Type 1 Diabetes, Type 2 Diabetes, Type 2 Diabetes Treated With Insulin
Conditions
Keywords
T1D, T2D
Brief summary
The main purpose of this study is to assess participant adherence and glucose control while using a connected insulin management platform. Approximately 50 participants will be enrolled in each country.
Interventions
DRUGInsulin Lispro
As prescribed.
DEVICETempo Smart Button
Attached to the Tempo Pen
DEVICEDexcom G6 CGM
Continuous glucose monitor
DEVICEGlooko Research Mobile App (RMA)
Installed on a study provided android phone.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed (clinically) with T1D for at least 1 year or are patients with T2D on basal bolus insulin therapy for at least 6 months * HbA1c ≥8% as confirmed by point-of-care test at screening * Are currently using the Dexcom G6 CGM or agree to start using the Dexcom G6 during the study and agree to switch to Glooko RMA * Are currently using Humalog ® insulin or another rapid acting insulin analogue (e.g., Apidra® , or Novorapid ® ) and agree to switch to study-provided Humalog mealtime insulin for duration of trial * Have been prescribed ≥3 doses of bolus insulin per day * Must be taking a stable insulin dose regimen (per investigator's judgement) for at least 3 months preceding study screening * Have in-home refrigeration for storage of insulin
Exclusion criteria
* Previously used the Glooko RMA and/or Dexcom G6 CGM and were judged by the investigator to be non-adherent * Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed * Have previously used or have been using an approved or investigational connected pen system within the 3 months prior to screening * Are currently breastfeeding, pregnant, or plan to become pregnant during the next 4-6 months * Are on ultra-rapid insulin (e.g., Fiasp or Lyumjev) or rapid acting human insulin (i.e., Humulin) for previous 3 months, at the time of screening * Are currently undergoing dialysis treatment or have any other medical condition which may preclude them from participating in this trial as per the investigator's judgement * Have vision loss or vision impairment that does not allow recognition of Glooko RMA screen features
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Missed Bolus Doses (MBDs) Per Week | Study Period 1: Week 6 ; Study Period 2: Week 18 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM | Study Period 1: Week 6; Study Period 2: Week 18 | — |
| Percentage of Time in Hypoglycemic Range <54 mg/dL and 54 to 69 mg/dL Captured by CGM | Study Period 1: Week 6; Study Period 2: Week 18 | — |
| Coefficient of Variation for Glucose | Study Period 1: Week 6; Study Period 2: Week 18 | — |
| Mean Glucose as Measured by CGM | Study Period 1: Week 6; Study Period 2: Week 18 | — |
| Number of Mistimed Bolus Dose Per Week | Study Period 1: Week 6 ; Study Period 2: Week 18 | A mistimed bolus dose is defined as a bolus dose administered from the start of a glucose excursion up to 1 hour after the start of glucose excursion and before the peak of glucose excursion. |
| Total Insulin Dose Per Day | Study Period 1: Week 6; Study Period 2: Weeks 18 | — |
| Number of Correction Bolus Dose Per Week | Study Period 1: Week 6; Study Period 2: Week 18 | 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. |
| 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 | Study Period 1: Week 6; Study Period 2: Week 18 | 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. |
| 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 | Study Period 1: Week 6; Study Period 2: Week 18 | 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. |
| Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen? | At Baseline | 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 |
| 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? | At Baseline | 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 |
| Percentage of Time in Blood Glucose (BG) Range 70 to 180 mg/dL Captured by Continuous Glucose Monitoring (CGM) | Study Period 1: Week 6; Study Period 2: Week 18 | — |
| Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses | Study Period 2: Week 18 | 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 |
| Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses | Study Period 2: Week 18 | 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 |
| Study Period 2: Participant Questionnaires (Device Usefulness) - I no Longer Had to Worry About When my Last Dose Was Injected or Not | Study Period 2: Week 18 | 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 |
| Study Period 2: Participant Questionnaires (Device Usefulness) - Having All my Insulin and Glucose Data in One Place Simplified my Diabetes Management | Study Period 2: Week 18 | 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 |
| Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use | Study Period 2: Week 18 | 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 |
| 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 | Study Period 2: Week 18 | 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 |
| 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? | Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18) | 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 |
| Health Care Provider (HCP) Questionnaires (Device Usefulness) - Offered me Objective Date on my Patients Dosing History Allowing me to Provide Appropriate Dosing Guidance | Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18) | 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 |
| Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions | Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18) | 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 |
| Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly | Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18) | 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 |
| Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients | Following completion of participant's Last visit in the study (approximately 3 days after last visit on week 18) | 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 |
| Study Period 2: Participant Questionnaires (Device Preference) - I Prefer the Connected Insulin Pen Compared to the Insulin Pen I Used Before the Study? | Study Period 2: Week 18 | 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 |
Countries
France
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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
| Characteristic | Humalog Tempo Pen With CGM Monitoring | — |
|---|---|---|
| Age, Continuous | 47.6 years STANDARD_DEVIATION 15.4 | — |
| Diabetes duration | 20.06 years STANDARD_DEVIATION 9.12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 36 Participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
| Type of diabetes diagnosed Type 1 diabetes mellitus | 20 Participants | — |
| Type of diabetes diagnosed Type 2 diabetes mellitus | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 7 / 36 |
| serious Total, serious adverse events | 3 / 36 |
Outcome results
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).
Time frame: Study Period 1: Week 6 ; Study Period 2: Week 18
Population: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Number of Missed Bolus Doses (MBDs) Per Week | 2.3 missed bolus dose per week | Standard Deviation 2.29 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | Number of Missed Bolus Doses (MBDs) Per Week | 2.3 missed bolus dose per week | Standard Deviation 1.56 |
Secondary
Coefficient of Variation for Glucose
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Population: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Coefficient of Variation for Glucose | 28.8 percentage of coefficient of variation | Standard Deviation 5.82 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | Coefficient of Variation for Glucose | 28.9 percentage of coefficient of variation | Standard Deviation 6.13 |
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.
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | 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) | 0.079 Correlation coefficient |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | 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 | -0.058 Correlation coefficient |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | 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) | 0.156 Correlation coefficient |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | 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) | -0.111 Correlation coefficient |
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.
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | 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) | -0.060 Correlation coefficient |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | 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 | -0.150 Correlation coefficient |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | 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) | -0.054 Correlation coefficient |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | 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) | 0.020 Correlation coefficient |
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. 1. Extremely Unsatisfied 2. Unsatisfied 3. Neutral 4. Satisfied 5. Extremely Satisfied
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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
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. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients | Strongly Disagree | 2 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients | Disagree | 3 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients | Neutral | 10 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients | Agree | 15 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness)- Allowed me to Objectively Discuss Missed Doses or Mistimed Doses With my Patients | Strongly Agree | 7 Participants |
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. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly | Strongly Disagree | 4 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly | Disagree | 8 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly | Neutral | 19 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly | Agree | 5 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness) - I Suspect That my Patients Miss Insulin Doses Regularly | Strongly Agree | 1 Participants |
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. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions | Strongly Disagree | 1 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions | Disagree | 4 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions | Neutral | 15 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions | Agree | 13 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Health Care Provider (HCP) Questionnaires (Device Usefulness)- It Improved my Confidence in Making Appropriate Dosing Decisions | Strongly Agree | 4 Participants |
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. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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
Mean Glucose as Measured by CGM
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Population: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Mean Glucose as Measured by CGM | 202.8 mg/dL | Standard Deviation 33.18 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | Mean Glucose as Measured by CGM | 206 mg/dL | Standard Deviation 35.44 |
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.
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Population: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Number of Correction Bolus Dose Per Week | 2.4 Correction bolus dose per week | Standard Deviation 1.73 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | Number of Correction Bolus Dose Per Week | 2.6 Correction bolus dose per week | Standard Deviation 1.6 |
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.
Time frame: Study Period 1: Week 6 ; Study Period 2: Week 18
Population: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Number of Mistimed Bolus Dose Per Week | 3.1 Mistimed bolus dose per week | Standard Deviation 2.02 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | Number of Mistimed Bolus Dose Per Week | 2.6 Mistimed bolus dose per week | Standard Deviation 1.55 |
Secondary
Percentage of Time in Blood Glucose (BG) Range 70 to 180 mg/dL Captured by Continuous Glucose Monitoring (CGM)
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Population: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | Percentage of Time in Blood Glucose (BG) Range 70 to 180 mg/dL Captured by Continuous Glucose Monitoring (CGM) | 41.6 Percentage of Time | Standard Deviation 17.76 |
Secondary
Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Population: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM | >180 mg/dL | 57.5 Percentage of Time | Standard Deviation 17.89 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | Percentage of Time in Hyperglycemic Range of >180 mg/dL and >250 mg/dL Captured by CGM | >250 mg/dL | 26.3 Percentage of Time | Standard Deviation 17.76 |
Secondary
Percentage of Time in Hypoglycemic Range <54 mg/dL and 54 to 69 mg/dL Captured by CGM
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Population: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | 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 0.43 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | 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 0.79 |
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. 1. Extremely Unsatisfied 2. Unsatisfied 3. Neutral 4. Satisfied 5. Extremely Satisfied
Time frame: At Baseline
Population: Study period 1: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 - Humalog Tempo Pen With CGM Monitoring | 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 - Humalog Tempo Pen With CGM Monitoring | 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 - Humalog Tempo Pen With CGM Monitoring | 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 - Humalog Tempo Pen With CGM Monitoring | 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
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 1. Extremely Unsatisfied 2. Unsatisfied 3. Neutral 4. Satisfied 5. Extremely Satisfied
Time frame: At Baseline
Population: Study period 1: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 - Humalog Tempo Pen With CGM Monitoring | Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen? | Unsatisfied | 1 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen? | Neutral | 5 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen? | Satisfied | 10 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 1: Participant Questionnaires (Device Satisfaction)- On Average, How Satisfied Are You With Your Current Insulin Pen? | Extremely satisfied | 9 Participants |
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 1. Strongly disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly agree
Time frame: Study Period 2: Week 18
Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
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 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: Study Period 2: Week 18
Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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
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. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: Study Period 2: Week 18
Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses | Disagree | 10 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses | Neutral | 3 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses | Agree | 3 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness) - I Found the App Difficult to Use to Monitor my Insulin Doses | Strongly Agree | 0 Participants |
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. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: Study Period 2: Week 18
Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use | Neutral | 3 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use | Strongly Disagree | 13 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use | Disagree | 7 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use | Agree | 2 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness): I Found the Connected Pen to be Difficult to Use | Strongly Agree | 0 Participants |
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 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: Study Period 2: Week 18
Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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
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 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: Study Period 2: Week 18
Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses | Strongly Disagree | 5 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses | Disagree | 1 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses | Neutral | 7 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses | Agree | 6 Participants |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Study Period 2: Participant Questionnaires (Device Usefulness) - It Helped me to Forget Fewer Doses | Strongly Agree | 6 Participants |
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. 1. Strongly Disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly Agree
Time frame: Study Period 2: Week 18
Population: Study period 2: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | 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 |
Secondary
Total Insulin Dose Per Day
Time frame: Study Period 1: Week 6; Study Period 2: Weeks 18
Population: All participants from main analysis set who had evaluable data for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Period 1 - Humalog Tempo Pen With CGM Monitoring | Total Insulin Dose Per Day | 61.6 Total insulin units per day | Standard Deviation 57.75 |
| Study Period 2 - Humalog Tempo Pen With CGM Monitoring | Total Insulin Dose Per Day | 60.8 Total insulin units per day | Standard Deviation 51.56 |