Assessment of Mealtime Bolus Insulin Behavior

An Objective Assessment of Mealtime Bolus Insulin Behavior and Associated Factors

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Continuous Glucose Monitoring; Drug: Insulin Lispro

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States, 92025
      • AMCR Institute, Inc.
    • Los Angeles, California, United States, 90045
      • Science 37 Inc
    • Ventura, California, United States, 93003
      • Coastal Metabolic Research Ctr
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes and Osteoporosis Center
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes & Endocrinology Research Center
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Type 1 and Type 2 Diabetics

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blinded CGM (Continuous Glucose Monitoring); 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; Commercially available; Drug: Insulin Lispro; As prescribed.
Unblinded CGM; 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; Commercially available; Drug: Insulin Lispro; As prescribed.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 11, 2017
• Primary Completion (ACTUAL): June 12, 2018
• Study Completion (ACTUAL): July 23, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (ACTUAL): December 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 16866; F3Z-MC-IOQV (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No