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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Mild Cognitive Impairment
• Intervention / Treatment: Device: Continuous Glucose Monitor (CGM)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yaguang Zheng; Phone Number: 212-998-5170; Email: Yaguang.zheng@nyu.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Bellevue Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Older adults must meet all of the following criteria:

1. be ≥ 65 years old;
2. have had a diagnosis of T2D for at least one year;
3. have MCI, defined as score 19-25 on the Montreal Cognitive Assessment (MoCA);60,61
4. have a care partner (e.g., spouse or adult children);
5. be willing to use CGM;
6. be fluent in English.

Eligible care partners must be:

1. ≥ 18 years old;
2. living with older adults with T2D-MCI;
3. willing to be involved in patients' daily care;
4. fluent in English.

Exclusion Criteria:

Older adults who meet any of the following criteria will be excluded from participation in this study:

1. Refuse or are unable to provide informed consent;
2. Have serious physical illness (e.g., end-stage renal disease);
3. Presence of mental illness (e.g., schizophrenia or bipolar disorder) that would preclude participation.

The care partners will be excluded if they:

1. Refuse or are unable to provide informed consent;
2. Have MCI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CP-CGMH; CP-CGMH: Care Partner-Assisted Intervention through linking continuous glucose monitoring and Mobile Health. Participants will receive a CGM device and asked to share CGM data with their care partners for daily decision-making for diabetes self-management for two weeks. The LibreLinkup mHealth app will be used to share data.	Device: Continuous Glucose Monitor (CGM); FDA-cleared FreeStyle Libre Glucose Monitoring System manufactured by Abbott. Integrated continuous glucose monitoring system that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts.; Other Names: Freestyle Libre CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technology Acceptance Subscale Score	13-item questionnaire assessing participants' acceptance of the CGM technology. Items ranked on 7-point Likert scale ranging from 1-7. The total score is the sum of responses and ranges from 13 to 91; lower scores indicate greater overall acceptance.	Day 14
Total CGM Use Time		Up to Day 14
Total Scan Time	Patients can use the reader or their personal smartphone to scan the CGM sensor to get the real-time glucose values.	Up to Day 14

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Yaguang Zheng, PhD, RN, Rory Meyers College of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring (CGM)
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Neurocognitive Disorders; Endocrine System Diseases; Cognition Disorders; Diabetes Mellitus; Cognitive Dysfunction
• Other Study ID Numbers: 22-01170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Yaguang.zheng@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Yaguang.zheng@nyu.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes