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
1 other identifier
interventional
14
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 type-2-diabetes
Started Apr 2023
Longer than P75 for phase_1 type-2-diabetes
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 27, 2022
CompletedFirst Posted
Study publicly available on registry
November 1, 2022
CompletedStudy Start
First participant enrolled
April 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
ExpectedOctober 15, 2025
October 1, 2025
4 months
October 27, 2022
October 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
CP-CGMH
EXPERIMENTALCP-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Older adults must meet all of the following criteria:
- be ≥ 65 years old;
- have had a diagnosis of T2D for at least one year;
- have MCI, defined as score 19-25 on the Montreal Cognitive Assessment (MoCA);60,61
- have a care partner (e.g., spouse or adult children);
- be willing to use CGM;
- be fluent in English.
- Eligible care partners must be:
- ≥ 18 years old;
- living with older adults with T2D-MCI;
- willing to be involved in patients' daily care;
- fluent in English.
You may not qualify if:
- Older adults who meet any of the following criteria will be excluded from participation in this study:
- Refuse or are unable to provide informed consent;
- Have serious physical illness (e.g., end-stage renal disease);
- Presence of mental illness (e.g., schizophrenia or bipolar disorder) that would preclude participation.
- The care partners will be excluded if they:
- Refuse or are unable to provide informed consent;
- Have MCI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bellevue Hospital
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaguang Zheng, PhD, RN
Rory Meyers College of Nursing
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2022
First Posted
November 1, 2022
Study Start
April 19, 2023
Primary Completion
August 29, 2023
Study Completion (Estimated)
August 31, 2027
Last Updated
October 15, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.