A Study of LY8888AX in Participants Using a Connected Insulin Management Platform
NCT ID: NCT05893797
Last Updated: 2025-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2023-10-05
2024-09-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Insulin Lispro
As prescribed.
Tempo Smart Button
Attached to the Tempo Pen
Dexcom G6 CGM
Continuous glucose monitor
Glooko Research Mobile App (RMA)
Installed on a study provided android phone.
Interventions
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Insulin Lispro
As prescribed.
Tempo Smart Button
Attached to the Tempo Pen
Dexcom G6 CGM
Continuous glucose monitor
Glooko Research Mobile App (RMA)
Installed on a study provided android phone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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CHU Strasbourg-Hautepierre
Strasbourg, Alsace, France
CHU de Caen Hôpital Cote de Nacre
Caen, Cedex 9, France
CHU de Besancon Hopital Jean Minjoz
Besançon, , France
Centre Hospitalier Sud Francilien-Pharmacie
Corbeil-Essonnes, , France
Chu de Grenoble
Grenoble Cédex 9, , France
CHU de Lyon
Lyon, , France
CHU - l'Assistance Publique - Hôpitaux de Marseille
Marseille, , France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, , France
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux, , France
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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F3Z-MC-IORW
Identifier Type: OTHER
Identifier Source: secondary_id
2022-A02807-36
Identifier Type: OTHER
Identifier Source: secondary_id
18171
Identifier Type: -
Identifier Source: org_study_id