Trials / Recruiting
RecruitingNCT04201600
Glucose Variability and Cognition in Prediabetes
Relations of Glucose Variability with Cognitive Function and Functional Status Among Older Adults At Risk for Diabetes
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- University of Maryland, Baltimore · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
This study examines the association of variability in glucose values over a 10-day period with cognitive function and functional status among individuals with prediabetes, aged 50 or older.
Detailed description
Type 2 diabetes (T2DM) is now widely considered a major public health epidemic. T2DM is highly prevalent worldwide, is among the leading causes of death, and is an independent risk factor for dementia and less severe forms of cognitive dysfunction. The investigators are utilizing novel technology to understand the role of variability in glucose on neurocognition and functional status among middle-aged and older adults at risk for diabetes. The central hypothesis is that even before diabetes onset, variability in glucose will be associated with worse cognitive function and lower functional status. Participants will be asked to wear a glucose monitoring device over a 10-day period in their home environment. Assessment of functional status and neurocognitive function, in addition to sociodemographic factors, health habits and mood will also occur over two study visits.
Conditions
- Glucose Metabolism Disorders (Including Diabetes Mellitus)
- Cognitive Decline
- Functional Status
- PreDiabetes
- Aging
- Depression
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Continuous Glucose Monitoring System (CGMS) | Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days. |
Timeline
- Start date
- 2022-03-01
- Primary completion
- 2026-11-30
- Completion
- 2026-12-31
- First posted
- 2019-12-17
- Last updated
- 2025-03-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04201600. Inclusion in this directory is not an endorsement.