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Assessment of Mealtime Bolus Insulin Behavior

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ClinicalTrials.gov Identifier: NCT03368807
Recruitment Status : Completed
First Posted : December 11, 2017
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Device: Continuous Glucose Monitoring Drug: Insulin Lispro

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: An Objective Assessment of Mealtime Bolus Insulin Behavior and Associated Factors
Actual Study Start Date : December 11, 2017
Actual Primary Completion Date : June 12, 2018
Actual Study Completion Date : July 23, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Average Number of Days Per Month With a Missed Bolus Insulin Dose With Blinded CGM [ Time Frame: 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 Outcome Measures :
  1. Average Number of Days Per Month With a Missed Bolus Insulin Dose With Unblinded CGM [ Time Frame: 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

  2. Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Blinded CGM [ Time Frame: 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.

  3. Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Unblinded CGM [ Time Frame: 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.

  4. Percentage of Missed Bolus Doses Per Month With Blinded CGM [ Time Frame: 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.

  5. Percentage of Missed Bolus Doses Per Month With Unblinded CGM [ Time Frame: 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.

  6. Average Number of Missed Bolus Insulin Doses Per Day With Blinded CGM [ Time Frame: 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.

  7. Average Number of Missed Bolus Insulin Doses Per Day With Unblinded CGM [ Time Frame: 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.

  8. Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Blinded CGM [ Time Frame: 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.

  9. Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Unblinded CGM [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 1 and Type 2 Diabetics
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368807


Locations
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United States, California
AMCR Institute, Inc.
Escondido, California, United States, 92025
Science 37 Inc
Los Angeles, California, United States, 90045
Coastal Metabolic Research Ctr
Ventura, California, United States, 93003
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Iowa
Iowa Diabetes & Endocrinology Research Center
West Des Moines, Iowa, United States, 50265
United States, Utah
Advanced Research Institute
Ogden, Utah, United States, 84405
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] November 20, 2017
Statistical Analysis Plan  [PDF] August 1, 2018

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03368807    
Other Study ID Numbers: 16866
F3Z-MC-IOQV ( Other Identifier: Eli Lilly and Company )
First Posted: December 11, 2017    Key Record Dates
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs