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

(CP-CGMH Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Yaguang Zheng, PhD, RN

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: Serious physical illness, Mental illness, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a small device that continuously checks blood sugar levels for older adults with Type 2 Diabetes and Mild Cognitive Impairment. The device helps patients and caregivers make better daily decisions by showing trends and sending alerts when blood sugar levels are too high or too low. These devices have evolved to provide real-time feedback and alerts, helping patients and caregivers manage diabetes more effectively.

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 data supports the effectiveness of the treatment Continuous Glucose Monitor (CGM) for older adults with mild cognitive impairment?

Research shows that continuous glucose monitoring (CGM) can help reduce low blood sugar episodes in older adults with diabetes, which is particularly beneficial for those with memory problems. CGM provides real-time glucose level information, helping to improve overall diabetes management and potentially enhancing quality of life. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for older adults?

Continuous glucose monitoring (CGM) has been studied in older adults with diabetes and is generally considered safe. It helps track blood sugar levels in real-time and can reduce the risk of low blood sugar (hypoglycemia) without significant safety concerns. ^{3 4 6 7 8}

How is the treatment Continuous Glucose Monitor (CGM) unique for older adults with mild cognitive impairment?

Continuous Glucose Monitor (CGM) is unique because it provides real-time monitoring of glucose levels, which can help older adults with mild cognitive impairment manage their diabetes more effectively by reducing the risk of low blood sugar (hypoglycemia) and offering continuous data that can be easily accessed through a mobile device. ^{1 2 3 4 9}

Research Team

Yaguang Zheng, PhD, RN

Principal Investigator

Rory Meyers College of Nursing

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Continuous Glucose Monitor (CGM) (Device)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

Findings from Research

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 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) 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]

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]

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 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) 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of continuous glucose monitoring in insulin-treated older adults with type 2 diabetes. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in older people with diabetes and memory problems: a mixed-methods feasibility study in the UK. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Use of Continuous Glucose Monitoring in Older People With Type 2 Diabetes. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Hungary 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. [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Canada 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. [2023]