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

C

Centre Hospitalier Sud Francilien

Status

Completed

Conditions

Adolescents
Young Adults
Type1 Diabetes

Treatments

Device: Hybrid closed loop (HCL)

Study type

Observational

Funder types

Other

Identifiers

NCT06253351
2023/0060

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

15 to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

101 participants in 1 patient group

Group1
Description:
Patients between 15 and 25 years old with type 1 diabetes and treated by hybrid closed loop
Treatment:
Device: Hybrid closed loop (HCL)

Trial contacts and locations

1

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Central trial contact

Caroline TOURTE; Juliette EROUKHMANOFF, MD

Data sourced from clinicaltrials.gov

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