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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

GluCoCare Trial Summary

This trial will compare two different glucose monitoring strategies (SMBG vs. CGM) by randomly assigning 30 primary care clinics and 354 patients to one of the two strategies. The trial will last for 12 months.

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.Check my eligibility

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.See study design

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.

GluCoCare Trial 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.

GluCoCare Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in A1C

Change in Diabetes Distress

GluCoCare 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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

HealthPartners InstituteLead Sponsor

184 Previous Clinical Trials

3,715,805 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

549 Previous Clinical Trials

29,996,194 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study accept participants of 40 years and above?

"As outlined in the inclusion criteria, only those aged 18 to 75 can qualify for this trial. There are specialised trials available for children up to age 17 and seniors over 65; 46 and 679 respectively."

Answered by AI

Are any additional participants being accepted for the current clinical trial?

"This clinical trial is not currently enrolling, as evidenced by the data hosted on clinicialtrials.gov; this study was published and last updated on August 29th, 2022. However, there are 790 other research projects actively recruiting participants at present."

Answered by AI

What are the requirements for me to be considered an applicant in this clinical study?

"This trial is recruiting 354 diabetics of type 2 aged between 18 and 75. Qualified candidates must meet the following requirements: age (18-75), diagnosis of diabetes mellitus, two months' history of insulin/glycemia medication use, no severe comorbidities which could prevent primary care team from managing diabetes, already established in HealthPartners Care Group with intention to stay for a year or more, not using personal CGM currently; A1C 7.5%-12% within last two months (if older than that – point-of-care/lab A1C may be used); readiness to collect"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Glucose Monitoring Comparison in Primary Care

2022. "Glucose Monitoring Comparison in Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05222815.

All > Diabetes Type 2