Clinical trial NCT04484779: A Study of an Insulin Management System in Participants With Type 1 or Type 2 Diabetes
Official title: User Experience and Daily Use Patterns With the Integrated Insulin Management (IIM) System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-07-24
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility 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.

Primary outcomes:
measure: Total and Domain Specific Score of the mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
timeFrame: 10 Weeks
Secondary outcomes:
measure: Overall Ease of Use of the IIM System
timeFrame: 10 Weeks
measure: Likelihood of Site to Recommend the IIM System
timeFrame: 10 Weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Medical Investigations Inc.
state: Arkansas
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: