| Primary | Number of Missed Bolus Doses (MBDs) Per Week | 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). | All participants from main analysis set who had evaluable data for this outcome. | Posted | | Mean | Standard Deviation | missed bolus dose per week | | Study Period 1: Week 6 ; Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | 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.
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| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0002.3± 2.29
- OG0012.3± 1.56
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| Secondary | Percentage of Time in Blood Glucose (BG) Range 70 to 180 mg/dL Captured by Continuous Glucose Monitoring (CGM) | | All participants from main analysis set who had evaluable data for this outcome. | Posted | | Mean | Standard Deviation | Percentage of Time | | Study Period 1: Week 6; Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | 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.
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| Secondary | Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM | | All participants from main analysis set who had evaluable data for this outcome. | Posted | | Mean | Standard Deviation | Percentage of Time | | Study Period 1: Week 6; Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | 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.
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| Secondary | Percentage of Time in Hypoglycemic Range <54 mg/dL and 54 to 69 mg/dL Captured by CGM | | All participants from main analysis set who had evaluable data for this outcome. | Posted | | Mean | Standard Deviation | Percentage of Time | | Study Period 1: Week 6; Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | 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.
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| Secondary | Coefficient of Variation for Glucose | | All participants from main analysis set who had evaluable data for this outcome. | Posted | | Mean | Standard Deviation | percentage of coefficient of variation | | Study Period 1: Week 6; Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | 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.
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| Secondary | Mean Glucose as Measured by CGM | | All participants from main analysis set who had evaluable data for this outcome. | Posted | | Mean | Standard Deviation | mg/dL | | Study Period 1: Week 6; Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | 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.
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| Secondary | Number of Mistimed Bolus Dose Per Week | 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. | All participants from main analysis set who had evaluable data for this outcome. | Posted | | Mean | Standard Deviation | Mistimed bolus dose per week | | Study Period 1: Week 6 ; Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | 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.
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| Secondary | Total Insulin Dose Per Day | | All participants from main analysis set who had evaluable data for this outcome. | Posted | | Mean | Standard Deviation | Total insulin units per day | | Study Period 1: Week 6; Study Period 2: Weeks 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | 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.
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| Secondary | Number of Correction Bolus Dose Per Week | 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. | All participants from main analysis set who had evaluable data for this outcome. | Posted | | Mean | Standard Deviation | Correction bolus dose per week | | Study Period 1: Week 6; Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | 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.
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| 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 | 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. | 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. | Posted | | Number | | Correlation coefficient | | Study Period 1: Week 6; Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | Study Period 2 - Humalog Tempo Pen With CGM Monitoring |
|
| 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 | 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. | 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. | Posted | | Number | | Correlation coefficient | | Study Period 1: Week 6; Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
| | OG001 | Study Period 2 - Humalog Tempo Pen With CGM Monitoring |
|
| Secondary | Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen? | 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
- Extremely Unsatisfied
- Unsatisfied
- Neutral
- Satisfied
- Extremely Satisfied
| Study period 1: All participants from main analysis set who had evaluable data for this outcome. | Posted | | Count of Participants | | Participants | No | At Baseline | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
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| 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? | 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.
- Extremely Unsatisfied
- Unsatisfied
- Neutral
- Satisfied
- Extremely Satisfied
| Study period 1: All participants from main analysis set who had evaluable data for this outcome. | Posted | | Count of Participants | | Participants | No | At Baseline | | | | ID | Title | Description |
|---|
| OG000 | Study Period 1 - 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.
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| Secondary | Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study? | 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
- Strongly disagree
- Disagree
- Neutral
- Agree
- Strongly agree
| Study period 2: All participants from main analysis set who had evaluable data for this outcome. | Posted | | Count of Participants | | Participants | No | Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | 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.
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| Secondary | Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses | 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.
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
| Study period 2: All participants from main analysis set who had evaluable data for this outcome. | Posted | | Count of Participants | | Participants | No | Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | 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.
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| Secondary | Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses | 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
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
| Study period 2: All participants from main analysis set who had evaluable data for this outcome. | Posted | | Count of Participants | | Participants | No | Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | 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.
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| Secondary | Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not | 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
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
| Study period 2: All participants from main analysis set who had evaluable data for this outcome. | Posted | | Count of Participants | | Participants | No | Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | 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.
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| Secondary | Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management | 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
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
| Study period 2: All participants from main analysis set who had evaluable data for this outcome. | Posted | | Count of Participants | | Participants | No | Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | 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.
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| |
| Secondary | Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use | 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.
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
| Study period 2: All participants from main analysis set who had evaluable data for this outcome. | Posted | | Count of Participants | | Participants | No | Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | 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.
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| 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 | 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.
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
| Study period 2: All participants from main analysis set who had evaluable data for this outcome. | Posted | | Count of Participants | | Participants | No | Study Period 2: Week 18 | | | | ID | Title | Description |
|---|
| OG000 | 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.
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| |
| 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? | 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.
- Extremely Unsatisfied
- Unsatisfied
- Neutral
- Satisfied
- Extremely Satisfied
| 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. | Posted | | Count of Participants | | Participants | No | Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18) | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance | 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.
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
| 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. | Posted | | Count of Participants | | Participants | No | Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions | 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.
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
| 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. | Posted | | Count of Participants | | Participants | No | Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly | 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.
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
| 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. | Posted | | Count of Participants | | Participants | No | Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients | 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.
- Strongly Disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
| 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. | Posted | | Count of Participants | | Participants | No | Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18) | | | | ID | Title | Description |
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| OG000 | 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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