2014.
Title
Neonatal gestational age
Description
Neonatal gestational age will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Title
Neonatal hypoglycemia
Description
Neonatal hypoglycemia will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2013.
Title
Neonatal Intensive Care Unit (NICU) Admission
Description
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Title
Number of days in the hospital (neonatal)
Description
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Title
Birth injuries (neonatal)
Description
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Title
Jaundice (neonatal)
Description
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Title
Delivery in a community or teaching hospital
Description
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Title
Caesarean section rate (maternal)
Description
This will be collected from the Neonatal Examination Form/Birth Record and Maternal Discharge Summary.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Title
Delivery Methods
Description
Forceps, vacuum-assisted. This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Title
Cephalopelvic disproportion
Description
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Title
Number of days in hospital post delivery (maternal)
Description
This will be collected from the Maternal Discharge Summary.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
Title
Shoulder Dystocia (neonatal)
Description
This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.
Time Frame
At Delivery. This will occur between May 2012 to September 2014.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stewart Harris, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 4X8
Country
Canada
12. IPD Sharing Statement
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Healthy Moms, Healthy Babies
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