Trial Outcomes & Findings for Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes (NCT NCT05243628)

NCT ID: NCT05243628

Last Updated: 2025-04-08

Results Overview

Change in glycated hemoglobin (HbA1c) from baseline to end of study

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2025-04-08

Participant Flow

Per protocol, participants who complete the informed consent process are enrolled in the study. In this study, 33 participants were enrolled in the study. The study has a run-in period of up to 28 days. After completion of the run-in period, and confirmation of all eligibility requirements, the participant may be assigned to a study arm/group. In this study, only 28 participants started the treatment phase and were assigned to a study arm/group (5 participants are considered PreRand drops).

Participant milestones

Measure	Afrezza + Automatic Insulin Delivery (AID) Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Overall Study STARTED	13	10	5
Overall Study COMPLETED	9	10	5
Overall Study NOT COMPLETED	4	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes

Baseline characteristics by cohort

Measure	Afrezza + Automatic Insulin Delivery (AID) n=13 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=93 Participants	10 Participants n=4 Participants	5 Participants n=27 Participants	28 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	9 Participants n=4 Participants	3 Participants n=27 Participants	19 Participants n=483 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	9 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	3 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=93 Participants	10 Participants n=4 Participants	5 Participants n=27 Participants	25 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) White	13 Participants n=93 Participants	10 Participants n=4 Participants	5 Participants n=27 Participants	28 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	13 participants n=93 Participants	10 participants n=4 Participants	5 participants n=27 Participants	28 participants n=483 Participants

PRIMARY outcome

Timeframe: 90 days

Change in glycated hemoglobin (HbA1c) from baseline to end of study

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=9 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Change in HbA1c	0.32 percent of glycated hemoglobin Standard Deviation 0.55	0.35 percent of glycated hemoglobin Standard Deviation 0.58	0.52 percent of glycated hemoglobin Standard Deviation 0.29

SECONDARY outcome

Timeframe: 90 days

Events of hypoglycemia (SMBG <70 mg/dL for SMBG values more than 30 minutes apart)

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=11 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Events of Level 1 Hypoglycemia (SMBG < 70mg/dL)	12 Count of events Standard Deviation 12	20 Count of events Standard Deviation 12	14 Count of events Standard Deviation 7

SECONDARY outcome

Timeframe: 90 days

Events of hypoglycemia (SMBG <54 mg/dL for SMBG values more than 30 minutes apart)

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=11 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Events of Level 2 Hypoglycemia (SMBG < 54 mg/dL)	3 Count of events Standard Deviation 3	5 Count of events Standard Deviation 4	4 Count of events Standard Deviation 5

SECONDARY outcome

Timeframe: 90 days

Events of severe hypoglycemia requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=11 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Events of Severe Hypoglycemia	0 Count of events	0 Count of events	0 Count of events

SECONDARY outcome

Timeframe: baseline and 90 days

Change from baseline to end of study in Time in Range (TIR), defined as the percentage of time spent with glucose in the range of 70 to 180 mg/dL, based on continuous glucose monitoring derived glucose values

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=9 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Change in Time in Range (Glucose of 70 - 180 mg/dL)	4.69 percent of TIR Standard Deviation 27.61	-3.89 percent of TIR Standard Deviation 16.00	1.99 percent of TIR Standard Deviation 10.12

SECONDARY outcome

Timeframe: baseline and 90 days

Change from baseline to end of study in Time Below Range (TBR), defined as the percentage of time spent with glucose <70 mg/dL, based on continuous glucose monitoring derived glucose values

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=9 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Change in Time Below Range (Glucose <70 mg/dL)	-0.06 percent of TBR Standard Deviation 1.72	1.92 percent of TBR Standard Deviation 4.23	-0.18 percent of TBR Standard Deviation 0.44

SECONDARY outcome

Timeframe: baseline and 90 days

Change from baseline to end of study in percentage of time spent with glucose <54 mg/dL, based on continuous glucose monitoring derived glucose values

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=9 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Change in Percentage of Time With Glucose <54 mg/dL	0.03 percent of time with glucose <54mg/dL Standard Deviation 0.43	0.88 percent of time with glucose <54mg/dL Standard Deviation 2.04	-0.1 percent of time with glucose <54mg/dL Standard Deviation 0.12

SECONDARY outcome

Timeframe: baseline and 90 days

Change from baseline to end of study in Time Above Range (TAR), defined as the percentage of time spent with glucose >180 mg/dL, based on continuous glucose monitoring derived glucose values

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=9 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Change in Time Above Range (Glucose >180 mg/dL)	-4.63 percent of TAR Standard Deviation 28.69	1.97 percent of TAR Standard Deviation 17.89	-1.81 percent of TAR Standard Deviation 10.17

SECONDARY outcome

Timeframe: baseline and 90 days

Change from baseline to end of study in percentage of time spent with glucose >250 mg/dL, based on continuous glucose monitoring derived glucose values

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=9 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Change in Percentage of Time With Glucose >250 mg/dL	-1.04 percent of time with glucose >250mg/dL Standard Deviation 23.57	0.84 percent of time with glucose >250mg/dL Standard Deviation 9.86	-4.47 percent of time with glucose >250mg/dL Standard Deviation 3.03

SECONDARY outcome

Timeframe: baseline and 90 days

Change from baseline to end of study in glycemic variability as measured by coefficient of variation (CV), based on continuous glucose monitoring derived glucose values

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=9 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Change in Coefficient of Variation (CV)	1 percent of coefficient of variation Standard Deviation 5	4 percent of coefficient of variation Standard Deviation 9	-5 percent of coefficient of variation Standard Deviation 3

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 90 days

Change in percent predicted forced expiratory volume in 1 second (FEV1) from baseline to end of study

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=9 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Change in Percent Predicted Forced Expiratory Volume in 1 Second	-2 percent predicted FEV1 Standard Deviation 5	2 percent predicted FEV1 Standard Deviation 6	-2 percent predicted FEV1 Standard Deviation 6

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Total Number of Treatment-Emergent Adverse Events (TEAEs)

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=13 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Total Number of Treatment-Emergent Adverse Events	26 count of TEAEs	12 count of TEAEs	1 count of TEAEs

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Total Number of Serious Adverse Events (SAEs)

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=13 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Total Number of Serious Adverse Events	2 count of SAEs	1 count of SAEs	0 count of SAEs

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Total Number of Adverse Events of Special Interest (AESIs)

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=13 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Total Number of Adverse Events of Special Interest	3 count of AESIs	0 count of AESIs	0 count of AESIs

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Total Number of Device Complaints

Outcome measures

Measure	Afrezza + Automatic Insulin Delivery (AID) n=13 Participants Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 Participants Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 Participants Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Total Number of Device Complaints	0 Count of Device Complaints	0 Count of Device Complaints	0 Count of Device Complaints

Adverse Events

Afrezza + Automatic Insulin Delivery (AID)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Afrezza + Insulin Degludec

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

AID Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Afrezza + Automatic Insulin Delivery (AID) n=13 participants at risk Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 participants at risk Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 participants at risk Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID): Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Metabolism and nutrition disorders Diabetic Ketoacidosis	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Cardiac disorders Angina pectoris	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Infections and infestations Localised infection	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.

Other adverse events

Measure	Afrezza + Automatic Insulin Delivery (AID) n=13 participants at risk Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a Continuous Subcutaneous Insulin Infusion (CSII) pump with an AID algorithm using Rapid Acting Insulin Analogs (RAA) for their basal and correction insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation CSII pump with AID: Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ	Afrezza + Insulin Degludec n=10 participants at risk Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. Afrezza (insulin human) Inhalation Powder: Pharmaceutical form: powder Route of administration: inhalation insulin degludec: Pharmaceutical form: solution for injection Route of administration: subcutaneous	AID Control n=5 participants at risk Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID): Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Infections and infestations COVID-19 respiratory infection	30.8% 4/13 • Number of events 5 • Adverse Event data were collected for a period of up to 120 days.	40.0% 4/10 • Number of events 4 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Nervous system disorders Headache	7.7% 1/13 • Number of events 3 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Gastrointestinal disorders Vomiting	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Infections and infestations Urinary Tract Infection	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 3 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Infections and infestations Sinusitis	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	20.0% 1/5 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.
Infections and infestations Cellulitis	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Infections and infestations Laryngitis	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Psychiatric disorders Anxiety	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Infections and infestations Bronchitis	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Metabolism and nutrition disorders Decreased Appetitie	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Injury, poisoning and procedural complications Contusion	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Skin and subcutaneous tissue disorders Skin Irritation	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Metabolism and nutrition disorders Anormal weight gain	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Ear and labyrinth disorders Vertigo	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Skin and subcutaneous tissue disorders Actinic Keratosis	0.00% 0/13 • Adverse Event data were collected for a period of up to 120 days.	10.0% 1/10 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Number of events 2 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	15.4% 2/13 • Number of events 2 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 1/13 • Number of events 3 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Respiratory, thoracic and mediastinal disorders Respiration Abnormal	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Investigations Pulmonary function test decreased	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Respiratory, thoracic and mediastinal disorders Sneezing	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Infections and infestations Upper Respiratory Tract Infection	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 1/13 • Number of events 1 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/10 • Adverse Event data were collected for a period of up to 120 days.	0.00% 0/5 • Adverse Event data were collected for a period of up to 120 days.

Additional Information

Jennifer Pleitez, Director of Clinical Operations

Mannkind Corporation

Phone: 818-661-5032

Email: endocrineresearch@mannkindcorp.com

Results disclosure agreements

• Principal investigator is a sponsor employee Neither the Institution nor the Principal Investigator will disclose any of the results arising out of or in connection with the Clinical Trial or information provided by the Sponsor to the Institution without the prior express written consent of the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER