A Study of an Insulin Management System in Participants With Type 1 or Type 2 Diabetes

January 6, 2021 updated by: Eli Lilly and Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Medical Investigations Inc.
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Texas
      • Austin, Texas, United States, 78731-4309
        • Texas Diabetes & Endocrinology, P.A.
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology, P.A.
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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)
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IIM System
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).
Device: IIM System
IIM System
Drug: Insulin Lispro and/or Insulin Glargine
Administered subcutaneously (SC)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
10 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Ease of Use of the IIM System
Time Frame: 10 Weeks
Overall Ease of Use of the IIM System Assessed by the Participant Feedback Form
10 Weeks
Likelihood of Site to Recommend the IIM System
Time Frame: 10 Weeks
Likelihood of Site to Recommend the IIM System Assessed by the Site Feedback Form
10 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16928
  • F3Z-MC-IOQY (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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