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CGM-Assisted Diabetes Management for Older Adults with Mild Cognitive Impairment (CP-CGMH Trial)

Phase 1
Recruiting
Led By Yaguang Zheng, PhD, RN
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14
Awards & highlights
No Placebo-Only Group

Summary

This trial uses a small device that continuously checks blood sugar levels for older adults with Type 2 Diabetes and Mild Cognitive Impairment. The device helps patients and caregivers make better daily decisions by showing trends and sending alerts when blood sugar levels are too high or too low. These devices have evolved to provide real-time feedback and alerts, helping patients and caregivers manage diabetes more effectively.

Who is the study for?
This trial is for older adults aged 65+ with Type 2 Diabetes and Mild Cognitive Impairment (scoring 19-25 on the MoCA test), who have a care partner willing to assist. Participants must be fluent in English, diagnosed with diabetes for at least a year, and agree to use a CGM device. Care partners need to be over 18 and involved in daily care.
What is being tested?
The study tests if using Continuous Glucose Monitoring (CGM) devices helps older adults with mild cognitive issues manage their diabetes better when data is shared with their care partners for daily management decisions.
What are the potential side effects?
While not explicitly stated, potential side effects may include skin irritation from the CGM device adhesive, possible allergic reactions or discomfort at the sensor site, and stress or anxiety related to constant glucose monitoring.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Technology Acceptance Subscale Score
Total Scan Time

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CP-CGMHExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitor (CGM)
2017
Completed Phase 3
~680

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Mild Cognitive Impairment (MCI) often involve non-pharmacological interventions such as lifestyle modifications, cognitive training, and the use of technology for health monitoring. In the context of the Care Partner-Assisted Intervention through Continuous Glucose Monitoring and Mobile Health app, the mechanism of action involves real-time glucose monitoring and data sharing to optimize diabetes management. This is crucial for MCI patients as it helps maintain stable blood glucose levels, which can prevent further cognitive decline and improve overall brain health. Effective diabetes management through continuous monitoring can reduce the risk of hypoglycemia and hyperglycemia, both of which are associated with cognitive impairment. By involving care partners, the intervention ensures that patients receive timely support and decision-making assistance, enhancing adherence to treatment plans and improving outcomes.
[Mild cognitive impairment: what's next?]Neurodegeneration and cognition in Parkinson's disease: a review.Type 2 diabetes and cognitive compromise: potential roles of diabetes-related therapies.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,402 Previous Clinical Trials
855,042 Total Patients Enrolled
Yaguang Zheng, PhD, RNPrincipal InvestigatorRory Meyers College of Nursing
1 Previous Clinical Trials
12 Total Patients Enrolled
~8 spots leftby Oct 2025