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

Recruiting in Palo Alto (17 mi)

Overseen byThomas W Martens, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: HealthPartners Institute

No Placebo Group

Trial Summary

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.

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.

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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

Treatment Details

Interventions

CGM (Behavioural Intervention)
SMBG (Behavioural Intervention)

Trial OverviewThe 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

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.

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

🇪🇺 Approved in European Union as Continuous Glucose Monitoring for: