What side effects are associated with this type of intervention?

Common treatments for Mild Cognitive Impairment (MCI) often include lifestyle interventions such as diet and exercise, as well as the use of continuous glucose monitoring (CGM) and mobile health (mHealth) technologies for diabetes management. Known side effects of these interventions can include mild hypoglycemia, especially when intensive lifestyle modifications are implemented without proper monitoring. Additionally, overly aggressive management of vascular risk factors, such as hypertension, can lead to orthostatic hypotension. It is important to closely monitor and adjust treatments to minimize these risks.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's disease, which can also be relevant for Mild Cognitive Impairment (MCI). These include cholinesterase inhibitors like Donepezil (Aricept) and Rivastigmine (Exelon), which are used to manage symptoms by improving cognitive function. While these drugs are primarily for Alzheimer's, they may be prescribed off-label for MCI. The Care Partner-Assisted Intervention through Continuous Glucose Monitoring and Mobile Health app focuses on diabetes management, which is not directly related to FDA-approved cognitive enhancers but highlights the importance of integrated care approaches in managing comorbid conditions like diabetes and cognitive impairment.

What other types of research exist?

Promising alternatives to Care Partner-Assisted Intervention through Continuous Glucose Monitoring and Mobile Health apps for patients with Mild Cognitive Impairment and diabetes include: 1) Telemedicine and telecare interventions for remote monitoring and support. 2) Intensive lifestyle interventions focusing on diet and physical activity. 3) Pharmacologic advancements like GLP-1 receptor agonists and SGLT-2 inhibitors. 4) Group medical visits and shared medical appointments for peer support and education. 5) Advanced insulin delivery systems, such as hybrid closed-loop systems.

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Device

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14

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

Do I qualify?Apply below to find out

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.

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