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; Drug: Insulin Lispro; Device: Glooko Research Mobile App (RMA); Device: Dexcom G6 CGM

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)

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36 participants in 1 patient group

Humalog Tempo Pen With CGM Monitoring

Experimental group

Description:

Study Period 1: Weeks 1 to 6 * Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs. Study Period 2: Weeks 7 to 18 * Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.

Treatment:

Device: Glooko Research Mobile App (RMA)

Device: Dexcom G6 CGM

Drug: Insulin Lispro

Device: Tempo Smart Button