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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)
Must not have
Patient has a bleeding disorder
Patient has a pre-existing arm skin lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bleeding disorder.
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I have skin lesions on my arm.
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I am currently undergoing dialysis treatment.
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I am younger than 65 years old.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Level of Situation Awareness (Aim 2)
Patient and Caregiver Unmet Needs (Aim 1)
Secondary study objectives
Feasibility: CGM data completeness (Aim 1)
Feasibility: Percentage of patients recruited (Aim 1)
Feasibility: Retention rate of participants (Aim 1)
+6 more

Awards & Highlights

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

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

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,785 Previous Clinical Trials
28,184,674 Total Patients Enrolled
292 Trials studying Dementia
23,634,811 Patients Enrolled for Dementia
Indiana UniversityLead Sponsor
1,037 Previous Clinical Trials
1,218,911 Total Patients Enrolled
18 Trials studying Dementia
57,092 Patients Enrolled for Dementia

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
~34 spots leftby Aug 2026
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