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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893797
• Other study ID #: 18171
• Secondary ID: F3Z-MC-IORW2022-
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: June 19, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-877-CTLILLY (1-877-285-4559)
• Email: clinicaltrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 19, 2024
• Est. primary completion date: June 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes
• Type 2 Diabetes Treated With Insulin

Intervention

Drug:
• Insulin Lispro
As prescribed.

Device:
• Tempo Smart Button
Attached to the Tempo Pen
• Dexcom G6 CGM
Continuous glucose monitor
• Glooko Research Medical App (RMA)
Installed on a study provided android phone.

Locations

Country	Name	City	State
France	CHU de Besancon Hopital Jean Minjoz	Besancon Cedex
France	CHU de Caen Hôpital Cote de Nacre	Caen	Cedex 9
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	CHU Strasbourg-Hautepierre	Strasbourg	Alsace
France	Groupe Hospitalier Mutualiste Les Portes du Sud	Venissieux

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)