Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes

NCT ID: NCT06253351

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-13
• Study Completion Date: 2024-05-06

Brief Summary

The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.

Detailed Description

Type 1 diabetes (T1D) constitutes a major public health challenge due to acute complications requiring emergency hospitalizations, as well as many chronic complications that need to be managed over the long term. However, these complications can be prevented by maintaining correct glycemic control, according to international guidelines.

For the past few years, the arrival of new technologies as insulin pump and particularly Continuous Glucose Monitoring (CGM) showed a significant improvement on metabolic control.

Nevertheless, adolescents and young adults with type 1 diabetes need a special focus because they still fail to meet glycemic control targets.

At this time, hybrid closed loop, pairing Continuous Glucose Monitoring with insulin pump, enables insulin delivery in a semi-autonomous way thanks to algorithms, and leads to the best metabolic results we've never got in randomized trials and real-world studies.

Conditions

Type1 Diabetes; Adolescents; Young Adults

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group1

Patients between 15 and 25 years old with type 1 diabetes and treated by hybrid closed loop

Hybrid closed loop (HCL)

Intervention Type: DEVICE

• Control IQ : T-Slim pump with Dexcom G6
• Smartguard : Medtronic 780G pump with Guardian G4S
• Diabeloop : Kaliedo pump with Dexcom G6

Interventions

Hybrid closed loop (HCL)

• Control IQ : T-Slim pump with Dexcom G6
• Smartguard : Medtronic 780G pump with Guardian G4S
• Diabeloop : Kaliedo pump with Dexcom G6

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient aged between 15 and 25 years old
• Type 1 diabetes since at least 1 year at the moment of instauring HCL
• At least 3 months of HCL use

Exclusion Criteria

• Informed patient that have been opposed for their data collect

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliette EROUKHMANOFF, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Countries

France

Other Identifiers

2023/0060

Identifier Type: -

Identifier Source: org_study_id