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Continuous Glucose Monitoring Device

Smart Insulin Pen + CGM for Diabetes

N/A
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Insulin-treated patients with DM2 (treated with basal-bolus insulin regimens (MDI), ± non-insulin medications) and Uncontrolled glycemic control
Be older than 18 years old
Must not have
Significant psychiatric illness or any other condition rendering the subject incapable of understanding the objectives and potential consequences of the study
History of type 1 DM (DM1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial is testing if using smart insulin pens, continuous glucose monitors, and telemedicine can help people with type 2 diabetes manage their blood sugar better. These tools keep track of blood sugar levels and insulin use all the time and send this information to doctors. Doctors can then adjust treatments quickly without needing in-person visits. The goal is to see if this approach leads to better blood sugar control and more exercise. Smart insulin pens and continuous glucose monitors have been increasingly used to improve diabetes management by providing real-time data and insights into insulin use and blood sugar levels.

Who is the study for?
This trial is for adults with type 2 diabetes who are currently using insulin and have not been able to control their blood sugar levels well. It's not open to those with type 1 diabetes, severe skin issues or allergies that prevent wearing a CGM device, kidney disease requiring dialysis, pregnant women, or individuals with significant psychiatric conditions.
What is being tested?
The study is testing if smart insulin pens along with Continuous Glucose Monitoring (CGM) devices can help better manage blood sugar in people with type 2 diabetes compared to standard glucose monitoring methods.
What are the potential side effects?
Potential side effects may include skin irritation from the CGM sensor adhesive, possible hypoglycemia due to insulin adjustments based on more frequent glucose data, and any typical risks associated with insulin use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type 2 diabetes, use insulin, and my blood sugar is not well controlled.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I understand the study's goals and potential risks.
Select...
I have type 1 diabetes.
Select...
I am on dialysis for end-stage kidney disease.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Glucose Variability
Change in Time Above Range (>180 mg/dl)
Change in Time Below Range (<70 mg/dl)
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Smart insulin pens and CGMActive Control1 Intervention
Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices
Group II: Point of Care Glucose GroupPlacebo Group1 Intervention
Participants in this group will be monitored by point of care glucose values

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,340 Total Patients Enrolled
4 Trials studying Diabetes
23,990 Patients Enrolled for Diabetes

Media Library

CGM (Continuous Glucose Monitoring Device) Clinical Trial Eligibility Overview. Trial Name: NCT04800471 — N/A
Diabetes Research Study Groups: Smart insulin pens and CGM, Point of Care Glucose Group
Diabetes Clinical Trial 2023: CGM Highlights & Side Effects. Trial Name: NCT04800471 — N/A
CGM (Continuous Glucose Monitoring Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04800471 — N/A
~7 spots leftby Dec 2025
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