62 Participants Needed

Continuous Glucose Monitoring for Diabetes Management in Dementia

AS
SR
KN
Overseen ByKelli Norton, BS
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
Must be taking: Diabetes medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Aim 1: Characterize shared decision-making and unmet patient-caregiver dyads needs for patients with diabetes and Alzheimer's Disease and related dementias (ADRD) while using a continuous glucose monitoring (CGM) device.Aim 2: Develop an interactive tool to enhance shared decision-making for diabetes management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have active prescriptions for diabetes. You cannot participate if you use an automated insulin delivery system or take ascorbic acid during the monitoring period.

Is continuous glucose monitoring safe for humans?

The research articles do not provide specific safety data for continuous glucose monitoring, but they discuss its use in diabetes management, suggesting it is generally considered safe for this purpose.12345

How is continuous glucose monitoring different from other treatments for diabetes management in dementia?

Continuous glucose monitoring (CGM) is unique because it provides real-time glucose level data, helping to manage diabetes more effectively by reducing the frequency and severity of low blood sugar episodes. Unlike traditional methods, CGM offers continuous insights into glucose trends, which can be particularly beneficial for individuals with dementia who may have difficulty managing their diabetes.26789

What data supports the effectiveness of continuous glucose monitoring for diabetes management in dementia?

Research shows that continuous glucose monitoring (CGM), including flash glucose monitoring, helps people with diabetes by providing real-time data that can improve blood sugar control. This technology has been linked to more time spent in the target blood sugar range and less time in high or low blood sugar levels, which can be beneficial for managing diabetes in people with dementia.234510

Who Is on the Research Team?

AS

April Savoy, PhD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am currently taking medication for diabetes.
Patient and caregiver must both reside in the community
Clinician must be a primary care physician, nurse, pharmacist, nutritionist, psychologist, or medical resident
See 5 more

Exclusion Criteria

Patient has an allergy to medical adhesive or isopropyl alcohol
I have a bleeding disorder.
I have skin lesions on my arm.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and CGM Training

Patient-caregiver dyads participate in a semi-structured interview to establish a baseline and receive CGM training and instructions for device use.

1 day
1 visit (in-person)

CGM Monitoring

Participants wear the CGM device for 14 days with follow-up interviews and a debrief interview for assessment and technical support.

2 weeks
3 follow-up interviews (virtual), 1 debrief interview (virtual)

User-Centered Design Session

Patient-caregiver dyads and clinicians participate in a user-centered design session to guide the design of interactive information displays.

1 day
1 session (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention.

2 months

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous Glucose Monitoring
  • Interactive Tool
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Patient-Caregiver DyadsExperimental Treatment1 Intervention
Group II: Patient-Caregiver Dyads & Clinicians (first iteration)Active Control1 Intervention
Group III: Patient-Caregiver Dyads & Clinicians (second iteration)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

Flash continuous glucose monitoring (CGM) offers an affordable and user-friendly option for patients, allowing them to scan a sensor for real-time glucose data, which can help in adjusting therapy and understanding glucose patterns.
Increased scanning frequency with flash CGM is linked to better glycemic control, showing more time spent in the target glucose range and less time in hyperglycemia and hypoglycemia, highlighting its potential benefits for diabetes management.
Flash Continuous Glucose Monitoring: Implications for Use of Continuous Data in Daily Diabetes Management.Hirsch, IB., Nardacci, E., Verderese, CA.[2020]
A survey of 291 adults with type 1 diabetes revealed that nearly 80% regularly reviewed their ambulatory glucose profile (AGP) report, highlighting its importance in diabetes management, with 92% of respondents considering it essential.
Key facilitators for effectively using the AGP report included motivation and support from healthcare providers and family, while the main barrier was the high cost of glucose monitoring devices.
Patient Perspectives on the Ambulatory Glucose Profile Report for Type 1 Diabetes Management in Adults: A National Online Survey.Mackett, K., Gerstein, H., Santesso, N.[2023]
New 'flash' continuous glucose monitoring (CGM) technology is emerging as a more affordable and user-friendly option for diabetes management, potentially increasing its accessibility for patients.
This novel CGM approach aims to provide continuous data that can be used more routinely in primary care settings, enhancing daily diabetes management for a larger number of patients.
Using Flash Continuous Glucose Monitoring in Primary Practice.Hirsch, IB., Wright, EE.[2021]

Citations

Flash Continuous Glucose Monitoring: Implications for Use of Continuous Data in Daily Diabetes Management. [2020]
Patient Perspectives on the Ambulatory Glucose Profile Report for Type 1 Diabetes Management in Adults: A National Online Survey. [2023]
Using Flash Continuous Glucose Monitoring in Primary Practice. [2021]
Expert Roundtable on Continuous Glucose Monitoring. [2022]
Issues for the coming age of continuous glucose monitoring. [2018]
Use of Freestyle Libre ProTM Flash Glucose Monitoring System in Different Clinical Situations at a Diabetes Centre. [2022]
7.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Safety and Performance of Continuous Glucose Monitoring: An Overview. [2023]
Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. [2022]
Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy. [2022]
Usability and Teachability of Continuous Glucose Monitoring Devices in Older Adults and Diabetes Educators: Task Analysis and Ease-of-Use Survey. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity