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Automated Insulin Delivery System
Omnipod 5 for Type 2 Diabetes (SECURE-T2D Trial)
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 comparing the change in hba1c during the 13 weeks study phase
Awards & highlights
Summary
This trial will assess a new automated insulin delivery system to improve treatment of adults with Type 2 diabetes.
Who is the study for?
Adults aged 18-75 with type 2 diabetes on insulin therapy are eligible for this trial. They must have an A1C between 7.0% and <12.0%, be able to use specific U-100 insulins, and not plan any major surgeries during the study. Participants should not have had severe hypoglycemia recently, take steroids, or have skin issues affecting device placement.
What is being tested?
The Omnipod 5 Automated Insulin Delivery System is being tested for safety and effectiveness in managing blood sugar levels in adults with type 2 diabetes who require insulin therapy. This single-arm study involves continuous system wear throughout the trial period.
What are the potential side effects?
Potential side effects may include skin irritation from adhesive tape, possible low or high blood sugar events due to improper dosing or system malfunction, and discomfort at the infusion site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ comparing the change in hba1c during the 13 weeks study phase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~comparing the change in hba1c during the 13 weeks study phase
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HbA1c
Secondary outcome measures
% Meeting MCID for HCS
% Meeting MCID for Pittsburgh Sleep Quality Index
% Meeting MCID for T2-DDAS
+14 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All subjects wearing the Omnipod 5 Automated Glucose Monitoring System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omnipod 5 Automated Glucose Control System
2023
N/A
~370
Find a Location
Who is running the clinical trial?
Insulet CorporationLead Sponsor
20 Previous Clinical Trials
19,032 Total Patients Enrolled
Jaeb Center for Health ResearchOTHER
154 Previous Clinical Trials
34,756 Total Patients Enrolled
Francisco J Pasquel, MDStudy ChairEmory School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can read and understand either English or Spanish.I agree to supply my own insulin throughout the study.I plan to receive a blood transfusion during the study.I can understand and follow the study's procedures and use its devices.I have used an automated insulin delivery pump in the last 3 months.I am not pregnant, breastfeeding, planning to become pregnant, or if capable of becoming pregnant, I am using effective birth control.I don't have any health conditions that would make it unsafe for me to join.I haven't had a blood disorder or used hydroxyurea in the last 3 months.I have not taken steroids in the last 8 weeks and do not plan to during the study.I am not planning any major surgeries during the study.I am between 18 and 75 years old.I use insulin for my diabetes and my A1C is between 7.0% and 12.0%.I am willing to use only Humalog, Novolog, or Admelog insulin during the study.My heart condition is not stable despite medication, or I've had a heart attack or surgery on my heart's arteries in the last year.My diabetes medication doses have been stable for the last 4 weeks.I have had more than one severe diabetes complication in the last 6 months.My weight loss medication dose has been stable for the last 4 weeks.I have type 2 diabetes and have been on insulin for at least 3 months.My doctor thinks a pump is right for me due to my severe sugar level swings.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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