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

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: Completed
• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Intervention / Treatment: Device: IIM System; Drug: Insulin Lispro and/or Insulin Glargine

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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	Total and Domain Specific Score of the MAUQ for Standalone mHealth Apps Used by Patients	10 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Ease of Use of the IIM System	Overall Ease of Use of the IIM System Assessed by the Participant Feedback Form	10 Weeks
Likelihood of Site to Recommend the IIM System	Likelihood of Site to Recommend the IIM System Assessed by the Site Feedback Form	10 Weeks

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Actual): December 22, 2020
• Study Completion (Actual): December 22, 2020

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin Glargine; Insulin Lispro
• Other Study ID 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