CGM-Assisted Diabetes Management for Older Adults with Mild Cognitive Impairment

(CP-CGMH Trial)

Overseen By Yaguang Zheng

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: NYU Langone Health

Disqualifiers: Serious physical illness, Mental illness, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a Continuous Glucose Monitor (CGM) can help older adults with Type 2 Diabetes and mild memory problems manage their condition more effectively. Participants will use the CGM to track blood sugar levels and share this information with a care partner, such as a spouse or adult child, to assist in daily decision-making. The trial seeks individuals who have lived with Type 2 Diabetes for at least a year and have mild cognitive impairment, along with a care partner willing to help manage their care. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to explore this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Continuous Glucose Monitoring device is safe for older adults with mild cognitive impairment?

Research shows that continuous glucose monitors (CGMs) are generally safe and easy for older adults to use. Studies have found that using a CGM can improve blood sugar control and lower the risk of low blood sugar episodes, which is especially beneficial for older people with diabetes. These studies have reported no major safety issues, suggesting that CGMs reliably monitor blood sugar levels. Although this trial is in the early stages, existing evidence on CGMs indicates their safety for older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Continuous Glucose Monitors (CGMs) in diabetes management for older adults with mild cognitive impairment because this approach links glucose monitoring directly with mobile health technology. Unlike traditional methods that rely on periodic finger-prick tests, CGMs provide real-time glucose data continuously. This trial also involves care partners in the management process through the LibreLinkup app, which allows for shared decision-making and support. This integration of technology and social support aims to enhance self-management and improve overall outcomes, offering a novel and potentially more effective way to manage diabetes in this vulnerable population.

What evidence suggests that this CGM device is effective for managing Type 2 Diabetes with Mild Cognitive Impairment?

Research has shown that continuous glucose monitoring (CGM) can help older adults manage diabetes more effectively. Studies have found that CGM keeps blood sugar levels within the target range and reduces episodes of low blood sugar. This trial will evaluate a Care Partner-Assisted Intervention using CGM, where participants share CGM data with their care partners for daily decision-making. This approach aids those with memory issues in managing diabetes daily. Additionally, older patients find CGM easy to use and well-liked. These findings suggest that CGM could be a useful tool for older adults with type 2 diabetes and mild memory problems. ^{1 2 6 7 8}

Who Is on the Research Team?

Yaguang Zheng, PhD, RN

Principal Investigator

Rory Meyers College of Nursing

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I live with an older adult who has type 2 diabetes and mild cognitive impairment.

I am 65 years old or older.

I am fluent in English.

Exclusion Criteria

I am an older adult with a serious illness like end-stage kidney disease.

I do not have a mental illness like schizophrenia or bipolar disorder that would stop me from participating.

Care partners who refuse or are unable to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a CGM device and share data with care partners for diabetes self-management for two weeks

2 weeks

1 visit (in-person) for final assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor (CGM)

Trial Overview 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.

How Is the Trial Designed?

Group I: CP-CGMH Experimental Treatment 1 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.

Continuous Glucose Monitor (CGM) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Continuous Glucose Monitoring System for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control
• Hypoglycemia prevention

Approved in European Union as Continuous Glucose Monitoring System for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control
• Hypoglycemia prevention

Approved in Canada as Continuous Glucose Monitoring System for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control
• Hypoglycemia prevention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Continuous glucose monitoring (CGM) can be beneficial for older adults with type 2 diabetes mellitus (T2DM), helping to manage unique challenges like hypoglycemia and fluctuating glucose levels.

Despite the potential advantages of CGM, its use in older patients is not well established, highlighting the need for further research and education, particularly by pharmacists, to improve diabetes management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Continuous Glucose Monitoring in Older People With Type 2 Diabetes. Rao, H., Fakourfar, N., Sun, C., et al.[2021]

The FreeStyle Libre Flash continuous glucose monitoring (CGM) system was well accepted by older adults with type 2 diabetes, showing a high sensor utilization rate of 93.1% over a 6-week study period involving 66 participants.

While the time in range (TIR) remained stable, significant reductions in time below range (TBR) and glycemic variability were observed, indicating that CGM can help older adults manage their diabetes more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of continuous glucose monitoring in insulin-treated older adults with type 2 diabetes. Leite, SAO., Silva, MP., Lavalle, ACR., et al.[2023]

In a study of 277 adults with type 1 diabetes, those using continuous glucose monitoring (CGM) had better glycemic control compared to non-users, highlighting the efficacy of CGM in managing blood sugar levels.

While CGM users reported feeling more empowered about their diabetes management, they also experienced more disease-related problems and discomfort from the device, indicating a mixed satisfaction with its use despite the clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring (CGM) satisfaction and its effect on mental health and glycemic control in adults with type 1 diabetes. Lukács, A., Szerencsi, LB., Barkai, L.[2022]

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]

A feasibility study involving 17 older participants (mean age 85) with diabetes and memory problems showed that the FreeStyle Libre continuous glucose monitoring (CGM) device was generally acceptable and helpful for both users and their carers in monitoring glucose levels.

However, data capture varied widely, with an average of 55% over 14 days, indicating that the requirement for users to perform at least three scans daily may limit its effectiveness; automated data transfer devices could be more suitable for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in older people with diabetes and memory problems: a mixed-methods feasibility study in the UK. Mattishent, K., Lane, K., Salter, C., et al.[2020]

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]

Continuous glucose monitoring (CGM) effectively identifies asymptomatic hypoglycemic episodes in older patients with diabetes, with 28-65% of participants experiencing these episodes, often spending nearly 2 hours per day in the hypoglycemic range.

Older patients reported high acceptability of CGM and experienced improved health-related well-being and reduced diabetes-related stress, indicating that CGM can enhance the quality of life for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of asymptomatic drug-induced hypoglycemia using continuous glucose monitoring in older people - Systematic review. Mattishent, K., Loke, YK.[2019]

The continuous glucose monitoring system (CGMS) demonstrated high accuracy in measuring glucose levels, with a strong correlation to capillary glucose measurements (correlation coefficient of 0.87), and effectively identified glycemic excursions and postprandial hyperglycemia in diabetic patients.

After three months of using CGMS, patients showed a significant reduction in A1c levels (p=0.001), indicating improved long-term glycemic control, while 89.8% of patients experienced no complications, highlighting the system's safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Metabolic/glycemic control accuracy, effect and complications of the continuous glucose monitoring system in diabetic patients]. Maia, FF., Araújo, LR.[2019]

Continuous glucose monitoring (CGM) has been shown to improve blood sugar control and reduce hypoglycemia in older adults with type 2 diabetes, similar to its benefits in younger populations.

The article emphasizes the need for personalized approaches when considering CGM for older adults, taking into account their diverse clinical and psychosocial needs to enhance diabetes management and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring Use in Older Adults for Optimal Diabetes Management. Munshi, MN.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9835808/

Use of Continuous Glucose Monitoring in Older Adults This article will discuss the benefits of continuous glucose monitoring in older adults with diabetes, the clinical studies that support its use and the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12085541/

Narrative Review: Continuous Glucose Monitoring (CGM) ... There is good evidence that CGM can improve time-in-range and reduce hypoglycaemia and glucose variability in older adults.

3. diabetesjournals.org diabetesjournals.org/care/article/48/5/694/157295/Continuous-Glucose-Monitoring-With-Geriatric

Continuous Glucose Monitoring With Geriatric Principles in ... Continuous glucose monitoring (CGM) use in older adults with type 1 diabetes (T1D) has shown benefits. However, the impact of CGM use, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S019745722400185X

Advancing elderly diabetes care: exploring the usability ... This study aimed to evaluate the acceptability, usability, compliance, and satisfaction of Continuous Glucose Monitoring (CGM) among elderly diabetic patients.

5. 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.

6. diabetes.jmir.org diabetes.jmir.org/2022/1/e35687/

Continuous Glucose Monitoring Data Sharing in Older Adults ... This study aimed to address the barriers to sharing CGM data. Our objective was to examine the feasibility of using CGM with the Follow app and a data-sharing ...

7. liebertpub.com liebertpub.com/doi/10.1089/dia.2023.0111

Continuous Glucose Monitoring Use in Older Adults for ... Numerous studies have shown that use of continuous glucose monitoring (CGM) has been shown to improve glycemic control and reduce the incidence and severity of ...

8. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15842?af=R

Continuous glucose monitoring and all‐cause mortality in ... The prevalence of older adults with diabetes experiencing mild cognitive impairment or dementia is currently about 18–39% in the United States.