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NCT06253351 Clinical Trial

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

Adolescents Clinical Trial

— BFHado  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06253351
Other study ID # 2023/0060
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 13, 2024
Est. completion date December 31, 2024

Study information
Verified date January 2024
Source Centre Hospitalier Sud Francilien
Contact Juliette EROUKHMANOFF, MD
Phone 01 61 69 33 89
Email juliette.eroukhmanoff@chsf.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 15 Years to 25 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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

Locations
Country Name City State
France Centre Hospitalier Sud Francilien Corbeil-essonnes Cedex

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after HCL Comparison of HbA1c (%) before and after HCL (at least 3 months of use) at 3 months
Secondary HbA1c after HCL Comparison of HbA1c (%) before and after HCL (at least 3 months of use) at 6 months
Secondary HbA1c after HCL Comparison of HbA1c (%) before and after HCL (at least 3 months of use) at 12 months
Secondary HbA1c after HCL Comparison of HbA1c (%) before and after HCL (at least 3 months of use) at 24 months
Secondary Use of HCL Percentage of use of HCL at 3 months
Secondary HCL stop number of HCL stop at 3 months
Secondary Glycemic parameters with CGM pourcentage time In Range (TIR) 70-180 mg/dl at 3 months
Secondary Glycemic parameters with CGM pourcentage time Below Range (TBR) < 70 mg/dl at 3 months
Secondary Glycemic parameters with CGM pourcentage Coefficient of Variation (CV) at 3 months
Secondary keto-acidosis and severe hypoglycemia Comparision of keto-acidose and severe hypoglycemia events the year before HCL and after HCL at 3 months
Secondary retinopathy Comparison of retinography results before HCL and after HCL at 3 months
Secondary nephropathy Comparison microalbuminuria/creatininuria dosage the year before HCL and after HCL at 3 months
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