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CGM Use for Type 2 Diabetes

N/A

Waitlist Available

Led By Drew C Prescott, PharmD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 2 diabetes

On/initiating insulin or on two or more diabetes medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will study the effects of CGM use on diabetes management among people with type 2 diabetes who have limited access to healthcare.

Who is the study for?

This trial is for underserved patients with type 2 diabetes who have an A1c level over 9% and are using insulin or at least two diabetes medications. It's not open to those currently on dialysis, pregnant, using an insulin pump, with language barriers (non-English speakers), implanted medical devices, or cognitive/physical disabilities affecting CGM use.Check my eligibility

What is being tested?

The study compares the effectiveness of a Continuous Glucose Monitor (CGM) versus a traditional glucometer in managing blood sugar levels in people with type 2 diabetes. The aim is to understand the benefits and challenges of CGM use in primary care for underserved populations.See study design

What are the potential side effects?

While there may be minimal side effects directly from using a CGM device, potential issues include skin irritation where the sensor is placed, inaccurate readings leading to incorrect insulin dosing, and possible discomfort during insertion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have type 2 diabetes.

Select...

I am taking insulin or two or more diabetes medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Hemoglobin A1c

Secondary outcome measures

Blood glucose capture rate

Hyperglycemia

Hypoglycemia

+1 more

Side effects data

From 2009 Phase 3 trial • 451 Patients • NCT00406133

11%

Severe Hypoglycemia

100%

80%

60%

40%

20%

Study treatment Arm

Secondary Cohort Control Group

Primary Cohort RT-CGM Group

Primary Cohort Control Group

Secondary Cohort RT-CGM Group

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Continuous Glucose Monitoring ArmExperimental Treatment1 Intervention

Participants in this arm will use a Freestyle Libre 2 monitoring device for 6 months to track their blood glucose levels while receiving usual patient care within an interprofessional primary care team.

Group II: Traditional Glucometer ArmActive Control1 Intervention

Participants in this arm will use a traditional glucose monitoring device (glucometer) to self-monitor their blood glucose for 6 months while receiving usual patient care within an interprofessional primary care team.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous glucose monitor

2006

Completed Phase 3

~640

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

537 Previous Clinical Trials

1,143,904 Total Patients Enrolled

Great Plains IDeA-CTRUNKNOWN

1 Previous Clinical Trials

43 Total Patients Enrolled

Drew C Prescott, PharmDPrincipal InvestigatorUniversity of Nebraska

Media Library

Continuous glucose monitor Clinical Trial Eligibility Overview. Trial Name: NCT05766488 — N/A

Type 2 Diabetes Research Study Groups: Continuous Glucose Monitoring Arm, Traditional Glucometer Arm

Type 2 Diabetes Clinical Trial 2023: Continuous glucose monitor Highlights & Side Effects. Trial Name: NCT05766488 — N/A

Continuous glucose monitor 2023 Treatment Timeline for Medical Study. Trial Name: NCT05766488 — N/A

Frequently Asked Questions

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

Are there still open vacancies for participants in this experiment?

"According to the data on clinicaltrials.gov, this medical research is actively seeking participants; it was first publicized on July 24th 2023 and last modified on August 3rd of the same year."

Answered by AI

What is the approximate number of participants in this clinical trial?

"Affirmative. Clinicaltrials.gov reports that the trial, initially posted on July 24th 2023, is actively enrolling participants across 1 site with a maximum enrollment of 50 patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Drew Prescott 2023. "Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05766488.