A Study to Assess Glycemic Variability and Fluctuations in Cognitive Status in Adults with Type 1 Diabetes
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-008080
About this study
The objective for thisstudy is to characterize the impact of glycemic excursions on cognition in Type 1 Diabetes (T1D) and determine mediators and moderators of this relationship. This study will allow us to determine how glycemic excursions impact cognition, as well as to identify mediators and moderators of this relationship that could lead to novel interventions.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Aged ≥ 18 years of age.
- Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the site investigator.
- Disease duration of > 1 year.
- Fluent in English (capable of consenting to the study and following task instructions in English).
- Participant understands the ecological momentary assessment and agrees to comply with it to the best of their ability.
- Has 24-hour access to a smart phone with reliable internet access.
Exclusion Criteria:
- Individuals < 18 years of age.
- Unable to complete cognitive assessments due to significant visual, motor or hearing impairment.
- Any medical or psychiatric condition or treatment (via clinic medical records) that is judged by the PIs to interfere with the completion of the study (e.g., active dialysis or chemotherapy, recent myocardial infarction, inpatient psychiatric admission, organ transplant, acute neurological insult, terminal medical condition).
- Clinical diagnosis of dementia based on clinic medical record data.
- Current use of real-time continuous glucose monitoring.
- Unable to complete EMA assessments between 9am – 9pm through the study period (e.g., night shift work, planned travel across time zones, or occupation that does not reliably allow breaks to complete assessments within a reasonable period; e.g., within an hour).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Yogish Kudva, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available