Health TrialsbyHealthPanel

Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D

ConditionsType 1 DiabetesType 1 Diabetes MellitusDiabetes (DM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-70
SponsorInsulet Corporation

About this trial

Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age at time of consent 2-70 years (inclusive)

Type 1 diabetes diagnosis for at least 6 months, for those aged 8-70 years, or 3 months for those aged 2-7 years, based on Investigator assessment

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

Willing to use the following types of U-100 insulin during the study: Humalog U-100, Novorapid or their generic equivalents

Disqualifiers

Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.

Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or arrhythmias requiring intervention within the 12 months prior to screening

Any planned surgery during the study which could be considered major in the opinion of the Investigator

History of more than 1 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions

Trial design

Design model

Single group

Treatments tested in this trial

  • Omnipod M System

    Device

    Participants will use the Omnipod M System

  • Omnipod S

    Device

    Participants will use the Omnipod S System

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Adults with T1D using Omnipod MExperimental treatment 1 intervention
Group B: Adults and pediatrics with T1D using Omnipod SExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of time <54 mg/dL

CGM percent time \<54 mg/dL compared to standard therapy

Time frame
72-hour Omnipod M Hotel Period
2

Percentage of time <70 mg/dL

CGM percent time \<70 mg/dL compared to standard therapy

Time frame
72-hour Omnipod M Hotel Period
3

Percentage of time >180 mg/dL

CGM percent time \>180 mg/dL compared to standard therapy

Time frame
72-hour Omnipod M Hotel Period
4

Percentage of time <54 mg/dL

CGM percent time \<54 mg/dL compared to standard therapy

Time frame
4-week Omnipod M outpatient

Secondary outcomes

Other outcomes

Sponsors and contacts

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Insulet Corporation

Lead sponsor

Source ClinicalTrials.gov
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