Enhanced Care Models for Childhood-onset Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
The overall objective: to co-design and implement targeted and timely community led strategies to improve the health of the Next Generation and end the intergenerational impact of T2D in this population.
Who Is on the Research Team?
Brandy A Wicklow, MD, MSc
Principal Investigator
University of Manitoba, Children's Hospital Research Institute of Manitoba
Are You a Good Fit for This Trial?
This trial is for First Nations children and families at risk of developing type 2 diabetes, including those with a history of gestational diabetes. It focuses on communities wanting to improve health outcomes for their next generation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Perinatal Support Program
Co-development and implementation of a community-based perinatal education and support program using navigators to support maternal and early childhood nutrition and activity, including breastfeeding supports aimed at diabetes prevention.
Early Childhood Screening
Community-based early childhood screening for evidence of dysglycemia using point of care HbA1c testing and CGM to detect early dysglycemia.
Land-based Program
Co-development and implementation of a community-led land-based program for children ages 4-5 years and their caregivers to encourage and educate about the benefits of traditional nutrition and activities to maintain wellness.
Follow-up
Participants are monitored for safety and effectiveness after intervention programs.
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests community-led programs like breastfeeding and perinatal education, providing blood sugar testing machines, continuous glucose monitoring, and wellness activities based on traditional land practices.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Community based point of care HbA1c testing will improve access to annual screening for pre-diabetes and diabetes in the Next Gen Cohort. CGM can detect early dysglycemia (below the threshold for the diagnosis of prediabetes) in young children at high risk for childhood-onset T2D. In addition, we hypothesize that CGM use will be well tolerated and feasible in young children.
Land-based community programming for caregivers and children aged 4-5 years is feasible and will encourage healthy nutrition choices and physical activity. Ultimately, we hypothesize that this will improve the health and well-being of this high-risk population and improve cardiometabolic health.
The implementation of a community-based navigator to facilitate multiple points of pre and post-partum contact as well as individualized connection to preexisting and co-developed urban and northern pre- and post-natal supports, will increase rates of initiation and duration (≥6 month) of breastfeeding in the NextGen mothers from 58% to ≥75%.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor
Children's Hospital Research Institute of Manitoba
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.