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

359 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment CGM for Type 2 Diabetes?

Research shows that using continuous glucose monitoring (CGM) helps improve diabetes control in people with both type 1 and type 2 diabetes. This suggests that CGM can be effective for managing blood sugar levels in type 2 diabetes as well. ^{1 2 3 4 5}

Is continuous glucose monitoring (CGM) safe for humans?

Continuous glucose monitors (CGMs) are non-invasive devices that have been used safely in various studies, including those involving children and adults with type 1 diabetes. These devices provide regular glucose readings without the need for frequent finger pricks, and no significant safety concerns have been reported in the available research. ^{1 4 6 7 8}

How is the treatment CGM different from other treatments for type 2 diabetes?

Continuous Glucose Monitoring (CGM) is unique because it provides real-time, continuous tracking of glucose levels throughout the day, unlike traditional methods that only offer a snapshot at specific times. This allows for better management of blood sugar levels by showing trends and patterns, which can help improve overall diabetes control. ^{6 9 10 11 12}

What is the purpose of this trial?

This trial compares two ways of checking blood sugar in people with type 2 diabetes who use insulin. One method involves pricking the finger, and the other uses a sensor that continuously monitors blood sugar. The study will see which method is better at managing blood sugar over time.

Research Team

Richard Bergenstal, MD

Principal Investigator

International Diabetes Center, HealthPartners Institute

Thomas W Martens, MD

Principal Investigator

International Diabetes Center, HealthPartners Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Marked Improvement in A1C Levels After Initiation of Intermittently Scanned Continuous Glucose Monitoring Is Maintained Over 4 Years in Patients With Type 1 Diabetes. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance. [2022]

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

Evaluation of conventional blood glucose monitoring as an indicator of integrated glucose values using a continuous subcutaneous sensor. [2019]

4. England 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. [2023]

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

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. [2019]

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

Use of Continuous Glucose Monitoring System in Children with Type 1 Diabetes Mellitus in a Resource Limited Setting. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Accuracy Evaluation of Five Blood Glucose Monitoring Systems in Patients from Different Departments. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Addition of intermittently scanned continuous glucose monitoring to standard care in a cohort of pregnant women with type 1 diabetes: effect on glycaemic control and pregnancy outcomes. [2023]

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

Common Questions on Continuous Glucose Monitoring in Primary Care. [2022]

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

Comparison of the clinical information provided by the FreeStyle Navigator continuous interstitial glucose monitor versus traditional blood glucose readings. [2010]

11. England pubmed.ncbi.nlm.nih.gov

Effects of continuous glucose monitoring on glycaemic control in type 2 diabetes: A systematic review and network meta-analysis of randomized controlled trials. [2023]

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

Minimally Invasive Implant Type Electromagnetic Biosensor for Continuous Glucose Monitoring System: In Vivo Evaluation. [2023]