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

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

No Placebo-Only Group

Summary

This trial aims to see if the InPen® smart insulin pen helps teens and young adults with type 1 diabetes manage their condition better. The InPen® tracks insulin doses and provides helpful reminders through an app. Participants will be monitored for a period to see if it improves their blood sugar control and quality of life. The InPen® is a smart insulin pen that tracks doses and provides reminders through an app, aiming to improve blood sugar control and quality of life.

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

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

Primary study objectives

Change in Hemoglobin A1c

Glucose

Glucose Time in Range

+1 more

Secondary study objectives

Change in Diabetes Distress Scale Score

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

Change in Transition Readiness

Awards & Highlights

No Placebo-Only Group

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

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

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