NCT02636491

Use of an Automated Insulin Delivery System Compared to Sensor Augmented Pump at Patients With Type 1 Diabetes (T1D)

Open-label, 3 Center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of 60 Hours Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy at T1D Patients at Home

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Kinderkrankenhaus auf der Bult · Academic / Other
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Title: An open-label, three-center, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy at patients with type 1 diabetes at home Indication: Type 1 Diabetes mellitus using an insulin pump therapy and continues glucose sensors The objective of this pilot study is to evaluate the safety and efficacy of 60 hours blood glucose control, using the MD-Logic System in individuals with type 1 diabetes at patient's home. The duration of study participation for one subject is 28-56 days and the overall duration of the study is 6 months The participants of the study are patients ≥ 10 years until 65 years with Type 1 Diabetes mellitus using and insulin pump therapy and continuous glucose sensors. Sample Size n = 45

Detailed description

Up to 45 eligible patients will be enrolled to participate in two crossover sessions of 60 hours of consecutive days, with closed-loop or sensor-augmented pump therapy (Minimed ®Paradigm). The sequence of the sessions will be randomly assigned. The randomization will be blocked randomization (1:1). Patients will be assigned to one of the following arm: Group A: 60 hours under closed-loop control and then 60 hours of sensor augmented pump therapy and Group B: 60 hours using sensor augmented pump therapy and then 60 hours under closed-loop control. Subjects will be enrolled according to the following schedule/ successive phases: Phase 1: 5 Adult subjects: After all adult subjects have completed the study the 2nd enrollment phase starts. Phase 2: 5 Adolescent subjects aged 14-18. After these subjects have completed the study the 3rd enrollment phase starts. Phase 3: 5 Children aged 10-14 will be enrolled. The enrollment of phase 2 and phase 3 will not be started before all participants of the previous phase completed the study and the safety and efficacy of the system has been analyzed based on the occurrence of (serious) adverse Events (AE) or any other issue relevant for patient's safety. If the observed AEs or device problems do not exceed the amount or severity of the risks expected during a regular diabetes therapy and the recruitment of the next age category is considered reasonable from the medical point of view, the next enrollment phase will be started.Screening Failures will be replaced to get a total of 45 completed patients.The average duration of study participation for subjects completing the study is estimated to be approximately 28-56 days. The estimated duration of the total study is 6 months.In this study 45 patients will be included, 15 are planned to be enrolled in Germany. The study will consist of 5 visits (3 clinical visits and 2 visits will be done by phone) as followed: * Visit 1: Screening, eligibility, enrolment and sensor and diabetes guidelines training. (Day - 21) * Run-in period * Visit 2: Randomization and preparation visit for the outpatient period. (Day 0) * Intervention session 1 (same weekdays as Intervention session 2) * Visit 3: Phone call visit between arms. (Day 4) * Washout period * Visit 4: Phone call visit before session 2 (Day 18) * Intervention session 2 (same weekdays as Intervention session 1) * Visit 5: Final visit. (Day 21) There is no follow up visit or observation planned after the end of the study or after a subject discontinued study participation. In case of a Serious Adverse Event (SAE) a follow up period until this SAE is resolved/ recovered is planned.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	MD-Logic-Automated Insulin Delivery System	Subjects will undergo 60 hours at home under MD-Logic control and continuing with their regular routine life. At evening of the first intervention day patients will switch to MD-Logic control. Patients will be asked to connect study sensor and pump to the computer using the MD-Logic software. After the activation of the MD-Logic system, basal insulin dosing and correction boluses will be fully automated and controlled by the MD-Logic system except to meal boluses. Patients will be encouraged to measure capillary blood glucose at least 4 times a day, before each meal and before bed time. After the third night the patient will turn the closed-loop controller "OFF", this will automatically save the log file. The patient will return to his regular insulin treatment.
DEVICE	MiniMed Paradigm® Veo™ System	Subjects use 60 hours at home their conventional insulin pump and continuing with their regular Routine life. During this therapy the Insulin pump operating separately and are not controlled by the MD-Logic System.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-12-21
• Last updated: 2018-02-28

Locations

1 site across 1 country: Germany