| Outcome Measures: |
Primary: Difference in the Average Number of Missed Bolus Doses (MBDs), Difference in the average number of MBDs per week in the masked versus unmasked portions of the study. 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 \>70 mg/dL (\>3.9 mmol/L) rise within 2 hours, not preceded by a value \<70 mg/dL (\<3.9 mmol/L)., Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18) | Secondary: Continuous Glucose Monitoring (CGM) Time in Range (TIR) (≥70 to 180 mg/dL), CGM TIR (≥70 to 180 mg/dL) in the masked versus unmasked portions of the study., Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)|CGM Time Above Range (TAR) (>180 mg/dL and > 250 mg/dL), CGM TAR (\>180 mg/dL and \>250 mg/dL) in the masked versus unmasked portions of the study., Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)|CGM Time Below Range (TBR) (54 mg/dL ≤ TBR < 70 mg/dL and < 54 mg/dL), CGM TBR (54 mg/dL ≤ TBR \< 70 mg/dL and \< 54 mg/dL) in the masked versus unmasked portions of the study., Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)|Coefficient of Variation of CGM Data Collected from Each Participant, Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)|Mean Sensor Glucose of CGM Data Collected from Each Participant, Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)|Occurrence and Change of Mistimed Boluses, 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., Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)|Total Insulin Dose Per Day (Inclusive of Basal Insulin Dose and All bolus Insulin Doses at Meals and Correction Doses), dose per type of meal (B, L, snacks, D) as well as corrections doses., Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)|Occurrence and Change in Correction Boluses, A 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., Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)|CGM Curves integrated with data received from the Tempo Pen, The association between mistimed bolus dose (MBD), TIR, TAR, TBR and HbA1c will be measured by CGM Curves integrated with data received from the tempo pen., Run in (Study Period 1 Week 5 and 6), Intervention (Study Period 2 Week 15 to 18)|Change from Baseline in Participant Questionnaires, Participants will be assessed on device preference, satisfaction, convenience, and ease of use., Baseline (Run in Study Period 1 Week 0, Day 1 and Week 6, Day 1-7), Intervention (Study Period 2 Week 18 Day 1-7)|Change from Baseline (Run in Week 0) in Health Care Provider (HCP) Questionnaires, HCPs will assess their experience with insulin prior to this study (Run in Week 0) and the specific study device following the conclusion of all participant visits at their site., Baseline (Run in Week 0) to Last Trial-Related Participant Site Contact (Month 10)
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| Locations: |
CHU Strasbourg-Hautepierre, Strasbourg, Alsace, 67098, France|CHU de Caen Hôpital Cote de Nacre, Caen, Cedex 9, 14033, France|CHU de Besancon Hopital Jean Minjoz, Besancon Cedex, 25030, France|Centre Hospitalier Sud Francilien-Pharmacie, Corbeil-Essonnes, 91100, France|Chu de Grenoble, Grenoble Cédex 9, 38043, France|CHU de Lyon, Lyon, 69008, France|CHU - l'Assistance Publique - Hôpitaux de Marseille, Marseille, 13005, France|Centre Hospitalier Universitaire de Nice - Hôpital l'Archet, Nice, 6202, France|Groupe Hospitalier Mutualiste Les Portes du Sud, Venissieux, 69200, France
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