NCT06154135

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
Last Updated

December 12, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

November 6, 2023

Last Update Submit

December 11, 2023

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Time in range

    Change in the percentage of time spent in range (sensor glucose 70-180 mg/dL) from before start to 12 months after start of the DBLG1 system

    12 months after start

Secondary Outcomes (20)

  • Time in range [exc. primary outcome]

    from before start to 4,8,12 and 24 months after start, with the exclusion of the primary outcome

  • Time in tigh range

    from before start to 4,8,12 and 24 months after start

  • Time in level 2 hypoglycemia

    from before start to 4,8,12 and 24 months after start

  • Time in level 1 hypoglycemia

    from before start to 4,8,12 and 24 months after start

  • Time below range

    from before start to 4,8,12 and 24 months after start

  • +15 more secondary outcomes

Other Outcomes (10)

  • Composite endpoint of HbA1c and Time in Hypoglycemia

    from before start to 4,8,12 and 24 months after start

  • Severe hypoglycemia

    from before start to 4,8,12 and 24 months after start

  • Diabetic ketoacidosis

    from before start to 4,8,12 and 24 months after start

  • +7 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with T1D, aged 18 years and older, who start with the DBLG1 system in Belgium

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Department of Endocrinology, OLVZ Aalst

Aalst, 9300, Belgium

Location

Department of Endocrinology, Imeldaziekenhuis

Bonheiden, 2820, Belgium

Location

Department of Endocrinology, ULB-Hôpital Erasme

Brussels, 1070, Belgium

Location

Department of Endocrinology and Nutrition, Cliniques Universitaires St. Luc

Brussels, 1200, Belgium

Location

Department of Endocrinology, UZ Antwerpen

Edegem, 2650, Belgium

Location

Department of Endocrinology and metabolic diseases, UZ Gent

Ghent, 9000, Belgium

Location

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

Gilly, 6060, Belgium

Location

Department of Endocrinology, UZ Leuven

Leuven, 3000, Belgium

Location

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

Liège, 4000, Belgium

Location

Department of Endocrinology, CHR de la Citadelle

Liège, 4000, Belgium

Location

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

Lodelinsart, 6042, Belgium

Location

Department of Endocrinology, CHR Mons-Hainaut (Warquignies)

Mons, 7000, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Laurent Crenier, PhD

    CUB - Hôpital Erasme

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2023

First Posted

December 1, 2023

Study Start

December 30, 2022

Primary Completion

July 30, 2024

Study Completion

July 30, 2026

Last Updated

December 12, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

The protocol is published online

Shared Documents
STUDY PROTOCOL
Time Frame
Available since May,1 2022
Access Criteria
open access
More information

Locations

BE(12)