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Smart Insulin Pen

InPen® for Type 1 Diabetes

N/A

Waitlist Available

Led By Ana Creo, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial will test if the InPen®, a device that helps deliver insulin to people with type 1 diabetes, decreases burden and improves glycemic control in teens and young adults up to age 21.

Eligible Conditions

Type 1 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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 Hemoglobin A1c

Glucose

Glucose Time in Range

+1 more

Secondary outcome measures

Change in Diabetes Distress Scale Score

Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score

Change in Transition Readiness

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of care and CGM, then InPen® and CGMExperimental Treatment1 Intervention

Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) will receive standard of care with traditional insulin injections and CGM for first 90 days then switch to the InPen® and CGM for 90 days.

Group II: InPen® and CGM, then standard of care and CGMExperimental Treatment1 Intervention

Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) will use the InPen® and CGM for the first 90 days then switch to standard of care with traditional insulin injections and CGM for 90 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

InPen®

2021

N/A

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,767,070 Total Patients Enrolled

Ana Creo, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

39 Total Patients Enrolled

Frequently Asked Questions

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

Does my profile qualify me to participate in this experiment?

"Those who are between 13 and 21 years old, suffering from type 1 diabetes mellitus, may qualify for the trial. The research team is aiming to recruit 60 eligible individuals."

Answered by AI

Is this medical research seeking participants at this time?

"As assessed on clinicaltrials.gov, this exact trial is no longer recruiting participants as it was last modified on September 1st 2022. However, there are presently 1235 other studies that require patient enrolment."

Answered by AI

Is the eligibility for this trial limited to individuals aged 18 or older?

"The age requirement to qualify for this trial is between 13 and 21 years old. Of the trials hosted on clinicaltrials.gov, 209 are meant for minors while 909 focus primarily on seniors over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens

Ana L. Creo 2021. "A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05036343.