Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IOQV | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | Device | Commercially available |
|
| 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 |
| 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 |
Not provided
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)
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:
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
Not provided
Not provided
Type 1 and Type 2 Diabetics
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute, Inc. | Escondido | California | 92025 | United States | ||
| Science 37 Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39930566 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Study Period 1/Study Period 2 | Participants with type 1 diabetes or type 2 diabetes received prescribed insulin regimen suitable for their disease state using insulin lispro 100 units per millilitre (U/mL) injected via the pen. During the study, participants had their glucose monitored via the continuous glucose monitoring (CGM) device, which was blinded during Study Period 1 and unblinded during Study Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Blinded CGM) |
|
| |||||||||||||||||||||||||||
| Period 2 (Unblinded CGM) |
|
All enrolled participants who received study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Participants received prescribed insulin regimen suitable for their disease state using insulin lispro 100 U/mL injected via the pen. During the study, participants had their glucose monitored via the CGM device, which was blinded during Study Period 1 and unblinded during Study Period 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All enrolled participants who received at least one dose of study drug and have missed bolus insulin dose data. | Posted | Mean | Standard Deviation | Days per month | Week 1 up to 6 weeks |
|
Up To 12 Weeks
All enrolled participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blinded CGM | Participants received Insulin lispro 100 U/mL injected via the pen and they were blinded to CGM device recording as directed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2017 | May 27, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2018 | May 29, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
| Insulin Lispro | Drug | As prescribed. |
|
| 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 |
| Los Angeles |
| California |
| 90045 |
| United States |
| Coastal Metabolic Research Ctr | Ventura | California | 93003 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| Iowa Diabetes & Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| Lost to Follow-up |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | All enrolled participants who received at least one dose of study drug and have missed bolus insulin dose data. | Posted | Mean | Standard Deviation | Days per month | Week 6 up to 12 weeks |
|
|
|
| Secondary | 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. | All enrolled participants who received at least one dose of study drug and have data for Percentage of Time-in-Range. | Posted | Mean | Standard Deviation | Percentage of time | Baseline up to 6 weeks |
|
|
|
| Secondary | 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. | All enrolled participants who received at least one dose of study drug and have data for Percentage of Time-in-Range. | Posted | Mean | Standard Deviation | Percentage of time | Week 6 up to 12 weeks |
|
|
|
| Secondary | 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. | All enrolled participants who received at least one dose of study drug and have data for missed bolus doses. | Posted | Mean | Standard Deviation | Percentage of missed bolus dose | Baseline up to 6 weeks |
|
|
|
| Secondary | 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. | All enrolled participants who received at least one dose of study drug and have data for missed bolus doses. | Posted | Mean | Standard Deviation | Percentage of missed bolus dose | Week 6 up to 12 weeks |
|
|
|
| Secondary | 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. | All enrolled participants who received at least one dose of study drug and have data for missed bolus doses. | Posted | Mean | Standard Deviation | Dose per day | Baseline up to 6 weeks |
|
|
|
| Secondary | 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. | All enrolled participants who received at least one dose of study drug and have data for missed bolus doses. | Posted | Mean | Standard Deviation | Dose per day | Week 6 up to 12 weeks |
|
|
|
| Secondary | 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. | All enrolled participants who received at least one dose of study drug and have data for missed bolus doses. | Posted | Mean | Standard Deviation | Dose per month | Baseline up to 6 weeks |
|
|
|
| Secondary | 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. | All enrolled participants who received at least one dose of study drug and have data for missed bolus doses. | Posted | Mean | Standard Deviation | Dose per month | Week 6 up to 12 weeks |
|
|
|
| 0 |
| 78 |
| 3 |
| 78 |
| 22 |
| 78 |
| EG001 | Unblinded CGM | Participants received Insulin lispro 100 U/mL injected via the pen and they were unblinded to CGM device recording as directed. | 0 | 73 | 2 | 73 | 9 | 73 |
| Localised infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Medical device removal | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Application site bruise | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Application site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Device damage | Product Issues | MedDRA 20.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diabetic microangiopathy | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Some investigators wait until a multi-site publication is published (or 2 years if not published sooner) plus a 90 day review period.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |