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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
As prescribed.
Attached to the Tempo Pen
Continuous glucose monitor
CHU Strasbourg-Hautepierre
Strasbourg, Alsace, France
CHU de Caen Hôpital Cote de Nacre
Caen, Cedex 9, France
CHU de Besancon Hopital Jean Minjoz
Besançon, France
Centre Hospitalier Sud Francilien-Pharmacie
Corbeil-Essonnes, France
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
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
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
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
Coefficient of Variation for Glucose
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
Mean Glucose as Measured by CGM
Time frame: Study Period 1: Week 6; Study Period 2: Week 18
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
Total Insulin Dose Per Day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Installed on a study provided android phone.
Chu de Grenoble
Grenoble Cédex 9, France
CHU de Lyon
Lyon, France
CHU - l'Assistance Publique - Hôpitaux de Marseille
Marseille, France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, France
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux, France
Time frame: Study Period 1: Week 6; Study Period 2: Weeks 18
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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)
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)