Alzheimer's and Blood Glucose Levels

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04614376

Enrollment

100

Registered

2020-11-04

Start date

2020-11-30

Completion date

2022-03-31

Last updated

2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Mild Cognitive Impairment

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Blood Glucose Levels	This will be measured throughout the study which is a period of up to 90 days.	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.

Countries

Canada

Contacts

Primary ContactAmir Hayeri, MSc

amir@bioconscious.tech+1-778-986-3030

Outcome results