Assessment of Mealtime Bolus Insulin Behavior

Study Overview
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Brief Summary
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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.

Official Title
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An Objective Assessment of Mealtime Bolus Insulin Behavior and Associated Factors

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Continuous Glucose Monitoring
* Drug: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blinded CGM (Continuous Glucose Monitoring)<br>Participants received Insulin lispro 100 U/mL (units per millilitre) injected via the pen and they were blinded to CGM device recording as directed in study period 1. | Device: Continuous Glucose Monitoring<br>* Commercially available<br>Drug: Insulin Lispro<br>* As prescribed.<br>|
| Unblinded CGM<br>Participants received Insulin lispro 100 U/mL injected via the pen and they were unblinded to CGM device recording as directed in study period 2. | Device: Continuous Glucose Monitoring<br>* Commercially available<br>Drug: Insulin Lispro<br>* As prescribed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 1 up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 6 up to 12 weeks | 
| Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Blinded CGM | 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. | Baseline up to 6 weeks | 
| Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Unblinded CGM | 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. | Week 6 up to 12 weeks | 
| Percentage of Missed Bolus Doses Per Month With Blinded CGM | 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. | Baseline up to 6 weeks | 
| Percentage of Missed Bolus Doses Per Month With Unblinded CGM | 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. | Week 6 up to 12 weeks | 
| Average Number of Missed Bolus Insulin Doses Per Day With Blinded CGM | 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. | Baseline up to 6 weeks | 
| Average Number of Missed Bolus Insulin Doses Per Day With Unblinded CGM | 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. | Week 6 up to 12 weeks | 
| 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. | Baseline up to 6 weeks | 
| Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Unblinded 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. | Week 6 up to 12 weeks |