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b'In order to be eligible to participate in this study, an individual must meet all of the' |
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b'following criteria:' |
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b'Participants are 18 - 70 years of age inclusive' |
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b'Participant is in generally good health, as determined by the investigator' |
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b'Participant is willing and able to individually complete written informed consent and' |
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b'agrees to comply with all study related testing and examinations' |
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b'Participant must be geographically stable (e.g., expects to be available and capable' |
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b'of returning for all study specified test and examinations) during the study period' |
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b'Participant has been diagnosed with T1DM for at least 12 months' |
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b'C-peptide <0.6 nmol/L at screening' |
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b'Participant has been using insulin pump therapy for at least 6 months and is currently' |
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b'using a Medtronic MiniMed pump, model series 530 or higher. Use of 670G in auto mode' |
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b'is acceptable.' |
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b'Participant can provide a minimum of 14 days of insulin pump data to demonstrate pump' |
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b'use compliance' |
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b'Participant is willing to perform frequent (4 times per day or more) self-monitoring' |
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b'of blood glucose (SMBG), including before meals and before bed, and using a meter and' |
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b'test strips provided by the sponsor during the two weeks of active treatment. This' |
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b'includes participants who are currently using real-time continuous glucose monitoring' |
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b'and may continue to do so, but must also collect SMBG values as instructed.' |
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b'Participant is willing to perform serum ketone measurements whenever the blood glucose' |
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b'is determined to be greater than 250 mg/dL after extended fasting (e.g. overnight or' |
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b'more than five hours after a meal) using a ketone meter and strips provided by the' |
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b'ponsor' |
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b'Participant has BMI in the range 20 - 35 kg/m2 inclusive' |
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b'Participant has experience infusing a rapid-acting insulin analog for at least 6' |
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b'months' |
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b'Participant has been using or is willing to use CGM (reading data available for at' |
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b'least 80% of time for a week of data collection during the screening period).' |
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b'Participants already using - Dexcom G6 real time CGM may continue to use their own CGM' |
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b'unit; participants not using the G6 will be provided with a G6 monitor. All' |
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b'participants will be provided with CGM disposables for use during the treatment' |
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b'period.' |
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b'Participant has ability to understand and comply with protocol procedures and to' |
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b'provide informed consent' |
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b'HbA1c \\u22648.5%' |
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b'Stable body weight in the 3 months prior to enrollment (change in body weight <5%)' |
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b'An individual who meets any of the following criteria will be excluded from participation'
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b'in this study:'
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b'Participants whose average total daily insulin dose exceeds 85 units/day (i.e.'
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b'typically change insulin reservoirs more often than every 4 days on average)'
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b'Participants who routinely change their commercial insulin infusion sets on average'
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b'less often than every 4.5 days'
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b'Female participant is pregnant or nursing'
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b'Participant has abnormal skin at intended device infusion sites (existing infection,'
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b'inflammation, burns, or other extensive scarring)'
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b'Participant has hemoglobin <12.0 g/dL or potassium < 3.5 mEq/L at screening'
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b'Participant has documented history in last 6 months of severe hypoglycemia associated'
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b'with cognitive dysfunction sufficiently severe to require third party intervention or'
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b'a history of impaired awareness of hypoglycemia.'
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b'Participant has a history of diabetic ketoacidosis in the last 6 months'
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b'Participant has known cardiovascular disease considered to be clinically relevant by'
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b'the investigator'
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b'Participant has known arrhythmias considered to be clinically relevant by the'
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b'investigator'
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b'Participant has known history of:'
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b"Cushing's Disease,"
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b'pancreatic islet cell tumor, or'
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b'insulinoma'
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b'Participant has:'
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b'Lipodystrophy,'
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b'extensive lipohypertrophy, as assessed by the investigator'
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b'Participant is undergoing current treatment with:'
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b'Systemic oral or intravenous corticosteroids,'
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b'monoamine oxidase (MAO) inhibitors,'
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b'non-selective systemic beta-blockers,'
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b'growth hormone,'
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b'thyroid hormones, unless use has been stable during the past 3 months'
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b'SGLT2 inhibitors'
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b'Participant has significant history of any of the following, that in the opinion of'
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b"the investigator would compromise the participant's safety or successful study"
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b'participation:'
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b'Alcoholism,'
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b'drug abuse'
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b"Significant acute or chronic illness, that in the investigator's opinion, might"
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b'interfere with participant safety or integrity of study results'
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b'Planned operation, MRI or CT which require removal of infusion set or CGM sensor'
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b'during wear periods'
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b'Current treatment with systemic (oral or IV) corticosteroids, monoamine oxidase (MAO)'
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b'inhibitors, non-selective beta-blockers, growth hormone, herbal products that, in the'
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b'opinion of the investigator, may alter insulin sensitivity or confer undue risk to the'
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b"participant's participation in the study or non-routine vitamins. Furthermore, thyroid"
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b'hormones are not allowed unless the use of these has been stable during the past 3'
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b'months.'
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b'Current participation in another clinical drug or device study'
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b'Inability of the participant to comply with all study procedures or to understand the'
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b'participant instructions'
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