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: Completed

Administrative data

• NCT number: NCT06253351
• Other study ID #: 2023/0060
• Status: Completed
• Start date: March 13, 2024
• Est. completion date: May 6, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 101
• Est. completion date: May 6, 2024
• Est. primary completion date: May 6, 2024
• 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

Related Conditions & MeSH terms

• Adolescents
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes
• Young Adults

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