Impact of blood sugar fluctuations on brain function and eating habits in people with Type 1 Diabetes
Impact of Glycemic Variability on Cognitive Impairment, Disordered Eating Behavior, and Self-management Skills in Patients Living with Type 1 Diabetes
Laval University · NCT05487534
This study looks at how changes in blood sugar levels affect thinking and eating habits in people with Type 1 Diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Laval University (other) |
| Locations | 2 sites (Montreal and 1 other locations) |
| Trial ID | NCT05487534 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how variations in blood glucose levels affect cognitive function and eating behaviors in individuals with Type 1 Diabetes. Participants will wear a continuous glucose sensor for 10 days while maintaining a food diary and completing online questionnaires and tests. The study aims to explore the relationship between glycemic variability, disordered eating behaviors, and cognitive impairment, particularly in the context of self-management skills. Additionally, a qualitative phase will involve in-depth interviews to gather more insights into participants' experiences.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with Type 1 Diabetes for more than 12 months and an A1C level between 6.5% and 9%.
Not a fit: Patients with Type 2 Diabetes, recent major cardiovascular events, or severe mental health disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for Type 1 Diabetes by addressing the cognitive and behavioral aspects of the condition.
How similar studies have performed: While the specific focus on glycemic variability's impact on cognitive function and eating behaviors is novel, related studies have shown success in understanding the broader implications of blood glucose management in diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 diabetes (\> 12 months) * Age between 18 and 65 years old * 6.5 % \< A1C \< 9% (to avoid potential severe eating disorder) Exclusion Criteria: * Type 2 diabetes or other form of diabetes; gastroparesis (clinical diagnosis); * Recent (\< 6 months) major cardiovascular event (e.g. myocardial infarction, cerebrovascular accident, major revascularization) * Recent (\< 12 weeks) severe hypoglycemia episodes (\<2.8 mmol/L or assistance from a third party) * Recent (\< 12 weeks) changes in insulin type or delivery method * Automated Insulin Delivery * History of severe brain trauma, epilepsy, schizophrenia or bipolar disorders * Inability to use a computer * Incorrect vision or auditory problems
Where this trial is running
Montreal and 1 other locations
- IRCM — Montreal, Canada (RECRUITING)
- CHU de Québec — Québec, Canada (RECRUITING)
Study contacts
- Principal investigator: Sylvain Iceta, MD, PhD — Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study coordinator: Sylvain Iceta, MD, PhD
- Email: equipe.iceta@criucpq.ulaval.ca
- Phone: +1 (418) 656-8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Diabetes, Cognition, Eating behaviors, Glycemic variation, Blood glucose