A Study of LY8888AX in Participants Using a Connected Insulin Management Platform

• Status: Not yet recruiting
• Trial end date: 2024-04-15
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to assess participant adherence and glucose control while using a connected insulin management platform. Approximately 50 participants will be enrolled in each country.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin Lispro; TEMPO

Criteria

Inclusion Criteria:

• Have been diagnosed (clinically) with T1D for at least 1 year or are patients with T2D on basal bolus insulin therapy for at least 6 months

• HbA1c ≥8% as confirmed by point-of-care test at screening

• Are currently using the Dexcom G6 CGM or agree to start using the Dexcom G6 during the study and agree to switch to Glooko RMA

• Are currently using Humalog ® insulin or another rapid acting insulin analogue (e.g., Apidra® , or Novorapid ® ) and agree to switch to study-provided Humalog mealtime insulin for duration of trial

• Have been prescribed ≥3 doses of bolus insulin per day

• Must be taking a stable insulin dose regimen (per investigator's judgement) for at least 3 months preceding study screening

• Have in-home refrigeration for storage of insulin

Exclusion Criteria:

• Previously used the Glooko RMA and/or Dexcom G6 CGM and were judged by the investigator to be non-adherent

• Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed

• Have previously used or have been using an approved or investigational connected pen system within the 3 months prior to screening

• Are currently breastfeeding, pregnant, or plan to become pregnant during the next 4-6 months

• Are on ultra-rapid insulin (e.g., Fiasp or Lyumjev) or rapid acting human insulin (i.e., Humulin) for previous 3 months, at the time of screening

• Are currently undergoing dialysis treatment or have any other medical condition which may preclude them from participating in this trial as per the investigator's judgement

• Have vision loss or vision impairment that does not allow recognition of Glooko RMA screen features