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

NCT05893797 | Completed Results FDA Device

• 3 other identifiers: 18171F3Z-MC-IORW2022-A02807-36
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

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

Keywords

T1D; T2D

Outcome Measures

Primary Outcomes (1)

• Number of Missed Bolus Doses (MBDs) Per Week

  Missed bolus dose is defined as no insulin dose from 1 hour prior to through 1 hour after the start of a glucose excursion (meal), where a glucose excursion was defined as a greater than (\>) 70 milligrams per deciliter (mg/dL) (\>3.9 millimoles per liter \[mmol/L\]) rise within 2 hours, not preceded by a value \<70 mg/dL (\<3.9 mmol/L).

  Study Period 1: Week 6 ; Study Period 2: Week 18

Secondary Outcomes (24)

• Percentage of Time in Blood Glucose (BG) Range 70 to 180 mg/dL Captured by Continuous Glucose Monitoring (CGM)

  Study Period 1: Week 6; Study Period 2: Week 18

• Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM

  Study Period 1: Week 6; Study Period 2: Week 18

• Percentage of Time in Hypoglycemic Range <54 mg/dL and 54 to 69 mg/dL Captured by CGM

  Study Period 1: Week 6; Study Period 2: Week 18

• Coefficient of Variation for Glucose

  Study Period 1: Week 6; Study Period 2: Week 18

• Mean Glucose as Measured by CGM

  Study Period 1: Week 6; Study Period 2: Week 18

Study Arms (1)

Humalog Tempo Pen With CGM Monitoring

EXPERIMENTAL

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.

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

Interventions

Insulin Lispro DRUG

As prescribed.

Also known as: Humalog Tempo Pen

Humalog Tempo Pen With CGM Monitoring

Tempo Smart Button DEVICE

Attached to the Tempo Pen

Humalog Tempo Pen With CGM Monitoring

Dexcom G6 CGM DEVICE

Continuous glucose monitor

Humalog Tempo Pen With CGM Monitoring

Glooko Research Mobile App (RMA) DEVICE

Installed on a study provided android phone.

Humalog Tempo Pen With CGM Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (9)

CHU Strasbourg-Hautepierre

Strasbourg, Alsace, 67098, France

Location

CHU de Caen Hôpital Cote de Nacre

Caen, Cedex 9, 14033, France

Location

CHU de Besancon Hopital Jean Minjoz

Besançon, 25030, France

Location

Centre Hospitalier Sud Francilien-Pharmacie

Corbeil-Essonnes, 91100, France

Location

Chu de Grenoble

Grenoble Cédex 9, 38043, France

Location

CHU de Lyon

Lyon, 69008, France

Location

CHU - l'Assistance Publique - Hôpitaux de Marseille

Marseille, 13005, France

Location

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, 6202, France

Location

Groupe Hospitalier Mutualiste Les Portes du Sud

Vénissieux, 69200, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: October 5, 2023
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)