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Type 2 Diabetes MellitusHMHBNCT01578460

Healthy Moms, Healthy Babies

A study testing Continuous Glucose Monitoring and Glucose Meter in people with Type 2 Diabetes Mellitus and Gestational Diabetes, run by Stewart Harris at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Continuous Glucose Monitoring and Glucose Meter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteCanada
Study dates
May 2012to 29 Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Western University

    London, Ontario, N6G 4X8

Other trials in Canada

About this study

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

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.

Being tested
Continuous Glucose Monitoring, Glucose Meter
Keywords
Pregnancy, Gestational Diabetes, Type 2 Diabetes Mellitus, Continuous Glucose Monitor, Glucose
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Glucose MonitoringDevice

    Also called iPro2 by Medtronic

    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 MeterDevice

    Also called Lifescan One Touch Ultra Mini

    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.

Study groups in NCT01578460
Study groupRoleWhat they receive
Control GroupActive comparatorParticipants 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.
Receives: Device: Glucose Meter
Continuous Glucose Monitor (CGM) GroupExperimentalParticipants 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.
Receives: Device: Continuous Glucose Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal HbA1c

    Lab collected at the specific time periods listed above.

    Measured: 24, 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014

  2. Offspring Birth Weight

    Offspring birth weight will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

Secondary outcomes (17)

  1. 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.

    Measured: 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014.

  2. 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.

    Measured: Weight is recorded at each visit from May 2012 to September 2014.

  3. 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.

    Measured: 28, 32, and 36 weeks of gestation. This will occur between May 2012 to September 2014.

  4. Daily mean glucose values (maternal)

    This will be calculated from the glucose measurements taken using either the CGM or the glucose meter.

    Measured: 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014.

  5. 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.

    Measured: 24, 28, 32, and 36 weeks of gestation. This will occur between May 2012 to September 2014.

  6. Neonatal gestational age

    Neonatal gestational age will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

  7. Neonatal hypoglycemia

    Neonatal hypoglycemia will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2013.

  8. Neonatal Intensive Care Unit (NICU) Admission

    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

  9. Number of days in the hospital (neonatal)

    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

  10. Birth injuries (neonatal)

    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

  11. Jaundice (neonatal)

    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

  12. Delivery in a community or teaching hospital

    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

  13. Caesarean section rate (maternal)

    This will be collected from the Neonatal Examination Form/Birth Record and Maternal Discharge Summary.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

  14. Delivery Methods

    Forceps, vacuum-assisted. This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

  15. Cephalopelvic disproportion

    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

  16. Number of days in hospital post delivery (maternal)

    This will be collected from the Maternal Discharge Summary.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

  17. Shoulder Dystocia (neonatal)

    This will be collected from the Neonatal Examination Form/Birth Record and Maternal and Offspring Discharge Summaries.

    Measured: At Delivery. This will occur between May 2012 to September 2014.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completion29 Aug 2014
  4. Study completion29 Aug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01578460
Sponsor's protocol ID
R-11-223
Other IDs
17686
Acronym
HMHB
Status last verified
Mar 2017
First submitted
5 Apr 2012
Last updated
13 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Glucose Monitoring and Glucose Meter in people with Type 2 Diabetes Mellitus and Gestational Diabetes, run by Stewart Harris at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal HbA1c (time frame: 24, 28, 32 and 36th week of gestation. This will occur between May 2012 to September 2014). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01578460.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.

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