Assessment of Mealtime Bolus Insulin Behavior

NCT03368807 | Completed Results FDA Drug FDA Device

• 2 other identifiers: 16866F3Z-MC-IOQV
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

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

  Week 6 up to 12 weeks

• 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) With Unblinded CGM

  Week 6 up to 12 weeks

• Percentage of Missed Bolus Doses Per Month With Blinded CGM

  Baseline up to 6 weeks

• Percentage of Missed Bolus Doses Per Month With Unblinded CGM

  Week 6 up to 12 weeks

Study Arms (2)

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; Drug: Insulin Lispro

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; Drug: Insulin Lispro

Interventions

Continuous Glucose Monitoring DEVICE

Commercially available

Blinded CGM (Continuous Glucose Monitoring); Unblinded CGM

Insulin Lispro DRUG

As prescribed.

Blinded CGM (Continuous Glucose Monitoring); Unblinded CGM

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 1 and Type 2 Diabetics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

AMCR Institute, Inc.

Escondido, California, 92025, United States

Location

Science 37 Inc

Los Angeles, California, 90045, United States

Location

Coastal Metabolic Research Ctr

Ventura, California, 93003, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Iowa Diabetes & Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Related Publications (1)

• Wolpert H, Rodbard D, Xue J, Johnson J, Dassau E. Characterizing insulin dosing behaviour and glycaemic excursions: Development of metrics using connected insulin pen and continuous glucose monitoring. Diabetes Obes Metab. 2025 May;27(5):2507-2514. doi: 10.1111/dom.16249. Epub 2025 Feb 10.

  PMID: 39930566 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 11, 2017
• Study Start: December 11, 2017
• Primary Completion: June 12, 2018
• Study Completion: July 23, 2018
• Last Updated: August 2, 2019
• Results First Posted: August 2, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)