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

Free University of Brussels (ULB)

Status: Invitation-only

Conditions: Diabetes Mellitus, Type 1

Study type: Observational

Funder types: Other

Identifiers

NCT06154135

SRB2022123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with type 1 diabetes
• aged 18 years and older
• starting with the DBLG1 system in the participating centers
• who signed the informed consent

Exclusion criteria

• patients who do not have type 1 diabetes
• younger than 18 years
• who do not start with the DBLG1 system
• who are not able to sign the informed consent
• who do not want to sign the informed consent