Trial Outcomes & Findings for Feasibility Study Using Zone-MPC Controller, HMS and Technosphere® Insulin Inhalation System From MannnKind Corp (NCT NCT01874392)

Results Overview

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range 5 hours after meal: \[70-180\] mg/dL.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

5 hours

Results posted on

2021-11-11

Participant Flow

Participant milestones

Participant milestones
Measure	T1DM Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729 Artificial Pancreas (AP) device (APS©): Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T1DM n=9 Participants Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729 Artificial Pancreas (AP) device (APS©): Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants
Age, Continuous	49 years STANDARD_DEVIATION 10 • n=9 Participants
Sex: Female, Male Female	6 Participants n=9 Participants
Sex: Female, Male Male	3 Participants n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 5 hours

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range 5 hours after meal: \[70-180\] mg/dL.

Outcome measures

Outcome measures
Measure	T1DM n=9 Participants Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729 Artificial Pancreas (AP) device (APS©): Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.	81.6 percentage time in range (70 - 180 mg/dL Interval 72.5 to 85.0

PRIMARY outcome

Timeframe: 25-28 hours

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range for the entire study: \[80-140\] mg/dL

Outcome measures

Outcome measures
Measure	T1DM n=9 Participants Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729 Artificial Pancreas (AP) device (APS©): Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.	67.5 percentage time in range(80-140mg/dL) Interval 48.5 to 73.1

PRIMARY outcome

Timeframe: 30 minutes

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range during exercise: \[70-150\] mg/dL

Outcome measures

Outcome measures
Measure	T1DM n=9 Participants Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729 Artificial Pancreas (AP) device (APS©): Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting	94.4 percentage time in range (70-150 mg/dL) Interval 91.6 to 94.4

PRIMARY outcome

Timeframe: 3 hours

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Target range 3 hours after exercise: \[70-150\] mg/dL

Outcome measures

Outcome measures
Measure	T1DM n=9 Participants Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729 Artificial Pancreas (AP) device (APS©): Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting	94.4 percentage time in range (70-150 mg/dL) Interval 91.6 to 94.4

PRIMARY outcome

Timeframe: 7 hours overnight

This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within Overnight target range: \[70-180\] mg/dL

Outcome measures

Outcome measures
Measure	T1DM n=9 Participants Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729 Artificial Pancreas (AP) device (APS©): Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Test the Safety of the AP Device While the Subject is Under Close Medical Supervision in the Clinical Research Center (CRC) Setting.	100 percentage time in range (70 - 180 mg/dL Interval 95.2 to 100.0

SECONDARY outcome

Timeframe: 150 minutes

To evaluate the performance of the AP device combined with the Technosphere® Insulin Powder System after dinner by measuring the postprandial excursion of blood glucose.

Outcome measures

Outcome measures
Measure	T1DM n=9 Participants Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729 Artificial Pancreas (AP) device (APS©): Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System	64 mg/dL Interval 30.0 to 120.0

SECONDARY outcome

Timeframe: 120 minutes

To evaluate the performance of the AP device combined with the Technosphere® Insulin Powder System after breakfast by measuring the postprandial excursion of blood glucose

Outcome measures

Outcome measures
Measure	T1DM n=9 Participants Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months Investigational inhaled insulin (Technosphere): by MannKind Corp. IND 61,729 Artificial Pancreas (AP) device (APS©): Device includes: * OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp. * Dexcom® G4® CGM System (CGM) from Dexcom® Corp * Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Test the Benefits of the AP Device Combined With the Technosphere® Insulin Powder System	61 mg/dL Interval 56.0 to 85.0

Adverse Events

T1DM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Research and Innovation

Sansum Diabetes Research Institute

Phone: 8056827640

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place