Trial Outcomes & Findings for Assessment of Mealtime Bolus Insulin Behavior (NCT NCT03368807)

Last Updated: 2019-08-02

Results Overview

The average number of days per month with a missed bolus insulin dose was calculated in participants with Type 1 Diabetes or Type 2 Diabetes using blinded CGM measurements and the pen. The time of insulin dosing and glucose excursions were assessed using the display times recorded by the pen and CGM devices, respectively.

Recruitment status

COMPLETED

Target enrollment

79 participants

Primary outcome timeframe

Week 1 up to 6 weeks

Results posted on

2019-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	Study Period 1/Study Period 2 Participants with type 1 diabetes or type 2 diabetes received prescribed insulin regimen suitable for their disease state using insulin lispro 100 units per millilitre (U/mL) injected via the pen. During the study, participants had their glucose monitored via the continuous glucose monitoring (CGM) device, which was blinded during Study Period 1 and unblinded during Study Period 2.
Period 1 (Blinded CGM) STARTED	79
Period 1 (Blinded CGM) Received at Least 1 Dose of Study Drug	78
Period 1 (Blinded CGM) COMPLETED	73
Period 1 (Blinded CGM) NOT COMPLETED	6
Period 2 (Unblinded CGM) STARTED	73
Period 2 (Unblinded CGM) COMPLETED	73
Period 2 (Unblinded CGM) NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Period 1/Study Period 2 Participants with type 1 diabetes or type 2 diabetes received prescribed insulin regimen suitable for their disease state using insulin lispro 100 units per millilitre (U/mL) injected via the pen. During the study, participants had their glucose monitored via the continuous glucose monitoring (CGM) device, which was blinded during Study Period 1 and unblinded during Study Period 2.
Period 1 (Blinded CGM) Withdrawal by Subject	3
Period 1 (Blinded CGM) Protocol Violation	1
Period 1 (Blinded CGM) Sponsor Decision	1
Period 1 (Blinded CGM) Lost to Follow-up	1

Baseline Characteristics

Assessment of Mealtime Bolus Insulin Behavior

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=79 Participants Participants received prescribed insulin regimen suitable for their disease state using insulin lispro 100 U/mL injected via the pen. During the study, participants had their glucose monitored via the CGM device, which was blinded during Study Period 1 and unblinded during Study Period 2.
Age, Continuous	48.01 Years STANDARD_DEVIATION 11.71 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	79 Participants n=5 Participants
Body Mass Index (BMI)	30.9 kg/m² STANDARD_DEVIATION 6.1 • n=5 Participants

PRIMARY outcome

Timeframe: Week 1 up to 6 weeks

Population: All enrolled participants who received at least one dose of study drug and have missed bolus insulin dose data.

Outcome measures

Outcome measures
Measure	Blinded CGM n=68 Participants Participants received Insulin lispro 100 U/mL injected via the pen and they were blinded to CGM device recording as directed.
Average Number of Days Per Month With a Missed Bolus Insulin Dose With Blinded CGM	19.3 Days per month Standard Deviation 6.2

SECONDARY outcome

Timeframe: Week 6 up to 12 weeks

Population: All enrolled participants who received at least one dose of study drug and have missed bolus insulin dose data.

The average number of days per month with a missed bolus insulin dose was calculated in participants with Type 1 Diabetes or Type 2 Diabetes using unblinded CGM measurements and the pen. The time of insulin dosing and glucose excursions were assessed using the display times recorded by the pen and CGM devices, respectively

Outcome measures

Outcome measures
Measure	Blinded CGM n=65 Participants Participants received Insulin lispro 100 U/mL injected via the pen and they were blinded to CGM device recording as directed.
Average Number of Days Per Month With a Missed Bolus Insulin Dose With Unblinded CGM	17.9 Days per month Standard Deviation 5.7

SECONDARY outcome

Timeframe: Baseline up to 6 weeks

Population: All enrolled participants who received at least one dose of study drug and have data for Percentage of Time-in-Range.

Percentage of time-in-range (glucose \>70 and ≤180 milligrams per deciliter) was calculated in participants with Type 1 Diabetes or Type 2 Diabetes based on blinded CGM data collected in the study period. The time component of the time-in-range statistic was calculated using the display time recorded by the CGM device.

Outcome measures

Outcome measures
Measure	Blinded CGM n=68 Participants Participants received Insulin lispro 100 U/mL injected via the pen and they were blinded to CGM device recording as directed.
Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Blinded CGM	42.7 Percentage of time Standard Deviation 18.8

SECONDARY outcome

Timeframe: Week 6 up to 12 weeks

Population: All enrolled participants who received at least one dose of study drug and have data for Percentage of Time-in-Range.

Percentage of time-in-range (glucose \>70 and ≤180 milligrams per deciliter) was calculated in participants with Type 1 Diabetes or Type 2 Diabetes based on unblinded CGM data collected in the study period. The time component of the time-in-range statistic was calculated using the display time recorded by the CGM device.