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

Assessment of Participant Adherence and Glucose Control While Using a Connected Insulin Management Platform

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Type 2 Diabetes; Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Drug: Insulin Lispro; Device: Tempo Smart Button; Device: Dexcom G6 CGM; Device: Glooko Research Mobile App (RMA)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • CHU de Besancon Hopital Jean Minjoz
  • Corbeil-Essonnes, France, 91100
    • Centre Hospitalier Sud Francilien-Pharmacie
  • Grenoble Cédex 9, France, 38043
    • Chu de Grenoble
  • Lyon, France, 69008
    • CHU de Lyon
  • Marseille, France, 13005
    • CHU - l'Assistance Publique - Hôpitaux de Marseille
  • Nice, France, 6202
    • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
  • Vénissieux, France, 69200
    • Groupe Hospitalier Mutualiste Les Portes du Sud
  • Alsace
    • Strasbourg, Alsace, France, 67098
      • CHU Strasbourg-Hautepierre
  • Cedex 9
    • Caen, Cedex 9, France, 14033
      • CHU de Caen Hopital Cote de Nacre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Humalog Tempo Pen With CGM Monitoring; 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; As prescribed.; Other Names: Humalog Tempo Pen; Device: Tempo Smart Button; Attached to the Tempo Pen; Device: Dexcom G6 CGM; Continuous glucose monitor; Device: Glooko Research Mobile App (RMA); Installed on a study provided android phone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Mistimed Bolus Dose Per Week	A mistimed bolus dose is defined as a bolus dose administered from the start of a glucose excursion up to 1 hour after the start of glucose excursion and before the peak of glucose excursion.	Study Period 1: Week 6 ; Study Period 2: Week 18
Total Insulin Dose Per Day		Study Period 1: Week 6; Study Period 2: Weeks 18
Number of Correction Bolus Dose Per Week	Correction bolus is defined as taking a bolus dose given after the peak of a glucose excursion but within 4 hours from the start of a glucose excursion and prior to start of next glucose excursion.	Study Period 1: Week 6; Study Period 2: Week 18
Correlation Between Missed Bolus Dose and Glycemic Outcomes [i.e., HbA1c, Time in BG Range (70-180 mg/dL), Time in Hyperglycemic Range (>250 mg/dL), and Time in Hypoglycemia (<54 mg/dL)] Using Raw CGM Integrated Data From Tempo Pen and Tempo Smart Button	Correlation between Missed Bolus Dose and Glycemic Outcomes i.e., HbA1c, Time in Blood glucose (BG) Range (70-180 mg/dL), Time in Hyperglycemic Range (>250 mg/dL), and Time in Hypoglycemia (<54 mg/dL) was calculated by spearman correlation. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates a perfect negative correlation, and +1 indicates a perfect positive correlation.	Study Period 1: Week 6; Study Period 2: Week 18
Correlation Between Mistimed Bolus Dose and Glycemic Outcomes [i.e., HbA1c, Time in BG Range (70-180 mg/dL), Time in Hyperglycemic Range (>250 mg/dL), Time in Hypoglycemia (<54 mg/dL)] Using Raw CGM Integrated Data From Tempo Pen and Tempo Smart Button	Correlation between Mistimed Bolus Dose and Glycemic Outcomes i.e., HbA1c, Time in Blood glucose (BG) Range (70-180 mg/dL), Time in Hyperglycemic Range (>250 mg/dL), and Time in Hypoglycemia (<54 mg/dL) was calculated by spearman correlation. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates a perfect negative correlation, and +1 indicates a perfect positive correlation.	Study Period 1: Week 6; Study Period 2: Week 18
Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen?	Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess existing device satisfaction of tempo pen and smart button that participants were using before the study, participants were asked: "On average, how satisfied are you with your current insulin pen?" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported; Extremely Unsatisfied; Unsatisfied; Neutral; Satisfied; Extremely Satisfied	At Baseline
Study Period 1: Participant Questionnaires (Device Satisfaction) - On Average, How Satisfied Are You With the Way You Manage Your Insulin Treatment on a Day-to-day Basis?	Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess existing device satisfaction of tempo pen and smart button that participants were using before the study, participants were asked: "On average, how satisfied are you with the way you manage your insulin treatment on a day-to-day basis?" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported.; Extremely Unsatisfied; Unsatisfied; Neutral; Satisfied; Extremely Satisfied	At Baseline
Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study?	Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device preference of Humalog Tempo Pen and Tempo smart button participants were asked: "I prefer the connected insulin pen compared to the insulin pen I used before the study?" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported; Strongly disagree; Disagree; Neutral; Agree; Strongly agree	Study Period 2: Week 18
Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses	Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked: "I found the app difficult to use to monitor my insulin doses" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported.; Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree	Study Period 2: Week 18
Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses	Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked: "It helped me to forget fewer doses" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported; Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree	Study Period 2: Week 18
Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not	Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked "I no longer had to worry about when my last dose was injected or not" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported; Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree	Study Period 2: Week 18
Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management	Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked: "Having all my insulin and glucose data in one place simplified my diabetes management" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported; Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree	Study Period 2: Week 18
Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use	Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked: "I found the connected pen to be difficult to use" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported.; Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree	Study Period 2: Week 18
Study Period 2: Participant Questionnaires (Device Usefulness): The Use of the Connected Insulin Pen Reduced the Amount of Time I Spent on my Diabetes Management	Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked: "The use of the connected insulin pen reduced the amount of time I spent on my diabetes management". Participants were categorized based on their responses on a 5-point Likert scale as below and are reported.; Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree	Study Period 2: Week 18
Health Care Provider (HCP) Questionnaires (Device Satisfaction) - On Average, How Satisfied Are You With the Connected Insulin Pen Your Patients Have Been Using in the Study?	The Health Care Provider (HCP) questionnaires evaluated responses from HCPs related to Humalog Tempo Pen and Tempo smart button device focusing on satisfaction, preferences, and usefulness. Questionnaire was completed independently by HCPs (Including Principal Investigator, study coordinator or nurse). This evaluation was a general, aggregate assessment and was not linked to any specific participant. To assess Humalog Tempo Pen and Tempo smart button device satisfaction HCPs were asked: "On average, how satisfied are you with the connected insulin pen your patients have been using in the study?" HCPs were categorized based on their responses on a 5-point Likert scale as below and are reported.; Extremely Unsatisfied; Unsatisfied; Neutral; Satisfied; Extremely Satisfied	Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)
Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance	The Health Care Provider (HCP) questionnaires evaluated responses from HCPs related to Humalog Tempo Pen and Tempo smart button device focusing on device satisfaction, preferences, and usefulness. Questionnaire was completed independently by HCPs (including principal Investigator, study coordinator or nurse). This evaluation was a general, aggregate assessment and was not linked to any specific participant. To assess Humalog Tempo Pen and Tempo smart button device usefulness HCPs were asked: "Offered me objective date on my patients dosing history allowing me to provide appropriate dosing guidance". HCPs were categorized based on their responses on a 5-point Likert scale as below and are reported.; Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree	Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)
Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions	The Health Care Provider (HCP) questionnaires evaluated responses from HCPs related to Humalog Tempo Pen and Tempo smart button device focusing on satisfaction, preferences, and usefulness. Questionnaire was completed independently by HCPs (including principal Investigator, study coordinator or nurse). This evaluation was a general, aggregate assessment and was not linked to any specific participant. To assess Humalog Tempo Pen and Tempo smart button device usefulness HCPs were asked: "It improved my confidence in making appropriate dosing decisions". HCPs were categorized based on their responses on a 5-point Likert scale as below and are reported.; Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree	Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)
Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly	The Health Care Provider (HCP) questionnaires evaluated responses from HCPs related to Humalog Tempo Pen and Tempo smart button device focusing on satisfaction, preferences, and usefulness. Questionnaire was completed independently by HCPs (Including principal Investigator, study coordinator or nurse). This evaluation was a general, aggregate assessment and was not linked to any specific participant. To assess Humalog Tempo Pen and Tempo smart button device usefulness HCPs were asked: "I suspect that my patients miss insulin doses regularly". HCPs were categorized based on their responses on a 5-point Likert scale as below and are reported.; Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree	Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)
Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients	The Health Care Provider (HCP) questionnaires evaluated responses from HCPs related to Humalog Tempo Pen and Tempo smart button device focusing on satisfaction, preferences, and usefulness. Questionnaire was completed independently by HCP (Including principal Investigator, study coordinator or nurse. This evaluation was a general, aggregate assessment and was not linked to any specific participant. To assess Humalog Tempo Pen and Tempo smart button device usefulness HCPs were asked: "Allowed me to objectively discuss missed doses or mistimed doses with my patients". HCPs were categorized based on their responses on a 5-point Likert scale as below and are reported.; Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree	Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Actual): September 16, 2024
• Study Completion (Actual): September 16, 2024

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: T1D; T2D
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulins; Pancreatic Hormones; Insulin, Short-Acting; Insulin Lispro
• Other Study ID Numbers: 18171; F3Z-MC-IORW (Other Identifier: Eli Lilly and Company); 2022-A02807-36 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes