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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04484779
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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 application. The application will be used to record and track diabetes-data related information.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Device: IIM System Drug: Insulin Lispro and/or Insulin Glargine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: User Experience and Daily Use Patterns With the Integrated Insulin Management (IIM) System
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : January 13, 2021
Estimated Study Completion Date : January 13, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484779


Contacts
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Contact: There are multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-532-0186 Clinicaltrials.gov@lilly.com

Locations
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United States, Arkansas
Medical Investigations Inc. Recruiting
Little Rock, Arkansas, United States, 72211
Contact    501-666-3666      
Principal Investigator: James R Thrasher         
United States, California
Diablo Clinical Research, Inc. Recruiting
Walnut Creek, California, United States, 94598
Contact    9259307267      
Principal Investigator: Mark Peder Christiansen         
United States, Texas
Texas Diabetes & Endocrinology, P.A. Recruiting
Austin, Texas, United States, 78731-4309
Contact    512-334-3505      
Principal Investigator: Thomas Blevins         
Texas Diabetes & Endocrinology, P.A. Recruiting
Round Rock, Texas, United States, 78681
Principal Investigator: Kerem Ozer         
United States, Washington
Rainier Clinical Research Center Recruiting
Renton, Washington, United States, 98057
Principal Investigator: Ronald Brazg         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04484779    
Other Study ID Numbers: 16928
F3Z-MC-IOQY ( Other Identifier: Eli Lilly and Company )
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin Glargine
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs