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?

Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes.

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.

Is the treatment generally safe for humans?

Continuous glucose monitoring (CGM) is considered safe for older adults with type 2 diabetes and can help improve diabetes control by reducing risks like low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Pharmacists can assist in using this technology safely. ^{1 2 3 4 5}

How is the SAGE Group Sessions + Diabetes Pharmacist treatment different from other treatments for older adults with type 2 diabetes?

This treatment is unique because it combines group education sessions with continuous glucose monitoring (CGM) and personalized support from a diabetes pharmacist, which helps older adults manage their diabetes more effectively by providing real-time glucose data and tailored action plans. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment SAGE Group Sessions, Continuous Glucose Monitoring, CGM, SAGE Group Sessions + Diabetes Pharmacist, SAGE Group Sessions + Diabetes Pharmacist, Educational Program Leveraging Continuous Glucose Monitoring for older adults with Type 2 Diabetes?

Research shows that continuous glucose monitoring (CGM) can help improve diabetes management by reducing high and low blood sugar levels and stabilizing glucose fluctuations, especially when combined with pharmacist support and lifestyle changes. ^{2 3 4 5 8}

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 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]

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]

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]

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]

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]

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]

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. United States 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. [2023]

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

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

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

Design and development of a continuous glucose monitoring educational module for students and practicing pharmacists. [2022]

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

Pharmacist-driven continuous glucose monitoring in community and ambulatory care pharmacy practice: A scoping review. [2023]

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

Expert Roundtable on Continuous Glucose Monitoring. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Use of Retrospective Continuous Glucose Monitoring for Optimizing Management of Type 2 Diabetes in India. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Personal real-time continuous glucose monitoring in patients 65 years and older. [2022]