Alzheimer's and Blood Glucose Levels

Study Overview
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Brief Summary
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The Alzheimer's and Blood Glucose Levels Study is researching the differences in blood glucose levels between people with and without Mild Cognitive Impairment or Alzheimer's disease with the aim of early detection of Alzheimer's Disease.

Detailed Description
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This study will collect continuous glucose monitor (CGM) data from participants already using CGMs to better understand the relationship between Alzheimer's Disease and blood glucose levels. This study will use the  Endobits Companion  app for data collection. The Endobits Companion app is freely available for Android and iOS mobile devices, and was designed to keep track of patients diabetes management through a journal and relay this information with their CGM readings to their caring physician.

Official Title
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A Machine Learning Approach to Alzheimer's Detection From Continuous Blood Glucose Monitoring Data

Conditions
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Mild Cognitive Impairment, Alzheimer Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the case group: have been diagnosed with MCI or AD within the past 5 years. For the control group: have not been diagnosed with MCI or AD or another major dementia disease Currently using a continuous glucose monitor (CGM). Willing and able to provide informed consent, and to have their data collected through the Endobits Companion app. If the participant themself is unable to provide informed consent, it will be sought from their primary caregiver. Exclusion Criteria: Patients younger than 50 years of age. Patients with a BMI lower than 18 or higher than 35. Patients with a major psychiatric illness (e.g., major depressive disorder, schizophrenia, bipolar disorder) Patients diagnosed with another major dementia disease, including vascular dementia, Lewy Body disease, Huntington's disease, Creutzfeldt-Jakob disease, and Parkinson's disease.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>The control group participants have not been diagnosed with mild cognitive impairment or Alzheimer's disease within the past 5 years. There are no interventions to this group. | |
| Case Group<br>The case group participants have been diagnosed with mild cognitive impairment or Alzheimer's disease within the past 5 years. There are no interventions to this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose Levels | All participants will use continuous glucose monitors for the period of the study. The primary outcome is to determine the difference in mean values, variability, and other patterns in blood glucose levels between the case and control groups. As there is no intervention in this study, the difference between the case and control group will be measured over the entire study period. | This will be measured throughout the study which is a period of up to 90 days. |