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Continuous Glucose Monitoring Device

Smart Insulin Pen + CGM for Diabetes

Q: Are there any opportunities to volunteer for this research experiment?

<p>Affirmative. According to clinicaltrials.gov, this study is presently recruiting patients who enrolled on the 16th of August 2021 and was last edited on 25th of August 2022. Approximately 30 individuals must be recruited from a single medical site.</p>

Q: How many participants is this clinical trial limited to?

<p>That is correct. The information located on clinicaltrials.gov verifies that this medical trial, first posted on August 16th 2021, remains in need of participants. A total of 30 patients must be secured from a single site.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing whether using a smart insulin pen with a CGM device can help people with type 2 diabetes better control their 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.Check my eligibility

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.See study design

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

Select...

I have type 2 diabetes, use insulin, and my blood sugar is not well controlled.

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.

Secondary outcome measures

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,626 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

Frequently Asked Questions

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

Are there any opportunities to volunteer for this research experiment?

"Affirmative. According to clinicaltrials.gov, this study is presently recruiting patients who enrolled on the 16th of August 2021 and was last edited on 25th of August 2022. Approximately 30 individuals must be recruited from a single medical site."

Answered by AI

How many participants is this clinical trial limited to?

"That is correct. The information located on clinicaltrials.gov verifies that this medical trial, first posted on August 16th 2021, remains in need of participants. A total of 30 patients must be secured from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Glycemic Control in DM2 Patients in the Ambulatory Setting

Ilias Spanakis 2021. "Improving Glycemic Control in DM2 Patients in the Ambulatory Setting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04800471.

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