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

NCT ID: NCT06154135

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-30

Study Completion Date

2026-07-30

Brief Summary

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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

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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

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Crenier, PhD

Role: PRINCIPAL_INVESTIGATOR

CUB - Hôpital Erasme

Locations

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Department of Endocrinology, OLVZ Aalst

Aalst, , Belgium

Site Status

Department of Endocrinology, Imeldaziekenhuis

Bonheiden, , Belgium

Site Status

Department of Endocrinology, ULB-Hôpital Erasme

Brussels, , Belgium

Site Status

Department of Endocrinology and Nutrition, Cliniques Universitaires St. Luc

Brussels, , Belgium

Site Status

Department of Endocrinology, UZ Antwerpen

Edegem, , Belgium

Site Status

Department of Endocrinology and metabolic diseases, UZ Gent

Ghent, , Belgium

Site Status

Department of Endocrino-Diabetology, Grand Hôpital de Charleroi - site Saint-Joseph

Gilly, , Belgium

Site Status

Department of Endocrinology, UZ Leuven

Leuven, , Belgium

Site Status

Department of Diabetes, Nutrition and Metabolic disorders, CHU de Liège - site du Sart Tilman

Liège, , Belgium

Site Status

Department of Endocrinology, CHR de la Citadelle

Liège, , Belgium

Site Status

Department of internal Medicine, CHU de Charleroi - Hôpital Civil Marie Curie

Lodelinsart, , Belgium

Site Status

Department of Endocrinology, CHR Mons-Hainaut (Warquignies)

Mons, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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SRB2022123

Identifier Type: -

Identifier Source: org_study_id