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Behavioral Intervention
Electronically Connected Health Coaching in Type 2 Diabetes
Phase 3
Waitlist Available
Led By Paul Ritvo, PhD
Research Sponsored by York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months follow up from baseline
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).
Eligible Conditions
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months follow up from baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months follow up from baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hemoglobin A1c
Secondary study objectives
Center for Epidemiological Studies Depression Scale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle counseling with smartphonesExperimental Treatment1 Intervention
Lifestyle counseling assisted by smartphones
Group II: Lifestyle counselingActive Control1 Intervention
Lifestyle counseling
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Who is running the clinical trial?
Public Health Agency of Canada (PHAC)OTHER_GOV
49 Previous Clinical Trials
99,232 Total Patients Enrolled
York UniversityLead Sponsor
63 Previous Clinical Trials
521,276 Total Patients Enrolled
Paul Ritvo, PhDPrincipal InvestigatorYork University
2 Previous Clinical Trials
96 Total Patients Enrolled