Diabetes Mellitus, Type 1NCT03368807
Assessment of Mealtime Bolus Insulin Behavior
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Continuous Glucose Monitoring and Insulin Lispro
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Dec 2017to 23 Jul 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 1 and Type 2 Diabetics
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
AMCR Institute, Inc.
Escondido, California, 92025
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Science 37 Inc
Los Angeles, California, 90045
Advanced Research Institute
Ogden, Utah, 84405
Coastal Metabolic Research Ctr
Ventura, California, 93003
Iowa Diabetes & Endocrinology Research Center
West Des Moines, Iowa, 50265
About this study
Official title: 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.
- Being tested
- Continuous Glucose Monitoring, Insulin Lispro
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitoringDevice
Commercially available
Insulin LisproDrug
As prescribed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Continuous Glucose Monitoring; Drug: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 up to 6 weeks
Secondary outcomes (9)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6 up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start11 Dec 2017
- Primary completion12 Jun 2018
- Study completion23 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368807
- Sponsor's protocol ID
- 16866
- Other IDs
- F3Z-MC-IOQV
- Status last verified
- Jul 2018
- First submitted
- 30 Nov 2017
- Last updated
- 2 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39930566
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Objective Assessment of Mealtime Bolus Insulin Behavior and Associated Factors
- ClinicalTrials.gov ID
- NCT03368807
- Acronym / sponsor ID
- 16866
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 23 Jul 2018 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 2 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded CGM (Continuous Glucose Monitoring) | – | Device: Continuous Glucose Monitoring, Drug: Insulin LisproParticipants 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 | – | Device: Continuous Glucose Monitoring, Drug: Insulin LisproParticipants received Insulin lispro 100 U/mL injected via the pen and they were unblinded to CGM device recording as directed in study period 2. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 and Type 2 Diabetics
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose MonitoringCommercially available | Device | Blinded CGM (Continuous Glucose Monitoring), Unblinded CGM |
| Insulin LisproAs prescribed. | Drug | Blinded CGM (Continuous Glucose Monitoring), Unblinded CGM |
Primary outcome
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.
9 secondary outcomes
Average Number of Days Per Month With a Missed Bolus Insulin Dose With Unblinded CGM
Time frame: Week 6 up to 12 weeks
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) With Unblinded CGM
Time frame: Week 6 up to 12 weeks
Percentage of Missed Bolus Doses Per Month With Blinded CGM
Time frame: Baseline up to 6 weeks
Percentage of Missed Bolus Doses Per Month With Unblinded CGM
Time frame: Week 6 up to 12 weeks
Average Number of Missed Bolus Insulin Doses Per Day With Blinded CGM
Time frame: Baseline up to 6 weeks
Average Number of Missed Bolus Insulin Doses Per Day With Unblinded CGM
Time frame: Week 6 up to 12 weeks
Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Blinded CGM
Time frame: Baseline up to 6 weeks
Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Unblinded CGM
Time frame: Week 6 up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39930566Wolpert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Number of Days Per Month With a Missed Bolus Insulin Dose With Blinded CGM (time frame: Week 1 up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03368807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.