| Outcome Measures: |
Primary: Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters, Safety and tolerability of ZP4207 in the BP using either the iPhone or the iLet platform, as measured by adverse events (AEs), local tolerability of infusion site reactions, and clinical laboratory parameters. See adverse events section for results on AEs by system organ class and preferred term. Clinical laboratory parameters in terms of overall 'investigations' AEs and abnormal hematology parameters that did not resolve by the follow-up visit are presented below. LLN = lower limit of the normal range. Investigations and vital signs AEs by preferred term are presented in the AE section. Participants with infusion site pain and nausea measured by visual analog scales (VAS) are presented below; mean values are presented under secondary outcomes. For the VAS, individuals marked on a 10-cm line corresponding to the amount of pain or nausea being experienced, with low scores (cm) indicating no feelings of pain or nausea and high scores (cm) indicating high feelings of pain or nausea., Up to 50 days | Secondary: Pain Measured on a Visual Analog Scale (VAS), The VAS scale was used to measure pain at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of pain. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of pain being experienced, with low scores (cm) indicating no feelings of pain and high scores (cm) indicating high feelings of pain. Actual values are shown. The maximum value in the Lilly glucagon group was recorded at hour 3., 16 hours|Nausea Measured on a Visual Analog Scale (VAS), The VAS scale was used to measure nausea at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of nausea. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of nausea being experienced, with low scores (cm) indicating no feelings of nausea and high scores (cm) indicating high feelings of nausea. Actual values are shown. The maximum values in both groups were recorded at hour 6, the start of the exercise period., 16 hours|Glycemic Regulation, Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor \[CGM\] glucose\<60mg/dL), 16 hours|Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump., Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis., 16 hours|Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump., Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis., 16 hours|Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data, Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis., 16 hours|Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured, Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis., 16 hours|CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM, Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis., 16 hours|CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download, Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis., 16 hours|Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues, Technical faults in terms of calibration issues were listed by patient., 16 hours|Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues, Technical faults related to connectivity issues were listed, 16 hours|Diabetes Treatment Satisfaction Questionnaire - Status, This questionnaire was not assessed as per protocol amendment 7., Up to 3 months|Diabetes Treatment Satisfaction Questionnaire - Change, This questionnaire was not assessed as per protocol amendment 7., Up to 3 months|T1-Diabetes Distress Scale, This questionnaire was not assessed as per protocol amendment 7., Up to 3 months|Problem Areas in Diabetes Survey, This questionnaire was not assessed as per protocol amendment 7., Up to 3 months|Hypoglycemia Fear Survey, This questionnaire was not assessed as per protocol amendment 7., Up to 3 months|Impact of Daily Diabetes Demands, This questionnaire was not assessed as per protocol amendment 7., Up to 3 months|Bionic Pancreas User Opinion Survey, This questionnaire was not assessed as per protocol amendment 7., Up to 3 months
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