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Insulin Delivery Device

Intervention Arm for Type 1 Diabetes

N/A
Waitlist Available
Research Sponsored by Insulet Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline compared to end of study visit (day -30 to day 90)
Awards & highlights

Study Summary

This trial will test a new insulin system called the Omnipod 5. Subjects will use it for 14 days and then either continue using it for 90 days or go back to their regular insulin pump. Data will be collected throughout.

Who is the study for?
Adults aged 18-70 with Type 1 Diabetes for at least a year, currently on pump therapy, and familiar with insulin delivery concepts. They must be willing to use the Omnipod 5 system or their own pump with continuous glucose monitoring and have an A1C between 7.0-11.0%. Exclusions include severe hypoglycemia history, steroid treatment, skin conditions affecting device placement, certain medication use (except metformin), pregnancy/lactation without birth control, participation in other trials recently.Check my eligibility
What is being tested?
The trial is testing the Omnipod 5 System against personal insulin pumps over a period of about three months. Participants will first undergo a standard therapy phase for two weeks before using either the new system or continuing their current pump therapy alongside continuous glucose monitoring.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include skin irritation from adhesive tape used by devices, hypoglycemia due to insulin delivery errors or malfunctions within the systems being tested.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline compared to end of study visit (day -30 to day 90)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline compared to end of study visit (day -30 to day 90) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of time in range 70-180 mg/dL
Secondary outcome measures
Change in A1C
Change in Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS) total score
Change in Diabetes Quality of Life (DQL)-brief total score
+5 more

Trial Design

2Treatment groups
Active Control
Group I: Intervention ArmActive Control1 Intervention
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Group II: Control ArmActive Control1 Intervention
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system

Find a Location

Who is running the clinical trial?

Insulet CorporationLead Sponsor
20 Previous Clinical Trials
19,218 Total Patients Enrolled
Eric Renard, MDStudy ChairLapeyronie Montpellier University Hospital
1 Previous Clinical Trials
200 Total Patients Enrolled
Eric Renard, PrStudy ChairLapeyronie Montpellier University Hospital

Media Library

Omnipod 5 System (Insulin Delivery Device) Clinical Trial Eligibility Overview. Trial Name: NCT05409131 — N/A
Type 1 Diabetes Research Study Groups: Intervention Arm, Control Arm
Type 1 Diabetes Clinical Trial 2023: Omnipod 5 System Highlights & Side Effects. Trial Name: NCT05409131 — N/A
Omnipod 5 System (Insulin Delivery Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05409131 — N/A

Frequently Asked Questions

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

How many sites are actively participating in this experimental research?

"The University of Washington in Seattle, the Sansum Diabetes Research Institute in Santa Barbara and Joslin Diabetes Center based out of Boston are three sites actively recruiting patients. Additionally, there are 4 other clinical trial locations that have been approved to take part in this medical study."

Answered by AI

What criteria must individuals meet to be eligible for this experiment?

"This clinical trial seeks 200 individuals aged between 18 and 70 that suffer from diabetes and/or autoimmune diseases. Additional criteria includes: a point-of-care A1C measure of 7.0 - 11.0%, three months experience with pump therapy, the ability to safely use study devices, access to a compatible smartphone for downloading the Dexcom app, the willingness to wear system continuously throughout study period, and signing an Informed Consent Form (ICF)."

Answered by AI

What is the current enrollment number for this trial?

"In total, 200 patients who are suitable for the clinical trial must be recruited. The study sponsor is Insulet Corporation and will take place at two sites - University of Washington in Seattle, WA and Sansum Diabetes Research Institute in Santa Barbara, CA."

Answered by AI

Is a minimum age requirement precluding those younger than 50 from participating in this research?

"The eligibilty requirements for this medical experiment stipulate that the minimum age of participants is 18, while those over 70 are excluded."

Answered by AI

Is recruitment for this medical experiment still underway?

"According to data hosted on clinicaltrials.gov, this investigation is actively seeking participants with the trial having been initially posted on July 7th 2022 and most recently updated September 8th 2022."

Answered by AI
~75 spots leftby Mar 2025