Clinical trial NCT05893797: A Study of LY8888AX in Participants Using a Connected Insulin Management Platform
Official title: Assessment of Participant Adherence and Glucose Control While Using a Connected Insulin Management Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Type 2 Diabetes Treated With Insulin
Keywords: T1D
T2D
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in the Average Number of Missed Bolus Doses (MBDs)
timeFrame: Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Secondary outcomes:
measure: Continuous Glucose Monitoring (CGM) Time in Range (TIR) (≥70 to 180 mg/dL)
timeFrame: Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
measure: CGM Time Above Range (TAR) (>180 mg/dL and > 250 mg/dL)
timeFrame: Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
measure: CGM Time Below Range (TBR) (54 mg/dL ≤ TBR < 70 mg/dL and < 54 mg/dL)
timeFrame: Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
measure: Coefficient of Variation of CGM Data Collected from Each Participant
timeFrame: Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
measure: Mean Sensor Glucose of CGM Data Collected from Each Participant
timeFrame: Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
measure: Occurrence and Change of Mistimed Boluses
timeFrame: Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
measure: Total Insulin Dose Per Day (Inclusive of Basal Insulin Dose and All bolus Insulin Doses at Meals and Correction Doses)
timeFrame: Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
measure: Occurrence and Change in Correction Boluses
timeFrame: Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
measure: CGM Curves integrated with data received from the Tempo Pen
timeFrame: Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
measure: Change from Baseline in Participant Questionnaires
timeFrame: 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)
measure: Change from Baseline (Run in Week 0) in Health Care Provider (HCP) Questionnaires
timeFrame: Baseline (Run in Week 0) to Last Trial-Related Participant Site Contact (Month 10)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Strasbourg-Hautepierre
state: Alsace
city: Caen
country: France
facility: CHU de Caen Hôpital Cote de Nacre
state: Cedex 9
city: Besancon Cedex
country: France
facility: CHU de Besancon Hopital Jean Minjoz
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien-Pharmacie
city: Grenoble Cédex 9
country: France
facility: Chu de Grenoble
city: Lyon
country: France
facility: CHU de Lyon
city: Marseille
country: France
facility: CHU - l'Assistance Publique - Hôpitaux de Marseille
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
city: Venissieux
country: France
facility: Groupe Hospitalier Mutualiste Les Portes du Sud
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: