Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the user experience of InPen™ with InPen™ Diabetes Management App and Guardian 4 system in adult patients with type 1 diabetes for the design of a future pivotal study.


Clinical Trial Description

This study is a multi-center, single arm study in insulin-requiring adult subjects with type 1 diabetes treated with MDI (basal and bolus) therapy. The total study duration will be approximately 10 weeks long for each participant. The study consists of a run-in (phase 1) and study phases 2, 3 and 4. Phase 1: The purpose of the run-in phase is to collect baseline HbA1c and blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current MDI therapy. Phase 2: All subjects will utilize a smart bolus insulin pen injector (InPen™) and app with dose calculator (InPen™ Diabetes Management App), and will continue their own SMBG, iscCGM or RT-CGM for two weeks. Phase 3: Subjects will continue on the InPen and InPen App for another two weeks utilizing the HCP insights gained during the titration follow-up visit. Phase 4: All subjects will utilize the InPen™ system consisting of: - InPen™ and InPen™ Diabetes Management App - Guardian™ 4 system (RT-CGM) - Guardian™ 4 sensor - Guardian™ 4 transmitter - Guardian™ 4 app ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05029271
Study type Interventional
Source Medtronic Diabetes
Contact Fabiona Hoevelaken
Phone +31 (0)6 115 978 31
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 2021
Completion date March 2022

See also
  Status Clinical Trial Phase
Recruiting NCT02546401 - Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump Phase 3
Withdrawn NCT02057497 - An Exploratory Clinical Trial to Generate Whole Blood Samples for Analysing Genetic Polymorphisms N/A
Withdrawn NCT01501032 - Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes Phase 1
Completed NCT01770561 - Feasibility Study of an Integrated Sensor and Infusion Set N/A
Completed NCT00417131 - Imaging of Islet Transplantation With PET and MRT N/A
Completed NCT03538106 - Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes
Completed NCT01565824 - Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web) N/A
Recruiting NCT04257877 - Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)
Withdrawn NCT01322321 - ACZ885 in Type 1 Diabetes Mellitus Phase 2
Active, not recruiting NCT04794283 - Antenatal Hand Milking for Pregnant Women With Diabetes'
Completed NCT03842683 - CGM Precision and Glycaemic Variability
Enrolling by invitation NCT04874532 - A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia N/A
Terminated NCT00925977 - Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents N/A
Completed NCT02066350 - Cardiovascular Risk Factors After Single Pancreas Transplantation N/A
Completed NCT02137174 - Home and School Visits Intervention for Children With DM TYPE 1 Phase 2/Phase 3
Completed NCT03433677 - A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes Phase 3
Not yet recruiting NCT04587297 - Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy
Completed NCT02490124 - The Effect of Type 1 Diabetes on Pan-Arterial Vascular Function and Insulin Sensitivity in Humans N/A
Recruiting NCT03529188 - French Version of the Scales of Fear of Hypoglycaemia in Children With Type 1 Diabetes and Their Parents
Recruiting NCT02734745 - Accuracy of Freestyle Libre N/A