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Automated Insulin Delivery System

Omnipod 5 Automated Insulin Delivery System for 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

Study Summary

This study is evaluating whether a wearable insulin pump can improve glucose control in people with type 1 diabetes.

Eligible Conditions
  • Type 2 Diabetes

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hyperglycemia
Hypoglycemia
Secondary outcome measures
Change in Hemoglobin A1c (HbA1c)
Coefficient of Variation
Mean glucose
+9 more

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

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

Find a Location

Who is running the clinical trial?

Insulet CorporationLead Sponsor
20 Previous Clinical Trials
19,342 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
2020. "Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04617795.
~5 spots leftby Apr 2025
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