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

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Type 2 Diabetes; Type 2 Diabetes Treated With Insulin
• Interventions: Drug: Insulin Lispro; Device: Tempo Smart Button; Device: Dexcom G6 CGM; Device: Glooko Research Medical App (RMA)

• Registration Number: NCT05893797
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-08
• Study Start: 2023-10-05
• Primary Completion: 2024-09-16
• Study Completion: 2024-09-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Connected Management Platform	Dexcom G6 CGM	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.
Connected Management Platform	Tempo Smart Button	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.
Connected Management Platform	Glooko Research Medical App (RMA)	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.
Connected Management Platform	Insulin Lispro	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.

Primary Outcome Measures

Name	Time	Method
Difference in the Average Number of Missed Bolus Doses (MBDs)	Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)	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).

Secondary Outcome Measures

Name	Time	Method
Occurrence and Change of Mistimed Boluses	Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 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.
Total Insulin Dose Per Day (Inclusive of Basal Insulin Dose and All bolus Insulin Doses at Meals and Correction Doses)	Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)	dose per type of meal (B, L, snacks, D) as well as corrections doses.
Occurrence and Change in Correction Boluses	Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)	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.
Continuous Glucose Monitoring (CGM) Time in Range (TIR) (≥70 to 180 mg/dL)	Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)	CGM TIR (≥70 to 180 mg/dL) in the masked versus unmasked portions of the study.
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)
CGM Time Above Range (TAR) (>180 mg/dL and > 250 mg/dL)	Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)	CGM TAR (\>180 mg/dL and \>250 mg/dL) in the masked versus unmasked portions of the study.
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)	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.
CGM Time Below Range (TBR) (54 mg/dL ≤ TBR < 70 mg/dL and < 54 mg/dL)	Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)	CGM TBR (54 mg/dL ≤ TBR \< 70 mg/dL and \< 54 mg/dL) in the masked versus unmasked portions of the study.
Change from Baseline in Participant Questionnaires	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)	Participants will be assessed on device preference, satisfaction, convenience, and ease of use.
Change from Baseline (Run in Week 0) in Health Care Provider (HCP) Questionnaires	Baseline (Run in Week 0) to Last Trial-Related Participant Site Contact (Month 10)	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.

Trial Locations

Locations (9)

Centre Hospitalier Sud Francilien-Pharmacie; 🇫🇷 Corbeil-Essonnes, France

CHU de Caen Hôpital Cote de Nacre; 🇫🇷 Caen, Cedex 9, France

Chu de Grenoble; 🇫🇷 Grenoble Cédex 9, France

Groupe Hospitalier Mutualiste Les Portes du Sud; 🇫🇷 Venissieux, France

CHU Strasbourg-Hautepierre; 🇫🇷 Strasbourg, Alsace, France

CHU de Lyon; 🇫🇷 Lyon, France

CHU de Besancon Hopital Jean Minjoz; 🇫🇷 Besancon Cedex, France

CHU - l'Assistance Publique - Hôpitaux de Marseille; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet; 🇫🇷 Nice, France