Healthy Moms, Healthy Babies

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578460
• Other study ID #: R-11-223
• Secondary ID: 17686
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: March 9, 2017
• Start date: May 2012
• Est. completion date: August 29, 2014

Study information

• Verified date: March 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 29, 2014
• Est. primary completion date: August 29, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes
• Type 2 Diabetes Mellitus

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Western University	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Stewart Harris	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.