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

Lilly

Status: Completed

Conditions: Type 1 Diabetes; Type 2 Diabetes Treated With Insulin; Type 2 Diabetes

Treatments: Device: Tempo Smart Button; Device: Glooko Research Medical App (RMA); Device: Dexcom G6 CGM; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT05893797

F3Z-MC-IORW (Other Identifier)

2022-A02807-36 (Other Identifier)

18171

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

36 participants in 1 patient group

Connected Management Platform

Experimental group

Description:

Participants with type 1 and type 2 diabetes wearing continuous glucose monitoring (CGM) will receive insulin lispro via the Tempo Pen as part of the connected insulin management platform.

Treatment:

Drug: Insulin Lispro

Device: Dexcom G6 CGM

Device: Glooko Research Medical App (RMA)

Device: Tempo Smart Button