NCT06154135

Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes

Insulin Delivery Using the DBLG1 Closed-loop Algorithm on Glycemic Control and Patient-reported Outcomes in Adults Living With Type 1 Diabetes: a Multicenter Real-world Observational Study in Belgium

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 165 (estimated)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the impact of the DBLG1 hybrid closed-loop system on glycemic control and patient-reported outcomes in adults living with type 1 diabetes under real-life conditions.

Detailed description

This is a multicenter real-world observational study analyzing data on the use of the DBLG1 system in patients with T1D treated in the participating centers in Belgium. Data from patients with T1D who start(ed) with the DBLG1 between may-01 2022 up to and including August-01 2023 will be analyzed. Data will be collected during clinical routine follow-up from electronic medical records, questionnaires, standard of care laboratory tests and CGM-data. Baseline data from before start (up to -12 months) of the DBLG1 system and follow-up data at 4, 8, 12, 16, 20 and 24 months will be analyzed. There are no medical interventions, nor extra visits or laboratory tests planned outside normal clinical routine. Glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.

Conditions

• Diabetes Mellitus, Type 1

Timeline

• Start date: 2022-12-30
• Primary completion: 2024-07-30
• Completion: 2026-07-30
• First posted: 2023-12-01
• Last updated: 2023-12-12

Locations

12 sites across 1 country: Belgium