Trial Outcomes & Findings for Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy (NCT NCT03554486)
NCT ID: NCT03554486
Last Updated: 2021-08-18
Results Overview
Measured as percentage of time in range (days).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
7 days (during 2nd half of 2-week intervention period)
Results posted on
2021-08-18
Participant Flow
27 participants signed informed consent. 3 participants failed screening and did not enter the run-in period (a 2-week period for pump-setting adjustments and monitoring).
Participant milestones
| Measure |
All Participants (run-in Period)
Participants entered a 2-week run-in period prior to randomization.
|
Fiasp Then Novolog
Following randomization after a 2-week run-in period, participants use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks.
|
Novolog Then Fiasp
Following randomization after a 2-week run-in period, participants use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks.
|
|---|---|---|---|
|
Run-in Period (2 Weeks)
STARTED
|
24
|
0
|
0
|
|
Run-in Period (2 Weeks)
COMPLETED
|
21
|
0
|
0
|
|
Run-in Period (2 Weeks)
NOT COMPLETED
|
3
|
0
|
0
|
|
Treatment Period 1 (2 Weeks)
STARTED
|
0
|
11
|
10
|
|
Treatment Period 1 (2 Weeks)
COMPLETED
|
0
|
10
|
9
|
|
Treatment Period 1 (2 Weeks)
NOT COMPLETED
|
0
|
1
|
1
|
|
Treatment Period 2 (2 Weeks)
STARTED
|
0
|
10
|
9
|
|
Treatment Period 2 (2 Weeks)
COMPLETED
|
0
|
10
|
9
|
|
Treatment Period 2 (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
All Participants (run-in Period)
Participants entered a 2-week run-in period prior to randomization.
|
Fiasp Then Novolog
Following randomization after a 2-week run-in period, participants use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks.
|
Novolog Then Fiasp
Following randomization after a 2-week run-in period, participants use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks.
|
|---|---|---|---|
|
Run-in Period (2 Weeks)
Need for steroid injection
|
1
|
0
|
0
|
|
Run-in Period (2 Weeks)
Lost to Follow-up
|
2
|
0
|
0
|
|
Treatment Period 1 (2 Weeks)
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
Baseline characteristics by cohort
| Measure |
Fiasp Then Novolog
n=10 Participants
Following a 2-week run-in period, participants use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks.
|
Novolog Then Fiasp
n=9 Participants
Following a 2-week run-in period, participants use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 15.2 • n=99 Participants
|
44.1 years
STANDARD_DEVIATION 20.4 • n=107 Participants
|
40.4 years
STANDARD_DEVIATION 17.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Hemoglobin A1C
|
7.1 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.9 • n=99 Participants
|
7.1 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.5 • n=107 Participants
|
7.1 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: 7 days (during 2nd half of 2-week intervention period)Population: Participants who completed the protocol are included in the analysis.
Measured as percentage of time in range (days).
Outcome measures
| Measure |
Fiasp Insulin
n=19 Participants
Participants use Fiasp insulin for 2 weeks.
|
Novolog Insulin
n=19 Participants
Participants use Novolog insulin for 2 weeks.
|
|---|---|---|
|
Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl
|
78.4 percentage of time
Standard Deviation 9.3
|
75.3 percentage of time
Standard Deviation 9.5
|
PRIMARY outcome
Timeframe: 7 days (during 2nd half of 2-week intervention period)Population: Participants who completed the protocol are included in the analysis.
Percentage of time in range (days) as a measure of hypoglycemia.
Outcome measures
| Measure |
Fiasp Insulin
n=19 Participants
Participants use Fiasp insulin for 2 weeks.
|
Novolog Insulin
n=19 Participants
Participants use Novolog insulin for 2 weeks.
|
|---|---|---|
|
Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl
|
2.3 percentage of time
Standard Deviation 2.0
|
3.1 percentage of time
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 7 days (during 2nd half of 2-week intervention period)Population: Participants who completed the protocol are included in the analysis.
Mean sensor data over the second week of using a randomized, blinded insulin.
Outcome measures
| Measure |
Fiasp Insulin
n=19 Participants
Participants use Fiasp insulin for 2 weeks.
|
Novolog Insulin
n=19 Participants
Participants use Novolog insulin for 2 weeks.
|
|---|---|---|
|
Mean Sensor Glucose in mg/dl
|
146 mg/dL
Standard Deviation 12
|
147 mg/dL
Standard Deviation 12
|
Adverse Events
Run-in Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fiasp Insulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Novolog Insulin
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-in Period
n=28 participants at risk
Participants with events occurring prior to randomization.
|
Fiasp Insulin
n=19 participants at risk
Participants with events occurring during Fiasp insulin treatment.
|
Novolog Insulin
n=19 participants at risk
Participants with events occurring during Novolog insulin treatment.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Infusion set failure
|
0.00%
0/28 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
Other adverse events
| Measure |
Run-in Period
n=28 participants at risk
Participants with events occurring prior to randomization.
|
Fiasp Insulin
n=19 participants at risk
Participants with events occurring during Fiasp insulin treatment.
|
Novolog Insulin
n=19 participants at risk
Participants with events occurring during Novolog insulin treatment.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Irritation/Inflammation
|
0.00%
0/28 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
5.3%
1/19 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place