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Device

Continuous Glucose Monitors for Uncontrolled Type 2 Diabetes

N/A

Recruiting

Led By Kasia Lipska, MD MHS

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Diagnosed with type 2 diabetes mellitus

Age greater than or equal to 18

Must not have

End-Stage Renal Disease (ESRD)

Insulin naïve

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks, 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how giving free continuous glucose monitoring (CGM) sensors to adult patients with poorly controlled type 2 diabetes at Fair Haven Community Health Care can improve their blood sugar levels and quality

Who is the study for?

This trial is for adults with poorly controlled type 2 diabetes who are patients at Fair Haven Community Health Care. It's designed to see if using a Continuous Glucose Monitor (CGM) helps manage their condition better.

What is being tested?

The study provides free CGM sensors to participants and observes any changes in blood sugar control and quality of life before and after the use of CGMs, without comparing different groups or treatments.

What are the potential side effects?

While not specified here, potential side effects from using a CGM may include skin irritation where the device attaches, possible allergic reaction to adhesive, or inaccuracies leading to mismanagement of insulin.

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 am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have end-stage kidney disease.

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I have never taken insulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks, 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks, 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Hemoglobin A1c concentration

Mean Illness Intrusiveness Ratings Scale score (IIRS)

Secondary study objectives

Mean Diabetes Distress Scale score (DDS-17)

Mean Summary of Diabetes Self-Care Activities (SDSCA) score

Mean Treatment Burden Questionnaire (TBQ) score

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Poorly Controlled Type 2 Diabetes- CGMExperimental Treatment1 Intervention

Participants will have CGM sensor placed at first visit and will be worn for 12 weeks. Sensor must be scanned 3 times daily. Adjustments to medication regimen will be recommended at 6 weeks. Follow-up appointments will be at 12 weeks and 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Glucose Monitor (CGM)

2017

Completed Phase 3

~680

0 / 4Eligibility criteria met