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Automated Insulin Delivery System
Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 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 automated mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for group a and group b
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the Omnipod 5 system, a wearable device that automatically delivers insulin, in people with diabetes who need better blood sugar control. It monitors blood sugar levels and adjusts insulin delivery to maintain target ranges. The Omnipod 5 Automated Insulin Delivery System is a recent advancement in diabetes technology, designed to improve glycemic control and reduce the burden of diabetes management.
Eligible Conditions
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ automated mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for group a and group b
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~automated mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for group a and group b
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hyperglycemia
Hypoglycemia
Secondary study objectives
Change in Hemoglobin A1c (HbA1c)
Coefficient of Variation
Mean glucose
+9 moreAwards & 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: Basal-Bolus (Group A)Experimental Treatment1 Intervention
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 6-month optional extension using Automated Mode
Group II: Basal (Group B)Experimental Treatment1 Intervention
* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 6-month optional extension using Automated Mode
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omnipod 5 Automated Insulin Delivery System
2020
N/A
~30
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Who is running the clinical trial?
Insulet CorporationLead Sponsor
21 Previous Clinical Trials
19,426 Total Patients Enrolled
Anders Carlson, MDStudy ChairInternational Diabetes Center at Park Nicollet
Anne Peters, MDStudy ChairKeck School of Medicine of USC
1 Previous Clinical Trials
10 Total Patients Enrolled