N/A
Completed N=36
A Study of LY8888AX in Participants Using a Connected Insulin Management Platform
Type 1 Diabetes · Type 2 Diabetes · Type 2 Diabetes Treated With Insulin
Source: ClinicalTrials.gov NCT05893797 ↗
Enrolled (actual)
36
Serious AEs
8.3%
Results posted
Nov 2025
Primary outcomePrimary: Number of Missed Bolus Doses (MBDs) Per Week — 2.3; 2.3 missed bolus dose per week
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Missed Bolus Doses (MBDs) Per Week |
2.3; 2.3 | — |
| SECONDARY Percentage of Time in Blood Glucose (BG) Range 70 to 180 mg/dL Captured by Continuous Glucose Monitoring (CGM) |
43.1; 41.6 | — |
| SECONDARY Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM |
56; 57.5; 24.7; 26.3 | — |
| SECONDARY Percentage of Time in Hypoglycemic Range <54 mg/dL and 54 to 69 mg/dL Captured by CGM |
0.2; 0.2; 0.7; 0.7 | — |
| SECONDARY Coefficient of Variation for Glucose |
28.8; 28.9 | — |
| SECONDARY Mean Glucose as Measured by CGM |
202.8; 206 | — |
| SECONDARY Number of Mistimed Bolus Dose Per Week |
3.1; 2.6 | — |
| SECONDARY Total Insulin Dose Per Day |
61.6; 60.8 | — |
| SECONDARY Number of Correction Bolus Dose Per Week |
2.4; 2.6 | — |
| SECONDARY Correlation Between Missed Bolus Dose and Glycemic Outcomes [i.e., HbA1c, Time in BG Range (70-180 mg/dL), Time in Hyperglycemic Range (>250 mg/dL), and Time in Hypoglycemia (<54 mg/dL)] Using Raw CGM Integrated Data From Tempo Pen and Tempo Smart Button |
-0.084; -0.058; 0.175; -0.111; -0.217; 0.156 | — |
| SECONDARY Correlation Between Mistimed Bolus Dose and Glycemic Outcomes [i.e., HbA1c, Time in BG Range (70-180 mg/dL), Time in Hyperglycemic Range (>250 mg/dL), Time in Hypoglycemia (<54 mg/dL)] Using Raw CGM Integrated Data From Tempo Pen and Tempo Smart Button |
-0.132; -0.150; 0.139; 0.020; -0.082; -0.054 | — |
| SECONDARY Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen? |
0; 1; 5; 10; 9 | — |
| SECONDARY Study Period 1: Participant Questionnaires (Device Satisfaction) - On Average, How Satisfied Are You With the Way You Manage Your Insulin Treatment on a Day-to-day Basis? |
3; 2; 9; 8; 3 | — |
| SECONDARY Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study? |
1; 3; 4; 8; 9 | — |
| SECONDARY Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses |
9; 10; 3; 3; 0 | — |
| SECONDARY Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses |
5; 1; 7; 6; 6 | — |
| SECONDARY Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not |
3; 4; 2; 7; 9 | — |
| SECONDARY Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management |
1; 1; 6; 9; 8 | — |
| SECONDARY Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use |
13; 7; 3; 2; 0 | — |
| SECONDARY Study Period 2: Participant Questionnaires (Device Usefulness): The Use of the Connected Insulin Pen Reduced the Amount of Time I Spent on my Diabetes Management |
6; 5; 5; 5; 4 | — |
| SECONDARY Health Care Provider (HCP) Questionnaires (Device Satisfaction) - On Average, How Satisfied Are You With the Connected Insulin Pen Your Patients Have Been Using in the Study? |
3; 11; 14; 7; 2 | — |
| SECONDARY Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance |
1; 3; 10; 18; 5 | — |
| SECONDARY Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions |
1; 4; 15; 13; 4 | — |
| SECONDARY Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly |
4; 8; 19; 5; 1 | — |
| SECONDARY Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients |
2; 3; 10; 15; 7 | — |
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
Data sourced from ClinicalTrials.gov (NCT05893797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.