Type 1 DiabetesNCT05893797
A Study of LY8888AX in Participants Using a Connected Insulin Management Platform
A study testing Insulin Lispro, Tempo Smart Button and Dexcom G6 CGM in people with Type 1 Diabetes and Type 2 Diabetes, run by Eli Lilly and Company at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes, Type 2 Diabetes Treated With Insulin
- What is being tested?
- Insulin Lispro, Tempo Smart Button and Dexcom G6 CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 9 sitesFrance
- Study dates
- 5 Oct 2023to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU de Besancon Hopital Jean Minjoz
Besançon, 25030
CHU de Caen Hôpital Cote de Nacre
Caen, Cedex 9, 14033
Centre Hospitalier Sud Francilien-Pharmacie
Corbeil-Essonnes, 91100
Chu de Grenoble
Grenoble Cédex 9, 38043
CHU de Lyon
Lyon, 69008
CHU - l'Assistance Publique - Hôpitaux de Marseille
Marseille, 13005
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, 6202
CHU Strasbourg-Hautepierre
Strasbourg, Alsace, 67098
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux, 69200
About this study
Official title: 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.
- Being tested
- Insulin Lispro, Tempo Smart Button, Dexcom G6 CGM, Glooko Research Mobile App (RMA)
- Keywords
- T1D, T2D
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin LisproDrug
Also called Humalog Tempo Pen
As prescribed.
Tempo Smart ButtonDevice
Attached to the Tempo Pen
Dexcom G6 CGMDevice
Continuous glucose monitor
Glooko Research Mobile App (RMA)Device
Installed on a study provided android phone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Insulin Lispro; Device: Tempo Smart Button; Device: Dexcom G6 CGM; Device: Glooko Research Mobile App (RMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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
Measured: 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
Measured: Study Period 1: Week 6; Study Period 2: Week 18
Coefficient of Variation for Glucose
Measured: Study Period 1: Week 6; Study Period 2: Week 18
Mean Glucose as Measured by CGM
Measured: 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.
Measured: Study Period 1: Week 6 ; Study Period 2: Week 18
Total Insulin Dose Per Day
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start5 Oct 2023
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893797
- Sponsor's protocol ID
- 18171
- Other IDs
- F3Z-MC-IORW, 2022-A02807-36
- Status last verified
- Oct 2025
- First submitted
- 30 May 2023
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Participant Adherence and Glucose Control While Using a Connected Insulin Management Platform
- ClinicalTrials.gov ID
- NCT05893797
- Acronym / sponsor ID
- 18171
- Keywords
- T1D, T2D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Humalog Tempo Pen With CGM Monitoring | Experimental | Drug: Insulin Lispro, Device: Tempo Smart Button, Device: Dexcom G6 CGM, Device: Glooko Research Mobile App (RMA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin LisproAlso: Humalog Tempo PenAs prescribed. | Drug | Humalog Tempo Pen With CGM Monitoring |
| Tempo Smart ButtonAttached to the Tempo Pen | Device | Humalog Tempo Pen With CGM Monitoring |
| Dexcom G6 CGMContinuous glucose monitor | Device | Humalog Tempo Pen With CGM Monitoring |
| Glooko Research Mobile App (RMA)Installed on a study provided android phone. | Device | Humalog Tempo Pen With CGM Monitoring |
Primary outcome
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).
24 secondary outcomes
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
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
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
Coefficient of Variation for Glucose
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Mean Glucose as Measured by CGM
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Number of Mistimed Bolus Dose Per Week
Time frame: Study Period 1: Week 6 ; Study Period 2: Week 18
Total Insulin Dose Per Day
Time frame: Study Period 1: Week 6; Study Period 2: Weeks 18
Number of Correction Bolus Dose Per Week
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 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 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
Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen?
Time frame: 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?
Time frame: 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?
Time frame: Study Period 2: Week 18
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
Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses
Time frame: 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
Time frame: 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
Time frame: Study Period 2: Week 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
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
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin Lispro, Tempo Smart Button and Dexcom G6 CGM in people with Type 1 Diabetes and Type 2 Diabetes, run by Eli Lilly and Company at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Missed Bolus Doses (MBDs) Per Week (time frame: Study Period 1: Week 6 ; Study Period 2: Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.