Trial Outcomes & Findings for A Study of LY8888AX in Participants Using a Connected Insulin Management Platform (NCT NCT05893797)
NCT ID: NCT05893797
Last Updated: 2025-11-10
Results Overview
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 greater than (\>) 70 milligrams per deciliter (mg/dL) (\>3.9 millimoles per liter \[mmol/L\]) rise within 2 hours, not preceded by a value \<70 mg/dL (\<3.9 mmol/L).
COMPLETED
NA
36 participants
Study Period 1: Week 6 ; Study Period 2: Week 18
2025-11-10
Participant Flow
A total of 36 participants were enrolled in the study, defined as those who provided informed consent and met eligibility criteria. Additionally, 49 healthcare providers (HCPs) consisting of principal investigator, study coordinator or nurse associated with this study were only surveyed regarding certain study outcomes specific to HCP questionnaires. As per prespecified study design HCPs were not enrolled in the study.
Of the 49 HCPs, 37 completed at least one post-baseline questionnaire assessing device preference, satisfaction, and usefulness. HCP responses were collected as part of a pre-specified endpoint and data represent independent evaluations, are not linked to any specific participant.
Participant milestones
| Measure |
Humalog Tempo Pen With CGM Monitoring
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|
|
Study Period 1 (Weeks 1 to 6)
STARTED
|
36
|
|
Study Period 1 (Weeks 1 to 6)
Main Analysis Set
|
25
|
|
Study Period 1 (Weeks 1 to 6)
Number of HCPs Surveyed for Study Outcomes Specific to HCP Questionnaires
|
49
|
|
Study Period 1 (Weeks 1 to 6)
COMPLETED
|
32
|
|
Study Period 1 (Weeks 1 to 6)
NOT COMPLETED
|
4
|
|
Study Period 2 (Weeks 7 to 18)
STARTED
|
32
|
|
Study Period 2 (Weeks 7 to 18)
Main Analysis Set
|
24
|
|
Study Period 2 (Weeks 7 to 18)
COMPLETED
|
30
|
|
Study Period 2 (Weeks 7 to 18)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Humalog Tempo Pen With CGM Monitoring
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
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|---|---|
|
Study Period 1 (Weeks 1 to 6)
Adverse Event
|
1
|
|
Study Period 1 (Weeks 1 to 6)
Lost to Follow-up
|
1
|
|
Study Period 1 (Weeks 1 to 6)
Withdrawal by Subject
|
2
|
|
Study Period 2 (Weeks 7 to 18)
Physician Decision
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Humalog Tempo Pen With CGM Monitoring
n=36 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 15.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=36 Participants
|
|
Region of Enrollment
France
|
36 Participants
n=36 Participants
|
|
Type of diabetes diagnosed
Type 1 diabetes mellitus
|
20 Participants
n=36 Participants
|
|
Type of diabetes diagnosed
Type 2 diabetes mellitus
|
16 Participants
n=36 Participants
|
|
Diabetes duration
|
20.06 years
STANDARD_DEVIATION 9.12 • n=36 Participants
|
PRIMARY outcome
Timeframe: Study Period 1: Week 6 ; Study Period 2: Week 18Population: All participants from main analysis set who had evaluable data for this outcome.
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 greater than (\>) 70 milligrams per deciliter (mg/dL) (\>3.9 millimoles per liter \[mmol/L\]) rise within 2 hours, not preceded by a value \<70 mg/dL (\<3.9 mmol/L).
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Number of Missed Bolus Doses (MBDs) Per Week
|
2.3 missed bolus dose per week
Standard Deviation 2.29
|
2.3 missed bolus dose per week
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: Study Period 1: Week 6; Study Period 2: Week 18Population: All participants from main analysis set who had evaluable data for this outcome.
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
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|---|---|---|
|
Percentage of Time in Blood Glucose (BG) Range 70 to 180 mg/dL Captured by Continuous Glucose Monitoring (CGM)
|
43.1 Percentage of Time
Standard Deviation 17.17
|
41.6 Percentage of Time
Standard Deviation 17.76
|
SECONDARY outcome
Timeframe: Study Period 1: Week 6; Study Period 2: Week 18Population: All participants from main analysis set who had evaluable data for this outcome.
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
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Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM
>180 mg/dL
|
56 Percentage of Time
Standard Deviation 17.22
|
57.5 Percentage of Time
Standard Deviation 17.89
|
|
Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM
>250 mg/dL
|
24.7 Percentage of Time
Standard Deviation 17.91
|
26.3 Percentage of Time
Standard Deviation 17.76
|
SECONDARY outcome
Timeframe: Study Period 1: Week 6; Study Period 2: Week 18Population: All participants from main analysis set who had evaluable data for this outcome.
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
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|---|---|---|
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Percentage of Time in Hypoglycemic Range <54 mg/dL and 54 to 69 mg/dL Captured by CGM
<54 mg/dL
|
0.2 Percentage of Time
Standard Deviation 0.39
|
0.2 Percentage of Time
Standard Deviation 0.43
|
|
Percentage of Time in Hypoglycemic Range <54 mg/dL and 54 to 69 mg/dL Captured by CGM
54 to 69 mg/dL
|
0.7 Percentage of Time
Standard Deviation 0.67
|
0.7 Percentage of Time
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Study Period 1: Week 6; Study Period 2: Week 18Population: All participants from main analysis set who had evaluable data for this outcome.
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Coefficient of Variation for Glucose
|
28.8 percentage of coefficient of variation
Standard Deviation 5.82
|
28.9 percentage of coefficient of variation
Standard Deviation 6.13
|
SECONDARY outcome
Timeframe: Study Period 1: Week 6; Study Period 2: Week 18Population: All participants from main analysis set who had evaluable data for this outcome.
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
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|---|---|---|
|
Mean Glucose as Measured by CGM
|
202.8 mg/dL
Standard Deviation 33.18
|
206 mg/dL
Standard Deviation 35.44
|
SECONDARY outcome
Timeframe: Study Period 1: Week 6 ; Study Period 2: Week 18Population: All participants from main analysis set who had evaluable data for this outcome.
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.
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Number of Mistimed Bolus Dose Per Week
|
3.1 Mistimed bolus dose per week
Standard Deviation 2.02
|
2.6 Mistimed bolus dose per week
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Study Period 1: Week 6; Study Period 2: Weeks 18Population: All participants from main analysis set who had evaluable data for this outcome.
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
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|---|---|---|
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Total Insulin Dose Per Day
|
61.6 Total insulin units per day
Standard Deviation 57.75
|
60.8 Total insulin units per day
Standard Deviation 51.56
|
SECONDARY outcome
Timeframe: Study Period 1: Week 6; Study Period 2: Week 18Population: All participants from main analysis set who had evaluable data for this outcome.
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.
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Number of Correction Bolus Dose Per Week
|
2.4 Correction bolus dose per week
Standard Deviation 1.73
|
2.6 Correction bolus dose per week
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Study Period 1: Week 6; Study Period 2: Week 18Population: All participants from main analysis set who had evaluable data for this outcome. Number analyzed are the participants who were evaluable for the given categories.
Correlation between Missed Bolus Dose and Glycemic Outcomes i.e., HbA1c, Time in Blood glucose (BG) Range (70-180 mg/dL), Time in Hyperglycemic Range (\>250 mg/dL), and Time in Hypoglycemia (\<54 mg/dL) was calculated by spearman correlation. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates a perfect negative correlation, and +1 indicates a perfect positive correlation.
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
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
HbA1c
|
-0.084 Correlation coefficient
|
-0.058 Correlation coefficient
|
|
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
Time in BG Range (70-180 mg/dL)
|
0.175 Correlation coefficient
|
-0.111 Correlation coefficient
|
|
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
Time in Hyperglycemic Range (>250 mg/dL)
|
-0.217 Correlation coefficient
|
0.156 Correlation coefficient
|
|
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
Time in Hypoglycemia Range (<54 mg/dL)
|
0.068 Correlation coefficient
|
0.079 Correlation coefficient
|
SECONDARY outcome
Timeframe: Study Period 1: Week 6; Study Period 2: Week 18Population: All participants from main analysis set who had evaluable data for this outcome. Number analyzed are the participants who were evaluable for the given categories.
Correlation between Mistimed Bolus Dose and Glycemic Outcomes i.e., HbA1c, Time in Blood glucose (BG) Range (70-180 mg/dL), Time in Hyperglycemic Range (\>250 mg/dL), and Time in Hypoglycemia (\<54 mg/dL) was calculated by spearman correlation. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates a perfect negative correlation, and +1 indicates a perfect positive correlation.
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
n=24 Participants
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
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
HBa1C
|
-0.132 Correlation coefficient
|
-0.150 Correlation coefficient
|
|
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
Time in BG Range (70-180 mg/dL)
|
0.139 Correlation coefficient
|
0.020 Correlation coefficient
|
|
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
Time in Hyperglycemic Range (>250 mg/dL)
|
-0.082 Correlation coefficient
|
-0.054 Correlation coefficient
|
|
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
Time in Hypoglycemia (<54 mg/dL)
|
-0.203 Correlation coefficient
|
-0.060 Correlation coefficient
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Study period 1: All participants from main analysis set who had evaluable data for this outcome.
Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess existing device satisfaction of tempo pen and smart button that participants were using before the study, participants were asked: "On average, how satisfied are you with your current insulin pen?" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported 1. Extremely Unsatisfied 2. Unsatisfied 3. Neutral 4. Satisfied 5. Extremely Satisfied
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen?
Extremely satisfied
|
9 Participants
|
—
|
|
Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen?
Extremely unsatisfied
|
0 Participants
|
—
|
|
Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen?
Unsatisfied
|
1 Participants
|
—
|
|
Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen?
Neutral
|
5 Participants
|
—
|
|
Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen?
Satisfied
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Study period 1: All participants from main analysis set who had evaluable data for this outcome.
Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess existing device satisfaction of tempo pen and smart button that participants were using before the study, participants were asked: "On average, how satisfied are you with the way you manage your insulin treatment on a day-to-day basis?" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported. 1. Extremely Unsatisfied 2. Unsatisfied 3. Neutral 4. Satisfied 5. Extremely Satisfied
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
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?
Extremely unsatisfied
|
3 Participants
|
—
|
|
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?
Unsatisfied
|
2 Participants
|
—
|
|
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?
Neutral
|
9 Participants
|
—
|
|
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?
Satisfied
|
8 Participants
|
—
|
|
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?
Extremely satisfied
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Study Period 2: Week 18Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device preference of Humalog Tempo Pen and Tempo smart button participants were asked: "I prefer the connected insulin pen compared to the insulin pen I used before the study?" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported 1. Strongly disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study?
Agree
|
8 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study?
Strongly agree
|
9 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study?
Strongly disagree
|
1 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study?
Disagree
|
3 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study?
Neutral
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Study Period 2: Week 18Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked: "I found the app difficult to use to monitor my insulin doses" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses
Strongly Disagree
|
9 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses
Disagree
|
10 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses
Neutral
|
3 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses
Agree
|
3 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses
Strongly Agree
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Study Period 2: Week 18Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked: "It helped me to forget fewer doses" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses
Strongly Disagree
|
5 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses
Strongly Agree
|
6 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses
Disagree
|
1 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses
Neutral
|
7 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses
Agree
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Study Period 2: Week 18Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked "I no longer had to worry about when my last dose was injected or not" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not
Strongly Disagree
|
3 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not
Disagree
|
4 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not
Neutral
|
2 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not
Agree
|
7 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not
Strongly Agree
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Study Period 2: Week 18Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked: "Having all my insulin and glucose data in one place simplified my diabetes management" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management
Strongly Disagree
|
1 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management
Disagree
|
1 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management
Neutral
|
6 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management
Agree
|
9 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management
Strongly Agree
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Study Period 2: Week 18Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked: "I found the connected pen to be difficult to use" Participants were categorized based on their responses on a 5-point Likert scale as below and are reported. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use
Strongly Disagree
|
13 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use
Disagree
|
7 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use
Neutral
|
3 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use
Agree
|
2 Participants
|
—
|
|
Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use
Strongly Agree
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Study Period 2: Week 18Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
Participant questionnaires evaluated responses to the Humalog Tempo Pen and Tempo smart button device focusing on platform satisfaction, preferences, and usefulness. To assess device usefulness of Humalog Tempo Pen and Tempo smart button participants were asked: "The use of the connected insulin pen reduced the amount of time I spent on my diabetes management". Participants were categorized based on their responses on a 5-point Likert scale as below and are reported. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=25 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
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
Disagree
|
5 Participants
|
—
|
|
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
Neutral
|
5 Participants
|
—
|
|
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
Strongly Agree
|
4 Participants
|
—
|
|
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
Strongly Disagree
|
6 Participants
|
—
|
|
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
Agree
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)Population: All Health Care Providers (HCPs) who completed at least one question on the post baseline HCP questionnaire following completion of participant's last visit in the study. Overall Number of Participants Analyzed are the HCPs who provided responses to the HCP questionnaire and not the study participants.
The Health Care Provider (HCP) questionnaires evaluated responses from HCPs related to Humalog Tempo Pen and Tempo smart button device focusing on satisfaction, preferences, and usefulness. Questionnaire was completed independently by HCPs (Including Principal Investigator, study coordinator or nurse). This evaluation was a general, aggregate assessment and was not linked to any specific participant. To assess Humalog Tempo Pen and Tempo smart button device satisfaction HCPs were asked: "On average, how satisfied are you with the connected insulin pen your patients have been using in the study?" HCPs were categorized based on their responses on a 5-point Likert scale as below and are reported. 1. Extremely Unsatisfied 2. Unsatisfied 3. Neutral 4. Satisfied 5. Extremely Satisfied
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=37 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
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?
Extremely Unsatisfied
|
3 Participants
|
—
|
|
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?
Unsatisfied
|
11 Participants
|
—
|
|
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?
Neutral
|
14 Participants
|
—
|
|
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?
Satisfied
|
7 Participants
|
—
|
|
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?
Extremely satisfied
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)Population: All Health Care Providers (HCPs) who completed at least one question on the post-baseline HCP questionnaire following completion of participant's last visit in the study. Overall Number of Participants Analyzed are the HCPs who provided responses to the HCP questionnaire and not the study participants.
The Health Care Provider (HCP) questionnaires evaluated responses from HCPs related to Humalog Tempo Pen and Tempo smart button device focusing on device satisfaction, preferences, and usefulness. Questionnaire was completed independently by HCPs (including principal Investigator, study coordinator or nurse). This evaluation was a general, aggregate assessment and was not linked to any specific participant. To assess Humalog Tempo Pen and Tempo smart button device usefulness HCPs were asked: "Offered me objective date on my patients dosing history allowing me to provide appropriate dosing guidance". HCPs were categorized based on their responses on a 5-point Likert scale as below and are reported. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=37 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance
Strongly Disagree
|
1 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance
Disagree
|
3 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance
Neutral
|
10 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance
Agree
|
18 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance
Strongly Agree
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)Population: All Health Care Providers (HCPs) who completed at least one question on the post-baseline HCP questionnaire following completion of participant's last visit in the study. Overall Number of Participants Analyzed are the HCPs who provided responses to the HCP questionnaire and not the study participants.
The Health Care Provider (HCP) questionnaires evaluated responses from HCPs related to Humalog Tempo Pen and Tempo smart button device focusing on satisfaction, preferences, and usefulness. Questionnaire was completed independently by HCPs (including principal Investigator, study coordinator or nurse). This evaluation was a general, aggregate assessment and was not linked to any specific participant. To assess Humalog Tempo Pen and Tempo smart button device usefulness HCPs were asked: "It improved my confidence in making appropriate dosing decisions". HCPs were categorized based on their responses on a 5-point Likert scale as below and are reported. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=37 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions
Agree
|
13 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions
Strongly Disagree
|
1 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions
Disagree
|
4 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions
Neutral
|
15 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions
Strongly Agree
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)Population: All Health Care Providers (HCPs) who completed at least one question on the post-baseline HCP questionnaire following completion of participant's last visit in the study. Overall Number of Participants Analyzed are the HCPs who provided responses to the HCP questionnaire and not the study participants.
The Health Care Provider (HCP) questionnaires evaluated responses from HCPs related to Humalog Tempo Pen and Tempo smart button device focusing on satisfaction, preferences, and usefulness. Questionnaire was completed independently by HCPs (Including principal Investigator, study coordinator or nurse). This evaluation was a general, aggregate assessment and was not linked to any specific participant. To assess Humalog Tempo Pen and Tempo smart button device usefulness HCPs were asked: "I suspect that my patients miss insulin doses regularly". HCPs were categorized based on their responses on a 5-point Likert scale as below and are reported. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=37 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly
Neutral
|
19 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly
Agree
|
5 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly
Strongly Agree
|
1 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly
Strongly Disagree
|
4 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly
Disagree
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18)Population: All Health Care Providers (HCPs) who completed at least one question on the post-baseline HCP questionnaire following completion of participant's last visit in the study. Overall Number of Participants Analyzed are the HCPs who provided responses to the HCP questionnaire and not the study participants.
The Health Care Provider (HCP) questionnaires evaluated responses from HCPs related to Humalog Tempo Pen and Tempo smart button device focusing on satisfaction, preferences, and usefulness. Questionnaire was completed independently by HCP (Including principal Investigator, study coordinator or nurse. This evaluation was a general, aggregate assessment and was not linked to any specific participant. To assess Humalog Tempo Pen and Tempo smart button device usefulness HCPs were asked: "Allowed me to objectively discuss missed doses or mistimed doses with my patients". HCPs were categorized based on their responses on a 5-point Likert scale as below and are reported. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Outcome measures
| Measure |
Study Period 1 - Humalog Tempo Pen With CGM Monitoring
n=37 Participants
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
|
Study Period 2 - Humalog Tempo Pen With CGM Monitoring
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|---|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients
Strongly Disagree
|
2 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients
Disagree
|
3 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients
Neutral
|
10 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients
Agree
|
15 Participants
|
—
|
|
Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients
Strongly Agree
|
7 Participants
|
—
|
Adverse Events
Humalog Tempo Pen With CGM Monitoring
Serious adverse events
| Measure |
Humalog Tempo Pen With CGM Monitoring
n=36 participants at risk
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|
|
Gastrointestinal disorders
Gastric ulcer
|
2.8%
1/36 • Number of events 1 • Baseline Up to Week 18
All enrolled participants. Based on the planned safety analysis, adverse events were collected per the overall treatment period, irrespective of study period (Period 1 or Period 2).
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
2.8%
1/36 • Number of events 1 • Baseline Up to Week 18
All enrolled participants. Based on the planned safety analysis, adverse events were collected per the overall treatment period, irrespective of study period (Period 1 or Period 2).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.8%
1/36 • Number of events 1 • Baseline Up to Week 18
All enrolled participants. Based on the planned safety analysis, adverse events were collected per the overall treatment period, irrespective of study period (Period 1 or Period 2).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.8%
1/36 • Number of events 1 • Baseline Up to Week 18
All enrolled participants. Based on the planned safety analysis, adverse events were collected per the overall treatment period, irrespective of study period (Period 1 or Period 2).
|
Other adverse events
| Measure |
Humalog Tempo Pen With CGM Monitoring
n=36 participants at risk
Study Period 1: Weeks 1 to 6
* Participants used a Sponsor-provided Humalog Tempo Pen with Tempo Smart Button (TSB), Dexcom G6 continuous glucose monitoring (CGM), and the Glooko Research Mobile App (RMA) to share insulin dose and timing data with healthcare providers (HCPs) via the Glooko HCP platform. Mealtime insulin data was masked to participants but visible to HCPs. Participants followed their usual insulin regimen and lifestyle, manually logged basal insulin and activities in the app. After 6 weeks, data was unmasked and reviewed with HCPs.
Study Period 2: Weeks 7 to 18
* Participants used the Humalog Tempo Pen with TSB, Dexcom G6 CGM, and Glooko RMA study app for 12 weeks. Insulin dose and timing data was unmasked and visible to both participants and HCPs via the Glooko RMA and HCP platform. Participants regularly upload CGM and pen data. HCPs monitor adherence and follow up as needed to ensure data transfer and CGM use.
|
|---|---|
|
Infections and infestations
Bronchitis
|
5.6%
2/36 • Number of events 2 • Baseline Up to Week 18
All enrolled participants. Based on the planned safety analysis, adverse events were collected per the overall treatment period, irrespective of study period (Period 1 or Period 2).
|
|
Infections and infestations
Covid-19
|
8.3%
3/36 • Number of events 3 • Baseline Up to Week 18
All enrolled participants. Based on the planned safety analysis, adverse events were collected per the overall treatment period, irrespective of study period (Period 1 or Period 2).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
5.6%
2/36 • Number of events 2 • Baseline Up to Week 18
All enrolled participants. Based on the planned safety analysis, adverse events were collected per the overall treatment period, irrespective of study period (Period 1 or Period 2).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60