Trial Outcomes & Findings for FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump (NCT NCT03977727)

NCT ID: NCT03977727

Last Updated: 2020-09-29

Results Overview

Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 40 participants
• Primary outcome timeframe: 6th week of therapy
• Results posted on: 2020-09-29

Participant Flow

45 patients were screened for eligibility between June 11,2019 and November 21, 2019 at a diabetes clinic in Austin, TX

40 of 45 participants were randomized. All 5 who were not randomized did not meet inclusion criteria.

Participant milestones

Measure	Fiasp/Novolog 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII	Novolog/Fiasp 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII
First Treatment STARTED	20	20
First Treatment Received Treatment	20	20
First Treatment COMPLETED	20	20
First Treatment NOT COMPLETED	0	0
Second Treatment STARTED	20	20
Second Treatment COMPLETED	20	17
Second Treatment NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Fiasp/Novolog 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII	Novolog/Fiasp 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII
Second Treatment Lost to Follow-up	0	3

Baseline Characteristics

FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump

Baseline characteristics by cohort

Measure	Fiasp/Novolog n=20 Participants 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII	Novolog/Fiasp n=17 Participants 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII	Total n=37 Participants Total of all reporting groups
Age, Continuous	47.2 years STANDARD_DEVIATION 13.17 • n=5 Participants	43.8 years STANDARD_DEVIATION 12.77 • n=7 Participants	45.7 years STANDARD_DEVIATION 27.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	17 participants n=7 Participants	37 participants n=5 Participants
BMI	26.9 kg/m^2 STANDARD_DEVIATION 3.69 • n=5 Participants	27.3 kg/m^2 STANDARD_DEVIATION 3.15 • n=7 Participants	27.1 kg/m^2 STANDARD_DEVIATION 3.41 • n=5 Participants
Weight	80.3 kg STANDARD_DEVIATION 14.7 • n=5 Participants	83.3 kg STANDARD_DEVIATION 12.45 • n=7 Participants	81.7 kg STANDARD_DEVIATION 13.61 • n=5 Participants
Height	172.3 cm STANDARD_DEVIATION 10.82 • n=5 Participants	174.6 cm STANDARD_DEVIATION 7.22 • n=7 Participants	173.4 cm STANDARD_DEVIATION 9.29 • n=5 Participants

PRIMARY outcome

Timeframe: 6th week of therapy

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
1-Hour Change in Postprandial Plasma Glucose (PPG) Fiasp	105.15 mg/dL Standard Deviation 56.73	154.24 mg/dL Standard Deviation 54.25
1-Hour Change in Postprandial Plasma Glucose (PPG) NovoLog	99.90 mg/dL Standard Deviation 82.70	114.94 mg/dL Standard Deviation 61.14

SECONDARY outcome

Timeframe: 6th week of therapy

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Change was calculated as the value at 2 hour minus the value at baseline during meal test

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
2-Hour Change in Postprandial Plasma Glucose (PPG) Fiasp	72.55 mg/dL Standard Error 90.62	65.00 mg/dL Standard Error 57.22
2-Hour Change in Postprandial Plasma Glucose (PPG) NovoLog	69.10 mg/dL Standard Error 92.55	104.53 mg/dL Standard Error 80.57

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients for whom continuous glucose monitoring data was available during the specified time periods

Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Percentage of Time Spent Between Below 70 mg/dL Fiasp	1.94 percentage of time Standard Deviation 1.48	1.72 percentage of time Standard Deviation 1.20
Percentage of Time Spent Between Below 70 mg/dL NovoLog	2.42 percentage of time Standard Deviation 1.62	2.03 percentage of time Standard Deviation 1.36

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients for whom continuous glucose monitoring data was available during the specified time periods

Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Percentage of Time Spent Between 70 mg/dL and 180 mg/dL Fiasp	74.80 percentage of time Standard Deviation 8.08	73.67 percentage of time Standard Deviation 6.80
Percentage of Time Spent Between 70 mg/dL and 180 mg/dL NovoLog	70.28 percentage of time Standard Deviation 8.12	75.04 percentage of time Standard Deviation 5.95

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients for whom continuous glucose monitoring data was available during the specified time periods

Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Percentage of Time Spent Above 200 mg/dL Fiasp	14.90 percentage of time Standard Deviation 6.90	15.44 percentage of time Standard Deviation 5.65
Percentage of Time Spent Above 200 mg/dL NovoLog	18.57 percentage of time Standard Deviation 7.85	14.11 percentage of time Standard Deviation 4.43

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients for whom continuous glucose monitoring data was available during the specified time periods

Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL) Fiasp	.46 percentage of time Standard Deviation .53	.40 percentage of time Standard Deviation .48
Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL) NovoLog	.50 percentage of time Standard Deviation .50	.35 percentage of time Standard Deviation .36

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients for whom continuous glucose monitoring data was available during the specified time periods

Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL) Fiasp	0 percentage of time Standard Deviation 0	0 percentage of time Standard Deviation 0
Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL) NovoLog	0 percentage of time Standard Deviation 0	0 percentage of time Standard Deviation 0

SECONDARY outcome

Timeframe: Week 6, Week 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each period

1,5 anhydroglucitol levels were measured on the 6th week of each therapy

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
1,5 Anhydroglucitol Levels Fiasp	6.50 µg/mL Standard Deviation 3.37	7.12 µg/mL Standard Deviation 3.23
1,5 Anhydroglucitol Levels NovoLog	6.28 µg/mL Standard Deviation 3.54	6.95 µg/mL Standard Deviation 3.31

SECONDARY outcome

Timeframe: Week 6, Week 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each period

Cumulative glycemic control expressed in fructosamine levels (micromol/Liter) were measured on the 6th week of each therapy

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Fructosamine Levels Fiasp	322.60 mcmol/L Standard Deviation 42.24	296.35 mcmol/L Standard Deviation 31.10
Fructosamine Levels NovoLog	305.40 mcmol/L Standard Deviation 32.28	314.31 mcmol/L Standard Deviation 28.97

SECONDARY outcome

Timeframe: Week 6, Week 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each period

Cumulative glycemic control expressed in HbA1c% measured on the 6th week of each therapy

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
HbA1c Fiasp	7.09 HbA1c% Standard Deviation .47	7.00 HbA1c% Standard Deviation .31
HbA1c NovoLog	7.09 HbA1c% Standard Deviation .44	6.88 HbA1c% Standard Deviation .33

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Change was calculated as the value on the last day of therapy minus the value on the 1st day of therapy in each period

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Insulin Use - Change in Daily Dose Fiasp	-2.1 units Standard Deviation 7.45	.29 units Standard Deviation 13.35
Insulin Use - Change in Daily Dose NovoLog	1.10 units Standard Deviation 11.80	-2.65 units Standard Deviation 9.13

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Change in %bolus insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Insulin Use - Bolus NovoLog	1.83 percentage of units Standard Deviation 7.62	-1.34 percentage of units Standard Deviation 5.35
Insulin Use - Bolus Fiasp	-1.54 percentage of units Standard Deviation 6.54	-4.32 percentage of units Standard Deviation 7.85

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Change in %basal insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Insulin Use - Basal Fiasp	1.54 percentage of units Standard Deviation 6.54	4.32 percentage of units Standard Deviation 7.85
Insulin Use - Basal NovoLog	-1.83 percentage of units Standard Deviation 7.62	1.34 percentage of units Standard Deviation 5.35

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Average amount per day (units) calculated for each participant under each therapy

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Insulin Use - Automatic Basal Insulin Fiasp	.87 units Standard Deviation .307	1.20 units Standard Deviation .65
Insulin Use - Automatic Basal Insulin NovoLog	.86 units Standard Deviation .32	1.20 units Standard Deviation .66

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Average time per day (hours) calculated for each participant under each therapy

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Insulin Pump - Active Insulin Time Fiasp	3 hours Standard Deviation .06	3 hours Standard Deviation 0
Insulin Pump - Active Insulin Time NovoLog	3 hours Standard Deviation 0	3 hours Standard Deviation .02

SECONDARY outcome

Timeframe: Weeks 3 through 6, Weeks 10 through 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Percentage of time spent in auto-mode after calibration under each therapy

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Insulin Pump - Auto Mode Fiasp	89.28 percentage of time Standard Deviation 6.42	89.31 percentage of time Standard Deviation 8.42
Insulin Pump - Auto Mode NovoLog	86.17 percentage of time Standard Deviation 11.43	87.2 percentage of time Standard Deviation 15.6

SECONDARY outcome

Timeframe: Weeks 3 through 6, Weeks 10 through 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Percentage of time spent in manual-mode after calibration under each therapy

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Insulin Pump - Manual Mode Fiasp	10.72 percentage of time Standard Deviation 6.42	10.69 percentage of time Standard Deviation 8.42
Insulin Pump - Manual Mode NovoLog	13.45 percentage of time Standard Deviation 11.44	12.8 percentage of time Standard Deviation 15.6

SECONDARY outcome

Timeframe: Weeks 1 through 6, Weeks 8 through 13

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Change was calculated as the carbohydrate ratio on the last day of therapy minus the carbohydrate ratio on the 1st day of therapy in each period

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Change in Carbohydrate Ratio NovoLog	-.14 I:CR Standard Deviation .95	.2 I:CR Standard Deviation .76
Change in Carbohydrate Ratio Fiasp	-.27 I:CR Standard Deviation 1.09	-.02 I:CR Standard Deviation .47

SECONDARY outcome

Timeframe: 14 week treatment period

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Number of Infusion site reactions reported by patient

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Infusion Site Reactions Fiasp	0 occurances	1 occurances
Infusion Site Reactions NovoLog	3 occurances	2 occurances

SECONDARY outcome

Timeframe: 14 week treatment period

Population: All patients who participated in the meal test after 6 weeks of therapy in each arm

Number of Occlusion events reported by patient

Outcome measures

Measure	Fiasp/Novolog n=20 Participants Participants with type 1 diabetes spent 6 weeks on Fiasp® then crossed over to 6 weeks on Novolog®	Novolog/Fiasp n=17 Participants Participants with type 1 diabetes spent 6 weeks on Novolog® then crossed over to 6 weeks on Fiasp®
Pump Occlusions Fiasp	7 occurances	6 occurances
Pump Occlusions NovoLog	7 occurances	9 occurances

Adverse Events

Fiasp/Novolog

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Novolog/Fiasp

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fiasp/Novolog n=19 participants at risk 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII	Novolog/Fiasp n=18 participants at risk 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII
Musculoskeletal and connective tissue disorders Herniated Disc	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.

Other adverse events

Measure	Fiasp/Novolog n=19 participants at risk 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII	Novolog/Fiasp n=18 participants at risk 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII
Eye disorders Non Proliferative Diabetic Retinopathy	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
General disorders Worsening of Seasonal Allergic Rhinitis	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Infections and infestations Influenza	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Skin and subcutaneous tissue disorders Redness at infusion site (right abdomen)	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Cardiac disorders Trivial tricuspid regurgitation	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Cardiac disorders Trivial mitral regurgitation	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Infections and infestations Viral infection	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
General disorders Sore Throat	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Musculoskeletal and connective tissue disorders Headache	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
General disorders Nasal Congestion	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Cardiac disorders First Degree AV Block	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Cardiac disorders Intermittent Heart Palpitations	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Cardiac disorders Intermittent bradycardia	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Cardiac disorders Worsening of Hypertension	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Infections and infestations Conjuntivitis	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
General disorders Fever	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Gastrointestinal disorders Gasteroenteritis	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Cardiac disorders Supraventricular Tachycardia	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Respiratory, thoracic and mediastinal disorders Bronchitis	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Musculoskeletal and connective tissue disorders Herniated Disc	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
General disorders Abdominal Cramps	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
General disorders Emesis	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Gastrointestinal disorders Traveler's Diarrhea	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Gastrointestinal disorders Hiatial Hernia	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Gastrointestinal disorders Gastroesophageal reflux disease	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Product Issues Irritation at Infusion site (abdoment)	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Gastrointestinal disorders Nausea	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Skin and subcutaneous tissue disorders Right Thumb laceration	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Infections and infestations Common Cold	10.5% 2/19 • Number of events 3 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Musculoskeletal and connective tissue disorders Back pain	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Endocrine disorders Worsening of hypocalcemia	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Skin and subcutaneous tissue disorders erythema at infusion site	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Infections and infestations Sinus Infection	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Musculoskeletal and connective tissue disorders Right index finger dislocation	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Musculoskeletal and connective tissue disorders Triangular fibrocartilage band tear (left wrist)	0.00% 0/19 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	5.6% 1/18 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Endocrine disorders Worsening of hypothyroidsm	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Musculoskeletal and connective tissue disorders myalgia (bilateral shoulders0	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
General disorders Ecchymosis (bilateral hands)	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Renal and urinary disorders acute kidney injury	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Cardiac disorders Hyperkalemia	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
Eye disorders Center involved diabetic macular edema (right eye)	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.
General disorders Vasovagal Syncope	5.3% 1/19 • Number of events 1 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.	0.00% 0/18 • Approximately 20 weeks. The entire duration of the subjects study period. Adverse event information was collected at all phone or office visits during the trial.

Additional Information

Thomas Blevins, MD

Texas Diabetes & Endocrinology

Phone: 512-334-3505

Email: blevins@texasdiabetes.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place