Clinical trial NCT06253351: Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes
Official title: Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1 Diabetes
Adolescents
Young Adults
Keywords: type 1 diabetes
hybrid closed-loop
adolescents
young adults
HbA1c
TIR
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 101
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary care center from Centre Hospitalier Sud Francilien

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.

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

Primary outcomes:
measure: HbA1c after HCL
timeFrame: at 3 months
Secondary outcomes:
measure: HbA1c after HCL
timeFrame: at 6 months
measure: HbA1c after HCL
timeFrame: at 12 months
measure: HbA1c after HCL
timeFrame: at 24 months
measure: Use of HCL
timeFrame: at 3 months
measure: HCL stop
timeFrame: at 3 months
measure: Glycemic parameters with CGM
timeFrame: at 3 months
measure: Glycemic parameters with CGM
timeFrame: at 3 months
measure: Glycemic parameters with CGM
timeFrame: at 3 months
measure: keto-acidosis and severe hypoglycemia
timeFrame: at 3 months
measure: retinopathy
timeFrame: at 3 months
measure: nephropathy
timeFrame: at 3 months
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Juliette EROUKHMANOFF, MD
role: PRINCIPAL_INVESTIGATOR
References: