NCT05893797

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

Completed NA Results posted Last updated 10 November 2025

What this trial tests

NA trial testing Insulin Lispro in Type 1 Diabetes in 36 participants. Completed in 16 September 2024.

Timeline

5 October 2023

Primary endpoint
16 September 2024

16 September 2024

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	5 October 2023
Primary completion	16 September 2024
Estimated completion	16 September 2024
Sites	9 locations across France

Drugs / interventions tested

• Insulin Lispro (INSULIN LISPRO) — full drug profile →
• Tempo Smart Button
• Dexcom G6 CGM
• Glooko Research Mobile App (RMA)

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →
• Type 2 Diabetes — all drugs for Type 2 Diabetes →
• Type 2 Diabetes Treated With Insulin — all drugs for Type 2 Diabetes Treated With Insulin →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Type 1 Diabetes or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Missed Bolus Doses (MBDs) Per Week Primary · 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).

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	2.3	± 2.29
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	2.3	± 1.56

Percentage of Time in Blood Glucose (BG) Range 70 to 180 mg/dL Captured by Continuous Glucose Monitoring (CGM) Secondary · Study Period 1: Week 6; Study Period 2: Week 18

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	43.1	± 17.17
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	41.6	± 17.76

Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM Secondary · Study Period 1: Week 6; Study Period 2: Week 18

>180 mg/dL

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	56	± 17.22
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	57.5	± 17.89

>250 mg/dL

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	24.7	± 17.91
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	26.3	± 17.76

Percentage of Time in Hypoglycemic Range <54 mg/dL and 54 to 69 mg/dL Captured by CGM Secondary · Study Period 1: Week 6; Study Period 2: Week 18

<54 mg/dL

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	0.2	± 0.39
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	0.2	± 0.43

54 to 69 mg/dL

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	0.7	± 0.67
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	0.7	± 0.79

Coefficient of Variation for Glucose Secondary · Study Period 1: Week 6; Study Period 2: Week 18

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	28.8	± 5.82
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	28.9	± 6.13

Mean Glucose as Measured by CGM Secondary · Study Period 1: Week 6; Study Period 2: Week 18

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	202.8	± 33.18
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	206	± 35.44

Number of Mistimed Bolus Dose Per Week Secondary · 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.

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	3.1	± 2.02
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	2.6	± 1.55

Total Insulin Dose Per Day Secondary · Study Period 1: Week 6; Study Period 2: Weeks 18

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	61.6	± 57.75
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	60.8	± 51.56

Number of Correction Bolus Dose Per Week Secondary · 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.

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	2.4	± 1.73
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	2.6	± 1.6

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 Secondary · 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.

HbA1c

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	-0.084
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	-0.058

Time in BG Range (70-180 mg/dL)

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	0.175
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	-0.111

Time in Hyperglycemic Range (>250 mg/dL)

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	-0.217
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	0.156

Time in Hypoglycemia Range (<54 mg/dL)

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	0.068
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	0.079

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 Secondary · 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.

HBa1C

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	-0.132
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	-0.150

Time in BG Range (70-180 mg/dL)

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	0.139
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	0.020

Time in Hyperglycemic Range (>250 mg/dL)

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	-0.082
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	-0.054

Time in Hypoglycemia (<54 mg/dL)

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	-0.203
Study Period 2 - Humalog Tempo Pen With CGM Monitoring	-0.060

Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen? Secondary · 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 1. Extremely Unsatisfied 2. Unsatisfied 3. Neutral 4. Satisfied 5. Extremely Satisfied

Group	Value	95% CI
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	0
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	1
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	5
Study Period 1 - Humalog Tempo Pen With CGM Monitoring	10

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline Up to Week 18. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Humalog Tempo Pen With CGM Monitoring

Serious: 3/36 (8%)

Deaths: 0/36

Serious adverse events (4 terms)

Reaction	System	Humalog Tempo Pen With CGM…
Gastric ulcer	Gastrointestinal disorders	—
Diabetic metabolic decompensation	Metabolism and nutrition disorders	—
Asthma	Respiratory, thoracic and mediastinal disorders	—
Lung disorder	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	Humalog Tempo Pen With CGM…
Covid-19	Infections and infestations	—
Bronchitis	Infections and infestations	—
Dermatitis allergic	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Gastric ulcer, Diabetic metabolic decompensation, Asthma, Lung disorder.

Data from ClinicalTrials.gov NCT05893797 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.