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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
Older adults must be ≥ 65 years old
Older adults must be fluent in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14
Awards & highlights

CP-CGMH Trial Summary

This trial will provide a CGM device and app to older adults with T2D-MCI and their care partners to help with diabetes self-management. Interviews will evaluate the effectiveness of the app.

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.Check my eligibility
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.See study design
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.

CP-CGMH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
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I am fluent in English.
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I am an older adult with mild cognitive impairment, scoring 19-25 on the MoCA test.

CP-CGMH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Technology Acceptance Subscale Score
Total CGM Use Time
Total Scan Time

CP-CGMH 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
~650

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,363 Previous Clinical Trials
816,396 Total Patients Enrolled
Yaguang Zheng, PhD, RNPrincipal InvestigatorRory Meyers College of Nursing
1 Previous Clinical Trials
20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial include participants who are aged fifty or older?

"As per the trial's eligibility rules, senior citizens aged 65-100 may take part in this clinical study."

Answered by AI

Is there an opportunity to join this experiment?

"This clinical trial seeks 20 participants between the ages of 65 and 100, all afflicted with type 2 diabetes mellitus. Additionally, enrollees must have a Montreal Cognitive Assessment score ranging from 19-25; possess knowledge of English language; have been living with T2D-MCI for at least one year; be willing to use CGM technology; as well as having an accompanying care partner (e.g., family member or close friend)."

Answered by AI

Has the Food and Drug Administration given their approval for CP-CGMH?

"Our team at Power assessed the safety of CP-CGMH to be a 1, as this is an initial phase trial with limited data supporting both efficacy and security."

Answered by AI

Are there any openings remaining for prospective participants in this research endeavor?

"Confirmation from clinicaltrials.gov reflects that this particular trial is no longer accepting participants, with the initial posting occurring on January 1st 2023 and its last amendment dating back to October 27th 2022. Nevertheless, there are 1847 trials currently seeking enrolment."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Bellevue Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
~6 spots leftby Aug 2024