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

Study Overview
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Brief Summary
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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.

Official Title
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User Experience and Daily Use Patterns With the Integrated Insulin Management (IIM) System

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Device: IIM System
* Drug: Insulin Lispro and/or Insulin Glargine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IIM System<br>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<br>* IIM System<br>Drug: Insulin Lispro and/or Insulin Glargine<br>* Administered subcutaneously (SC)<br>|

What is the study measuring?
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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 |