Alzheimer's and Blood Glucose Levels
A Machine Learning Approach to Alzheimer's Detection From Continuous Blood Glucose Monitoring Data
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedNovember 4, 2020
November 1, 2020
9 months
October 13, 2020
November 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Control Group
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
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.
Eligibility Criteria
The study population is drawn from older individuals (at least 50 years of age) with or without MCI or AD.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bio Conscious Technologies Inc.
Vancouver, British Columbia, V6B 4N6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2020
First Posted
November 4, 2020
Study Start
November 1, 2020
Primary Completion
August 1, 2021
Study Completion
March 1, 2022
Last Updated
November 4, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share