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Glucose Variability and Cognition in Prediabetes

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status

Enrolling

Conditions

Aging
Cognitive Decline
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Depression
Functional Status
PreDiabetes

Treatments

Device: Continuous Glucose Monitoring System (CGMS)

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04201600
HP-00087044

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged 50 years and older
  • At least 8th grade education

Exclusion criteria

  • Diagnosed type 1 or type 2 diabetes
  • Current use of mediation for diabetes (oral hypoglycemic agents, insulin), or with diabetic properties (e.g., steroids)
  • Chronic disorders (cardiovascular disease, peripheral vascular disease, stroke, transient ischemic attack, chronic kidney disease, past year cancer)
  • Neurological disorders (e.g., Parkinson's, epilepsy, multiple sclerosis)
  • History of dementia or suspected dementia
  • Known HIV
  • Serious mental illness, psychosis, or use of psychotropic medication
  • Heavy alcohol use

Trial design

30 participants in 1 patient group

Middle-aged and Older adults with Prediabetes
Description:
Middle-aged and Older adults with Prediabetes
Treatment:
Device: Continuous Glucose Monitoring System (CGMS)

Trial contacts and locations

1

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Central trial contact

Ashley Splain, BA; Kathleen Simpson

Data sourced from clinicaltrials.gov

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