Trial Outcomes & Findings for The Effect of Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes (NCT NCT03542682)

NCT ID: NCT03542682

Last Updated: 2024-02-13

Results Overview

time to maximum glucose infusion rate (GIR) in minutes

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 300 minutes
• Results posted on: 2024-02-13

Participant Flow

11 participants consented to participate but 2 were lost to follow up prior to randomization

Participant milestones

Measure	Individuals Given Standard Bolus First, Then Quick Bolus Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp. Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.	Individuals Given Quick Bolus First, Then Standard Bolus Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp. Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.
Overall Study STARTED	5	4
Overall Study Completed First Stage	5	4
Overall Study Completed Second Stage	5	3
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Individuals Given Standard Bolus First, Then Quick Bolus Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp. Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.	Individuals Given Quick Bolus First, Then Standard Bolus Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp. Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.
Overall Study COVID-19 Protocol	0	1

Baseline Characteristics

The Effect of Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes

Baseline characteristics by cohort

Measure	Individuals Given Standard Bolus First, Then Quick Bolus n=5 Participants Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp. Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.	Individuals Given Quick Bolus First, Then Standard Bolus n=3 Participants Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp. Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.	Total n=8 Participants Total of all reporting groups
Age, Continuous	22.8 years STANDARD_DEVIATION 3.3 • n=93 Participants	20.7 years STANDARD_DEVIATION 3.1 • n=4 Participants	22 years STANDARD_DEVIATION 3.2 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 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
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	5 participants n=93 Participants	3 participants n=4 Participants	8 participants n=27 Participants
Baseline mean percent Hemoglobin A1c	7.6 percent Hemoglobin A1c STANDARD_DEVIATION 1.3 • n=93 Participants	7.9 percent Hemoglobin A1c STANDARD_DEVIATION 1.1 • n=4 Participants	7.7 percent Hemoglobin A1c STANDARD_DEVIATION 1.1 • n=27 Participants

PRIMARY outcome

Timeframe: 300 minutes

Population: Complete case analysis

time to maximum glucose infusion rate (GIR) in minutes

Outcome measures

Measure	Quick Bolus n=8 Participants Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp.	Standard Bolus n=8 Participants Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.
Time to Maximum Glucose Infusion Rate	116.54 minutes Interval 74.74 to 158.34	172.21 minutes Interval 130.41 to 214.01

SECONDARY outcome

Timeframe: up to 5 hours

Population: Outcome was not part of the study protocol and therefore was not collected.

Time to reach baseline insulin concentrations is used to determine the completion of insulin as part bolus of bioavailability.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 300 minutes

Population: Complete case analysis.

maximum glucose infusion rate (GIRmax)

Outcome measures

Measure	Quick Bolus n=8 Participants Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp.	Standard Bolus n=8 Participants Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.
Maximum Glucose Infusion Rate	8.42 mg/kg/min Interval 4.91 to 11.92	7.45 mg/kg/min Interval 3.95 to 10.96

SECONDARY outcome

Timeframe: 300 minutes

area under the curve for the glucose infusion rate

Outcome measures

Measure	Quick Bolus n=8 Participants Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp.	Standard Bolus n=8 Participants Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.
Area Under the Curve for the Glucose Infusion Rate	1204.29 mg/kg Interval 716.72 to 1691.86	1072.44 mg/kg Interval 584.86 to 1560.01

Adverse Events

Individuals Given Standard Bolus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Individuals Given Quick Bolus

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Individuals Given Standard Bolus n=8 participants at risk Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.	Individuals Given Quick Bolus n=9 participants at risk Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp.
Infections and infestations Common Cold	0.00% 0/8 • Up to 5 hours post intervention for each intervention	11.1% 1/9 • Number of events 1 • Up to 5 hours post intervention for each intervention

Additional Information

Laura Marie Nally, MD

Yale School of Medicine

Phone: (877) 925-3637

Email: laura.nally@yale.edu

Results disclosure agreements

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