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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
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
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 moreSecondary 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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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,059,469 Total Patients Enrolled
Ana Creo, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
39 Total Patients Enrolled
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