Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

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NCT06144554 · readout ≤ 314 d

Sponsored by Insulet Corporation (industry) · PODD — their whole pipeline →.

Phase

—

Status

Recruiting

Study type

Observational

Enrollment

2,200estimated

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-09-25

actual

When the study began enrolling

Primary completion

Jun 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Sep 2028

estimated

The whole study's end, after follow-up

First posted

2023-11-22

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-01

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Type 1 Diabetes

Intervention

Device: Omnipod 5

Primary outcomes

what the primary-completion date above is the date OF

Incidence rate of severe hypoglycemia

measured From baseline to study completion, up to 12 months.

Incidence rate of DKA

measured From baseline to study completion, up to 12 months.

A1c at 3, 6, 9 and 12 months

measured Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months

Percentage of time < 54 mg/dL

measured From baseline to study completion, up to 12 months

Percentage of time < 70 mg/dL

measured From baseline to study completion, up to 12 months

Percentage of time > 180 mg/dL

measured From baseline to study completion, up to 12 months

Percentage of time > 250 mg/dL

measured From baseline to study completion, up to 12 months

Percentage of time in range 70-180 mg/dL

measured From baseline to study completion, up to 12 months

Mean Glucose mg/dL

measured From baseline to study completion, up to 12 months

Standard deviation of glucose mg/dL

measured From baseline to study completion, about 12 months

Glucose management indicator %

measured From baseline to study completion, up to 12 months

Percentage of participants achieving A1C < 7%

measured From baseline to study completion, up to 12 months

Percentage of participants with time in range > 70%

measured From baseline to study completion, up to12 months

Percentage of participants with time below range (<70mg/dL) of < 4%

measured From baseline to study completion, up to 12 months

Insulin Usage

measured From baseline to study completion, up to 12 months

Body Mass Index (BMI) or BMI z-score

measured at 6 months and at the end of registry participation, up to 12 months.

EQ-5D (inclusive of the Visual Analogue Scale (VAS))

measured at baseline, at 6 months and at the end of registry participation, up to 12 months.

Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE)

measured at baseline, at 6 months and at the end of registry participation, up to 12 months

System Usability Scale (SUS)

measured at baseline, at 6 months and at the end of registry participation, up to 12 months

Incidence rate of prolonged hyperglycemia (events per person months) during usage of Activity Feature

measured From baseline to study completion, up to 12 months

Incidence rate of prolonged hyperglycemia (events per person months)

measured From baseline to study completion, up to 12 months

Incidence rate of prolonged hyperglycemia (events per person months) during usage of a Target Glucose of 140 mg/dL or 150 mg/dL

measured From baseline to study completion, up to 12 months

Glucose Outcomes during the 4-hour post-bolus period using the SmartBolus Calculator: o Percentage of time < 54 mg/dL o Percentage of time in range 70-180 mg/dL

measured From baseline to study completion, up to 12 months

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