Assessment of Mealtime Bolus Insulin Behavior

An Objective Assessment of Mealtime Bolus Insulin Behavior and Associated Factors

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03368807

Enrollment

Registered

2017-12-11

Start date

2017-12-11

Completion date

2018-07-23

Last updated

2019-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Brief summary

The main purpose of this study is to estimate missed bolus insulin doses in diabetics. This is a 12-week, single-arm, outpatient, exploratory study with two study periods in Type 1 or Type 2 diabetics, with an investigational reusable injection pen, insulin, and a Continuous Glucose Monitoring (CGM) device.

Interventions

DEVICEContinuous Glucose Monitoring

Commercially available

DRUGInsulin Lispro

As prescribed.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Have a Type 1 Diabetes Mellitus (T1D) or a Type 2 Diabetes Mellitus (T2D) diagnosis * Must be taking a mealtime bolus dose insulin, greater than or equal to (≥) 3 doses * Each individual bolus insulin dose must be less than (\<) 40 units * Must be taking a stable insulin dose regimen for the last 3 months * Must be taking a bolus insulin analog (for example insulin lispro \[U-100\]/\[U-200\], insulin aspart, or insulin glulisine). In addition, must be able to switch to insulin lispro U-100 for the duration of the trial * Must have a hemoglobin A1c (HbA1c) ≥8.0% in the last 6 months * Participants with T1D must be ≥21 to less than or equal to (≤) 65 years of age. Participants with T2D must be ≥35 to ≤65 years of age * Women of childbearing potential must meet the following: (Note: females of childbearing potential are defined as those who have experienced menarche and who are NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause) * Must agree to use 1 highly effective method of contraception, or a combination of 2 effective methods of contraception for the entirety of the study * Must test negative for pregnancy as indicated by a negative serum or urine pregnancy test * Participants with prior CGM/flash glucose monitoring experience must have stopped CGM/flash glucose monitoring ≥3 months prior to enrollment

Exclusion criteria

* Have known tape/adhesive allergies with CGM sensors * Medical conditions, visual, physical, psychiatric, or cognitive impairment(s) that may preclude the ability to participate in the trial * Have history of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range within the last 6 months * Have history of chronic kidney disease stage 4 and higher within the last 6 months, or history of renal transplantation * Have active malignancy * Are pregnant or planning to become pregnant * Are on or are intending to begin a weight loss program * Participants with T1D who have taken off-label antihyperglycemic agents within last 3 months * Have received insulin by continuous subcutaneous insulin infusion in the last 3 months * Participants taking opioid medications for medically invalid reasons or at doses considered excessive * Participants on routine use of acetaminophen * Currently undergoing systemic treatment with: * Immunosuppressive medication * Chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the prior 2 weeks * Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study * Have participated, within the last 30 days, in a clinical study involving an investigational product * Are unwilling or unable to comply with the use of a data collection device to directly record data

Design outcomes

Primary

Measure	Time frame	Description
Average Number of Days Per Month With a Missed Bolus Insulin Dose With Blinded CGM	Week 1 up to 6 weeks	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.

Secondary

Measure	Time frame	Description
Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Blinded CGM	Baseline up to 6 weeks	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.
Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Unblinded CGM	Week 6 up to 12 weeks	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.
Percentage of Missed Bolus Doses Per Month With Blinded CGM	Baseline up to 6 weeks	Percentage of missed bolus doses per month was estimated in participants with Type 1 diabetes or Type 2 diabetes using blinded CGM measurements and the pen.
Percentage of Missed Bolus Doses Per Month With Unblinded CGM	Week 6 up to 12 weeks	Percentage of missed bolus doses per month was estimated in participants with Type 1 diabetes or Type 2 diabetes using unblinded CGM measurements and the pen.
Average Number of Days Per Month With a Missed Bolus Insulin Dose With Unblinded CGM	Week 6 up to 12 weeks	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
Average Number of Missed Bolus Insulin Doses Per Day With Unblinded CGM	Week 6 up to 12 weeks	The average number of missed bolus doses per day was estimated in participants with Type 1 diabetes or Type 2 diabetes using unblinded CGM data.
Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Blinded CGM	Baseline up to 6 weeks	The number of Missed and Suboptimal Doses (MSBDs) per month was calculated in participants with Type 1 Diabetes or Type 2 Diabetes as the sum of the identified missed bolus doses and suboptimal bolus doses for each participant for each period.
Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Unblinded CGM	Week 6 up to 12 weeks	The number of Missed and Suboptimal Doses (MSBDs) per month was calculated in participants with Type 1 Diabetes or Type 2 Diabetes as the sum of the identified missed bolus doses and suboptimal bolus doses for each participant for each period.
Average Number of Missed Bolus Insulin Doses Per Day With Blinded CGM	Baseline up to 6 weeks	The average number of missed bolus doses per day was estimated in participants with Type 1 diabetes or Type 2 diabetes using blinded CGM measurements and the pen.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Overall Study 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.	79
Total	79

Withdrawals & dropouts

Period	Reason	FG000
Period 1 (Blinded CGM)	Lost to Follow-up	1
Period 1 (Blinded CGM)	Protocol Violation	1
Period 1 (Blinded CGM)	Sponsor Decision	1
Period 1 (Blinded CGM)	Withdrawal by Subject	3

Baseline characteristics

Characteristic	Overall Study
Age, Continuous	48.01 Years STANDARD_DEVIATION 11.71
Body Mass Index (BMI)	30.9 kg/m² STANDARD_DEVIATION 6.1
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	73 Participants
Region of Enrollment United States	79 Participants
Sex: Female, Male Female	36 Participants
Sex: Female, Male Male	43 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 78	0 / 73
other Total, other adverse events	22 / 78	9 / 73
serious Total, serious adverse events	3 / 78	2 / 73

Outcome results

Primary

Average Number of Days Per Month With a Missed Bolus Insulin Dose With Blinded CGM

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.

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Blinded CGM	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

Average Number of Days Per Month With a Missed Bolus Insulin Dose With Unblinded CGM

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

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Blinded CGM	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

Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Blinded CGM

The number of Missed and Suboptimal Doses (MSBDs) per month was calculated in participants with Type 1 Diabetes or Type 2 Diabetes as the sum of the identified missed bolus doses and suboptimal bolus doses for each participant for each period.

Time frame: Baseline up to 6 weeks