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Continuous Glucose Monitoring for Diabetes Management in Dementia

N/A

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have active prescriptions for DM

Patient must have dual diagnosis of MCI or ADRD and diabetes (DM)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will research shared decision-making in diabetes & Alzheimer's care, then create an interactive tool to help people manage diabetes better.

Who is the study for?

This trial is for people with both diabetes and Alzheimer's or related dementias who have not used a continuous glucose monitoring device before. They need to be under the care of certain healthcare professionals, have internet access, speak English, and live in the community with a caregiver who interacts with them daily.Check my eligibility

What is being tested?

The study aims to understand how patients with dementia and diabetes make decisions together with their caregivers using a continuous glucose monitor. It also seeks to create a tool that helps improve decision-making about managing diabetes.See study design

What are the potential side effects?

While this trial does not involve medication that could cause typical side effects, participants may experience skin irritation from the adhesive on the glucose monitoring device or other minor discomforts associated with wearing it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently taking medication for diabetes.

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I have both mild cognitive impairment or Alzheimer's and diabetes.

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I have a caregiver who is at least 18 and sees me daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Level of Situation Awareness (Aim 2)

Patient and Caregiver Unmet Needs (Aim 1)

Secondary outcome measures

Feasibility: CGM data completeness (Aim 1)

Feasibility: Percentage of patients recruited (Aim 1)

Feasibility: Retention rate of participants (Aim 1)

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Patient-Caregiver DyadsExperimental Treatment1 Intervention

Participants will wear a continuous glucose monitor

Group II: Patient-Caregiver Dyads & Clinicians (first iteration)Active Control1 Intervention

Participants will participate in the first iteration of the user-centered design process.

Group III: Patient-Caregiver Dyads & Clinicians (second iteration)Active Control1 Intervention

Participants will participate in the second iteration of the user-centered design process.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Glucose Monitoring

2023

Completed Phase 2

~1000

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,863 Total Patients Enrolled

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,165 Total Patients Enrolled

Media Library

Patient-Caregiver Dyads Clinical Trial Eligibility Overview. Trial Name: NCT05643144 — N/A

Patient-Caregiver Dyads 2023 Treatment Timeline for Medical Study. Trial Name: NCT05643144 — N/A

Frequently Asked Questions

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

Are there any currently available slots to join this clinical trial?

"The information available on clinicaltrials.gov shows that this trial is not currently admitting new candidates, despite being initially posted January 15th 2023 and last updated December 1st 2022. However, there are 2,099 other trials actively enrolling participants as of now."

Answered by AI

What is the primary objective of this clinical investigation?

"The primary desired outcome of this two-month trial is the Level of Situation Awareness (Aim 2). Secondary metrics include Feasibility: Participant Retention Rate, CGM Data Completeness, and Mean Glucose with each having specific calculations for measuring their respective values."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes

April Savoy 2023. "Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05643144.

All > Hypoglycemia > Dementia