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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes, Type 2 Diabetes, Type 2 Diabetes Treated With Insulin

Intervention / Treatment
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* Drug: Insulin Lispro
* Device: Tempo Smart Button
* Device: Dexcom G6 CGM
* Device: Glooko Research Medical App (RMA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Baseline occurs at study period 1, week 5 and 6. During study period 1, participants will be masked to their bolus insulin delivery details in the connected insulin management platform. During study period 2, participants will not be masked to the bolus insulin delivery details.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connected Management Platform<br>Participants with type 1 and type 2 diabetes wearing continuous glucose monitoring (CGM) will receive insulin lispro via the Tempo Pen as part of the connected insulin management platform. | Drug: Insulin Lispro<br>* As prescribed.<br>* Other names: Humalog Tempo Pen;Device: Tempo Smart Button<br>* Attached to the Tempo Pen<br>Device: Dexcom G6 CGM<br>* Continuous glucose monitor<br>Device: Glooko Research Medical App (RMA)<br>* Installed on a study provided android phone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the Average Number of Missed Bolus Doses (MBDs) | Difference in the average number of MBDs per week in the masked versus unmasked portions of the study. 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 >70 mg/dL (>3.9 mmol/L) rise within 2 hours, not preceded by a value <70 mg/dL (<3.9 mmol/L). | Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Glucose Monitoring (CGM) Time in Range (TIR) (≥70 to 180 mg/dL) | CGM TIR (≥70 to 180 mg/dL) in the masked versus unmasked portions of the study. | Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | 
| CGM Time Above Range (TAR) (>180 mg/dL and > 250 mg/dL) | CGM TAR (>180 mg/dL and >250 mg/dL) in the masked versus unmasked portions of the study. | Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | 
| CGM Time Below Range (TBR) (54 mg/dL ≤ TBR < 70 mg/dL and < 54 mg/dL) | CGM TBR (54 mg/dL ≤ TBR < 70 mg/dL and < 54 mg/dL) in the masked versus unmasked portions of the study. | Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | 
| Coefficient of Variation of CGM Data Collected from Each Participant |  | Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | 
| Mean Sensor Glucose of CGM Data Collected from Each Participant |  | Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | 
| Occurrence and Change of Mistimed Boluses | 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. | Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | 
| Total Insulin Dose Per Day (Inclusive of Basal Insulin Dose and All bolus Insulin Doses at Meals and Correction Doses) | dose per type of meal (B, L, snacks, D) as well as corrections doses. | Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | 
| Occurrence and Change in Correction Boluses | A 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. | Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | 
| CGM Curves integrated with data received from the Tempo Pen | The association between mistimed bolus dose (MBD), TIR, TAR, TBR and HbA1c will be measured by CGM Curves integrated with data received from the tempo pen. | Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | 
| Change from Baseline in Participant Questionnaires | Participants will be assessed on device preference, satisfaction, convenience, and ease of use. | Baseline (Run in Study Period 1 Week 0, Day 1 and Week 6, Day 1-7), Intervention (Study Period 2 Week 18 Day 1-7) | 
| Change from Baseline (Run in Week 0) in Health Care Provider (HCP) Questionnaires | HCPs will assess their experience with insulin prior to this study (Run in Week 0) and the specific study device following the conclusion of all participant visits at their site. | Baseline (Run in Week 0) to Last Trial-Related Participant Site Contact (Month 10) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T1D, T2D