Safer Insulin Management for Older Adults with Type 2 Diabetes

(SAGE Trial)

Recruiting at 3 trial locations

Overseen By Carolina Gonzalez

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must be taking: Insulin

Disqualifiers: Renal dialysis, Dementia, Pacemaker, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help older adults with type 2 diabetes manage insulin safely, focusing on reducing the risk of severe low blood sugar (hypoglycemia). Participants will either continue their usual care or join SAGE Group Sessions. These educational sessions teach the use of continuous glucose monitors, which track blood sugar levels to prevent hypoglycemia. The trial targets individuals aged 75 or older who have type 2 diabetes, are on insulin, and have experienced low blood sugar episodes in the past year. As an unphased trial, it offers a unique opportunity to learn new strategies for effective diabetes management.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but it focuses on managing insulin use safely. It's best to discuss your current medications with the trial team.

What prior data suggests that this strategy of safe insulin prescribing is safe for older adults with type 2 diabetes?

Research has shown that continuous glucose monitoring (CGM) is helpful and safe for older adults with diabetes. Studies indicate that CGM can improve blood sugar control and reduce the risk of low blood sugar episodes, which can be dangerous for this age group.

The trial's educational sessions aim to help participants use CGM tools effectively. These sessions teach how to operate and interpret CGM devices and use this information to prevent low blood sugar events. Evidence suggests that CGM is easy to use and can lead to better health outcomes.

No major safety concerns have been reported with CGM use in older adults, making it a promising tool for managing diabetes safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods to manage insulin safely for older adults with Type 2 diabetes. Unlike standard treatments that primarily focus on medication adjustments, this trial investigates the impact of SAGE Group Sessions, which are educational meetings designed to teach participants how to effectively use continuous glucose monitors (CGMs). These sessions aim to empower patients to prevent hypoglycemia by understanding their CGM data and maintaining a hypoglycemia journal. By enhancing patient education and self-management, this approach has the potential to improve safety and quality of life for older adults managing their diabetes.

What evidence suggests that this trial's treatments could be effective for managing type 2 diabetes in older adults?

Studies have shown that continuous glucose monitoring (CGM) can greatly help adults with type 2 diabetes manage their condition more effectively. CGM provides real-time updates on blood sugar levels, enabling individuals to identify trends and make informed decisions to prevent low blood sugar. Research indicates that CGM use can lead to improved blood sugar control and fewer serious low blood sugar episodes. In this trial, participants in the Group Education Sessions arm will attend SAGE Group Sessions designed to teach effective CGM use. By learning to understand and respond to CGM data, older adults at high risk can reduce their chances of complications from low blood sugar. ^{6 7 8 9 10}

Who Is on the Research Team?

Richard W Grant, MD MPH

Principal Investigator

Kaiser Permanente Northern California - Division of Research

Are You a Good Fit for This Trial?

This trial is for older adults aged 75 and above with type 2 diabetes who are currently on insulin treatment. Participants should have experienced low blood sugar in the past year, be able to communicate in English, and have access to email and the Internet.

Inclusion Criteria

Increased hypoglycemia risk (prior year hypoglycemia by self-report or utilization)

Able to access email and the Internet

I am 75 years old or older.

Exclusion Criteria

Pacemaker or Automatic Implantable Cardioverter Defibrillator

Severe Mental Illness

Using insulin pump

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either group-based education sessions with CGM or continue with usual care

12 months

3 educational sessions for the experimental group

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term Follow-up

Participants are monitored for hypoglycemia-related outcomes and other measures

12 months

What Are the Treatments Tested in This Trial?

Interventions

• SAGE Group Sessions
• SAGE Group Sessions + Diabetes Pharmacist

Trial Overview The study tests a new educational program using continuous glucose monitoring to help prevent severe low blood sugar episodes. Participants will either attend SAGE group sessions, combine these sessions with support from a diabetes pharmacist, or receive usual care without additional education.

How Is the Trial Designed?

Group I: Group Education Sessions Experimental Treatment 1 Intervention

Participants will participate in 3 educational sessions designed to teach about applying and using continuous glucose monitors \[CGMs\] (Session 1) and how to prevent hypoglycemia episodes based on CGM readings and hypoglycemia journal entries (Sessions 2 \& 3).

Group II: Usual Care Active Control 1 Intervention

Participants allocated to the control arm will continue with usual care.

SAGE Group Sessions is already approved in United States, European Union for the following indications:

Approved in United States as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in European Union as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A 2-week hands-on continuous glucose monitoring (CGM) module significantly improved knowledge and confidence in CGM use among third-year pharmacy students and practicing pharmacists, with 36 students and 5 pharmacists participating in the study.

While students maintained their confidence in CGM tasks long-term, their knowledge showed a slight decline, indicating the need for ongoing education to reinforce learning about CGM technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and development of a continuous glucose monitoring educational module for students and practicing pharmacists. Sherrill, CH., Lee, S., Bradley, CL.[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]

A retrospective case series demonstrated that using a flash continuous glucose monitoring (CGM) system in pharmacist-managed diabetes cases effectively improved glycemic control by allowing for real-time monitoring and tailored interventions.

The combination of flash CGM with lifestyle and medication changes not only enhanced diabetes management but also ensured safety by reducing hypoglycemia and stabilizing blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Pharmacist-Assisted Flash Continuous Glucose Monitoring Improves Glycemic Outcomes in Patients With Poorly Controlled Diabetes: A Retrospective Case Series. Siemens, R.[2023]

In a 3-month study involving 181 adults with type 2 diabetes, the use of continuous glucose monitoring (CGM) with the iPro2 device led to a significant reduction in A1C levels from 8.6% to 8.0%, indicating improved glycemic control.

The majority of participants (91.2%) experienced therapy changes after reviewing their CGM data, and both healthcare professionals and patients found the iPro2 studies to be useful for understanding treatment compliance and making informed decisions about diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Retrospective Continuous Glucose Monitoring for Optimizing Management of Type 2 Diabetes in India. Mohan, V., Jain, S., Kesavadev, J., 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]

Pharmacist-driven continuous glucose monitoring (CGM) services show potential benefits in improving glycemic control and quality of life, particularly in ambulatory care settings, based on a review of 11 studies.

Barriers to implementing these services include educational, logistical, workflow, and financial challenges, indicating that while feasible, further exploration is needed to enhance their effectiveness in community pharmacies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist-driven continuous glucose monitoring in community and ambulatory care pharmacy practice: A scoping review. Vascimini, A., Saba, Y., Baskharoun, F., et al.[2023]

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 38 insulin-requiring patients aged 65 and older, regular use of personal continuous glucose monitoring (PCGM) significantly improved glycemic control, with A1C levels decreasing from 7.6% to 7.1% over an average of 37 months.

The use of PCGM also led to a substantial reduction in severe hypoglycemia incidents, with the percentage of patients reporting severe hypoglycemia dropping from 79% to 31%, highlighting the safety benefits of PCGM in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal real-time continuous glucose monitoring in patients 65 years and older. Argento, NB., Nakamura, K.[2022]

Citations

1. journals.sagepub.com journals.sagepub.com/doi/10.1177/26350106251326517

Intermittent Use of Continuous Glucose Monitoring in Type ... The purpose of the study was to explore experiences with use of a continuous glucose monitor (CGM) in people with type 2 diabetes (T2DM).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12530396/

Who is using continuous glucose monitoring for type 2 ... For adults with type 2 diabetes (T2D), continuous glucose monitoring (CGM) technology can improve diabetes self-management and clinical outcomes ...

3. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/dia.2023.0612

The Potential Impact of Continuous Glucose Monitoring ... While continuous glucose monitoring (CGM) has been linked to glycemic benefits in type 2 diabetes (T2D) populations, including insulin as well as noninsulin ...

4. liebertpub.com liebertpub.com/doi/full/10.1089/dia.2018.0177?doi=10.1089/dia.2018.0177

The Effectiveness of Continuous Glucose Monitoring in ... Background: Continuous glucose monitoring (CGM) provides glucose trend information that can be used to guide treatment and motivate patients with diabetes.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/2633559X241296156

Expanding Use of Continuous Glucose Monitoring in Type ... This narrative review summarizes the current evidence on the benefits of CGM use in individuals with non-insulin-treated T2DM.

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/19322968241234651?icid=int.sj-abstract.similar-articles.8

Continuous Glucose Monitoring in Older Adults This review article summarizes the available data for CGM use in older adults, discusses the benefits and obstacles with CGM use in this population,

7. 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.

8. journals.sagepub.com journals.sagepub.com/doi/abs/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 ...

9. 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 ...

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dme.15261

Continuous glucose monitoring in older adults with ... The aim of this study was to assess the use of continuous glucose monitoring (CGM) in people with type 1 diabetes and type 2 diabetes aged ≥60 ...