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OpenTrials
Completed

NCT Number: NCT05893797

A Study of LY8888AX in Participants 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Type 2 Diabetes Treated With Insulin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Strasbourg-Hautepierre, Strasbourg, Alsace, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Lispro

Drug

As prescribed.

Other names: Humalog Tempo Pen

Tempo Smart Button

Device

Attached to the Tempo Pen

DEXCOM G6 CGM

Device

Continuous glucose monitor

Glooko Research Mobile App (RMA)

Device

Installed on a study provided android phone.

Primary outcomes

  1. Number of Missed Bolus Doses (MBDs) Per Week

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

    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).

Secondary outcomes

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

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

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

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

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

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

  4. Coefficient of Variation for Glucose

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

  5. Mean Glucose as Measured by CGM

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

  6. Number of Mistimed Bolus Dose Per Week

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

    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.

  7. Total Insulin Dose Per Day

    Time frame: Study Period 1: Week 6; Study Period 2: Weeks 18

  8. Number of Correction Bolus Dose Per Week

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

    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.

  9. 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

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

    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.

  10. 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

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

    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.

  11. Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen?

    Time frame: At Baseline

    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

  12. 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?

    Time frame: At Baseline

    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

  13. Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study?

    Time frame: Study Period 2: Week 18

    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

  14. Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses

    Time frame: Study Period 2: Week 18

    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

  15. Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses

    Time frame: Study Period 2: Week 18

    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

  16. Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not

    Time frame: Study Period 2: Week 18

    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

  17. Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management

    Time frame: Study Period 2: Week 18

    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

  18. Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use

    Time frame: Study Period 2: Week 18

    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

  19. 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

    Time frame: Study Period 2: Week 18

    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

  20. 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?

    Time frame: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)

    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

  21. Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance

    Time frame: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)

    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

  22. Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions

    Time frame: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)

    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

  23. Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly

    Time frame: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)

    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

  24. Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients

    Time frame: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)

    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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2023
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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