A Study of LY8888AX in Participants Using a Connected Insulin Management Platform
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Connected Management Platform 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. |
Drug: Insulin Lispro
As prescribed.
Other Names:
Device: Tempo Smart Button
Attached to the Tempo Pen
Device: Dexcom G6 CGM
Continuous glucose monitor
Device: Glooko Research Medical App (RMA)
Installed on a study provided android phone.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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 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.
- 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)]
- 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.
- 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.
- 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.
Eligibility Criteria
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
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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
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Have been prescribed ≥3 doses of bolus insulin per day
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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
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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
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Have previously used or have been using an approved or investigational connected pen system within the 3 months prior to screening
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Are currently breastfeeding, pregnant, or plan to become pregnant during the next 4-6 months
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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
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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
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Have vision loss or vision impairment that does not allow recognition of Glooko RMA screen features
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18171
- F3Z-MC-IORW
- 2022-A02807-36