CGM vs. SMBG for Type 2 Diabetes

(GluCoCare Trial)

Overseen By Mary L Johnson, RN,BS,CDCES

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Must be taking: Insulin

Disqualifiers: End stage renal disease, cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods of monitoring blood sugar in people with type 2 diabetes who use insulin. One group will use continuous glucose monitors (CGM) to track blood sugar levels throughout the day, while the other group will use traditional blood sugar tests (SMBG) that require finger pricks. The goal is to determine which method better manages diabetes over a year. This trial suits those with type 2 diabetes who use insulin and have an A1C (a measure of blood sugar over time) between 7.5% and 12% in recent months. As an unphased trial, this study offers an opportunity to contribute to valuable research that could enhance diabetes management for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It mentions that participants can use insulin with or without other diabetes medications.

What prior data suggests that these glucose monitoring strategies are safe for managing type 2 diabetes?

Research has shown that continuous glucose monitoring (CGM) is safe for people with type 2 diabetes. Studies have found that it helps lower HbA1c, a measure of average blood sugar levels over time. CGM devices, such as the FreeStyle Libre 2, are easy to use and include features like alerts for low or high blood sugar, simplifying diabetes management.

No major negative effects have been widely reported with CGM use, indicating it generally does not cause harm or discomfort. Users have not reported significant problems, suggesting it is a safe option for managing type 2 diabetes.

Self-monitoring of blood glucose (SMBG) remains a common and long-standing method in diabetes care. It does not involve new or experimental treatments and is considered safe.

In summary, both CGM and SMBG are safe for monitoring blood sugar in type 2 diabetes, with CGM offering additional benefits in ease and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing continuous glucose monitoring (CGM) with self-monitoring of blood glucose (SMBG) for type 2 diabetes management. Unlike SMBG, which requires finger-pricking multiple times a day, CGM provides real-time glucose levels continuously through a small sensor placed under the skin. This allows for a more comprehensive glucose profile and potentially better management of blood sugar levels. Researchers hope that CGM will lead to improved outcomes by offering a more convenient and less invasive method for patients to manage their diabetes effectively.

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

This trial will compare continuous glucose monitoring (CGM) with self-monitoring of blood glucose (SMBG) for managing type 2 diabetes. Research has shown that CGM can significantly aid in managing blood sugar levels for those with type 2 diabetes. Specifically, studies have found that CGM helps lower HbA1c levels, a measure of average blood sugar over several months. CGM also enables individuals to maintain their blood sugar within a healthy range more consistently and enhances overall quality of life. In contrast, SMBG involves checking blood sugar with a finger stick several times a day. While SMBG is effective, CGM provides more detailed and continuous information, potentially leading to better diabetes management. ^{2 3 4 6 7}

Who Is on the Research Team?

Richard Bergenstal, MD

Principal Investigator

International Diabetes Center, HealthPartners Institute

Thomas W Martens, MD

Principal Investigator

International Diabetes Center, HealthPartners Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with Type 2 Diabetes, using insulin and possibly other medications, who have an A1C level between 7.5% to 12%. Participants should be receiving care within the HealthPartners Care Group, not planning to move or become pregnant in the next year, and able to follow study procedures for a year.

Inclusion Criteria

Not planning to become pregnant

I have been diagnosed with type 2 diabetes.

I use insulin for my diabetes, with or without other diabetes medications.

Exclusion Criteria

Deemed not suitable for participation in the study based on any other clinical criteria as determined by study investigator(s)

Unwillingness or inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 month

Treatment

Participants are assigned to either SMBG or CGM for glucose monitoring and management over 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• CGM
• SMBG

Trial Overview The trial compares two glucose monitoring methods: Self-Monitoring Blood Glucose (SMBG) versus Continuous Glucose Monitoring (CGM). It's conducted in primary care clinics over a year to see which method works better in regular healthcare settings.

How Is the Trial Designed?

Group I: CGM (continuous glucose monitoring) Experimental Treatment 1 Intervention

Use CGM, with availability of Ambulatory Glucose Profile (AGP) data, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources.

Group II: SMBG (Self-monitoring of blood glucose) Active Control 1 Intervention

Use SMBG, as currently used in primary care, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources.

CGM is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in United States as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Canada as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Japan as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The Eversense continuous glucose monitoring (CGM) system showed a mean absolute relative difference (MARD) of 8.8% compared to reference glucose measurements, significantly surpassing the accuracy goal of 20%, indicating its effectiveness in monitoring glucose levels in individuals with type 1 and type 2 diabetes.

The study, involving 90 participants over 90 days, reported a favorable safety profile with only one serious adverse event (1.1%) related to sensor removal, and 91% of sensors remained functional throughout the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Christiansen, MP., Klaff, LJ., Brazg, R., et al.[2019]

In a study of 104 adults with type 1 diabetes, those using intermittently scanned continuous glucose monitoring (isCGM) showed a significant reduction in HbA1c levels after 24 weeks compared to those using traditional blood glucose monitoring (BGM), with a difference of 0.3%.

The isCGM group also experienced a greater increase in time-in-range for blood glucose levels and a reduction in time spent in hyperglycemia, indicating improved glycaemic control overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intermittently scanned continuous glucose monitoring in adult type 1 diabetes patients with suboptimal glycaemic control: A multi-centre randomized controlled trial. Yan, J., Zhou, Y., Zheng, X., et al.[2023]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK603287/

Intermittently Scanned and Real-Time Continuous Glucose ... The evidence of the comparative effectiveness of isCGM versus rtCGM for improving time in range, time above range, A1C, and quality of life in people with type ...

2. diabetesjournals.org diabetesjournals.org/care/article/47/1/169/154009/Efficacy-and-Safety-of-Continuous-Glucose

Efficacy and Safety of Continuous Glucose Monitoring and ... Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

3. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.70008

Continuous glucose monitoring in noninsulin‐treated type 2 ... CGM use in noninsulin-treated individuals living with T2DM was associated with improved glycaemic outcomes and patient experience, reduced ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S016882272400809X

The effectiveness of continuous glucose monitoring with ... Conclusions. CGM with virtual diabetes educator visits is effective, safe, and acceptable in adults with type 2 diabetes not on insulin and should be considered ...

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

Advances in Continuous Glucose Monitoring: Clinical ... Continuous glucose monitoring systems have revolutionized diabetes management, significantly improving glycemic control in both Type 1 and Type 2 diabetes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38117991/

Efficacy and Safety of Continuous Glucose Monitoring and ... Both CGM and isCGM demonstrated a reduction in HbA1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

7. mdpi.com mdpi.com/2077-0383/13/3/642

Effectiveness and Safety of the Intermittently Scanned ... Real-time Continuous Glucose Monitoring (rt-CGM) does not require manual scanning, and it provides predictive alarms for hypo- or hyperglycaemia, thus resulting ...