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

F3Z-MC-IOQY -

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.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Type 1 Diabetes, Type 2 Diabetes
What the trial is testing?
Insulin Glargine, Insulin Lispro, Integrated Insulin Management System (IIM)
Could I receive a Placebo?
No
Enrollment Goal
67
Trial Dates
Jul 14, 2020 - Dec 22, 2020
How long will I be in the trial?
The study will last about 13 weeks and may include up to 6 visits.
Trial Phase
Not Specified

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have been diagnosed with type 1 diabetes (T1D) for at least 1 year or type 2 diabetes (T2D) for at least 6 months

  • Participants must be using insulin injection regimen of basal/bolus or basal only for 3 months prior to screening, which includes: (a). for bolus insulin (U-100) a rapid-acting insulin analog (glulisine, lispro, or aspart) (b). 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

  • Participants must be able to self-inject insulin dose (basal or basal/bolus) without assistance

  • If using Continuous Glucose Monitoring or Flash Glucose Monitoring device, participants must agree to stop use throughout duration of trial

Participants Must Not:

  • Participants must not have experienced an episode of severe hypoglycemia within 3 months

  • Participants must not have hypoglycemia unawareness as judged by the investigator

  • Participants must not have had 1 or more emergency room visits or hospitalization due to poor glucose control within 3 months prior to screening

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