Type 1 DiabetesNCT04484779
A Study of an Insulin Management System in Participants With Type 1 or Type 2 Diabetes
A study testing IIM System and Insulin Lispro and/or Insulin Glargine in people with Type 1 Diabetes and Type 2 Diabetes, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
The purpose of this study is to investigate the user experience of an integrated insulin management system (IIM) in participants with type 1 or type 2 diabetes. The IIM system is comprised of an insulin injection pen with a data transmission module and blood glucose meter which are connected to a mobile phone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- IIM System and Insulin Lispro and/or Insulin Glargine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Jul 2020to 22 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed (clinically) with type 1 diabetes (T1D) for at least 1 year or type 2 diabetes (T2D) for at least 6 months.
- Using insulin injection regimen of basal/bolus or basal only for 3 months prior to screening, which includes:
- for bolus insulin (U-100) - a rapid-acting insulin analog (glulisine, lispro, or aspart).
- for basal insulin - degludec (U-100 or U-200), detemir (U-100), or glargine (U- 100 or U-300).
- Participants with T2D may be on ≤ 3 anti-hyperglycemic medications in addition to insulin, including alpha-glucosidase inhibitors, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonist (GLP-1 RA; oral or injectable), meglitinides, metformin, sodium-glucose cotransporter-2 inhibitors (SGLTi-2), sulfonylureas, or thiazolidinediones consistent with product labeling.
- Participants with T1D must be on insulin only.
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- Have point-of-care hemoglobin A1c (HbA1c) value of ≤11% at screening.
- Must be able to self-inject insulin dose (basal or basal/bolus) without assistance.
- If using Continuous Glucose Monitoring or Flash Glucose Monitoring device, must agree to stop use throughout duration of trial.
- Must be able to read and speak English.
- Able and willing to use only study-provided insulin Basaglar and/or Humalog for duration of trial.
- Able and willing to follow insulin regimen specified by investigator throughout duration of trial, insulin dose may be titrated at investigator's discretion.
- Have no physical or cognitive disabilities that would, in the opinion of the investigator, preclude participant from using sponsor-provided iOS device for study activities and comply with study requirements.
- Agree not to post any personal medical data, pictures of the IIM system or information related to the study on any website or social media site (for example, Facebook, Twitter, LinkedIn, etc.).
- Have refrigeration in home for storage of insulin.
- Women of childbearing potential participating:
- Cannot be pregnant or intend to become pregnant during the trial period
- Cannot be breastfeeding (including the use of a breast pump)
- Must remain abstinent or
- Must use 1 highly effective method (less than 1% failure rate) of contraception or a combination of 2 effective methods of contraception for the entirety of the study and
- Test negative for pregnancy based on a urine pregnancy test at the time of screening. Additional local urine pregnancy tests may be conducted for duration of trial at discretion of investigator.
Who cannot join
- If not able to take the basal insulin dose in 1 injection per day.
- Have experienced an episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 3 months prior to screening.
- Have hypoglycemia unawareness as judged by the investigator.
- Have had 1 or more emergency room visits or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis [DKA]) within 3 months prior to screening.
- History of renal transplantation, receiving renal dialysis, or diagnosed with stage IV chronic kidney disease.
- Any of the following cardiovascular conditions within 6 months prior to screening: i. acute myocardial infarction (MI) ii. cerebrovascular accident (stroke) iii. unstable angina, or iv. hospitalization due to congestive heart failure (CHF)
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- Presence or history of severe congestive heart failure (New York Heart Association Class IV [CCNYHA 1994]).
- Have history of or clinical signs of liver disease (for example, acute or chronic hepatitis, or cirrhosis).
- Have active or untreated malignancy except basal cell or squamous cell skin cancer.
- Have any hypersensitivity or allergy to any of the insulins or excipients used in this trial.
- Have vision loss or vision impairment that does not allow recognition of MMA screen features.
- Have impaired dexterity which limits ability to use injection device or mobile MMA.
- 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. If the previous investigational product has a long halflife, 5 half-lives or 30 days (whichever is longer) should have passed.
- Have previously completed or withdrawn from this study.
- Have previously used or are currently using an approved or investigational connected pen system.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731-4309
Medical Investigations Inc.
Little Rock, Arkansas, 72211
Rainier Clinical Research Center
Renton, Washington, 98057
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
About this study
Official title: User Experience and Daily Use Patterns With the Integrated Insulin Management (IIM) System
The purpose of this study is to investigate the user experience of an integrated insulin management system (IIM) in participants with type 1 or type 2 diabetes. The IIM system is comprised of an insulin injection pen with a data transmission module and blood glucose meter which are connected to a mobile phone application. The application will be used to record and track diabetes-data related information.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- IIM System, Insulin Lispro and/or Insulin Glargine
- 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.
IIM SystemDevice
IIM System
Insulin Lispro and/or Insulin GlargineDrug
Administered subcutaneously (SC)
| Study group | Role | What they receive |
|---|---|---|
| IIM System | Experimental | The IIM system is comprised of an insulin lispro pen and/or an insulin glargine pen (both U-100), an investigational mobile medical application (MMA) that transmits data to cloud storage, an investigational Bluetooth Low Energy® (BLE)-paired insulin data transmission (IDT) module and a compatible commercially available BLE-paired blood glucose meter (BGM). Receives: Device: IIM System; Drug: Insulin Lispro and/or Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and Domain Specific Score of the mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
Total and Domain Specific Score of the MAUQ for Standalone mHealth Apps Used by Patients
Measured: 10 Weeks
Secondary outcomes (2)
Overall Ease of Use of the IIM System
Overall Ease of Use of the IIM System Assessed by the Participant Feedback Form
Measured: 10 Weeks
Likelihood of Site to Recommend the IIM System
Likelihood of Site to Recommend the IIM System Assessed by the Site Feedback Form
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start14 Jul 2020
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 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 1-317-532-0186 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
- NCT04484779
- Sponsor's protocol ID
- 16928
- Other IDs
- F3Z-MC-IOQY
- Status last verified
- Jan 2021
- First submitted
- 10 Jul 2020
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Experience and Daily Use Patterns With the Integrated Insulin Management (IIM) System
- ClinicalTrials.gov ID
- NCT04484779
- Acronym / sponsor ID
- 16928
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the user experience of an integrated insulin management system (IIM) in participants with type 1 or type 2 diabetes. The IIM system is comprised of an insulin injection pen with a data transmission module and blood glucose meter which are connected to a mobile phone application. The application will be used to record and track diabetes-data related information.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IIM System | Experimental | Device: IIM System, Drug: Insulin Lispro and/or Insulin GlargineThe IIM system is comprised of an insulin lispro pen and/or an insulin glargine pen (both U-100), an investigational mobile medical application (MMA) that transmits data to cloud storage, an investigational Bluetooth Low Energy® (BLE)-paired insulin data transmission (IDT) module and a compatible commercially available BLE-paired blood glucose meter (BGM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Diagnosed (clinically) with type 1 diabetes (T1D) for at least 1 year or type 2 diabetes (T2D) for at least 6 months.
- Using insulin injection regimen of basal/bolus or basal only for 3 months prior to screening, which includes:
- Participants with T2D may be on ≤ 3 anti-hyperglycemic medications in addition to insulin, including alpha-glucosidase inhibitors, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonist (GLP-1 RA; oral or injectable), meglitinides, metformin, sodium-glucose cotransporter-2 inhibitors (SGLTi-2), sulfonylureas, or thiazolidinediones consistent with product labeling.
- Participants with T1D must be on insulin only.
- Have point-of-care hemoglobin A1c (HbA1c) value of ≤11% at screening.
Key exclusion criteria (16 listed)
- If not able to take the basal insulin dose in 1 injection per day.
- Have experienced an episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 3 months prior to screening.
- Have hypoglycemia unawareness as judged by the investigator.
- Have had 1 or more emergency room visits or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis [DKA]) within 3 months prior to screening.
- History of renal transplantation, receiving renal dialysis, or diagnosed with stage IV chronic kidney disease.
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 |
|---|---|---|
| IIM SystemIIM System | Device | IIM System |
| Insulin Lispro and/or Insulin GlargineAdministered subcutaneously (SC) | Drug | IIM System |
Primary outcome
Total and Domain Specific Score of the mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
Time frame: 10 Weeks
Total and Domain Specific Score of the MAUQ for Standalone mHealth Apps Used by Patients
2 secondary outcomes
Overall Ease of Use of the IIM System
Time frame: 10 Weeks
Likelihood of Site to Recommend the IIM System
Time frame: 10 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- 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 1-317-532-0186 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IIM System and Insulin Lispro and/or Insulin Glargine in people with Type 1 Diabetes and Type 2 Diabetes, run by Eli Lilly and Company at 5 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 21 inclusion and 16 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 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total and Domain Specific Score of the mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients (time frame: 10 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2021.