Care Partner-Assisted Diabetes Self-Management Through Linking Continuous Glucose Monitoring With Mobile Health: Improving Outcomes for Older Adults With Mild Cognitive Impairment — CP-CGMH  

Type 2 Diabetes Clinical Trial

Official title: CP-CGMH: Care Partner-Assisted Diabetes Self-Management Through Linking Continuous Glucose Monitoring With Mobile Health: Improving Outcomes for Older Adults With Mild Cognitive Impairment

Status Recruiting

Clinical Trial Summary

Eligible older adults with Type 2 Diabetes-Mild Cognitive Impairment (T2D-MCI) will be provided a Continuous Glucose Monitoring (CGM) device and asked to share CGM data with their care partners for daily decision-making for diabetes self-management. After 2 weeks, individual interviews will be conducted in 20 participants (10 dyads). Older adults with T2D-MCI (n=10) and their care partners (n=10) will be interviewed separately to identify key features of the Care Partner-Assisted Intervention through linking continuous glucose monitoring and Mobile Health (CP-CGMH) app.

Clinical Trial Description

CGM sensors, measuring glucose levels every 1-5 minutes, can identify hyper- or hypoglycemic episodes that might not be captured by the routine glucose monitoring using finger stick. CGM also enables sharing real-time glucose values and visual trends with care partners as well as provides alerts and alarms when glucose levels are extremely high or low. These visual and alert cues can be used to inform and empower self-management decision making as well as motivate and engage self-management behavior changes (e.g., adjust insulin dose, reduce high-carbohydrate food intake, and increase exercise), which may address the unique issue of diabetes management caused by cognitive impairment for older adults with T2D-MCI. The investigators will use FDA cleared FreeStyle Libre Glucose Monitoring System (hereon referred to as the 'FreeStyle Libre System or 'System'), which is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. The use of this device provides ambulatory glucose profiles, giving graphic and quantitative information on 24-hour glucose patterns. It does not require finger-prick testing for calibration. The system consists of a reader and a sensor (35 mm x 5 mm). The sensor is applied to the back of a person's arm. The sensor automatically measures interstitial glucose at 1-minute intervals during daily activities like work, sleep, eating, and exercise. It is able to store blocks of glucose data for 14 days. Unlike previous versions, with this device, patients are not required to perform finger-stick blood glucose monitoring for calibration. Patients can use the reader or their personal smartphone to scan the CGM sensor to get the real-time glucose values. After 2- week wearing, the participants will return to the research lab (final assessment) to download the CGM report from the LibreView. The data can be viewed as graphical data and summary statistics, or as numerical data. The data report will be de-identified by the study's appointed trained RA before the data are used for analysis. The manufacturer of the device was not involved in the funding, the design or the interpretation of the study. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Diabetes Mellitus
• Mild Cognitive Impairment
• Type 2 Diabetes

• NCT number: NCT05601583
• Study type: Interventional
• Source: NYU Langone Health
• Contact: Yaguang Zheng
• Phone: 212-998-5170
• Email: Yaguang.zheng@nyu.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: April 19, 2023
• Completion date: August 31, 2024