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

Last updated: November 27, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

N/A

Condition

Diabetes Prevention

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

Tempo Smart Button

Dexcom G6 CGM

Glooko Research Medical App (RMA)

Clinical Study ID

NCT05893797
18171
2022-A02807-36
F3Z-MC-IORW
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have been diagnosed (clinically) with T1D for at least 1 year or are patients withT2D 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 duringthe 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 Humalogmealtime 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 atleast 3 months preceding study screening

  • Have in-home refrigeration for storage of insulin

Exclusion

Exclusion Criteria:

  • Previously used the Glooko RMA and/or Dexcom G6 CGM and were judged by theinvestigator to be non-adherent

  • Have participated, within the last 30 days, in a clinical study involving aninvestigational product. If the previous investigational product has a longhalf-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 pensystem 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 conditionwhich may preclude them from participating in this trial as per the investigator'sjudgement

  • Have vision loss or vision impairment that does not allow recognition of Glooko RMAscreen features

Study Design

Total Participants: 36
Treatment Group(s): 4
Primary Treatment: Tempo Smart Button
Phase:
Study Start date:
October 05, 2023
Estimated Completion Date:
September 16, 2024

Connect with a study center

  • CHU Strasbourg-Hautepierre

    Strasbourg, Alsace 67098
    France

    Site Not Available

  • CHU de Caen Hôpital Cote de Nacre

    Caen, Cedex 9 14033
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, Île-de-France 91106
    France

    Site Not Available

  • CHU de Besancon Hopital Jean Minjoz

    Besancon Cedex, 25030
    France

    Site Not Available

  • University Hospital Center Caen

    Caen, 14000
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien-Pharmacie

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • Chu de Grenoble

    Grenoble, 38700
    France

    Site Not Available

  • Chu de Grenoble

    Grenoble Cédex 9, 38043
    France

    Site Not Available

  • CHU De Grenoble Hopital Albert Michallon

    La Tronche, 38700
    France

    Site Not Available

  • CHU de Lyon

    Lyon, 69008
    France

    Site Not Available

  • Hôpital Edouard Herriot

    Lyon, 69003
    France

    Site Not Available

  • CHU - l'Assistance Publique - Hôpitaux de Marseille

    Marseille, 13005
    France

    Site Not Available

  • Marseille Public University Hospital

    Marseille, 13005
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, 6202
    France

    Site Not Available

  • University Hospital Center Strasbourg

    Strasbourg, 6700
    France

    Site Not Available

  • Chu Toulouse Hotel-Dieu Saint Jacques

    Toulouse Cedex, 31052
    France

    Site Not Available

  • Groupe Hospitalier Mutualiste Les Portes du Sud

    Venissieux, 69200
    France

    Site Not Available

  • Groupe Hospitalier Mutualiste Les Portes du Sud

    Vénissieux, 69200
    France

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, Florence 50134
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milano 20162
    Italy

    Site Not Available

  • AO Santa Maria della Misericordia

    Perugia, Umbria 06132
    Italy

    Site Not Available

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Azienda ospedaliero-universitaria Mater Domini

    Catanzaro, 88100
    Italy

    Site Not Available

  • ASL Gallura

    Olbia, 07026
    Italy

    Site Not Available

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