Back to resultsA Study of LY8888AX in Participants Using a Connected Insulin Management Platform
Primary Purpose
Type 1 Diabetes, Type 2 Diabetes, Type 2 Diabetes Treated With Insulin
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Insulin Lispro
Tempo Smart Button
Dexcom G6 CGM
Glooko Research Medical App (RMA)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring T1D, T2D
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
Sites / Locations
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
- CHU de Caen Hôpital Cote de NacreRecruiting
- CHU de Besancon Hopital Jean Minjoz
- Centre Hospitalier Sud Francilien-Pharmacie
- Chu de Grenoble
- CHU de Lyon
- CHU - l'Assistance Publique - Hôpitaux de Marseille
- CHU Strasbourg-Hautepierre
- Groupe Hospitalier Mutualiste Les Portes du SudRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Connected Management Platform
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
Coefficient of Variation of CGM Data Collected from Each Participant
Mean Sensor Glucose of CGM Data Collected from Each Participant
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.
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.
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.
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.
Change from Baseline in Participant Questionnaires
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05893797
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2023 (Actual)
Primary Completion Date
June 19, 2024 (Anticipated)
Study Completion Date
June 19, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Type 2 Diabetes, Type 2 Diabetes Treated With Insulin
Keywords
T1D, T2D
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Connected Management Platform
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro
Other Intervention Name(s)
Humalog Tempo Pen
Intervention Description
As prescribed.
Intervention Type
Device
Intervention Name(s)
Tempo Smart Button
Intervention Description
Attached to the Tempo Pen
Intervention Type
Device
Intervention Name(s)
Dexcom G6 CGM
Intervention Description
Continuous glucose monitor
Intervention Type
Device
Intervention Name(s)
Glooko Research Medical App (RMA)
Intervention Description
Installed on a study provided android phone.
Primary Outcome Measure Information:
Title
Difference in the Average Number of Missed Bolus Doses (MBDs)
Description
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).
Time Frame
Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Secondary Outcome Measure Information:
Title
Continuous Glucose Monitoring (CGM) Time in Range (TIR) (≥70 to 180 mg/dL)
Description
CGM TIR (≥70 to 180 mg/dL) in the masked versus unmasked portions of the study.
Time Frame
Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Title
CGM Time Above Range (TAR) (>180 mg/dL and > 250 mg/dL)
Description
CGM TAR (>180 mg/dL and >250 mg/dL) in the masked versus unmasked portions of the study.
Time Frame
Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Title
CGM Time Below Range (TBR) (54 mg/dL ≤ TBR < 70 mg/dL and < 54 mg/dL)
Description
CGM TBR (54 mg/dL ≤ TBR < 70 mg/dL and < 54 mg/dL) in the masked versus unmasked portions of the study.
Time Frame
Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Title
Coefficient of Variation of CGM Data Collected from Each Participant
Time Frame
Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Title
Mean Sensor Glucose of CGM Data Collected from Each Participant
Time Frame
Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Title
Occurrence and Change of Mistimed Boluses
Description
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.
Time Frame
Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Title
Total Insulin Dose Per Day (Inclusive of Basal Insulin Dose and All bolus Insulin Doses at Meals and Correction Doses)
Description
dose per type of meal (B, L, snacks, D) as well as corrections doses.
Time Frame
Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Title
Occurrence and Change in Correction Boluses
Description
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.
Time Frame
Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Title
CGM Curves integrated with data received from the Tempo Pen
Description
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.
Time Frame
Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)
Title
Change from Baseline in Participant Questionnaires
Description
Participants will be assessed on device preference, satisfaction, convenience, and ease of use.
Time Frame
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)
Title
Change from Baseline (Run in Week 0) in Health Care Provider (HCP) Questionnaires
Description
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.
Time Frame
Baseline (Run in Week 0) to Last Trial-Related Participant Site Contact (Month 10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-877-CTLILLY (1-877-285-4559)
Email
clinicaltrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06202
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas CHEVALIER
Facility Name
CHU de Caen Hôpital Cote de Nacre
City
Caen
State/Province
Cedex 9
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Joubert
Facility Name
CHU de Besancon Hopital Jean Minjoz
City
Besancon Cedex
ZIP/Postal Code
25030
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Borot
Facility Name
Centre Hospitalier Sud Francilien-Pharmacie
City
Corbeil-Essonnes
ZIP/Postal Code
91000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred Penfornis
Facility Name
Chu de Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine Lablanche
Facility Name
CHU de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Thivolet
Facility Name
CHU - l'Assistance Publique - Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Schaepelynk
Facility Name
CHU Strasbourg-Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Meyer
Facility Name
Groupe Hospitalier Mutualiste Les Portes du Sud
City
Vénissieux
ZIP/Postal Code
69200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucien MARCHAND
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY8888AX in Participants Using a Connected Insulin Management Platform
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