Alzheimer’s and Blood Glucose
Bio Conscious Technologies Inc. is conducting an open observational study to monitor blood glucose levels for patients recently diagnosed with Mild Cognitive Impairment or Alzheimer’s Disease.
The Alzheimer’s and Blood Glucose 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.
The study is collecting continuous glucose monitor (CGM) data from participants using CGMs to better understand the relationship between Alzheimer’s disease and blood glucose fluctuations Using the Endobits Companion app. The Endobits Companion app is available for Android and iOS mobile devices.
What is Involved:
Participants in this project will: * Use a continuous glucose monitor (CGM) for a period of 90 days. Due to this requirement, only participants who are already currently using a continuous glucose monitor will be selected for this study. * Connect their CGM to the Endobits Companion app for the duration of the study. This app is freely available from the Apple App Store and the Google Play Store. All assistance on using the app is available through the app’s support feature. * All information collected will be viewable by the participant and/or their primary caregiver(s)
Risks:
Normal use of the Endobits Companion app does not provide any additional information and will not lead to participants changing their current diabetes management.
Benefits:
There is no expected direct benefit to participants; however, the result may provide knowledge to improve clinical diagnosis of Mild Cognitive Impairment or Alzheimer’s Disease.
Compensation:
The compensatory period for this study has passed. Participants will have to pay for the test using their device or participation, and are not entitled to any compensation in the unlikely event of injury during the study.
Voluntary Participation Withdrawal:
Voluntary Participation and Withdrawal Participation in this study is completely voluntary. As such, participants may withdraw from the study at any time with no negative repercussions. If a participant does withdraw, they have the choice of whether their data will be used for the study or if the data will be destroyed at the time of their withdrawal.
Data Confidentiality:
All individual information about a participant in this program will be kept confidential. There will be no names used in any information shared among program team members. To ensure this, each participant will be identified by a number. Confidentiality may be breached if required by law, or an accidental privacy breach outside of the study team’s control. However, all data will be stored on a secure and compliant database with restricted access. The aggregated results of this study may be disseminated in academic journal articles or presentations. No identifying information will be included in these publications, nor in any datasets that may be made publicly available as a result of these publications. All data will be retained for a period of 3 years after the last approval of a marketing application or academic publication based on these data. After this point, data pertaining to this study will be destroyed. The de-identified data will be by the study team for analyses and development of products relating to the study’s aim.
Contact:
If you have any study related comments, complaints or concerns please email info@bioconscious.tech