Continuous Glucose Monitoring for Diabetes Management in Dementia

Overseen By Kelli Norton, BS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must be taking: Diabetes medications

Must not be taking: Ascorbic acid

Disqualifiers: Terminal illness, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve diabetes management for patients with both diabetes and memory issues, such as Alzheimer's disease, by using a continuous glucose monitor (CGM). Participants will assist researchers in understanding how patients and caregivers make decisions about diabetes care and in identifying any unmet needs. The goal is to develop an Interactive Tool for shared decision-making. This trial is suitable for patients who have both diabetes and memory problems and are cared for daily by someone who also speaks English and has internet access. As an unphased trial, it provides a unique opportunity to contribute to valuable research that could enhance care for those facing similar health challenges.

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.

What prior data suggests that the continuous glucose monitoring device is safe for patients with diabetes and dementia?

Research has shown that continuous glucose monitoring (CGM) is generally safe and easy to use, even for older adults with Type 2 diabetes. Studies have found that CGM can significantly reduce the risk of low blood sugar, a common concern for people with diabetes. Users find CGM devices easy to integrate into their daily routines without much trouble or discomfort. These devices continuously track blood sugar levels and provide real-time updates through a small sensor attached to the body.

No serious side effects have been widely reported, making CGM a reliable option for many. Notably, CGM has been successfully used to manage both Type 1 and Type 2 diabetes, supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of continuous glucose monitoring (CGM) specifically for individuals with both diabetes and dementia. Unlike traditional diabetes management methods like regular finger-stick testing or periodic lab tests, which can be challenging for those with cognitive impairments, CGM provides real-time data and alerts. This continuous flow of information helps caregivers and clinicians make more informed decisions quickly, potentially improving health outcomes. Moreover, the trial includes an interactive tool designed to enhance communication and decision-making between patients, caregivers, and healthcare providers, aiming to streamline diabetes management in the context of dementia.

What evidence suggests that continuous glucose monitoring is effective for diabetes management in dementia?

Research has shown that continuous glucose monitoring (CGM) can greatly benefit people with diabetes. Studies have found that CGM devices help maintain blood sugar control and reduce the risk of dangerously low blood sugar. In this trial, some participants will wear a CGM device, which provides real-time updates, making it particularly useful for older adults with both diabetes and memory issues. People using CGMs often report greater satisfaction with their diabetes care. Overall, CGM has proven effective and easy to use, especially for older adults. ^{1 2 5 6 7}

Who Is on the Research Team?

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

Exclusion Criteria

Patient has an allergy to medical adhesive or isopropyl alcohol

I have a bleeding disorder.

I have skin lesions on my arm.

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?

Group I: Patient-Caregiver Dyads Experimental Treatment 1 Intervention

Participants will wear a continuous glucose monitor

Group II: Patient-Caregiver Dyads & Clinicians (first iteration) Active Control 1 Intervention

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

Group III: Patient-Caregiver Dyads & Clinicians (second iteration) Active Control 1 Intervention

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

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 203 older adults (average age 68) with type 1 diabetes, continuous glucose monitoring (CGM) significantly reduced the time spent with low glucose levels (<70 mg/dL) compared to standard blood glucose monitoring (BGM), showing a decrease from 5.1% to 2.7% in the CGM group.

CGM also led to a meaningful reduction in HbA1c levels (average decrease of 0.3%) compared to BGM, indicating better overall glucose control, while the safety profile showed fewer severe hypoglycemia events in the CGM group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. Pratley, RE., Kanapka, LG., Rickels, MR., et al.[2022]

Flash Glucose Monitoring (FGM) is a valuable tool for tracking glucose levels over a 14-day period, providing both daily graphs and a consolidated view of glucose variability, hyperglycemia, and hypoglycemia.

FGM not only aids in clinical detection of glucose fluctuations but also serves as an effective educational resource, helping patients understand their glucose data and encouraging better glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Freestyle Libre ProTM Flash Glucose Monitoring System in Different Clinical Situations at a Diabetes Centre. Ratna, S., Subashini, R., Unnikrishnan, R., et al.[2022]

Continuous glucose monitoring (CGM) significantly improves glycemic control in diabetes patients compared to traditional monitoring methods, helping to reduce both the frequency and severity of hypoglycemic episodes.

CGM technology plays a crucial role in the development of the 'artificial pancreas', highlighting its importance in advancing diabetes management and treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Performance of Continuous Glucose Monitoring: An Overview. Singh, H., Venkatesan, V.[2023]

A symposium with 20 diabetes educators highlighted various concerns regarding the implementation of continuous glucose monitoring (CGM), including patient acceptance, professional practice implications, and data privacy issues.

The discussions emphasized the importance of preparing diabetes educators to address these challenges proactively, ensuring they can help shape policies and standards as CGM technology becomes more widely available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues for the coming age of continuous glucose monitoring. Pichert, JW., Campbell, K., Cox, DJ., et al.[2018]

The new seventh-generation (G7) continuous glucose monitoring (CGM) device significantly reduces the number of tasks required for deployment compared to the sixth-generation (G6), making it easier for older adults and diabetes care specialists to use.

With a high usability score of 92.8, the G7 CGM device is reported to have a low cognitive burden, which may lead to better diabetes management outcomes for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Teachability of Continuous Glucose Monitoring Devices in Older Adults and Diabetes Educators: Task Analysis and Ease-of-Use Survey. Psavko, S., Katz, N., Mirchi, T., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Flash Continuous Glucose Monitoring in Primary Practice. Hirsch, IB., Wright, EE.[2021]

The Eversense continuous glucose monitoring (CGM) system, which features a fully implantable sensor with a lifespan of up to 180 days, has shown a mean absolute relative difference (MARD) of 8.5% to 9.4%, indicating good accuracy in glucose monitoring.

Clinical trials reported no serious device-related adverse events, with minor issues such as site irritation (0.66%) and infection (0.96%), suggesting that the Eversense system is safe for long-term use in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy. Irace, C., Cutruzzolà, A., Tweden, K., et al.[2022]

Continuous glucose monitoring (CGM) is recommended as a valuable tool for managing type 2 diabetes, providing more detailed tracking of glucose levels and helping to predict issues like hypo and hyperglycemia, which can inform treatment decisions.

Despite its advantages, barriers such as provider education, costs, and data management challenges hinder the widespread adoption of CGM in clinical practice for people with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert Roundtable on Continuous Glucose Monitoring. Rosenfeld, C., Blevins, T., Aleppo, G., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flash Continuous Glucose Monitoring: Implications for Use of Continuous Data in Daily Diabetes Management. Hirsch, IB., Nardacci, E., Verderese, CA.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11653377/

Continuous Glucose Monitoring in Comorbid Dementia ... The CGM seems to be highly feasible and acceptable to use in older people with T2DM and has been shown to significantly reduce their hypoglycemic events, often ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/9/11/e032037

a mixed-methods feasibility study in the UK Our objective was to investigate the feasibility of trialling a CGM intervention in the community setting in older people with diabetes and memory problems.

3. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) CGMs continually monitor your blood glucose (blood sugar), giving you real-time updates through a device that is attached to your body.

4. e-enm.org e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ... Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.

5. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.10-b.s30

Using continuous glucose monitoring to measure and ... The Glucose Management Indicator can be used as a measure of glucose control. This article discusses the benefits of value-based care, the importance of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7755046/

Using Continuous Glucose Monitoring in Clinical Practice The visual display of CGM data allows patients to view their glycemic activity and monitor the effects of different types of food, timing of meals, activity ...

7. my.clevelandclinic.org my.clevelandclinic.org/health/articles/continuous-glucose-monitoring-cgm

Continuous Glucose Monitoring (CGM): What It Is A continuous glucose monitor (CGM) is a wearable device that tracks your glucose (sugar) levels in real time. It's a tool people with diabetes use.