Evaluating Glucose Control Using a Next-Generation AID Algorithm in Adults With T1D
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-70
SponsorInsulet Corporation
About this trial
Single-arm feasibility study to evaluate the safety and feasibility of the Omnipod M System in adults with type 1 diabetes. This study will enroll up to 40 adult participants to have a minimum of 24 participants to initiate the use of the study device. The study will include hotel and outpatient evaluation periods.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age at time of consent 16-70 years (inclusive)
Type 1 diabetes diagnosis for at least 6 months, 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
DeviceParticipants will use the Omnipod M System
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Adults with T1D using Omnipod MExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of time <54 mg/dL
CGM percent time \<54 mg/dL compared to baseline
Time frame
72-hour Hotel Period2
Percentage of time <70 mg/dL
CGM percent time \<70 mg/dL compared to baseline
Time frame
72-hour Hotel Period3
Percentage of time >180 mg/dL
CGM percent time \>180 mg/dL compared to baseline
Time frame
72-hour Hotel Period4
Percentage of time <70 mg/dL
CGM percent time \<70 mg/dL compared to baseline
Time frame
4-week outpatient treatment periodSecondary outcomes
1
Mean glucose
Mean glucose compared to baseline
Time frame
4-weeks2
Percentage of time <54 mg/dL
CGM percent time \<54 mg/dL compared to baseline
Time frame
4-weeks outpatient treatment period3
Percentage of time >250 mg/dL
CGM percent time \>250 mg/dL compared to baseline
Time frame
4-weeks outpatient treatment period4
Percentage of time >300 mg/dL
CGM percent time \>300 mg/dL compared to baseline
Time frame
4-weeks outpatient treatment periodSponsors and contacts
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Source ClinicalTrials.gov
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