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CGM vs. SMBG for Type 2 Diabetes (GluCoCare Trial)

N/A
Waitlist Available
Led By Richard M Bergenstal, MD
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of type 2 diabetes
Insulin use with or without other classes of glycemia medication use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While this study focuses on monitoring rather than medication side effects, participants may experience discomfort from frequent blood glucose testing or wearing CGM devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 2 diabetes.
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I use insulin for my diabetes, with or without other diabetes medications.
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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in A1C
Change in Diabetes Distress

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CGM (continuous glucose monitoring)Experimental Treatment1 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 Control1 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Type 2 Diabetes include metformin, which decreases hepatic glucose production and increases insulin sensitivity; sulfonylureas, which stimulate insulin secretion from pancreatic beta cells; and SGLT2 inhibitors, which reduce glucose reabsorption in the kidneys, leading to increased glucose excretion. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying. These mechanisms are crucial for Type 2 Diabetes patients as they help maintain blood glucose levels within a target range, reducing the risk of complications. Effective glucose monitoring, whether through SMBG or CGM, allows patients and healthcare providers to tailor these treatments to individual needs, optimizing glycemic control and improving overall health outcomes.
What next after basal insulin? Treatment intensification with lixisenatide in Asian patients with type 2 diabetes mellitus.A patient-centered approach to managing patients with type 2 diabetes.Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals.

Find a Location

Who is running the clinical trial?

HealthPartners InstituteLead Sponsor
192 Previous Clinical Trials
3,721,199 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
573 Previous Clinical Trials
27,077,873 Total Patients Enrolled
Richard M Bergenstal, MDPrincipal InvestigatorInternational Diabetes Center, HealthPartners Institute
8 Previous Clinical Trials
1,006 Total Patients Enrolled

Media Library

CGM Clinical Trial Eligibility Overview. Trial Name: NCT05222815 — N/A
Type 2 Diabetes Research Study Groups: CGM (continuous glucose monitoring), SMBG (Self-monitoring of blood glucose)
Type 2 Diabetes Clinical Trial 2023: CGM Highlights & Side Effects. Trial Name: NCT05222815 — N/A
CGM 2023 Treatment Timeline for Medical Study. Trial Name: NCT05222815 — N/A
~97 spots leftby Oct 2025