Health TrialsbyHealthPanel

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System

ConditionsType 2 Diabetes MellitusType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-75
SponsorInsulet Corporation

About this trial

This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age at time of consent 14-75 years (inclusive)

Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment

Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation

HbA1c ≥ 7.5%

Disqualifiers

Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk

Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening

Any planned surgery during the study which could be considered major in the judgment of the investigator

History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Omnipod 5 System

    Device

    The Omnipod 5 System with the study CGM

  • Omnipod 6 System

    Device

    The Omnipod 6 System with the study CGM

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Omnipod 5 SystemActive comparator 1 intervention
Group B: Omnipod 6 SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time in Range 70-180 mg/dL

Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5

Time frame
13 weeks
2

Time <54 mg/dL

Change in CGM percent time \<54 mg/dL compared between Omnipod 6 and Omnipod 5

Time frame
13 weeks
3

Time <70 mg/dL

Change in CGM percent time \<70 mg/dL compared between Omnipod 6 and Omnipod 5

Time frame
13 weeks
4

Time >180 mg/dL

Change in CGM percent time \>180 mg/dL compared between Omnipod 6 and Omnipod 5

Time frame
13 weeks

Secondary outcomes

1

Total boluses per day

Total blues per day will be compared between Omnipod 6 and Omnipod 5

Time frame
13 weeks
2

Total daily insulin per kg and total insulin delivered via automation

Total daily insulin per kg and total insulin delivered via automation will be compared between Omnipod 6 and Omnipod 5

Time frame
13 weeks
3

Percentage of time in automated mode

Percentage of time in automated mode will be compared between Omnipod 6 and Omnipod 5

Time frame
13 weeks
4

Percentage with HbA1c <7.0% and <7.5%

Percentage with HbA1c \<7.0% and \<7.5% will be compared between Omnipod 6 and Omnipod 5

Time frame
13 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insulet Corporation

Lead sponsor

Source ClinicalTrials.gov
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