Healthy Moms, Healthy Babies (HMHB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Lawson Health Research Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Dr. Stewart Harris, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01578460
First received: April 5, 2012
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Gestational Diabetes
Device: Continuous Glucose Monitoring
Device: Glucose Meter

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Healthy Moms, Healthy Babies: A Strategy to Improve the Care and OUtcome of Diabetes in Pregnancy in On-Reserve First Nations Women

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Maternal HbA1c [ Time Frame: 24, 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    Lab collected at the specific time periods listed above.

  • Offspring Birth Weight [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    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) [ Time Frame: 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    This will be collected from the CGM or glucose meter, depending on the group the participant consents to take part in.

  • Weight gain (maternal) [ Time Frame: Weight is recorded at each visit from May 2012 to September 2013. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28, 32, and 36 weeks of gestation. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    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) [ Time Frame: 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    This will be calculated from the glucose measurements taken using either the CGM or the glucose meter.

  • Insulin Use (maternal) [ Time Frame: 24, 28, 32, and 36 weeks of gestation. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    Neonatal gestational age will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

  • Neonatal hypoglycemia [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    Neonatal hypoglycemia will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

  • NICU Admission [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

  • Number of days in the hospital (neonatal) [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

  • Birth injuries (neonatal) [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

  • Jaundice (neonatal) [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

  • Delivery in a community or teaching hospital [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

  • Caesarean section rate (maternal) [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    This will be collected from the Neonatal Examination Form/Birth Record and Maternal Discharge Summary.

  • Delivery Methods [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    Forceps, vacumm-assisted. This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

  • Cephalopelvic disproportion [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    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) [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    This will be collected from the Maternal Discharge Summary.

  • Shoulder Dystocia (neonatal) [ Time Frame: At Delivery. This will occur between May 2012 to September 2013. ] [ Designated as safety issue: No ]
    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Other Name: Lifescan One Touch Ultra Mini
Experimental: 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.
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.
Other Name: iPro2 by Medtronic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 or type 2 diabetes
  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578460

Contacts
Contact: Mariam Naqshbandi Hayward, MSc 519-661-2111 ext 22115 mnaqshb2@uwo.ca
Contact: Stewart Harris, MD 519-661-2111 ext 22057 sharris1@uwo.ca

Locations
Canada, Ontario
Western University
London, Ontario, Canada, N6G 4X8
Sponsors and Collaborators
Dr. Stewart Harris
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Stewart Harris, MD Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Dr. Stewart Harris, Professor, CDA Chair in Diabetes Management, Ian McWhinney Chair of Family Medicine Studies, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01578460     History of Changes
Other Study ID Numbers: R-11-223, 17686
Study First Received: April 5, 2012
Last Updated: April 13, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Pregnancy
Gestational Diabetes
Type 2 Diabetes Mellitus
Continuous Glucose Monitor
Glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on October 29, 2014