Clinical trial NCT03368807: Assessment of Mealtime Bolus Insulin Behavior
Official title: An Objective Assessment of Mealtime Bolus Insulin Behavior and Associated Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-12-11
Enrollment: 79
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 and Type 2 Diabetics

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average Number of Days Per Month With a Missed Bolus Insulin Dose With Blinded CGM
timeFrame: Week 1 up to 6 weeks
Secondary outcomes:
measure: Average Number of Days Per Month With a Missed Bolus Insulin Dose With Unblinded CGM
timeFrame: Week 6 up to 12 weeks
measure: Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Blinded CGM
timeFrame: Baseline up to 6 weeks
measure: Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Unblinded CGM
timeFrame: Week 6 up to 12 weeks
measure: Percentage of Missed Bolus Doses Per Month With Blinded CGM
timeFrame: Baseline up to 6 weeks
measure: Percentage of Missed Bolus Doses Per Month With Unblinded CGM
timeFrame: Week 6 up to 12 weeks
measure: Average Number of Missed Bolus Insulin Doses Per Day With Blinded CGM
timeFrame: Baseline up to 6 weeks
measure: Average Number of Missed Bolus Insulin Doses Per Day With Unblinded CGM
timeFrame: Week 6 up to 12 weeks
measure: Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Blinded CGM
timeFrame: Baseline up to 6 weeks
measure: Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Unblinded CGM
timeFrame: Week 6 up to 12 weeks
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute, Inc.
state: California
city: Los Angeles
country: United States
facility: Science 37 Inc
state: California
city: Ventura
country: United States
facility: Coastal Metabolic Research Ctr
state: California
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Diabetes & Endocrinology Research Center
state: Iowa
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: