Real-time assessment of psychological factors in young people with Type 1 diabetes
Ecological Momentary Assessment Study of Adolescents and Young Adults With Type 1 Diabetes (EMA-T1D)
This study is trying to see how feelings like stress and anxiety affect the way young people with Type 1 diabetes manage their condition and their blood sugar levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 13 Years to 26 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06129994 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll up to 150 adolescents and young adults aged 13-26 with Type 1 diabetes to explore the real-time relationships between psychological factors such as distress, anxiety, and depression and their impact on self-efficacy, self-management behaviors, and glycemic outcomes. Participants will use ecological momentary assessment (EMA) methods, which involve carrying a mobile phone for daily monitoring and wearing a continuous glucose monitor (CGM) during the study. The goal is to gather data that can inform better management strategies for diabetes in this age group.
Who should consider this trial
Good fit: Ideal candidates are adolescents and young adults aged 13-26 who have been diagnosed with Type 1 diabetes for at least six months.
Not a fit: Patients with social or medical conditions that hinder participation or those with skin conditions affecting CGM sensor placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved psychological support and management strategies for young individuals with Type 1 diabetes.
How similar studies have performed: While the use of ecological momentary assessment in diabetes management is gaining traction, this specific approach focusing on psychological factors in adolescents and young adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of type 1 diabetes for at least six months * Fluent in spoken and written English * Willing to carry around their mobile phone during the home monitoring period with daily access to cellular or WiFi connectivity * Willing to wear a continuous glucose monitor (CGM) device during the home monitoring period Exclusion Criteria: * Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation * Skin conditions or diseases that would interfere with the CGM sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.) * Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor or insulin pump removal) that cannot be scheduled around or accommodated within the study assessment windows * Currently pregnant or plan to become pregnant during participation in the study
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Iyengar, MD — University of Michigan
- Study coordinator: Emily Dhadphale
- Email: ehirschf@med.umich.edu
- Phone: 734-936-6042
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.